Key Benefits:
The Prime Minister,
On the report of the Minister of Labour, Solidarity and Public Service and the Minister of Health and Sports,
Considering the code of social action and families;
Vu le general code of territorial authoritiesincluding articles R. 2213-1-3, R. 2213-1-4 and R. 4422-33;
Considering the code of entry and residence of foreigners and the right to asylum;
Considering the environmental code;
Vu le code of mutualityincluding article R. 421-3;
Considering the rural code;
Vu le Public Health Code ;
Vu le Social Security Code ;
Vu le Labour codeincluding its article R. 6341-32;
Vu le Tourism codeincluding articles R. 412-15 and R. 412-16;
Considering the urban planning code, including its article R. 121-15;
Vu la Act No. 64-1246 of 16 December 1964 amended to combat mosquitoes;
Vu la Act No. 79-587 of 11 July 1979 amended on the motivation of administrative acts and the improvement of relations between the administration and the public;
Vu la Act No. 2000-321 of 12 April 2000 amended on the rights of citizens in their relations with administrations;
Vu la Act No. 2009-879 of 21 July 2009 amended to reform the hospital and to deal with patients, health and territories;
See?Order No. 2010-49 of 13 January 2010 relating to medical biology;
Vu le Decree No. 86-442 of 14 March 1986 relating to the designation of registered physicians, the organization of medical committees and reform committees, the conditions of physical fitness for admission to public employment and the sick leave regime of public servants, following the installation of departmental directorates responsible for social cohesion, including articles 1 and 6;
Vu le Decree No. 88-321 of 7 April 1988 establishing the organization of the third cycle of medical studies;
Vu le Decree No. 88-996 of 19 October 1988 relating to specialized studies of the third cycle of pharmacy;
Vu le Decree No. 89-697 of 1 September 1989 relating to the accreditation of trainers services and the distribution of interns positions under the third cycle of medical biology;
Vu le Decree No. 90-97 of 25 January 1990 establishing the conditions for access to specialized training in the third cycle of medical studies for foreign physicians other than State nationals belonging to the European Communities or the Principality of Andorra, including Article 5;
Vu le Decree No. 90-949 of 26 October 1990 having special status of the midwives school directors of the hospital public service, including Article 4;
Vu le Decree No. 94-735 of 19 August 1994 relating to the competition and educational program of the boarding school in odontology, including its article 10;
Vu le Decree No. 95-589 of 6 May 1995 amended on the application of the decree of 18 April 1939 establishing the regime of war materials, weapons and ammunition, including articles 41 and 47-2;
Vu le Decree No. 2003-655 of 18 July 2003 relating to local and departmental administrative boards of the hospital public service;
Vu le Decree No. 2003-1010 of 22 October 2003 relating to the budgetary, accounting and financial management, and to the financing and pricing of social and medico-social institutions and services referred to in I of Article L. 312-1 of the Code of Social Action and Families, and of the institutions referred to in 2° of Article L. 6111-2 of the Public Health Code ;
Vu le Decree No. 2004-67 of 16 January 2004 the organization of the third cycle of medical studies;
Vu le Decree No. 2004-1463 of 23 December 2004 amended on judicial experts;
Vu le Decree No. 2006-672 of 8 June 2006 the establishment, composition and functioning of the administrative commissions of an advisory nature;
Vu le Decree No. 2007-435 of 25 March 2007 relating to acts and conditions of exercise of osteopathy;
Vu le Decree No. 2007-906 of 15 May 2007 the allocation of stewardship and the transfer of tobacco flows;
Vu le Decree No. 2007-1073 of 4 July 2007 Publication of the International Health Regulations (2005) adopted by the fifty-eighth World Health Assembly on 23 May 2005;
Vu le Decree No. 2007-1429 of 3 October 2007 related to the profession of genetic advisor and amending Public Health Codein particular its article 2;
Vu le Decree No. 2008-1500 of 30 December 2008 the financial and budgetary regulation of social and mediocial institutions and services;
Vu le Decree No. 2009-1026 of 25 August 2009 relating to the medical care of the State of the pharmaceutical and nursing costs necessary for persons in custody;
Considering the opinion of the Central Board of Directors of the Agricultural Social Mutuality dated 9 March 2010;
Having regard to the advice of the Board of the National Health Insurance Fund of Employees dated 11 March 2010;
Considering the opinion of the interdepartmental water mission of 12 March 2010;
Considering the opinion of the nuclear safety authority dated 16 March 2010;
Considering the opinion of the High Council of Public Health of 17 March 2010;
Having regard to the advice of the Board of Directors of the National Old Age Insurance Fund of Employees dated 17 March 2010;
Considering the referral of the Industrial Accidents and Occupational Diseases Board of the National Health Insurance Fund of Employee Workers dated 26 February 2010;
Having regard to the referral of the Board of the National Health Insurance Union dated 26 February 2010;
The State Council (Social Section) heard,
Decrete:
Section 2 of Chapter II of Book I is amended to read:
1° In R. 1112-12, the words: "Director of the Regional Hospitalization Agency" are replaced by the words: "Director General of the Regional Health Agency";
2° In sections R. 1112-21, R. 1112-23 and R. 1112-31, the words "or in a hospital structure referred to in Article L. 6146-10" are deleted;
3° In sections R. 1112-22, the words: "or a hospital structure referred to in article L. 6146-10" are deleted;
4° In articles R. 1112-22 and R. 1112-31, the word "or" is inserted after the words "special diet";
5° In R. 1112-67, the words: "administrative board" are replaced by the words: "monitor board" and the words: "leaders of regional hospitalization agencies" are replaced by the words "general directors of regional health agencies".
Section 3 of Chapter II of Book I is amended to read:
1° In R. 1112-80, the words: "the regional agency for hospitalization" are replaced by the words: "the regional health agency" and, in the last paragraph, the words: "to the regional health council" are replaced by the words: "at the regional conference of health and autonomy";
2° In R. 1112-81, the words: "Director of the Regional Hospitalization Agency" are replaced by the words: "Director General of the Regional Health Agency" and the words: "Administrative Board" are replaced by the words: "Guide Board";
3° In R. 1112-82, the words: "Director of the Regional Hospitalization Agency" are replaced by the words: "Director General of the Regional Health Agency";
4° Article R. 1112-83 is as follows:
"Art. R. 1112-83. - User representatives and their alternates are designated by the Director General of the Regional Health Agency among the persons proposed by the associations approved under Article L. 1114-1.
"However, when persons serving as representatives of the users on the supervisory board or the department authorized to do so in the institution concerned ask to sit in that capacity in the commission, the director general of the agency is exempt from soliciting such proposals. » ;
5° In R. 1112-84, the words: "Director of the Regional Hospitalization Agency" are replaced by the words: "Director General of the Regional Health Agency".
Section 3 of chapter IV of title I of Book I is amended to read:
1° In R. 1114-9, the word "prefect" is replaced by the words "Director General of the Regional Health Agency";
2° In article R. 1114-10, the words "regional prefect" are replaced by the words "general director of the regional health agency".
Section 4 of Chapter I of Book I title II is amended to read:
1° In the article R. 1121-13, the words "prefect of the region or, in Corsica, in the prefect of Corsica" are replaced by the words "Director General of the Regional Health Agency";
2° In the first paragraph of section R. 1121-14, after the words: "Public Health Inspector" are inserted the words: "or an inspector of the regional health agency with the quality of a doctor" and after the words: "Pharmacist public health inspector" are added the words: "or an inspector of the regional health agency with the quality of pharmacist".
Section 1 of Chapter III of Title II of Book I is amended as follows:
1° Article R. 1123-1 is as follows:
"Art.R. 1123-1.-The approval of a committee is issued by the Minister for Health on the proposal of the Director General of the regional health agency of the region concerned. The application for approval refers to the address of the committee's head office and is accompanied by a forecast budget and, for renewal applications, an activity report for the period since the previous approval. The contents of the forecast budget and the activity report are determined by order of the Minister for Health. Licence renewal applications are received no later than three months prior to the expiry of the current licence.
"The licence is issued for a period of six years. The decision making the approval determines the territorial jurisdiction of the committee. However, the Minister may, without waiting for renewal, change the territorial jurisdiction of a committee, on the proposal of the Director General of the relevant regional health agency.
"Renewal of the accreditation is pronounced in the same forms. » ;
2° In article R. 1123-2, the words "prefect of the region or, in Corsica, the prefect of Corsica" are replaced by the words: "Director General of the Regional Health Agency";
3° In the article R. 1123-3, the words "prefect of the region or, in Corsica, the prefect of Corsica" and the words "prefect of the region or, in Corsica, the prefect of Corsica" are replaced by the words "Director General of the Regional Health Agency";
4° In articles R. 1123-6, R. 1123-9, R. 1123-13 and R. 1123-15, the words "regional prefect or, in Corsica, the prefect of Corsica" are replaced by the words "general director of the regional health agency";
5° Section R. 1123-17 is amended as follows:
(a) The words: "either within the regional management of health and social affairs, or in a departmental direction of health and social affairs, or" are deleted;
(b) The words: "prefect of the region or, in Corsica, the prefect of Corsica" are replaced by the words: "Director General of the Regional Health Agency";
6° In the article R. 1123-19, the words "prefect of the region or, in Corsica, the prefect of Corsica" and the words "prefect of the region or, in Corsica, the prefect of Corsica" are replaced by the words "Director General of the Regional Health Agency".
Section 1 of Chapter I of Title III of Book I is amended as follows:
1° To articles R. 1131-10 and R. 1131-11, the words "regional agency for hospitalization" are replaced by the words "regional health agency";
2° In R. 1131-14, the words: "the executive commission of the regional hospitalization agency" are replaced by the words: "the director general of the regional health agency";
3° Section R. 1131-15 is amended as follows:
(a) In the first paragraph, the words: "from the regional committee of the health organization, the regional agency of hospitalization" are replaced by the words: "from the specialized commission of the regional conference of health and self-government competent for the health sector, the regional health agency";
(b) The words: "Director of the Regional Hospitalization Agency" are replaced by the words: "Director General of the Regional Health Agency";
4° In R. 1131-17, the words: "Director of the Regional Hospitalization Agency" are replaced by the words: "Director General of the Regional Health Agency";
5° In R. 1131-18, the words "regional agency for hospitalization" are replaced by the words "regional health agency".
In R. 1131-23, the words "regional agency for hospitalization" are replaced by the words "regional health agency".
In R. 1142-47, the words: "Director of the Regional Hospitalization Agency" are replaced by the words: "Director General of the Regional Health Agency".
Section 3 of the Single Chapter of Book II title I is amended as follows:
1° In article R. 1211-32, the words "under articles L. 6132-2 and L. 6133-1" are deleted;
2° In the j of the 2nd article R. 1211-38, after the words: "a doctor or pharmacist public health inspector" are inserted the words: "or an inspector of a regional health agency having the quality of a doctor or pharmacist".
Section 3 of chapter I of Book II title II:
1° In R. 1221-18, the words: "to the regional prefect and the regional agency for hospitalization" are replaced by the words: "to the director general of the regional health agency";
2° In article D. 1221-20, the words "regional agency for hospitalization" are replaced by the words "regional health agency";
3° In R. 1221-20-1, the words "health organization" are replaced by the words "care organization";
4° In R. 1221-20-2, the words: "regional agency for hospitalization" are replaced by the words: "regional health agency";
5° In sections R. 1221-20-3 and R. 1221-20-4, the words: "Regional Hospitalization Agency" are replaced by the words: "Regional Health Agency" and the words: "Director of the Regional Hospitalization Agency" are replaced by the words: "Director General of the Regional Health Agency";
6° In R. 1221-20-5, the words: "Director of the Regional Hospitalization Agency" are replaced by the words: "Director General of the Regional Health Agency";
7° In sections D. 1221-20-6 and D. 1221-20-7, the words "regional agency for hospitalization" are replaced by the words "regional health agency".
Section 4 of chapter I of Book II title II:
1° In article R. 1221-24, the words "under articles L. 6132-2 and L. 6133-1" are deleted;
2° In the seventeenth paragraph of section R. 1221-30, after the words: "physicist or pharmacist public health inspector" are inserted the words: "or an inspector of a regional health agency with the quality of a doctor or pharmacist";
3° Article R. 1221-32 is as follows:
"Art. R. 1221-32. - In each region, a Hemovigilance Coordinator placed with the Director General of the Regional Health Agency is responsible for:
« 1° To monitor the implementation by health and blood transfusion institutions in the region of the provisions of this section and, where appropriate, the decisions of the Director General of the French Health Safety Agency for Health Products and the actions undertaken by the Transfusion Safety and Hemovigilance Committees of the institutions;
« 2° To maintain direct relations with each of the region's hemovigilance correspondents, to ensure with them the quality and reliability of the information collected under articles R. 1221-39 and R. 1221-43 and to keep informed of any difficulties that the correspondents would encounter in carrying out their mission;
« 3° To inform the Director General of the Regional Health Agency and the Director General of the French Health Safety Agency of its activity, including an annual report of activity, which he sends a copy to the French Blood Establishment;
« 4° To propose, where appropriate, to the French Health Product Safety Agency under cover of the Director General of the Regional Health Agency, the adoption of any measures that could improve the quality, reliability and consistency of the hemovigilance device;
« 5° To promptly refer the Director General of the Regional Health Agency and the Director General of the French Health Safety Agency to any difficulty that could jeopardize transfusion security and simultaneously inform the French Blood Establishment;
« 6° To propose, where appropriate, to the Director General of the Regional Health Agency the measures to be taken in the light of the fact sheets received under section R. 1221-50. » ;
4° In R. 1221-33, the words: "Regional Prefect" are replaced by the words: "Director General of the Regional Health Agency";
5° In article R. 1221-35, the words: "arrest of the prefect of the region taken" are replaced by the words: "Decision of the director general of the regional health agency taken";
6° In article R. 1221-40, the words "under articles L. 6132-2 and L. 6133-1" are deleted;
7° In R. 1221-44, the words "under Article L. 6133-1" and the words "under Article L. 6132-2" are deleted;
8° In R. 1221-47, the words: "Director of the regional hospitalization agency and the department's prefect" are replaced by the words: "and the Director General of the regional health agency".
At the 6th of R. 1223-1, the words: "Regional union of caisses" are replaced by the words: "the primary body in the spring of which the headquarters of the establishment is located".
Section 3 of Chapter III of Book II is amended to read:
1° In R. 1223-15, the words: "the department's prefect" are replaced by the words: "the director general of the regional health agency" and the words: "the department" are replaced by the words: "the region";
2° In article R. 1223-16, the words "prefect of the department" are replaced by the words: "Director General of the Regional Health Agency";
3° In article R. 1223-17, the word "prefectural" is deleted;
4° In R. 1223-19, the words: "prefect of the department" are replaced by the words: "Director General of the Regional Health Agency".
In sections R. 1224-3 and R. 1224-4, the words "hospitalization" are replaced by the words "health".
In R. 1231-7, the words "the departmental or regional directorate of health and social affairs" are replaced by the words "the regional health agency".
In articles R. 1232-5, R. 1232-7, R. 1232-12, R. 1232-13 and R. 1232-14, the words: "French grafting" are replaced by the words: "Biomedicine Agency".
Section 1 of Chapter III of Title III of Book II is thus amended:
1° In article R. 1233-2, the words: "the director of the regional agency for hospitalization, acting on behalf of the State" are replaced by the words: "the director general of the regional health agency";
2° In R. 1233-4, the words: "Director of the Regional Hospitalization Agency" are replaced by the words: "Director General of the Regional Health Agency";
3° Article R. 1233-5 is as follows:
"Art. R. 1233-5. - The application for authorization or renewal of the authorization shall be sent in five copies, subject to a recommendation with a request for notice of receipt, to the Director General of the Regional Health Agency. It may also be filed against receipt. The application for renewal of the authorization is addressed to the Director General of the Regional Health Agency seven months before the expiry date of the authorization.
"The application for authorization or renewal of authorization is only instructed and forwarded to the Director General of the Biomedicine Agency for advice if it is accompanied by a complete record, the model of which is defined by order of the Minister for Health; This record must include information on the organization of the sampling activity and disclose the applicant's commitments with respect to the staffing and qualification of the required personnel.
"The file is deemed to be complete if, within one month of its receipt, the Director General of the Regional Health Agency did not notify the applicant, by registered letter with a request for notice of receipt, of the missing or incomplete items.
"The absence of a response from the Director General of the biomedicine agency within three months is a favourable opinion.
"For the purposes of the instruction, the Director General of the Regional Health Agency may conduct or conduct any investigation and request any additional documentation. » ;
4° Article R. 1233-6 is as follows:
"Art. R. 1233-6. - The Director General of the Regional Health Agency shall notify the applicant within six months of the date on which the complete file was transmitted. The absence of a decision within this period is a rejection of the application for authorization.
"The Director General of the Regional Health Agency prepares and maintains a list of authorized health facilities in the region; It transmits it to the Minister for Health and the Director General of the Biomedicine Agency. »
In R. 1233-10, the words: "Director of the Regional Hospitalization Agency" are replaced by the words: "Director General of the Regional Health Agency".
In R. 1233-12, the words "of the department's prefect and the director of the regional hospitalization agency" are replaced by the words "of the director general of the regional health agency".
In R. 1235-6, the words: "Director of the Regional Hospitalization Agency" are replaced by the words: "Director General of the Regional Health Agency".
In R. 1235-12, the words: "Director of the Regional Hospitalization Agency" are replaced by the words: "Director General of the Regional Health Agency".
In R. 1242-5, the words: "Director of the Regional Hospitalization Agency" are replaced by the words: "Director General of the Regional Health Agency".
In R. 1242-14, the words "of the department's prefect and the director of the regional hospitalization agency" are replaced by the words "of the director general of the regional health agency".
Section 1 of Chapter III of Title IV of Book II is amended as follows:
1° In the article R. 1243-4, the words: "Directors of the Regional Hospitalization Agency" are replaced by the words: "Directors General of Regional Health Agencies" and the words: "Regional Hospitalization Agency" are replaced by the words: "Regional Health Agency";
2° In R. 1243-6, the words: "Director of the Regional Hospitalization Agency" are replaced by the words: "Director General of the Regional Health Agency";
3° In R. 1243-7, the words: "Directors of the Regional Hospitalization Agencies" are replaced by the words: "Directors General of the Regional Health Agencies".
In sections R. 1243-22 and R. 1243-32, the words: "Director of the regional hospitalization agency" are replaced by the words: "Director General of the Regional Health Agency".
In sections R. 1243-51 to R. 1243-58, R. 1243-63 to R. 1243-67, R. 1243-69 to R. 1243-71 and R. 1243-73, the words: "Director of the regional hospitalization agency" are replaced by the words: "Director General of the Regional Health Agency".
In R. 1245-17, the words: "Director of the Regional Hospitalization Agency" are replaced by the words: "Director General of the Regional Health Agency".
In R. 1245-21, the words: "Director of the Regional Hospitalization Agency" are replaced by the words: "Director General of the Regional Health Agency".
At the beginning of Title I of Book III of Part I, a preliminary chapter is inserted as follows:
“Preliminary Chapter
“National Prevention Plan
environmental health risks
"Art. R. 1310-1. - The regional prefect establishes the necessary provisions for the implementation of the national plan for the prevention of environmental health risks following a review of the agreed proposals of the Director General of the regional health agency and the Regional Director of Environment, Planning and Housing. With respect to the competences of the regional health agency defined in articles L. 1431-1 and L. 1431-2, the project decided by the prefect of the region resumes the actions defined by the director general of the regional health agency. »
Section 1 of Chapter I of Book III title I is amended as follows:
1° In article R. 1311-2, the words "prefect of the department" are replaced by the words: "Director General of the competent regional health agency for the";
2° In article R. 1311-3, the words: "State representative in the region" are replaced by the words: "Director General of the Regional Health Agency".
Section 1 of Chapter II of Book III title I is amended as follows:
1° Article R. 1312-1 is as follows:
"Art. R. 1312-1. - may be empowered, within the limits of their respective jurisdictions, to observe the offences referred to in article L. 1312-1, in addition to the agents mentioned in articles L. 1421-1 and L. 1435-7, territorial physicians, territorial engineers, territorial superior technicians and territorial inspectors of work performing their duties in the communes or in community groups referred to in article L. 1422-1, Paris safety inspectors and
“Also may be authorized to non-owned local authorities who have been performing administrative and technical functions similar to those performed by officials mentioned in the first paragraph for more than six months. » ;
2° Article R. 1312-2 is as follows:
"Art. R. 1312-2. - The officers referred to in article R. 1312-1 shall be authorized by a name order of the following authorities:
« 1° The department prefect for territorial agents performing their functions in municipalities or community groups;
« 2° The Director General of the Regional Health Agency for officers under his authority;
« 3° The Minister of Health for National Officers. » ;
3° In the first paragraph of R. 1312-3, the words "Territorial Engineers and Technicians" are replaced by the words "Territorial Authorities Officers".
Paragraph 2 of sub-section 1 of chapter I, section 1, of title II of Book III is amended as follows:
1° At 5° of article R. 1321-6, the word "prefect" is replaced by the words "Director General of the Regional Health Agency";
2° In the first paragraph of article R. 1321-7, after the word "synthesis" are inserted the words "established by the Director General of the Regional Health Agency";
3° At the beginning of the 2nd of R. 1321-9, the words are inserted: "A report of the Director General of the Regional Health Agency states that";
4° In the first paragraph of Article R. 1321-10, the words: "the prefect" are replaced by the words: "the director general of the regional health agency shall perform";
5° In the first paragraph of article R. 1321-12, after the word "initiative", the words are inserted: "on the proposal of the Director General of the Regional Health Agency";
6° In R. 1321-14, the words: "Regional Prefect" are replaced by the words: "Director General of the Regional Health Agency".
Paragraph 3 of sub-section 1 of chapter I, section 1, of title II of Book III is amended as follows:
1° In R. 1321-15, the words: "the prefect" are replaced by the words: "the regional health agency", in the first paragraph, and the words: "an order of the prefect" are replaced by the words: "the decision of the director general of the regional health agency", in the seventh paragraph;
2° Article R. 1321-16 is as follows:
"Art. R. 1321-16. - The water sample analysis program taken from the production and distribution facilities may be modified by the Director General of the Regional Health Agency, at his initiative or at the request of the Prefect, and in accordance with the terms and conditions set out in the Ministerial Order referred to in R. 1321-15, if the conditions for the protection of the water capture and operation of the facilities, the audits carried out and the quality of the water. » ;
3° In the first paragraph of R. 1321-17, the words: "The Prefect may impose on" are replaced by the words: "The Director General of the Regional Health Agency may, at his initiative or at the request of the Prefect, carry out the duties of";
4° In article R. 1321-18, after the word: "prefect" are inserted the words: "or, for sanitary and medical facilities, the director general of the regional health agency";
5° In the first paragraph of article R. 1321-19, the words: "the departmental management of health and social affairs" are replaced by the words: "the regional health agency or by" and the end of the sentence is deleted after the mention of article R*. 1321-21;
6° In R. 1321-22, the words: "to the Prefect" are replaced by the words: "to the Director General of the Regional Health Agency who transmits them to the Prefect with his observations";
7° The seventh paragraph of Article R. 1321-23 is supplemented by the following sentence: "The Prefect shall communicate this information to the Director General of the Regional Health Agency. » ;
8° The eleventh paragraph of article R. 1321-24 is as follows:
"The results of these monitoring analyses are transmitted at least once a month to the Director General of the Regional Health Agency who communicates them to the Prefect with his observations. » ;
9° Article R. 1321-25 is as follows:
"Art. R. 1321-25. - The person responsible for water production or distribution shall make available to the Director General of the Regional Health Agency the results of water quality monitoring and any information related to that quality. It brings to its knowledge any incident that may have consequences for public health.
"The person responsible for the production or distribution of water shall, each year, address to the Director General of the Regional Health Agency, for the production facilities and water distribution units serving a population of more than 3,500 inhabitants, a balance sheet of operation of the production and distribution system, including the monitoring program defined in section R. 1321-23 and the work carried out and shall indicate, for the following year, any changes to this program. The director general of the agency transmits this report to the prefect with his observations. »
Paragraph 4 of sub-section 1 of chapter I, section 1, of title II of Book III is amended as follows:
1° In sections R. 1321-26 to R. 1321-29, the words: "the territorially competent prefect" are replaced by the words: "the Director General of the Regional Health Agency, who transmits this information to the territorially competent prefect";
2° In the first sentence of article R. 1321-28 and in the first paragraph of article R. 1321-29 after the word: "prefect" are inserted the words: ", on the report of the Director General of the Regional Health Agency",
3° In the first paragraph of article R. 1321-29, after the word: "estimate" are inserted the words: ", on the report of the Director General of the Regional Health Agency,"
4° In the second paragraph of article R. 1321-31, after the word "derogation" are inserted the words ", on the report of the Director General of the Regional Health Agency" and at the beginning of the 1st of this article are inserted the words; "The report of the Director General of the Regional Health Agency states that";
5° In the first paragraph of article R. 1321-32 and in the first sentence of article R. 1321-33, after the word: "prefect" are inserted the words: ", on the report of the Director General of the Regional Health Agency",
6° In R. 1321-35, the words: "to the Prefect" are replaced by the words: "to the Director General of the Regional Health Agency who communicates it to the Prefect with his observations";
7° In R. 1321-36, the words "advices" are replaced by the words "advices developed by the Director General of the Regional Health Agency".
In the first paragraph of section R. 1321-40, after the word: "prefect" are inserted the words: ", after verification by the Director General of the Regional Health Agency that the decision will not have consequences contrary to the health of persons," and the last paragraph is deleted.
In R. 1321-47, after the words "insurance" are inserted the words "with the assistance of the Director General of the Regional Health Agency".
In the third paragraph of R. 1321-56, the word "prefect" is replaced by the words "Director General of the Regional Health Agency".
Section 4 of chapter I of Book III title II is amended to read:
1° Section D. 1321-103 is amended as follows:
(a) In the second paragraph, the words: "State Service for Administrative and Technical Control of Hygiene Rules" are replaced by the words: "Director General of the Regional Health Agency";
(b) In the third paragraph, the words "this service" are replaced by the words "the director general of the agency";
2° In the second paragraph of Article D. 1321-104, after the words: "Annual synthesis" are inserted the words "of the Director General of the Regional Health Agency".
Paragraph 1 of sub-section 1 of chapter II, section 2, of title II of Book III is amended as follows:
1° Article R. 1322-5 is amended as follows:
(a) The 4th is repealed;
(b) At 5°, the word "prefect" is replaced by the words "Director General of the Regional Health Agency";
2° In the first paragraph of article R. 1322-6, after the word "synthesis" are inserted the words "established by the Director General of the Regional Health Agency";
3° Section R. 1322-7 is amended as follows:
(a) The first preambular paragraph shall be replaced by a subparagraph to read:
"When it is planned to use water for therapeutic purposes in a thermal institution or when the applicant wishes to report positive effects on the health of a water intended for the conditioning or distribution in public drinking water, and subject to the favourable opinion of the departmental environmental council and health and technological risks on the request for authorization to exploit the mineral water source, the file referred to in section 5 is completed. » ;
(b) In the second paragraph, the words: "completed clinical and therapeutic studies" are deleted;
(c) In the third paragraph, after the words: "to the Prefect" are inserted the words: "and to the Director General of the Health Agency";
4° In R. 1322-9, the words: "the prefect performs" are replaced by the words: "the prefect conducts by the regional health agency" and the last two paragraphs are replaced by the following:
"When the results of the analyses and schooling are in compliance, the prefect informs the licensee of the authorization, which can then ensure the distribution of water to the public. Otherwise, the prefect's refusal is motivated. The distribution of water is delayed until a new audit, conducted under the above conditions, found compliance.
"In all cases, the report of the regional health agency is forwarded to the licensee. »
In the first paragraph of article R. 1322-14, after the word: "initiative" are inserted the words: ", on the proposal of the Director General of the Regional Health Agency,".
Paragraph 2 of sub-section 2 of chapter II, section 2, of title II of Book III is amended as follows:
1° At 2° of article R. 1322-17, the word "prefect" is replaced by the words "Director General of the Regional Health Agency" in the fifth and seventh paragraphs;
2°In the first paragraph of section R. 1322-20, the words: "the prefect establishes a report" are replaced by the words: "the prefect entrusts the report to the director general of the regional health agency."
Paragraph 3 of sub-section 2 of chapter II, section 2, of title II of Book III is amended as follows:
1° In the first paragraph of Article R. 1322-23, after the word: "protection" are inserted the words: "and the request for occupation of a land provided for in Article L. 1322-10" and the words: "is addressed" are replaced by the words: "are addressed";
2° In section R. 1322-24, after the word "synthesis" are inserted the words "established by the Director General of the Regional Health Agency" and the second paragraph is supplemented by the following provisions: "The same applies to the owner of the land whose occupation is requested under section L. 1322-10. » ;
3° In R. 1322-25, after the words: "to this effect" are inserted the words: "by the Director General of the Regional Health Agency".
In R. 1322-30 the word "prefect" is replaced by the words: "Director General of the Regional Health Agency", the words "governments" are deleted and the first paragraph is supplemented by the following provisions: "The Director General transmits this report to the Prefect with his observations".
Sub-section 4 of chapter II, section 2 of Book III title II is amended to read:
1° Article R. 1322-40, the word "prefect" is replaced by the words "Director General of the Regional Health Agency";
2° In the second paragraph of article R. 1322-41, the words: "prefect order" are replaced by the words: "decision of the Director General of the Regional Health Agency";
3° In R. 1322-42, after the words: "the prefect may impose on the operator" are inserted the words: "on the proposal of the Director General of the Regional Health Agency";
4° The last paragraph of article R. 1322-44 is as follows:
"The results of these monitoring analyses are transmitted to the Director General of the Regional Health Agency who communicates them to the Prefect with his observations. » ;
5° In article R. 1322-44-1, after the words: "to the knowledge of" are inserted the words: "Director General of the Regional Health Agency, who immediately informs him";
6° In R. 1322-44-2, the words "prefect" are replaced by the words "regional health agency", in the first paragraph, and by the words "services of the agency", in the second paragraph;
7° In R. 1322-44-4, the word "prefect" is replaced by the words "Director General of the Regional Health Agency" and the following sentence is added: "The Director General of the Agency shall transmit to the prefect a synthesis of these results. »
Sub-section 5 of chapter II, section 2 of Book III title II is amended to read:
1° The 1° of the article R. 1322-44-6 is thus written:
« 1° Immediately inform the Director General of the regional health agency that transmits information to the Prefect; »
2° The 4th of the same article is thus written:
« 4° To inform the Director General of the agency of the measures taken to remove the cause of the overtaking of quality limits. The Director General shall transmit this information to the Prefect with his comments. » ;
3° In R. 1322-44-8, after the word "estimates" are inserted the words ", on the report of the Director General of the Regional Health Agency,".
Section 5 of chapter II of Book III title II is amended as follows:
1° In R. 1322-45, the words: "The Departmental Public Health Inspector" are replaced by the words: "The public health inspectors and the inspectors of the regional health agency who have the status of a doctor exercise";
2° In R. 1322-51, the words: "to the Prefect" are replaced by the words: "to the Director General of the Regional Health Agency" and the words: "by the Prefect" are replaced by the words: "by the Director General of the Agency to the Prefect and".
Section 1 of Chapter II of Title III of Book III is amended as follows:
1° In article D. 1332-4, the words: "Departmental Director of Health and Social Affairs" are replaced by the words: "Director General of the Regional Health Agency";
2° In article D. 1332-12, the words: "the departmental management of health and social affairs" are replaced by the words: "the regional health agency";
3° In article D. 1332-13, after the word: "prefect" are inserted the words: ", on the report of the Director General of the Regional Health Agency,".
Section 2 of chapter II of title III of Book III is amended as follows:
1° In the first paragraph of article D. 1332-18, after the word "prefect" are inserted the words "and to the Director General of the Regional Health Agency";
2° In sections D. 1332-21 to D. 1332-23, the word "prefect" is replaced by the words: "Director General of the Regional Health Agency. » ;
3° In article D. 1332-24, the words: "prefect" are replaced by the words: "Director General of the Regional Health Agency" and the words: "the Departmental Directorate of Health and Social Affairs" are replaced by the words: "the Regional Health Agency";
4° In article D. 1332-25, the word "prefect" is replaced by the words "Director General of the Regional Health Agency" and is added a paragraph as follows:
"The Director General of the Regional Health Agency shall transmit to the Prefect the information that he receives under this section, together with his observations. » ;
5° In article D. 1332-27, D. 1332-28 and D. 1332-29 the word "prefect" is replaced by the words "Director General of the Regional Health Agency";
6° Article D. 1332-30 is supplemented by the words: "and to the Director General of the Regional Health Agency";
7° Section D. 1332-31 is supplemented by the following provisions: "The Director General of the Regional Health Agency shall transmit to the Prefect the information he receives under these articles, together with his observations. » ;
8° In R. 1332-33, the word "prefect" is replaced by the words "Director General of the Regional Health Agency";
9° In article D. 1332-36, the words: "the prefect" are replaced by the words: "the director general of the regional health agency, who informs the prefect,"
10° In article D. 1332-38, the word "prefect" is replaced by the words "Director General of the Regional Health Agency" and the words "of his department" are replaced by the words "of his jurisdiction".
In R. 1333-91, after the word "guardianship" are inserted the words ", by the regional health agency".
Section 7 of Chapter III of Book III is amended to read as follows:
1° In the second paragraph of article R. 1333-96, the words "and the prefect" are replaced by the words ", to the prefect and, for health institutions and health-care agencies, to the Director General of the Regional Health Agency";
2° Article R. 1333-110 is supplemented by a paragraph as follows:
"When the loss or the flight involves a health care institution or a health service organization, the statement must also be addressed to the Director General of the regional health agency. »
Section 1 of chapter IV of title III of Book III is amended as follows:
1° In R. 1334-2, the word "prefect" is replaced by the words "Director General of the Regional Health Agency";
2° Article R. 1334-9 is as follows:
"Art. R. 1334-9. - The approval referred to in the last paragraph of Article L. 1334-1 for diagnostic and control activities shall be issued by the Director General of the Regional Health Agency in the light of the applicant's expertise in the use of lead measuring devices in coatings and in the sampling of scales and dust. When the purpose of the accreditation is to conduct diagnostics, the applicant must also meet the conditions set out in Article L. 271-6 of the Construction and Housing Code and the texts taken for its application.
"The approval referred to in the last paragraph of Article L. 1334-4 for the conduct of work is granted by the prefect in the light of the applicant's competence in the conduct of work, mastery of work or assistance in the mastery of work, rehabilitation work in the presence of paints containing lead and conduct of such work in occupied premises. » ;
3° In R. 1334-10, the word "prefect" is replaced by the words "Director General of the Regional Health Agency";
4° In the second paragraph of article R. 1334-12, the words "in article L. 1421-1" are replaced by the words "in articles L. 1421-1 and L. 1435-7".
In the first paragraph of article R. 1334-28, the words "in article L. 1421-1" are replaced by the words "in articles L. 1421-1 and L. 1435-7".
Article R. 1335-13 is as follows:
"Art.R. 1335-13.-The persons referred to in Article R. 1335-2 shall be made available to the competent supervisory officers, including officers referred to in Articles L. 1421-1 and L. 1435-7, the convention and follow-up documents referred to in Articles R. 1335-3 and R. 1335-4. »
In the third paragraph of section R. 1341-7, the words "regional health insurance funds" are replaced by the words "retirement and occupational health insurance funds".
In the twenty-first paragraph of Article D. 1411-37, the words: "every regional or territorial health conferences" are replaced by the words: "every regional health and autonomy conferences".
Section D. 1415-1-8 is amended to read:
1° At 1°, the words: "as well as regional agencies of hospitality and regional groups of public health" are replaced by the words: "in particular regional health agencies";
2° At 2°, the words: "Regional Hospitalization Agencies, Regional Health Insurance Unions, Regional Public Health Groups" are replaced by the words "Primary Health Insurance Funds".
I. ― Section 2 of chapter VI of Book IV title I is amended as follows:
1° Section R. 1416-17 is amended as follows:
(a) The 1° is replaced by the following:
« 1° Six representatives of state services;
"1° bis The Director General of the Regional Health Agency or his representative; »
(b) The article is supplemented by a paragraph to read:
"In case of equal sharing of votes, the President's voice is preponderant. » ;
2° 1° of article R. 1416-20 is thus written:
« 1° Two representatives of the state services and the Director General of the regional health agency or its representative; "
II. – The provisions of I come into force on May 1, 2010.
The single section of chapter VIII of Book IV title I is amended as follows:
1° In R. 1418-4, the words: "regional hospital agencies" are replaced by the words: "regional health agencies";
2° Section R. 1418-6 is amended as follows:
(a) The m and n of the 1° are deleted;
(b) The o of 1° is replaced by the following:
"(o) Three representatives of regional health agencies, including a doctor; »
(c) In the last paragraph, the words "m to p" are replaced by the words "o and p".
I. ― The beginning of the 10th article of R. 1421-1 is as follows:
« 10° She participates in the National Steering Board of Regional Health Agencies. It ensures the guardianship of other public institutions (the rest without change);
II. ― Book IV is supplemented by a title IV entitled "Council and Commissions" with a chapter I entitled "Rules deontologiques" including section R. 1421-2-1, which becomes section R. 1441-1.
Section 3 of chapter I of Book IV title II is amended as follows:
1° In R. 1421-13, the words: "under the authority of the Minister for Health" are replaced by the words: ", in regional health agencies,"
2° In the second paragraph of article R. 1421-14, after the word "supply" are inserted the words ", in regional health agencies,"
3° The first paragraph of Article R. 1421-15 is thus written: "The members of the body of the inspection of the health and social action are responsible for the implementation of the health, medical and social policies of the state and regional health agencies".
4° In the second paragraph of article R. 1421-16 after the word: "in particular" are inserted the words: ", in regional health agencies,"
5° In the second paragraph of article R. 1421-17 after the word "participate" are inserted the words ", in regional health agencies,"
6° In the first paragraph of article R. 1421-18, after the word "participate" are inserted the words ", in regional health agencies,".
Section 2 of chapter III of Book IV title II is amended as follows:
1° In R. 1423-16-3, the words: "Departmental and Regional Directorates of Health and Social Affairs" are replaced by the words: "Regional Health Agencies";
2° In R. 1423-16-4, the words: "the departmental management of health and social affairs" are replaced by the words: "the regional health agency".
Are repealed:
1° Articles D. 1321-67 and D. 1321-68;
2° Sub-sections 1 and 2 of chapter I, section 1, of Book IV title I, including sections D. 1411-1 to D. 1411-26 and Annex 14-1;
3° Article D. 1414-49;
4° Section 1 of Chapter VI of Title I of Book IV including articles R. 1416-1 to R. 1416-15;
5° Section 2 of chapter I of Book IV title II including articles R. 1421-3 to R. 1421-12; However, these provisions remain in force in the Ile-de-France region and its departments and in the overseas regions and departments, for missions that are not allocated to regional health agencies.
Book I is thus modified:
1° In R. 2112-10, the word "prefect" is replaced by the words "Director General of the Regional Health Agency";
2° Section R. 2123-2 is amended as follows:
(a) In the fifth paragraph, the words: "Prefect of the Region" are replaced by the words: "the Director General of the Regional Health Agency" and the words: "by the Region Prefect" are deleted;
(b) The sixth preambular paragraph shall be replaced by the following:
"The Director General of the Regional Health Agency designates the members of the committee. » ;
3° In article R. 2123-5, the words: "State" are replaced by the words: "regional health agency" and the words: "Regional management of health and social affairs" are replaced by the words: "The agency".
Section 1 of Chapter I of Title III of Book I is amended as follows:
1° To articles R. 2131-5-1 to R. 2131-5-3, R. 2131-5 and R. 2131-7, the words "regional agency for hospitalization" are replaced by the words "regional health agency";
2° In R. 2131-5-5, the words: "the executive commission" are replaced by the words: "the executive director";
3° In R. 2131-7, the words: "from the regional committee of the health organisation" are replaced by the words: "from the specialized commission of the regional conference of the health and autonomy competent for the health sector", the words: "to the director of" are replaced by the word: "to" and the words: "the director of" are deleted;
4° In R. 2131-8, the words: "Director of the Regional Hospitalization Agency" are replaced by the words: "Director General of the Regional Health Agency".
In sections R. 2131-13 and R. 2131-21, the words "Director of the regional hospitalization agency" are replaced by the words "Director General of the Regional Health Agency".
Section 3 of Chapter I of Title III of Book I is amended as follows:
1° In R. 2131-28, the words: "Director of the Regional Hospitalization Agency" are replaced by the words: "Director General of the Regional Health Agency";
2° In the article R. 2131-32, the words "regional agency for hospitalization" are replaced by the words "regional health agency".
Section 1 of Chapter II of Title IV of Book I is amended as follows:
1° In R. 2142-3, the words: "the executive commission of the regional hospitalization agency" are replaced by the words: "the director general of the regional health agency" and the words: "the regional health organization committee" are replaced by the words: "the specialized commission of the regional health and autonomy conference competent for the health sector";
2° In sections R. 2142-3 and R. 2142-4, the words: "Director of the regional hospitalization agency" are replaced by the words: "Director General of the Regional Health Agency";
3° In articles R. 2142-3 and R. 2142-8, the words "regional agency for hospitalization" are replaced by the words "regional health agency".
In articles R. 2142-10, R. 2142-15 and R. 2142-17, the words "regional agency for hospitalization" are replaced by the words "regional health agency".
In articles R. 2142-19 and R. 2142-20, the words "regional agency for hospitalization" are replaced by the words "regional health agency".
In R. 2142-30, the words "hospitalization" are replaced by the word "health".
The words "public health inspector" are replaced by the words "in office in a regional health agency" in the second part of article D. 2142-45.
Section 1 of Chapter II of Book II title I is amended as follows:
1° At 1° in R. 2212-1, the reference: "L. 2311-2" is replaced by the reference: "L. 2311-1";
2° In R. 2212-2, the words "223-11 and 223-12" are replaced by the words "226-13 and 226-14";
3° In the second paragraph of section R. 2212-3, the words "health" are replaced by the words "social action, a doctor of the regional health agency".
In R. 2222-2, the words "regional public health inspector" are replaced by the words "of the regional health agency designated by the director general of the agency".
In section R. 2311-2, the words "prefecture" are replaced by the words "regional health agency" and the words "of the minister responsible for health" are replaced by the words "deputies responsible for the family and health".
Section 2 of chapter I of Book III title I is amended as follows:
1° In sections R. 2311-9, R. 2311-15, R. 2311-17 and R. 2311-18, the word "prefect" is replaced by the words "Director General of the Regional Health Agency";
2° In sections R. 2311-9 and R. 2311-15, the words ", after the opinion of the departmental doctor of public health," are deleted;
3° In articles R. 2311-13 and R. 2311-20, the words: "State representative" are replaced by the words: "Director General of the Regional Health Agency" and the words: ", after the advice of the regional public health inspector pharmacist or, in Mayotte and Saint-Pierre-et-Miquelon, the pharmacist inspector of public health or, in Saint-Barthélemy and Saint-Martin, the pharmacist pharmacist inspectors
4° In article R. 2311-17, the words ", after notice of the regional inspector pharmacist," are deleted.
In sections R. 2321-2 and R. 2321-3, the words: "Department of Health and Social Affairs" are replaced by the words: "General of the Regional Health Agency".
Section 2 of chapter I of Book III title II is amended as follows:
1° In R. 2321-4, the word "prefect" is replaced by the words: "Director General of the Regional Health Agency after the advice of the Prefect";
2° In R. 2321-7, the words: "submitted to the Departmental Directorate of Health and Social Affairs" are replaced by the words: "to the Director General of the Regional Health Agency";
3° In articles R. 2321-8 and R. 2321-10, the words: "Department of Health and Social Affairs" are replaced by the words: "General of the Regional Health Agency";
4° In R. 2321-9, the words: "Prefect of the host department" are replaced by the words: "Director General of the Regional Health Agency" and the words: "of the department" are replaced by the words: "of the region";
5° In R. 2321-10, the words "prefect on proposal of the Departmental Director of Health and Social Affairs" are replaced by the words "Director General of the Regional Health Agency".
Chapter II of Book III title II is amended as follows:
1° In sections R. 2322-2 to R. 2322-5 and R. 2322-7, the word "prefect" is replaced by the words "Director General of the Regional Health Agency";
2° To articles R. 2322-2 and R. 2322-5, the words "of the department in which" are replaced by the words "of the region in which";
3° In R. 2322-14, the words "regional public health inspector" are replaced by the words "of the regional health agency designated by the director general of the agency".
In R. 2323-2, the word "prefect" is replaced by the words "Director General of the Regional Health Agency" and the words "and the Departmental Inspector of Public Health" are deleted.
Chapter I of Book I, title II, article R. 2212-1 and R. 2323-3 are repealed.
Section 5 of Chapter I of Book I is amended as follows:
1° 1° of Article D. 3111-22 is replaced by the following provisions:
« 1° Health facilities providing one or more of the public service missions defined in Article L. 6112-1; »
2° In sections D. 3111-23, D. 3111-25 and D. 3111-26, the word "prefect" is replaced by the words "Director General of the Regional Health Agency";
3° In article D. 3111-23, the words "of the department" are replaced by the words "of the region";
4° The last paragraph of Article D. 3111-24 is deleted;
5° In section D. 3111-26, the words: ", after the opinion of the public health inspector and, if applicable, of the public health inspector" are deleted.
The c of 4th of Article R. 3112-2 shall be replaced by the following provisions:
"(c) Home hospitalizations referred to in Article L. 6125-2; "
Section 2 of Chapter II of Book I is amended to read:
1° The 1° of Article D. 3112-6 is replaced by the following:
« 1° Health facilities providing one or more of the public service missions defined in Article L. 6112-1; »
2° In sections D. 3112-7, D. 3112-9 and D. 3112-10, the word "prefect" is replaced by the words "Director General of the Regional Health Agency";
3° In article D. 3112-7, the words "of the department" are replaced by the words "of the region";
4° The last paragraph of Article D. 3112-8 is deleted;
5° In article D. 3112-9, the words "of the department" are deleted;
6° In section D. 3112-10, the words: ", after the opinion of the public health inspector and, if applicable, of the public health inspector" are deleted.
Section 3 of Chapter II of Book I is amended to read:
1° 1° of Article D. 3112-12 is replaced by the following provisions:
« 1° Health facilities providing one or more of the public service missions defined in Article L. 6112-1; »
2° In article D. 3112-13, the words "prefect of the department" are replaced by the words "Director General of the Regional Health Agency of the Region".
In R. 3112-15, the word "prefect" is replaced by the words "Director General of the Regional Health Agency" and the words ", after notice of the pharmacist Regional Public Health Inspector," are deleted.
Section 1 of Chapter III of Title I of Book I is amended as follows:
1° In sections R. 3113-2 to R. 3113-4, the words "Departmental Public Health Inspector" are replaced by the words "of the regional health agency designated by the Director General of the agency";
2° In R. 3113-2, the word "inspections" is replaced by the words "regional health agencies";
3° In R. 3113-4, the words "or to the doctor designated by order of the department's prefect" are deleted.
In R. 3114-8, the words: "health authorities" are replaced by the words: "from the regional health agency and the French Health Product Safety Agency".
The first six paragraphs of section R. 3114-9 are replaced by the following:
"The measures that may be taken under section L. 3114-5 are as follows:
« 1° The collection of epidemiological data on human cases of diseases transmitted by insects and, as appropriate, on cases of resistance of infectious agents to treatment, as well as entomological monitoring of insect vectors and, in particular, their resistance to insecticide products. These missions are carried out by the regional health agency;
« 2° Implementation of public health information and education actions to reduce the proliferation of vector insects. This mission is carried out by the regional health agency;
« 3° Investigation into human cases of diseases referred to in 1°, including, if necessary, clinical and biological screening, in the event of an epidemic threat or for the purpose of limiting the spread of an epidemic. This mission is carried out by the regional health agency, which makes available to the population the means for the prophylaxis treatment of malaria;
« 4° The monitoring, by the competent State authorities and in accordance with the terms established by an order of the Minister for Agriculture, of animals that may be contaminated by pathogens transmitted by vector insects;
« 5° The prescription, when insects are mosquitoes and in delimited areas 1st of Article 1 of Law No. 64-1246 of 16 December 1964 concerning the control of mosquitoes, prospections, treatments, works and controls within the meaning of the last paragraph of this section, as well as any measures relevant to the control of mosquitoes under the conditions laid down in section 7-1 of this Act. This mission is carried out by the Prefect on the report of the Director General of the Regional Health Agency; "
Section 3 of chapter IV of title I of Book I is amended to read:
1° In article R. 3114-11, the words "health control service at the borders" are replaced by the words "prefect";
2° In article R. 3114-14, the words "health control service at the relevant borders" are replaced by the words "prefect";
3° In R. 3114-16, the words: "Health control services at the borders" are replaced by the words: "The Prefect", the word "receive" is replaced by the word "receive" and the words "health" are deleted;
4° In R. 3114-21, the first sentence is deleted and the word: "They" is replaced by the words: "The control officers";
5° The first two sentences of the last paragraph of section R. 3114-22 are replaced by the following provisions: "As soon as the operations company has recognized that the aeration is sufficient, it ensures that there is no danger before free practice is authorized by the prefect. »
Chapter V of title I of Book I is thus amended:
1° Its title is replaced by the following title: "Fighting the International Spread of Diseases";
2° Section R. 3115-3 is replaced by the following provisions:
"Art. R. 3115-3. - The authorization referred to in Article L. 3115-1 shall be pronounced on the proposal of those responsible for the services to which the officers concerned are responsible. »
In R. 3115-5, the words: "The border health control service is authorized to put its means" are replaced by the words: "The regional health agency is authorized by the prefect to put its means assigned to health control at the borders" and the word: "it" is replaced by the word "it".
Section R. 3115-8 becomes section D. 3115-8.
Section 3 of Chapter I of Book I title II is amended to read:
1° Section D. 3121-21 is amended as follows:
(a) The 1° is replaced by the following:
« 1° Health facilities providing one or more of the public service missions defined in Article L. 6112-1; »
(b) At 2°, the words: "State" are replaced by the words: "the Director General of the Regional Health Agency, acting on behalf of the State,"
2° In sections D. 3121-22, D. 3121-25 and D. 3121-26, the word "prefect" is replaced by the words "Director General of the Regional Health Agency";
3° In article D. 3121-23, after the word: "represent" are inserted the words: "to the Director General of the Regional Health Agency" and the second paragraph is deleted;
4° In article D. 3121-25, the words "of the department" are deleted;
5° In article D. 3121-26, the words: ", after the opinion of the departmental doctor of public health," are deleted.
In article D. 3121-35, the words: "regional hospital agencies, regional and departmental directors of health and social affairs, directors of regional public health groups and regional health conferences" are replaced by the words: "generals of regional health agencies and regional conferences of health and autonomy".
Section 8 of chapter I of Book I title II is amended to read:
1° 1° of Article D. 3121-38 is replaced by the following provisions:
« 1° Health facilities providing one or more of the public service missions defined in Article L. 6112-1; »
2° In the first paragraph of article D. 3121-39, the words "prefect of the department" are replaced by the words: "Director General of the Regional Health Agency of the Region";
3° The last paragraph of Article D. 3121-40 is deleted;
4° In article D. 3121-41, the words "prefect of the department" are replaced by the words: "Director General of the Regional Health Agency";
5° In section D. 3121-42, the words "prefect, after advice from the public health inspector and, if applicable, from the public health inspector" are replaced by the words "Director General of the Regional Health Agency".
In R. 3121-44, the word "prefect" is replaced by the words: "Director General of the Regional Health Agency" and the words: ", after the advice of the pharmacist Regional Public Health Inspector," are deleted.
In R. 3131-7, the words: "Department of Health and Social Affairs and in Guadeloupe, Guyana and Martinique, by the Director of Health and Social Development" are replaced by the words: "General of the Regional Health Agency".
Section 1 of Chapter I of Book II is amended as follows:
1° In R. 3221-1, the reference: "L. 3221-1" is replaced by the reference: "L. 3221-4;
2° Section R. 3221-2 is replaced by the following provisions:
"Art. R. 3221-2. - Each health facility referred to in Article L. 3221-1 is responsible for the fight against mental illness in the psychiatric sectors attached to it. » ;
3° In R. 3221-3, the word "health" is replaced by the words "health";
4° In article R. 3221-4, the words ", whether it be a department or a service," and the words "of this code" are deleted;
5° In R. 3221-5, the words: "health public or a private health institution admitted to participating in the execution of the public hospital service" are replaced by the words: "health ensuring the public service mission referred to in 12° of L. 6112-1".
Section 3 of Chapter I of Book II is amended as follows:
1° In his title, the words "of the public hospital service" are replaced by the words: "of the establishments referred to in Article L. 3221-4";
2° In sections R. 3221-12, R. 3221-13, R. 3221-15 and R. 3221-17, the words "insuring public hospital service" are replaced by the words "indicated to article L. 3221-4";
3° In section R. 3221-12, the words: "designated by the Director of the regional hospitalization agency" are deleted.
In R. 3223-7, the words: "the departmental management of health and social affairs" are replaced by the words: "the regional health agency".
Chapter IV of Book III title V is thus amended:
1° In article R. 3354-11, the words "and to the departmental public health inspector" are deleted;
2° In article R. 3354-12, the words: "the public hospital service" are replaced by the words: "one or more of the public service missions defined in article L. 6112-1" and the words: "public prosecutor, the prefect and the departmental health inspector" are replaced by the words: "prefect and the public prosecutor";
3° In R. 3354-20, the words "74-1184 of 31 December 1974" are replaced by the words "2004-1463 of 23 December 2004" and the third paragraph is deleted.
Section 1 of chapter I of Book IV title I is amended as follows:
1° In article D. 3411-9, the words "prefect after advice from the pharmacist Regional Public Health Inspector" are replaced by the words "Director General of the Regional Health Agency";
2° In section D. 3411-10, the word "prefect" is replaced by the words "Director General of the Regional Health Agency" and the words "Regional Public Health Inspector" are replaced by the words "of the Regional Health Agency designated by the Director General of the Agency among the agents referred to in sections L. 1421-1 and L. 1435-7".
In sections R. 3413-1 to R. 3413-5 and R. 3413-7, the word "prefect" is replaced by the words "Director General of the Regional Health Agency".
Section 2 of chapter III of Book IV title I is amended as follows:
1° Section R. 3413-10 is amended as follows:
(a) In the first paragraph, after the word "prefect" are inserted the words "and the Director General of the Regional Health Agency" and the word "prefect" is replaced by the word "their";
(b) In the last paragraph, the word "prefect" is replaced by the words "Director General of the Regional Health Agency";
2° In section R. 3413-15, the words "and the relay doctor" are replaced by the words "and the director general of the regional health agency, who informs the relay doctor".
In R. 3711-1, the word "prefect" is replaced by the words "Director General of the Regional Health Agency".
Appendix 31-1 is replaced by the provisions annexed to this Order.
Sections R. 3115-2, R. 3115-4, R. 3115-7 and R. 3116-16 and chapter I, section II, of Book II, are repealed.
Section 1 of Chapter II of Book I is amended to read:
1° In R. 4112-4, the word "prefect" is replaced by the words "Director General of the Regional Health Agency" and its fourth paragraph is deleted;
2° In R. 4112-6 the words "prefecture" are replaced by the words "regional health agency".
In article R. 4113-7, the words "prefect of the department" are replaced by the words "Director General of the Regional Health Agency".
In article R. 4113-32, the words "prefect of the department" are replaced by the words "Director General of the Regional Health Agency".
In R. 4123-15, the word "prefect" is replaced by the words "Director General of the Regional Health Agency".
In R. 4124-1, the words: "Prefets of the Regional or Interregional Council" are replaced by the words: "Directors General of Regional Health Agencies within the Regional or Interregional Council's jurisdiction".
Section 3 of chapter IV, title II, of Book I is amended as follows:
1° In R. 4124-3, the word "prefect" is replaced by the words: "Director General of the Regional Health Agency";
2° Section R. 4124-3-2 is amended as follows:
(a) The words: "Department Prefect" are replaced by the words: "Director General of the Regional Health Agency";
(b) The last sentence of the third paragraph reads as follows: "When the practitioner operates in a health facility, the Director General of the regional health agency communicates the suspension decision to the director of the institution. »
In R. 4124-7, the word: "prefects" is replaced by the words: "Directors General of Regional Health Agencies" and after the words: "Council Spring", the words "regional or" are deleted.
In R. 4125-7, the word "prefects" is replaced by the words "general directors of regional health agencies".
Section 1 of Chapter VI of Title II of Book I is amended as follows:
1° In the 2nd of article R. 4126-1, the words: "the prefect of the department to the table of which is registered the interested practitioner, the prefect of the region or the director of the regional agency of hospitalization in the jurisdiction of which the interested practitioner exercises" are replaced by the words: "the prefect of department in which the interested practitioner is registered in the table, the director
2° In R. 4126-1-1, the words: "Director of the Regional Hospitalization Agency" are replaced by the words: "Director General of the Regional Health Agency".
Section 6 of chapter VI of title II of Book I is amended as follows:
1° In article R. 4126-33, the words: "to the prefect and the prosecutor of the Republic in that same department, to the prefect of the region" are replaced by the words: "to the prosecutor of the Republic near the court of great instance in which the practitioner is registered in the table, to the director general of the regional health agency";
2° In R. 4126-34, the words: "Director of the Regional Hospitalization Agency" are replaced by the words: "Director General of the Regional Health Agency".
In R. 4131-2, the words "the department's prefect" are replaced by the words "the director general of the regional health agency of the region in which".
In R. 4133-2, the words: "Regional Prefect" are replaced by the words: "Director General of the Regional Health Agency".
Section 3 of Chapter III of Title III of Book I is amended as follows:
1° In R. 4133-17, the words: "Regional Prefect" are replaced by the words: "Director General of the Regional Health Agency";
2° In R. 4133-18, the words: "regional prefect" are replaced by the words: "Director General of the Regional Health Agency";
3° In R. 4133-20, the words: "Regional Prefect" are replaced by the words: "Director General of the Regional Health Agency".
In R. 4141-2, the words "the department's prefect" are replaced by the words "the director general of the regional health agency of the region in which".
Section 2 of chapter III of Book I title IV is amended as follows:
1° The second paragraph of section R. 4143-7 is replaced by the following:
"The Director General of the relevant regional health agency for the application of articles R. 4143-12 and R. 4343-13 is that of the region that has the largest number of dental surgeons registered in the order table. » ;
2° In R. 4143-10, the words: "regional prefect" are replaced by the words: "Director General of the Regional Health Agency";
3° In R. 4143-13, the words: "Regional Prefect" are replaced by the words: "Director General of the Regional Health Agency".
Section 1 of Chapter I of Book I title V is amended as follows:
1° In article D. 4151-7, the words: "Regional Directors of Health and Social Affairs" are replaced by the words: "the Director General of the Regional Health Agency in whose jurisdiction it is established";
2° In article D. 4151-10, the words "regional prefect" are replaced by the words "general director of the regional health agency".
In R. 4211-22, the words: "Director of the Regional Hospitalization Agency" are replaced by the words: "Director General of the Regional Health Agency".
In R. 4221-15, the words: "the Prefect or the Departmental Director of Health and Social Affairs" are replaced by the words: "the Director General of the Regional Health Agency".
In section D. 4233-15-2, the words "regional prefect" are replaced by the words "Director General of the Regional Health Agency".
In R. 4234-1, the words: "The Prefect, the Departmental Director of Health and Social Affairs, the Regional Director of Health and Social Affairs," and in the last paragraph, the words: "Regional Director of Health and Social Affairs" are replaced by the words: "Director General of the Regional Health Agency".
In R. 4234-25, the word "prefect" is replaced by the words "Director General of the Regional Health Agency".
Section 2 of Chapter VI of Title III of Book II is amended as follows:
1° The second paragraph of article R. 4236-8 is as follows:
"For interregional councils, the Director General of the relevant regional health agency for the application of articles R. 4236-13 and R. 4236-14 is the Director General of the regional health agency in the region that has the largest number of pharmacists listed in the order table";
2° In R. 4236-11, the words: "regional prefect" are replaced by the words: "Director General of the Regional Health Agency";
3° In R. 4236-12, the words: "Regional Prefect" are replaced by the words: "Director General of the Regional Health Agency";
4° In R. 4236-14, the words: "Regional Prefect" are replaced by the words: "Director General of the Regional Health Agency".
Section 1 of Chapter I of Book II title IV is amended as follows:
1° In Article D. 4241-8, the words: "Regional Director of Health and Social Affairs" are replaced by the words: "Director General of the Regional Health Agency";
2° In R. 4241-8-1, the words "prefect of the department in which" are replaced by the words: "Director General of the Regional Health Agency of the region in which";
3° In R. 4241-8-2, the word "prefecture" is replaced by the words "Director General of the Regional Health Agency" and the words "prefecture" are replaced by the words "regional health agency";
4° In R. 4241-8-3, the word "prefect" is replaced by the words "Director General of the Regional Health Agency".
Section 2 of chapter I of Book III title I is amended as follows:
1° In article D. 4311-19, the words: "prefects of the region and department or the prefect" are replaced by the words: "general directors of the regional health agencies" and the words: "arrested by the prefect of the region" are replaced by the words: "fixed by the directors of the institutes under the conditions fixed by a decree of the minister responsible for health";
2° Section D. 4311-25 is amended as follows:
(a) The words: "regional director of health and social affairs" are replaced by the word "prefect";
(b) After the 3rd it is inserted a paragraph as follows:
« 4° The Director General of the Regional Health Agency or its representative".
Section 3 of chapter I of Book III title I is amended as follows:
1° In article D. 4311-44, the words: "regional prefect" are replaced by the words: "Director General of the Regional Health Agency";
2° In article D. 4311-48, the words: "regional prefect" are replaced by the words: "Director General of the Regional Health Agency".
Section 6 of chapter I of Book III title I is amended as follows:
1° In R. 4311-61, before the words: "to the Prefect" are added the words: "to the Director General of the Regional Health Agency,"
2° In article R. 4311-87, the words "regional prefect" are replaced by the words "general director of the regional health agency".
Section 2 of chapter II of Book III title I is amended as follows:
1° In R. 4312-34, the word "prefect" is replaced by the words: "Director General of the Regional Health Agency";
2° In article R. 4312-44, the words "prefect of the department" are replaced by the words "Director General of the Regional Health Agency".
Section 2 of chapter I of Book III title II is amended as follows:
1° In article D. 4321-17, the words "Department Prefect" are replaced by the words "Director General of the Regional Health Agency";
2° In article D. 4321-23, the words: "prefects of region and departments" are replaced by the words: "Directors General of Regional Health Agencies" and the words: "arrested by the Prefect of Region" are replaced by the words: "fixed by the directors of institutes under the conditions fixed by a decree of the Minister for Health";
3° In section D. 4321-25, the words: "Regional Prefect" are replaced by the words: "Director General of the Regional Health Agency".
Section 2 of chapter II of Book III title II is amended as follows:
1° In article D. 4322-4, the words "Department Prefect" are replaced by the words "Director General of the Regional Health Agency";
2° Section D. 4322-10 is amended as follows:
(a) The words: "prefects of regions and departments" are replaced by the words: "Directors General of Regional Health Agencies";
(b) The words: "arrested by the prefect of the region" are replaced by the words: "fixed by the directors of institutes under the conditions fixed by decree of the minister responsible for health";
3° In section D. 4322-12, the words: "Regional Prefect" are replaced by the words: "Director General of the Regional Health Agency".
Section 3 of chapter II of Book III title II is amended as follows:
In the second paragraph of article R. 4322-27, the words "regional prefect" are replaced by the words "Director General of the Regional Health Agency".
Section 2 of chapter I of title III of Book III is amended as follows:
1° In section D. 4331-6, the words: "prefects of the region and departments" are replaced by the words: "Directors General of the Regional Health Agency in which they are located" and the words: "arrested by the Prefect of the Region" are replaced by the words: "fixed by the directors of institutes under the conditions fixed by the decree of the Minister responsible for health";
2° In article D. 4331-7, the words "regional prefect" are replaced by the words "general director of the regional health agency".
Section 2 of chapter II of title III of Book III is amended as follows:
1° Section D. 4332-6 is amended as follows:
(a) The words: "prefects of the region and departments" are replaced by the words: "Directors General of the Regional Health Agencies where they are located";
(b) The words: "arrested by the prefect of the region" are replaced by the words: "fixed by the directors of institutes under the conditions fixed by decree of the minister responsible for health";
2° In article D. 4332-7, the words "regional prefect" are replaced by the words "general director of the regional health agency".
In R. 4341-20, the words: "prefecture" are replaced by the words: "at the regional health agency" and the word "prefecture" is replaced by the words: "Director General of the Regional Health Agency".
In R. 4342-17, the words: "prefecture" are replaced by the words: "at the regional health agency" and the word "prefecture" is replaced by the words: "Director General of the Regional Health Agency".
Section D. 4351-11 is amended as follows:
(a) In the first paragraph, the words: "prefects of regions and departments" are replaced by the words: "Directors General of Regional Health Agencies";
(b) In the second paragraph, the words: "arrested by the prefect of the region" are replaced by the words: "fixed by the directors of institutes under the conditions fixed by a decree of the minister responsible for health".
In section D. 4351-12, the words: "Regional Prefect" are replaced by the words: "Director General of the Regional Health Agency".
In article D. 4364-17, the words "prefect of the department" are replaced by the words "Director General of the Regional Health Agency".
In R. 4381-7, the words: "Regional Prefect" are replaced by the words: "Director General of the Regional Health Agency".
Section 3 of Chapter I of Title VIII of Book III is amended as follows:
1° In R. 4381-10, the words: "Department Prefect" are replaced by the words: "Director General of the Regional Health Agency of the Region" and the word "Prefect" is replaced by the words: "Director General of the Regional Health Agency";
2° In article R. 4381-19, the words "prefect of the department" are replaced by the words "Director General of the Regional Health Agency".
In article D. 4381-23, the words "prefect of the department" are replaced by the words "Director General of the Regional Health Agency".
Section 5 of Chapter I of Title VIII of Book III is amended as follows:
1° To sections R. 4381-27, R. 4381-29, R. 4381-30, R. 4381-40, R. 4381-59, R. 4381-64, R. 4381-67, R. 4381-70, R. 4381-75, R. 4381-81, R. 4381-85 and R. 4381-87, the word "prefect" is replaced by the general terms:
2° In article R. 4381-28, R. 4381-31 and R. 4381-43, the words "prefect of the department" are replaced by the words "Director General of the Regional Health Agency".
In sections R. 4383-2 and R. 4383-5, the words "regional prefect" are replaced by the words "Director General of the Regional Health Agency".
Section R. 4362-8 is repealed.
Section 8 of chapter I of Book I title II is amended to read:
1° Section R. 5121-83 is replaced by the following provisions:
"Art.R. 5121-83.-The classification in the category of medicines reserved for hospital use has the following effects:
« 1° The prescription of the medication is reserved:
“(a) To a doctor, dentist or midwife who meets the conditions set out in Book I of Part IV of this Code, as well as to I of Article 60 of Law No. 99-641 of 27 July 1999 establishing universal health coverage, which is exercised in a public or private health institution and in an inter-hospital union or authorized health cooperation group, respectively under sections L. 6132-2, in its earlier drafting of the publication of the Act No. 2009-879 of 21 July 2009 reforming the hospital and relating to patients, health and territories, and L. 6133-7, to ensure the missions of a health institution;
“(b) To a doctor who meets the same conditions, within the strict framework of the activity he performs in an authorized cosmetic surgery facility;
"(c) In public health institutions, any other person authorized to prescribe, acting under the responsibility of a focal point or, on the delegation of the pole, a person responsible for an internal structure of the pole, excluding functional units;
« 2° The dispensation of the drug is reserved for pharmacies for the internal use of the establishments referred to in 1° or those of the inter-hospital unions and health cooperation groups acting on behalf of the health institutions that are members of it or, where appropriate, to persons in such institutions ensuring the responsibilities referred to in Article L. 5126-6;
« 3° The administration of the drug can only be carried out during a hospitalization in an establishment listed at 1°, including, unless otherwise stated, the authorization to market, the patient's home in a home hospitalization or home dialysis activity. » ;
2° Section R. 5121-85 is replaced by the following provisions:
"Art.R. 5121-85.-The classification in the category of hospital prescription drugs has the effect of booking the prescription of the medication:
« 1° To a doctor, dentist or midwife who meets the conditions set out in Book I of Part IV of this Code, as well as to I of Article 60 of Law No. 99-641 of 27 July 1999 establishing universal health coverage, which is exercised in a public or private health institution and in an inter-hospital union or authorized health cooperation group, respectively under sections L. 6132-2, in its earlier drafting of the publication of the Act No. 2009-879 of 21 July 2009 reforming the hospital and relating to patients, health and territories, and L. 6133-7, to ensure the missions of a health institution, or, subject to these assumptions, that its marketing authorization, temporary authorization of use or import authorization provides, in a blood transfusion institution authorized to provide drugs to the patients treated therein, pursuant to the provisions of section L.
« 2° To a doctor who meets the same conditions, within the strict framework of the activity he performs in a properly authorized cosmetic surgery facility;
« 3° In public health institutions, to any other person authorized to prescrime acting under the responsibility of a pole official or, on delegation of the pole manager, of an internal structure of the pole, excluding functional units. » ;
3° Section R. 5121-88 is replaced by the following provisions:
"Art.R. 5121-88.-The classification in the category of initial hospital prescription drugs has the following effects:
« 1° The initial prescription of the medication is reserved:
“(a) To a doctor, dentist or midwife who meets the conditions set out in Book I of Part IV of this Code, as well as to I of Article 60 of Law No. 99-641 of 27 July 1999 establishing universal health coverage in a public or private health institution as well as in an inter-hospital union or authorized health cooperation group, respectively pursuant to articles L. 6132-2, in its writing prior to the publication of the Act No. 2009-879 of 21 July 2009 reforming the hospital and relating to patients, health and territories, and L. 6133-7, to ensure the missions of a health institution, or, subject to these assumptions, that its marketing authorization, temporary authorization of use or import authorization provides, in a blood transfusion institution authorized to provide drugs to the patients treated therein, pursuant to the provisions of section L.
“(b) To a doctor who meets the same conditions, within the strict framework of the activity he performs in a properly authorized cosmetic surgery facility;
"(c) In public health institutions, to any other person authorized to prescrime acting under the responsibility of a pole official or, on delegation of the pole manager, of an internal structure of the pole, excluding functional units;
« 2° After this first prescription, the treatment may be renewed by any prescriptor under the conditions of common law. The Renewal Order, when it is written by a prescriptor other than those authorized to make the first limitation, shall include references to the original order. If necessary, it may include a modification of the dosage or duration of the treatment. »
Section 13 of chapter I of Book I title II is amended to read:
1° Section R. 5121-167 is replaced by the following provisions:
"Art.R. 5121-167.-Regional pharmacovigilance centres are responsible for:
« 1° To collect statements from health professionals pursuant to R. 5121-170;
« 2° To collect information relating to the adverse effects of the drugs or products referred to in Article R. 5121-150, which must be communicated to them by public health institutions, by poison centres and by private health institutions that provide one or more of the public service missions referred to in Article L. 6112-1 or are associated with its operation;
« 3° To gather information of the same nature that is transmitted to them by other health institutions, inter-hospital unions and health cooperation groups authorized under articles L. 6132-2, in its drafting prior to the publication of the Act No. 2009-879 of 21 July 2009 reforming the hospital and relating to patients, health and territories, and L. 6133-7 to ensure the missions of these institutions or, individually, members of health professions;
« 4° To transmit to the Director General of the French Health Products Agency the information collected pursuant to 1°, 2° and 3°, those concerning serious adverse effects to be transmitted without delay;
« 5° To complete with the Minister for Health and the Director General of the Agency a mission of expertise, conducting the studies and work that are requested by these authorities and conducting the assessment of information on adverse effects;
« 6° To contribute to the development of knowledge on pharmacovigilance methods and on the nature and mechanisms of the adverse effects of drugs and products referred to in R. 5121-150. » ;
2° In article R. 5121-181, after the words: "L. 6132-2" are inserted the words: "in its writing before the publication of Act No. 2009-879 of 21 July 2009 on hospital reform and on patients, health and territories," and the words: "L. 6133-1" are replaced by the words "L. 6133-7";
3° In article R. 5121-191, after the words: "L. 6132-2" are inserted the words: "in its writing before the publication of Act No. 2009-879 of 21 July 2009 on hospital reform and on patients, health and territories," and the words: "L. 6133-1" are replaced by the words "L. 6133-7".
Section 1 of chapter IV, title II, of Book I is amended as follows:
1° The first paragraph of section R. 5124-6 is replaced by the following provisions:
"The authorization to open, as provided for in the first paragraph of section L. 5124-3, a pharmaceutical establishment, a company or an organization referred to in section R. 5124-2 shall be issued by the Director General of the French Health Safety Agency, after notice of the competent central council of the national order of pharmacists and after investigation by an inspector of the agency or, in the case referred to in section 53-3. » ;
2° In R. 5124-29, the words: "regional prefect" are replaced by the words: "Director General of the Regional Health Agency";
3° In 3 of R. 5124-45, the words: "regional prefect" are replaced by the words: "Director General of the Regional Health Agency";
4° Section R. 5124-59 is amended as follows:
(a) At the 2nd and last paragraph, the words "of the department concerned" are deleted and the words "regional health and social affairs" are replaced by the words "general of the regional health agency";
(b) In the second paragraph (b) of the second paragraph, the words: "Regional Directorate of Health and Social Affairs and the Departmental Directorates of Health and Social Affairs of the region concerned" are replaced by the words: "Regional Health Agency territorially competent. » ;
5° In R. 5124-66, the words "regional prefect" are replaced by the words: "Director General of the Regional Health Agency".
Section 1 of chapter V of title II of Book I is amended as follows:
1° In article R. 5125-1, the words "prefect of the department" and "prefect" are replaced by the words: "Director General of the Regional Health Agency";
2° Section R. 5125-2 is amended as follows:
(a) The word "prefect" is replaced by the words "Director General of the Regional Health Agency";
(b) After the words: "the complete file" are inserted the words: "to the representative of the State in the department";
3° In sections R. 5125-4 and R. 5125-5, the word "prefect" is replaced by the words "Director General of the Regional Health Agency";
4° Section R. 5125-8 is amended as follows:
(a) The words: "The Prefectural Order" are replaced by the words: "The decision of the Director General of the Regional Health Agency";
(b) The words: "a neighbouring department" are replaced by the words: "a neighbouring region";
(c) The words: "Compliant opinion of the prefect of this department" are replaced by the words: "Notice of the Director General of the Regional Health Agency of this region";
5° In R. 5125-12, the words: "at the regional pharmacy inspection" are replaced by the words: "to the Director General of the Regional Health Agency";
6° In R. 5125-13, the word "prefect" is replaced by the words "Director General of the Regional Health Agency";
7° Section R. 5125-25 is amended as follows:
(a) In the second paragraph, the words "of the Prefect, the Regional Director of Health and Social Affairs, the Regional Inspector of Public Health" are replaced by the words "of the Director General of the Regional Health Agency";
(b) In the last paragraph, the words: "prefects of the departments in which" are replaced by the words "general directors of the regional health agencies in which";
8° Section R. 5125-33-1 is amended as follows:
(a) In I, the words "prefect of the department" are replaced by the words "Director General of the Regional Health Agency";
(b) In the III, IV and V of Article R. 5125-33-1, the word "prefect" is replaced by the words "Director General of the Regional Health Agency";
9° In sections R. 5125-33-2, R. 5125-33-3 and R. 5125-33-4, the words: "regional inspector" are replaced by the words: "Director General of the Regional Health Agency".
Section 2 of chapter V of title II of Book I is amended as follows:
1° In section R. 5125-37, the words "regional inspector" are replaced by the words "general director of the regional health agency".
2° In R. 5125-41, the words: "at the pharmacy inspection" are replaced by the words: "at the Director General of the Regional Health Agency";
3° In R. 5125-43, the word "prefect" is replaced by the words "Director General of the Regional Health Agency".
Section 1 of Chapter VI of Title II of Book I is amended as follows:
1° Article R. 5126-4 is supplemented by a paragraph as follows:
"They are intended for the special use of patients in health facilities or grouping structures, as well as, where appropriate, for the particular use of patients taken care of by the health coordination group established as a health facility pursuant to Article L. 6133-7. » ;
2° In article R. 5126-5, the words: "In-house hospitalization structures mentioned in article R. 6121-4" are replaced by the words: "In-house hospitalization facilities mentioned in article L. 6125-2" and after the words: " pharmacies that serve" are inserted the words: "institutions and";
3° In R. 5126-9, the words: "hospitalization structures" are replaced by the words: "hospitalization facilities";
4° Section R. 5126-10 is amended as follows:
(a) At 1°, the words: "Regional Pharmaceutical Inspection" are replaced by the words: "Director General of the Regional Health Agency";
(b) At 3°, the words: "hospitalization structures" are replaced by the words: "hospitalization facilities";
5° In R. 5126-14, the words: "hospitalization structures" are replaced by the words: "hospitalization facilities";
6° Section R. 5126-15 is replaced by the following provisions:
"Art. R. 5126-15. - The application for authorization under section L. 5126-7 for the creation of a pharmacy for internal use or for the transfer of a geographic site to another is submitted by the natural person who is authorized to operate the establishment or by the legal representative of the legal person concerned.
"It is addressed by registered letter with a request for notice of receipt to the competent administrative authority referred to in R. 5126-16.
"The application is accompanied by a file that includes, according to the establishment category, the following information:
« 1° The number of patients to be handled daily by the pharmacy, divided by activity or discipline by specifying their respective locations;
« 2° Listing of planned activities;
« 3° The number of pharmacists planned for the exercise of the pharmacy's missions and their time of presence expressed in half-day weekly;
« 4° For health facilities, a copy of the contract of objectives and means provided for in Article L. 6114-1;
« 5° The location(s) of the pharmacy, the location(s) of its premises on each pharmacy and, where applicable, the location(s) of the pharmacy, the location(s) of the pharmacy, the location(s) of the pharmacy premises and, where applicable, the location(s) of the pharmacy site(s) of the pharmacy, the location(s) of the pharmacy premises(s).
« 6° A detailed and side-by-side plan and information on the elements mentioned in articles R. 5126-8 to R. 5126-14;
« 7° The terms and conditions envisaged for the dispensation or possible withdrawal of the drugs and products or objects referred to in articles L. 4211-1 and L. 5137-1 as well as sterile medical devices, on the site(s) served by the pharmacy as well as in the domicile of patients supported by a home hospitalization or a home dialysis unit;
« 8° When the pharmacy has, in particular, the role of supplying other pharmacy for domestic use pursuant to R. 5126-5, any information concerning these pharmacy for domestic use with respect to their location and activity, as well as the terms and conditions of their supply;
« 9° In addition, for inter-hospital unions and health co-operation groups, the order or approval, respectively provided for in articles L. 6132-2, in its writing prior to the publication of the Act No. 2009-879 of 21 July 2009 reforming the hospital and relating to patients, health and territories, and L. 6133-3 to verify that such a request is consistent with the purpose of the union or grouping;
« 10° When the pharmacy of a health or cosmetic surgery facility, an inter-hospital union or a health cooperation group has the role of ensuring the sterilization of medical devices, a document attesting to the adoption of the system provided for in section L. 6111-1;
« 11° When the authorization is sought under Article L. 5126-3, the agreement setting out the commitments of the parties referred to in the same article;
« 12° When the authorization is requested by a home dialysis unit or a unit of autodialysis, the file also specifies the different categories of medicines, products, objects and medical devices dispensed. » ;
7° Section R. 5126-16 is replaced by the following provisions:
"Art. R. 5126-16. - The authorization for creation or transfer is issued by the Director General of the regional health agency of the area of the intended location, for health facilities, health cooperation groups, inter-hospital unions as well as penitentiary institutions, medical-social institutions referred to in R. 5126-1 and cosmetic surgery facilities. The Director General of the Regional Health Agency makes his decision after notice, as the case may be, of section E or H of the national pharmacist order. If the national order of pharmacists has not given its notice within three months of the date of signature of the acknowledgement of receipt of the file by order, the Director General of the Regional Health Agency may decide.
"The authorization states:
« 1° The location(s) of the pharmacy and the location(s) of its premises;
« 2° Activities at each location site and, where applicable:
“(a) The other geographical sites served;
“(b) The geographic area of intervention of home hospitalization institutions or home dialysis units;
"(c) Health institutions or professionals benefiting from the benefits provided under Article 8 R. 5126-9;
"(d) Derogations granted under 1 to 4° of Article R. 5126-10 and the conditions under which the activities under consideration are insured;
« 3° The time of presence of the pharmacist responsible for stewardship, expressed in half-day weekly.
"This authorization may be granted only for some of the geographic sites to be served in the application or for some of the activities requested under section R. 5126-9.
"For the realization of the preparations made necessary by biomedical research, including the preparation of experimental drugs and for the importation of experimental drugs, the authorization specifies the pharmaceutical form or, if not, the nature of the products and, in the case of preparation, the operations carried out. For the preparation of hospital preparations from raw materials or pharmaceutical specialties, this authorization specifies the pharmaceutical form of hospital preparations. The content of this authorization is determined by order of the Minister for Health.
"A copy of this authorization is sent to the Director General of the French Health Products Agency where the pharmacy for internal use is authorized to carry out activities referred to in R. 5126-9, with the exception of those mentioned at its 3° and 7°. » ;
8° In R. 5126-17, the words: "Director of the regional agency for hospitalization or prefect" and the words: "Director of the regional agency for hospitalization or prefect" are replaced by the words: "Director General of the regional health agency";
9° In R. 5126-19, the words: "Director of the Regional Hospitalization Agency or the Prefect" are replaced by the words: "Director General of the Regional Health Agency";
10° In the second paragraph of section R. 5126-20, the words: "after a regional pharmacy inspection notice" are replaced by the words: "on the report of an inspector referred to in section L. 5127-1";
11° In R. 5126-34, the words: "hospitalization structures" are replaced by the words: "hospitalization facilities";
12° In the article R. 5126-45, the words "regional agency for hospitalization" are replaced by the words "regional health agency" and the words "accreditation" are replaced by the words "certification";
13° Section R. 5126-53 is amended as follows:
After the words: "L. 6132-2" are inserted the words: ", in its writing before the publication of Act No. 2009-879 of 21 July 2009 on hospital reform and on patients, health and territories," and the words: "L. 6133-1" are replaced by the words "L. 6133-7";
14° In R. 5126-71, the words: "Department Prefect" are replaced by the words: "Director General of the Regional Health Agency" and the second paragraph is replaced by the following provisions: "It is addressed by registered letter with a request for acknowledgment of receipt to the Director General of the Regional Health Agency that addresses a copy to the prefect of the department";
15° In article R. 5126-72, the words "prefect du département" are replaced by the words: "Director General of the Regional Health Agency after the advice of the Department's Prefect";
16° In R. 5126-74, the word "prefect" is replaced by the words: "Director General of the Regional Health Agency", after the words: "copy of the stay", inserted the words "to the prefect of the department", and the words "regional director of health and social affairs" are replaced by the word "prefect";
17° In article R. 5126-111, after the words: "L. 6132-2", are inserted the words: ", in its writing before the publication of Act No. 2009-879 of 21 July 2009 on hospital reform and on patients, health and territories," and the words: "L. 6133-1" are replaced by the words "L. 6133-7".
Section 1 of Chapter II of Title III of Book I is amended as follows:
1° In R. 5132-31, the words: "regional pharmacy inspection" are replaced by the words: "regional health agency";
2° In article R. 5132-36:
(a) The words: "Departmental Director of Veterinary Services" are replaced by the words: "Departmental Director for Population Protection";
(b) The words: "Veterinary Inspector" are replaced by the words "official veterinarian";
(c) The words: "regional public health inspector" are replaced by the words: "Inspectors referred to in Article L. 5127-1. » ;
3° In R. 5132-37, the words "regional pharmacy inspection" are replaced by the words "regional health agency".
Section 2 of chapter II of title III of Book I is amended as follows:
1° Section R. 5132-76 is amended as follows:
(a) At 5°, the word "prefect" is replaced by the words "Director General of the Regional Health Agency";
(b) At 6°, the word "prefectural" is replaced by the words "of the Director General of the Regional Health Agency";
2° In R. 5132-80, the words: "regional pharmacy inspection" are replaced by the words: "regional health agency";
3° On the 9th of R. 5132-89, the word "prefect" is replaced by the words "Director General of the Regional Health Agency";
4° In R. 5132-95, the words "regional pharmacy inspection" are replaced by the words "regional health agency".
Section D. 5143-8 is amended as follows:
1° The 1° is replaced by the following:
« 1° Three State representatives and a representative of the regional health agency:
“(a) The Prefect of Region or its representative, President;
“(b) The Inspector General of Veterinary Public Health responsible for territorially competent interregional inspection or its representative, Vice-President;
"(c) The Director of one of the interdepartmental departmental directorates responsible for the protection of the populations of the region or his representative, designated by the regional prefect;
"(d) An inspector from the regional health agency with pharmacist status, designated by the Director General; »
2° At 2°, the words: "Regional Prefect" are replaced by the words: "Director General of the Regional Health Agency".
In R. 5146-1, the words: "under cover of the prefect of the region or department" are replaced by the words: "under cover of the director general of the regional health agency or the department prefect".
In R. 5212-35, the words: ", the director of the regional health insurance fund" are deleted and the words: "Director of the regional hospitalization agency" are replaced by the words: "Director General of the regional health agency".
In R. 5212-37, the words: "Inter-hospital unions and health cooperation groups authorized to carry out the missions of a health institution" are replaced by the words: "Inter-hospital unions authorized to carry out the missions of a health institution and health cooperation groups referred to in L. 6133-7".
Section R. 5313-6 is amended as follows:
1° In the third paragraph, the words "and chemical" are deleted;
2° In the fourth paragraph, the words: "regional public health inspector" are replaced by the words: "physicist inspector referred to in L. 5127-1".
Section R. 5411-1 is replaced by the following provisions:
"Art.R. 5411-1.-Pharmacists public health inspectors and inspectors of regional health agencies with pharmacists are empowered and sworn in for the search and recognition of the offences referred to in article L. 5411-1 under the conditions set out in articles R. 1312-2 and R. 1312-4 to R. 1312-7. »
Chapter III of Book IV title I is amended as follows:
In article R. 5413-1, after the words: "Public Health Inspectors" are inserted the words: "and the inspectors of regional health agencies with the quality of a doctor".
Sections R. 5125-31, R. 5125-32 and R. 5125-33 are repealed.
Section 1 of Chapter I of Book I is amended as follows:
1° In article R. 6111-1, after the words: "L. 6132-2" are inserted the words: ", in its writing before the publication of Act No. 2009-879 of 21 July 2009 on hospital reform and on patients, health and territories," and the words: "L. 6133-1" are replaced by the words: "L. 6133-7";
2° In R. 6111-2, the words: "the departmental directorate of health and social affairs" are replaced by the words: "the regional health agency" and the words: "subcommission to examine the issues referred to in 2° of II" are replaced by the words: "the commission referred to in";
3° In article R. 6111-8, after the words: "L. 6132-2" are inserted the words: ", in its writing before the publication of Act No. 2009-879 of 21 July 2009 on hospital reform and on patients, health and territories," and the words: "L. 6133-1" are replaced by the words "L. 6133-7";
4° In R. 6111-12, after the words: "L. 6132-2" are inserted the words: ", in its writing before the publication of Act No. 2009-879 of 21 July 2009 on hospital reform and on patients, health and territories," and the words: "L. 6133-1" are replaced by the words "L. 6133-7".
Section 2 of Chapter I of Book I is amended as follows:
1° In article R. 6111-16, the words "other than local hospitals" are deleted;
2° In R. 6111-17 the words: "Departmental Director of Health and Social Affairs" are replaced by the words: "Director General of the Regional Health Agency" and the words: "other than local hospitals" are deleted.
Section 2 of Chapter II of Book I is amended to read:
1° Article R. 6112-14 is as follows:
"Art. R. 6112-14. - For the purposes of the provisions of 12° to 14° of Article L. 6112-1, the Director General of the Regional Health Agency designates, for each penitentiary institution in the region, the public health facility located nearby, responsible for providing the care defined in Article L. 6111-1 to inmates, for the reception and treatment of emergencies and for the assistance of preventive and educational activities for organized health.
"This designation comes after the advice of the health facility's supervisory board. » ;
2° Article R. 6112-15 is as follows:
"Art. R. 6112-15. - Where the public health institution does not have a psychiatry service and that the penal institution is not served by a regional medico-psychological service referred to in R. 3221-6, the Director General of the regional health agency also designates, under the same conditions as those set out in R. 6112-14, the public health institution or the private health institution authorized to provide it » ;
3° Article R. 6112-16 is as follows:
"Art. R. 6112-16. - The procedure for the intervention of the public health institution referred to in R. 6112-14 shall be determined by a protocol signed by the Director General of the regional health agency, the Interregional Director of Prison Services, the Chief of the penitentiary institution and the Director of the relevant health institution, after the advice of the supervisory board.
"A supplementary protocol shall be signed under the same conditions to determine the terms and conditions of intervention of the health care facility, which may be designated under section R. 6112-15. In this case, the Director of the Public Health Institution referred to in R. 6112-14 is also a signatory to this supplementary protocol. » ;
4° In sections R. 6112-20 and R. 6112-27, the words: "Director of the regional hospitalization agency" are replaced by the words: "Director General of the Regional Health Agency".
In sections R. 6113-10 and R. 6113-11, the words: "regional hospitalization agencies" are replaced by the words: "regional health agencies";
In R. 6113-15, the words "regional agency for hospitalization" are replaced by the words "regional health agency".
Section 4 of Chapter III of Book I is amended to read:
1° In article R. 6113-28, the words: "regional hospital agencies" are replaced by the words: "regional health agencies";
2° In section R. 6113-29, the words: "Director of the regional agency for hospitalization" are replaced by the words: "Director General of the Regional Health Agency" and the words: "after the Executive Committee's opinion" are deleted.
In R. 6113-37, the words: "Director of the Regional Hospitalization Agency" are replaced by the words: "Director General of the Regional Health Agency".
Section 1 of Chapter I of Book I title II is amended to read:
1° Section R. 6121-1 is amended as follows:
(a) The words: "health organization" are replaced by the words: "care organization";
(b) The second paragraph is deleted;
2° Article R. 6121-2 is as follows:
"Art. R. 6121-2. - The draft plan for the organization of care is prepared by the Director General of the Regional Health Agency. It is submitted for advice, successively:
« 1° To health conferences;
« 2° To the specialized commission of the regional conference on health and self-reliance competent for the health sector.
"In the case of a draft interregional framework for the organization of care, only the opinion of the specialised commission of the regional conference on health and self-government competent for the health sector of each region is required. » ;
3° Article R. 6121-3 is as follows:
"Art. R. 6121-3. - Orders of the director of the regional health agency with a regional care organisation scheme are published in the collection of administrative acts of the prefecture of the region. When the schema is interregional, the corresponding decrees are published in the compendiums of administrative acts of each of the prefectures in the region. » ;
4° After article R. 6121-4, an article R. 6121-4-1 is inserted as follows:
"Art. R. 6121-4-1. - Home hospitalization facilities referred to in Article L. 6125-2 provide for the patient's home for a limited but revisable period, depending on the evolution of his or her health, continuous and coordinated medical and paramedical care. Such care differs from those usually provided at home by the complexity and frequency of acts. Home hospitalization institutions may also intervene in an institution welcoming older persons, referred to in 6° I of Article L. 312-1 of the Code of Social Action and Families.
"In this case, care may only be provided to a resident if the health condition of the resident requires a technical intervention, which does not replace the health and medical-social benefits provided by the institution, and if his admission to hospital at home meets the conditions of care defined by a decree of the Minister for Health and the Minister for Social Security. These conditions vary according to the nature of care. These include the complexity of care to be provided or the extent of the means to be used. Each home hospitalization facility is a geographical area specified by the authorization provided for in section L. 6122-1. » ;
5° In R. 6121-5, the words: "Director of the Regional Hospitalization Agency" are replaced by the words: "Director General of the Regional Health Agency".
Article D. 6121-6 reads as follows:
"Art. D. 6121-6. - The quantified objectives of the care supply that are specified in the care organization scheme relate to the care activities and heavy equipment covered by the care organization scheme referred to in Article L. 1434-9. »
In Article D. 6121-11, the words "health provided for in Article L. 6121-4" are replaced by the words "care provided for in Article L. 1434-10".
Section 3 of Chapter II of Book I is amended to read:
1° In R. 6122-15, the words: "and regional health organization committees" are deleted;
2° The second paragraph of article R. 6122-16 is as follows:
"The Specialized Commission of the Regional Conference on Health and Autonomy meets on the convocation of the Director General of the Regional Health Agency. The secretariat is provided by the regional health agency. » ;
3° In R. 6122-17, the words "of the regional committee" are replaced by the words: "of the specialised commission of the regional conference on health and autonomy" and the words: "Director of the regional agency for hospitalization" are replaced by the words: "Director General of the Regional Health Agency";
4° In R. 6122-18, the words: "Regional Committees" are replaced by the words: "Specialized Commissions of Regional Conferences on Health and Self-Government" and the words: "Committees" are replaced by the words: "National Committee and Specialized Committees";
5° Article R. 6122-20 is as follows:
"Art. R. 6122-20. - The national committee decides on file. Project promoters are heard on their request by the rapporteur. They may also, if the chair of the committee considers it useful, be heard by the competent section of the national committee. » ;
6° Article R. 6122-21 is as follows:
"Art. R. 6122-21. - The National Committee establishes its rules of procedure, which is subject to the approval of ministers responsible for social action, health and social security. »
Section 4 of Chapter I of Book I title II is amended to read:
1° In R. 6122-23, the words: "health and its specific annex to the care activity or the heavy equipment concerned" are replaced by the words: "care";
2° Article R. 6122-24 reads as follows:
"Art. R. 6122-24. - Assessment indicators for care activities or heavy equipment are defined by a decree of the Director General of the Regional Health Agency or, where there is an interregional schema, by joint decree of the Directors General of territorially competent agencies. These indicators take into account, inter alia, the objectives set out in the health care organization scheme of the region or in the group of regions concerned.
" Indicators specific to certain care activities and some heavy equipment can be defined by order of the Minister for Health.
"These indicators apply to the applicant for authorization.
"The licensee may use additional indicators specific to the care activity or the heavy equipment involved. » ;
3° In R. 6122-27, the words: "the executive commission of the regional agency for hospitalization" and the words: "the executive commission" are replaced by the words: "the director general of the regional health agency", and the word "third" is replaced by the word "fourth";
4° In R. 6122-28, the words: "Director of the Regional Hospitalization Agency" are replaced by the words: "Director General of the Regional Health Agency";
5° Article R. 6122-29 is as follows:
"Art. R. 6122-29. - Applications referred to in R. 6122-28 may only be received during periods and on schedules determined by order of the Director General of the Regional Health Agency, published in the compendium of administrative acts of the prefecture of the region.
"When applications for authorization or renewal of authorization are related to a care activity referred to in Article R. 6122-25 or to heavy equipment referred to in Article R. 6122-26, subject to an interregional plan for the organization of care provided for in Article L. 1434-10, the directors general of the regional health agencies that have established this scheme may determine these periods and those calendars by joint decree, published in the outline of the prefect
"These periods, whose number cannot be less than two or more than three per calendar year, are of at least two months. They may vary depending on the nature of the operations. They shall, from the date of their closure and subject to the completeness of the record, be the six-month period provided for in the fifth paragraph of Article L. 6122-9. » ;
6° Article R. 6122-30 is as follows:
"Art. R. 6122-30. - The quantified balance sheet of care provided for in the fourth paragraph of Article L. 6122-9 is decided by the Director General of the Regional Health Agency and published at least 15 days before the opening of each of the periods referred to in Article R. 6122-29.
"This report specifies, for each care activity referred to in section R. 6122-25 and heavy equipment referred to in section R. 6122-26, the health territories within which there are needs not covered by multi-year authorizations and contracts of objectives and means.
"It is published in the compendium of the administrative acts of the prefecture of the region and remains posted at the headquarters of the relevant regional health agency as long as the file reception period is not closed.
"When this period is common to several regions, the directors general of the regional health agencies that have established the interregional schema jointly stop the assessment of the health territories included in this scheme. This assessment is published and posted as stated in the previous paragraph in each of the regions included in the interregional schema. » ;
7° Article R. 6122-31 is as follows:
"Art. R. 6122-31. - When the quantified objectives defined by the regional plan for the organization of care are met in a health territory, the Director General of the Regional Health Agency may, after the advice of the Specialized Commission of the Regional Health Conference and the Competent Self-Government for the Health Sector, find that there are exceptional needs in the context of urgent and imperative need in public health and making the fourth request admissible, under the terms of section 61 In this case, the balance sheet referred to in R. 6122-30 reveals the nature and extent of these needs, the quantified objectives of the provision of care necessary to meet them, by care activities and by heavy equipment, as well as the places where the establishment is desired. » ;
8° Section R. 6122-32 is amended as follows:
(a) The words: "Director of the Regional Hospitalization Agency" are replaced by the words: "Director General of the Regional Health Agency";
(b) The words: "by the executive commission of this agency" are deleted;
(c) The word "third" is replaced by the word "fourth";
9° Section R. 6122-32-1 is amended as follows:
(a) The words: "and whose composition can be specified by order of the minister responsible for health" are deleted;
(b) The words: "administrative board" are replaced by the words: "monitor board";
(c) The words "health organization" are replaced by the words "care organization" and the words "and its annex" are deleted;
10° Section R. 6122-32-2 is amended as follows:
(a) The words: "the regional agency for hospitalization" are replaced by the words: "the regional health agency";
(b) The words: "health organization and its annex" are replaced by the words: "care organization";
11° Article R. 6122-33 is as follows:
"Art. R. 6122-33. - Where, pursuant to the fourth paragraph of Article L. 6122-10, the regional health agency shall instruct it under the conditions provided for in the second paragraph of Article R. 6122-27, the holder of the authorization shall file a file constituted as provided for in Article R. 6122-32-1.
"However, are not necessary if no change has occurred since the previous authorization or renewal of authorization or if no change is considered:
“– the copy of the statutes;
"—the presentation of the planned operation;
"—the presentation and description provided in the 3rd of that article.
"The applicant attached to this file a full report covering the period provided for in the last paragraph of section R. 6122-23 and reporting on the completion of the assessment procedure in accordance with the provisions of section R. 6122-32-1.
"This report also presents the licensee's responses to the regional health agency's observations in the above-mentioned injunction. » ;
12° Article R. 6122-34 is as follows:
"Art. R. 6122-34. - A decision to refuse authorization or, where the provisions of the fourth paragraph of section L. 6122-10 are applied, a refusal to renew authorization may only be made for one or more of the following reasons:
« 1° Where the applicant is not among the natural or legal persons referred to in Article L. 6122-3;
« 2° When the health needs defined by the care organization scheme are met;
« 3° When the project is not compatible with the objectives of the care organization scheme;
« 4° Where the project is not in accordance with the conditions for the operation of the care and heavy equipment activities undertaken pursuant to Article L. 6123-1 and the technical operating conditions established under Article L. 6124-1;
« 5° Where the applicant does not agree to subscribe to the conditions or commitments referred to in Articles L. 6122-5 and L. 6122-7;
« 6° In the event of a renewal application, where the applicant has not complied with either the undertakings referred to in section L. 6122-5, or the particular conditions or commitments with the authorization in question or to which it was subordinated under section L. 6122-7;
« 7° Where the applicant has not completed the assessment under section L. 6122-5 or has completed it without using the indicators referred to in the first two paragraphs of section R. 6122-24 and published no later than six months prior to the filing of the renewal application;
« 8° Where the assessment of the results of the evaluation indicates that the achievement of quantified objectives or conditions for the implementation of the care or heavy equipment activity established by the multi-year contract of objectives and means pursuant to Article L. 6114-2 are not satisfactory, including by reference to the indicators provided for in sections L. 6114-1 and R. 6122-24;
« 9° Where a commencement of work has been found prior to the granting of the authorization, except where the application tends to obtain the renewal of an authorization without modification or a replacement authorization for heavy equipment. » ;
13° Article R. 6122-35 is as follows:
"Art. R. 6122-35. - In the case of a transfer of authorization, including where the assignment is a result of a consolidation, the assignee shall send an application to the Director General of the Regional Health Agency to confirm the authorization.
"This request for confirmation is accompanied by a record including the documents listed in a, b, d, e and f of the 1st of article R. 6122-32-1 and those mentioned in 2°, b and c of 3° and 4° of this article. With respect to the care activity or the heavy equipment that is the subject of the assignment, the file also includes the signed act or certificate of assignment of the assignor, or the extract of the proceedings of the supervisory board or the legislative body of the assignor relating to the assignment, as well as a copy of the multi-year contract of objectives and means between the regional health agency and the assignor.
"The regional health agency shall decide on this application in accordance with the terms and conditions for an application for authorization. It may not refuse to confirm the authorization unless the file submitted by the assignee discloses amendments that would justify a refusal of authorization under the provisions of section R. 6122-34 or that would be incompatible with the compliance with the conditions and commitments to which the assigned authorization had been conditioned. » ;
14° Section R. 6122-40 is amended as follows:
(a) The first paragraph is as follows:
"The letter by which the Director General of the Regional Health Agency notifies the explicit decision that he has made after notice of the Specialized Commission of the Regional Conference on Health and Self-Government in the cases provided for in sections L. 6122-9, L. 6122-12 and L. 6122-13, shall include the reasons for this decision and shall be addressed to the applicant for the authorization or the holder of the suspended, amended or withdrew by registered letter. » ;
(b) The words: "the regional agency for hospitalization" are replaced by the words: "the regional health agency";
15° Article R. 6122-41 is as follows:
"Art. R. 6122-41. - In addition to the notification provided in section R. 6122-40, any express decision of authorization, renewal of authorization, rejection, modification, suspension or withdrawal of authorization made by the Director General of the Regional Health Agency is published in the compendium of administrative acts of the prefecture of the region.
"It is noted in the compendium of administrative acts of the prefecture of the region of implicit decisions of rejection made pursuant to the last paragraph of Article L. 6122-9 and the date on which they intervened, as well as tact renewals of authorization made pursuant to the fifth paragraph of Article L. 6122-10 and the date on which they take effect.
"The express or implied decisions relating to equipment referred to in Article L. 6122-14-1 are communicated by the competent regional health agency to the regional health agencies in the regions in which the equipment is operated. » ;
16° Article R. 6122-42 is as follows:
"Art. R. 6122-42. - The hierarchical remedy provided for in Article L. 6122-10-1 against the decision of the Director General of the Regional Health Agency setting out the regional plan for the organization of care or the orders bearing the interregional schemas provided for in Articles L. 1434-7 and L. 1434-10 shall be filed within two months of the publication provided for in Article R. 6121-3.
"The hierarchical remedy provided for in section L. 6122-10-1 against the decisions of the Director of the Regional Health Agency is filed by the applicant within two months of the notification of the decision. Where the applicant has requested, pursuant to the last paragraph of section L. 6122-9, the communication of the grounds for an implicit decision of rejection, the time limit of the hierarchical appeal shall be extended until two months after the day on which the reasons were communicated to the applicant. With respect to third parties, this deadline is short from the publication of the decision or the mention of the intervention of the tacit decision in the collection of administrative acts of the prefecture of the region.
"The appeal is sent to the Minister of Health by registered fold with a request for a notice of receipt.
"The appeal shall be deemed to be rejected on the expiry of a period of six months from its receipt by the Minister responsible for health if no decision of the contrary is made within that period.
"The hierarchical appeal by a third party against a decision of authorization made by the Director General of the Regional Health Agency shall be notified to the recipient without delay of the registered letter authorization with a request for a notice of receipt.
"The Minister's express decision on the appeal must be motivated. It is notified by registered letter with a request for a notice of receipt to the author of the hierarchical appeal and the recipient of the authorization. » ;
17° The first paragraph of article R. 6122-44 is as follows:
"The hierarchical remedy provided for in section L. 6122-10-1 against the decision of the Director General of the Regional Health Agency providing for the suspension of an authorization, the maintenance of the suspension, the amendment, the withdrawal of an authorization pursuant to sections L. 6122-12 and L. 6122-13, shall be filed within and under the terms and conditions set out in section R. 6122-42. »
In articles R. 6123-1, R. 6123-14, R. 6123-29, R. 6123-30, R. 6123-31, D. 6123-32-3 and R. 6123-32-6, the words "regional agency of hospitalization" are replaced by the words "regional agency of health", the words "health organization" are replaced by the words "regional agency of care" and "regional agency of care"
In R. 6123-37, the words: "Director of the Regional Hospitalization Agency" are replaced by the words: "Director General of the Regional Health Agency".
In sections R. 6123-47, R. 6123-50, R. 6123-51 and R. 6123-52, the words: "Director of the regional agency for hospitalization" are replaced by the words: "Director General of the Regional Health Agency" and the words: "Health Organization" are replaced by the words "organization of care".
In R. 6123-74, the words "health organization" are replaced by the words "care organization".
Section 7 of chapter III of title II of Book I is amended as follows:
1° In R. 6123-88, the words: "Director of the Regional Hospitalization Agency" are replaced by the words: "Director General of the Regional Health Agency" and the words: "Health Organization" are replaced by the words: "Health Organization";
2° In article D. 6123-95, the words "regional agency for hospitalization" are replaced by the words "regional health agency".
In R. 6123-101, the words: "health organisation of neurosurgery" are replaced by the words: "organization of neurosurgery care".
In R. 6123-108, the words "health organization" are replaced by the words "care organization".
In articles D. 6123-121 and D. 6123-126, the words: "regional agency for hospitalization" are replaced by the words: "regional health agency";
Section 1 of chapter IV, title II, of Book I is amended as follows:
1° In sections D. 6124-25 and D. 6124-177-16, the words "regional agency for hospitalization" are replaced by the words "regional health agency";
2° In section D. 6124-177-4, the words: "Director of the regional hospitalization agency" are replaced by the words: "Director General of the Regional Health Agency".
In section D. 6124-201, the words: "Director of the Regional Hospitalization Agency" are replaced by the words: "Director General of the Regional Health Agency".
Section 3 of chapter IV, title II, of Book I is amended as follows:
1° In section D. 6124-303, the words: "Director of the Regional Hospitalization Agency" are replaced by the words: "Director General of the Regional Health Agency";
2° In article D. 6124-306, the words "a so-called structure" are replaced by the words "an establishment", the words "this structure" are replaced by the words "this establishment", the words "the structure" are replaced by the words "the establishment" and the words "any so-called structure" are replaced by the words "any establishment";
3° In Article D. 6124-307, the words: "Every so-called structure" are replaced by the words: "Every establishment" and the word: "specified" is replaced by the word "specified";
4° Article D. 6124-308 reads as follows:
"Art. D. 6124-308. - The number and qualification of medical personnel, medical auxiliaries, rehabilitation personnel and the number of caregivers in hospitalization facilities at home are valued by the Director General of the Regional Health Agency, in view of the record referred to in section R. 6122-32, depending on the nature and volume of activity carried out, the frequency of benefits issued and their technical characteristics.
"A medical coordinator organizes the medical operation of the facility. In particular, it ensures the adequacy and permanence of the services provided to the needs of patients and the proper transmission of medical records and care required for the continuity of care.
"Personals referred to in the preceding paragraphs may be employed in the establishment, employees of any legal person who has entered into an agreement with that institution or a liberal exercise where the above-mentioned personnel are entitled to practice this practice. They are required to comply with the rules of procedure referred to in D. 6124-310.
"One of the staff mentioned in the first paragraph is that every home hospitalization facility has at all times at least one agent for six patients. This agent is, as the case may be, a medical assistant or a reeducation officer.
"The staff expressed in full-time equivalents, other than doctors, at the above-mentioned facility is composed of at least half nurses or nurses.
" Whatever the facility's authorized capacity, a nursing framework ensures the coordination of non-medical personnel interventions. The facility also has at least one nurse frame for 30 authorized places. » ;
5° Article D. 6124-309 reads as follows:
"Art. D. 6124-309. - Home hospitalization institutions are required to ensure the permanence and continuity of care, including Sundays and public holidays.
"They guarantee to patients that they take care of their transfer, if necessary, to a health facility that constantly welcomes patients in medical and surgical disciplines.
"In the event that the establishment of home hospitalization is not an institution with the above-mentioned disciplines, it is required to enter into a convention with another health institution with such disciplines. » ;
6° Section D. 6124-310 is amended as follows:
(a) In the first paragraph, the words: "the structure referred to in Article D. 6124-306" are replaced by the words "home hospitalization";
(b) In the seventh paragraph, the words: "the structure referred to in Article L. 6121-2" are replaced by the words "home hospitalization".
In section D. 6124-472, the words: "Director of the Regional Hospitalization Agency" are replaced by the words: "Director General of the Regional Health Agency".
Section 1 of Chapter II of Title III of Book I is amended as follows:
1° In sections R. 6132-2, R. 6132-7, R. 6132-8, R. 6132-10 and R. 6132-18, the words: "Director of the Regional Hospital Agency" are replaced by the words: "Director General of the Regional Health Agency";
2° Article R. 6132-3 is as follows:
"Art.R. 6132-3.-The person or representatives of each of the institutions adhering to the board of directors of the inter-hospital union shall be appointed by the director of the institution if it is a public institution, by his or her qualified organ if it is a private institution, and, with respect to institutions without a legal personality, by the public community or the private institution of which they belong.
“The number and distribution of seats allocated to these representatives shall be determined by the corresponding decisions of the establishments, as provided for in the first paragraph of this article.
"If there is no agreement, the number of representatives of the establishments on the union's board of directors is determined to:
« 1° A representative per institution with no means of hospitalization;
« 2° Two representatives per establishment of up to 750 beds;
« 3° Three representatives per establishment of more than 750 beds;
« 4° Six representatives per regional hospital centre.
"However, pursuant to the second paragraph of L. 6132-7 in its drafting prior to the publication of the Act No. 2009-879 of 21 July 2009 reforming the hospital and relating to patients, health and territories, no institution can obtain the absolute majority of seats.
"For the purposes of 2° and 3° of this article, it is not taken into account the beds that are not assigned to the missions defined in Article L. 6112-1 or the beds that are not actually and regularly in service. The number of medium or long stay beds is counted for half; that of the beds and places of psychiatry is counted for two thirds. In the event of a dispute, the number of beds to be retained is recognized by the Director General of the Regional Health Agency exercising guardianship over the union, after notice, if any, of the Director General of the Regional Health Agency of the region where the establishment is located. »
In section D. 6132-23, the words: "Director of the Regional Hospitalization Agency" are replaced by the words: "Director General of the Regional Health Agency".
Section R. 6132-26 is amended as follows:
(a) In the first paragraph, after the words: "in article L. 6132-2" are inserted the words: "in its writing before the publication of the Act No. 2009-879 of 21 July 2009 reforming the hospital and relating to patients, health and territories";
(b) The words: "Director of the regional hospitalization agency" are replaced by the words: "Director General of the Regional Health Agency".
Section 2 of chapter I of Book I title IV is amended as follows:
1° Article R. 6141-10 is as follows:
"Art. R. 6141-10. - Without prejudice to the application of the provisions of Article L. 6122-1:
« 1° Public health institutions with national, or interregional jurisdiction are created by decree after the advice of the National Committee of the Health and Social Organization;
« 2° Regional public health institutions are created by decree after the advice of the specialised commission of the organization of care of the regional conference of health and autonomy;
« 3° The public health institutions at the municipal, inter-communal and departmental levels are established by order of the Director General of the regional health agency of the region where the headquarters of the establishment is located after the advice of the specialized commission of the organisation of the care of the regional conference of health and autonomy and the commune where the headquarters of the establishment is located. » ;
2° The first paragraph of article R. 6141-11 is as follows:
"The transformation of one or more public health institutions, as provided for in section L. 6141-7-1, is decided by order of the Director General of the regional health agency of the region where the headquarters of the establishment is located, after the advice of the supervisory board of the institution(s) concerned and the municipality where the headquarters of the establishment is located. However, it is decided by decree when it concerns a national, interregional or regional public health institution";
3° Article R. 6141-12 is as follows:
"Art. R. 6141-12. - Public health institutions may be removed when the authorization provided for in Article L. 6122-1 is withdrawn or not renewed.
"The deletion is pronounced by order of the Director General of the Regional Health Agency of the region where the headquarters of the institution is located, after the advice of the Supervisory Board of the institution, the specialized commission of the organization of care of the Regional Health and Autonomy Conference and the municipality where the headquarters of the institution is located. However, the abolition of a public health institution whose jurisdiction is regional is pronounced by decree, after the advice of the supervisory board and the specialised commission of the organization of care of the regional conference of health and autonomy and the removal of a public health institution whose jurisdiction is national or interregional is decreed, after the advice of the supervisory council and the National Committee of the health and social organization.
"The deletion act defines the disposition of the establishment. In particular, it sets out the conditions for the devolution or realization of the assets and liabilities and provides, where applicable, the destination of the surplus of the assets. It designates the territorial community or the public institution to receive bequests and donations. Subject to the provisions of Article L. 6145-10, bequests and donations are deferred to this community or institution with the same assignment.
"The Director General of the Regional Health Agency makes his decision on the basis of a record that includes, in addition to the deliberations and notices provided for in the first and second paragraphs, the pieces to assess the justifications for deletion and its consequences, including financial and heritage. A decree of ministers responsible for health and social security sets out the composition of this case. » ;
4° In R. 6141-13, the words "administrative board" are replaced by the words "monitoring board".
Section 3 of Chapter I of Title IV of Book I is amended as follows:
1° Article R. 6141-14 is as follows:
"Art. R. 6141-14. - The modification of the list of regional hospital centres established by the decree referred to in the first paragraph of Article L. 6141-2 comes after notice of the supervisory board, the medical commission and the technical committee of the institution concerned, the specialized commission of the regional conference of health and self-government competent for the health sector of the region where the headquarters of this institution and the National Committee of Health and Social Organization is located. » ;
2° In R. 6141-26, the words: "Director of the Regional Hospitalization Agency" are replaced by the words: "Director General of the Regional Health Agency";
3° In sections D. 6141-48 and R. 6141-50, the words "administrative board" are replaced by the words "monitoring board".
Section R. 6143-38 is amended as follows:
1° The word "individual" is deleted;
2° The words "administration" are replaced by the words "monitoring".
In sections R. 6144-65 and R. 6144-66, the words: "Director of the regional hospitalization agency" are replaced by the words: "Director General of the Regional Health Agency".
In section D. 6144-85, the words "of the budget, the board of directors" are replaced by the words "of the statement of income and expenditure, the director".
Section 4 of chapter IV of title IV of Book I is amended to read:
1° In article R. 6144-86, the words: "local hospitals or" are deleted;
2° In article R. 6144-87, the words "of the establishment or" are deleted and the words ", in its writing before the publication of the Act No. 2009-879 of 21 July 2009 reforming the hospital and relating to patients, health and territories. are inserted after the reference: "L. 6132-3";
3°Aux articles R. 6144-88 and R. 6144-89, the words "the director of the establishment or" and "to the director of the establishment or" are deleted.
In sections R. 6147-62 and R. 6147-64, the words: "administrative board" are replaced by the words: "monitor board" and the words: "Director of the regional agency for hospitalization" are replaced by the words: "Director General of the regional health agency".
In R. 6147-75, the words: "Director of the Regional Hospitalization Agency" are replaced by the words: "Director General of the Regional Health Agency".
Section 2 of Chapter I of Book I title V is amended as follows:
1° In article D. 6151-2, the words "regional agency for hospitalization" are replaced by the words "regional health agency";
2° In section D. 6151-3, the words "administrative board" are replaced by the words "monitoring board" and the words "regional prefect" are replaced by the words "general director of the regional health agency".
Section R. 6154-5 is amended as follows:
1° The words: "Director of the Regional Hospitalization Agency" are replaced by the words: "Director General of the Regional Health Agency";
2° The words "administrative board" are replaced by the words "monitoring board".
Section 2 of chapter IV of Book I title V is amended to read:
1° Section R. 6154-11 is as follows:
"Art. R. 6154-11. - The commission of the institution's liberal activity is responsible for ensuring that this activity is carried out and that it is respected by law and regulations, as well as by the stipulations of the contracts of practitioners.
"It may take up any questions relating to the exercise of the liberal activity of practitioners or be seized by the Director General of the Regional Health Agency, the Director of the Primary Health Insurance Fund, the Chair of the Supervisory Board, the Chair of the Medical Establishment Commission and the Director of the Institution. A practitioner may refer to the Liberal Activity Commission for any matter relating to the exercise of his or her liberal activity.
"The Commission may submit to the authorities mentioned in the preceding paragraph any questions or proposals relating to the liberal activity of practitioners.
"The commission shall annually prepare a report on all the conditions under which this activity is carried out within the establishment and on the financial information provided to it under the last paragraph of Article L. 6154-5.
"For information, the report is provided to the Medical Establishment Commission, the Supervisory Board, the Director of the Institution and the Director General of the Regional Health Agency. » ;
2° Article R. 6154-12 is as follows:
"Art. R. 6154-12. - Members of the Liberal Activity Commission are appointed by the Director General of the Regional Health Agency.
"The commission includes:
« 1° A member of the Departmental Council for the Order of Physicians, not operating in the establishment and having no interest in the management of a private health institution, appointed on the proposal of the President of the Departmental Council for the Order of Physicians;
« 2° Two representatives designated by the Supervisory Board among its non-medical members;
« 3° A representative of the regional health agency designated by its Director General;
« 4° A representative of the primary health insurance fund designated by its director;
« 5° Two practitioners engaged in a liberal activity designated by the Medical Establishment Commission;
« 6° A full-time statutory practitioner, not exercising a liberal activity, designated by the medical establishment commission;
« 7° A representative of users of the health system designated by the director of the institution among users members of the supervisory board.
"The commission elects its president from among its members, by secret ballot, by an absolute majority in the first ballot, by a relative majority in the second round. In the event of equality of voice in the second round, the interested parties are departed for the benefit of the oldest. » ;
3° In sections D. 6154-15 and D. 6154-17, the words "Director of the regional hospitalization agency" are replaced by the words "Director General of the Regional Health Agency".
Section 3 of Chapter I of Title VI of Book I is amended as follows:
1° In sections R. 6161-14 and R. 6161-29, the words: "Director of the regional hospitalization agency" are replaced by the words: "Director General of the Regional Health Agency";
2° In R. 6161-15, the words "regional agency for hospitalization" are replaced by the words "regional health agency".
In R. 6161-37, the words: "Director of the Regional Hospitalization Agency" are replaced by the words: "Director General of the Regional Health Agency".
In sections D. 6162-2, D. 6162-4 and D. 6162-5, the words: "Director of the Regional Hospital Agency" are replaced by the words: "Director General of the Regional Health Agency".
Article R. 6211-25 is amended as follows:
1° In the first paragraph, the word "prefect" is replaced by the words: "Director General of the Regional Health Agency" and the words: "in his writing from Order No. 2010-49 of 13 January 2010 on medical biology" were inserted after the reference: "L. 6211-2";
2° In the second paragraph, the words: "the departmental management of health and social affairs" are replaced by the words: "the regional health agency".
In R. 6311-11, the word "prefect" is replaced by the words "Director General of the Regional Health Agency".
Section 3 of chapter I of Book III title I is amended as follows:
1° In article D. 6311-17, the words: "The Regional Directorate of Health and Social Affairs, which addresses an annual report of activity to the regional agency of hospitalization" are replaced by the words: "the regional health agency";
2° In article D. 6311-19, the words "region prefect" are replaced by the words "general director of the regional health agency".
Section 1 of Chapter II of Book III title I is amended as follows:
1° In sections R. 6312-1, R. 6312-5, R. 6312-21 and R. 6312-22, the word "prefect" is replaced by the words "Director General of the Regional Health Agency";
2° In R. 6312-4, the words: "the departmental management of health and social affairs" are replaced by the words: "the regional health agency";
3° In article R. 6312-17, the words: "the departmental directorate of health and social affairs of the department in which" are replaced by the words: "the regional health agency of the region in which" and the word "direction" is replaced by the word "agency";
4° Section R. 6312-20 is amended as follows:
(a) The words: "of the care-giving areas provided for in section L. 6314-1" are replaced by the words: "of the care-giving territories provided for in section R. 6315-1"
(b) The word "prefect" is replaced by the words "Director General of the Regional Health Agency".
Section 2 of chapter II of Book III title I is amended as follows:
1° In sections R. 6312-30, R. 6312-36, R. 6312-37 and R. 6312-40, the word "prefect" is replaced by the words "Director General of the Regional Health Agency";
2° In R. 6312-33, the word "prefect" is replaced by the words: "Director General of the Regional Health Agency" and the words: "The Departmental Directorate of Health and Social Affairs" are replaced by the words: "the Regional Health Agency";
3° In R. 6312-35, the word "prefect" is replaced by the words: "Director General of the Regional Health Agency" and the word "existing" is replaced by the words: "as mentioned in the second paragraph of R. 6312-33".
In R. 6314-4, the words: "the departmental management of health and social affairs" are replaced by the words: "the regional health agency".
In article R. 6315-1, the words: " prefect of the department and, in Paris, by the police chief" are replaced by the words: "Director General of the Regional Health Agency" and the word: "prefectural" is replaced by the words: "from the Director General of the Regional Health Agency".
In section D. 6321-1, the words: "of the national network development staffing under sections L. 162-43 to L. 162-46" are replaced by the words "of the intervention fund for the quality and coordination of care under section L. 221-1-1".
Section 1 of chapter II of Book III title II is amended as follows:
1° In R. 6322-2, the words: "prefect of the department" are replaced by the words: "Director General of the Regional Health Agency";
2° In sections R. 6322-3, R. 6322-5, R. 6322-6, R. 6322-9, R. 6322-10, R. 6322-11, R. 6322-12, R. 6322-13, R. 6322-19, R. 6322-20, R. 6322-22, R. 6322-26 and R. 6322-28, the word "prefect" is replaced by the words "regional health director";
3° In R. 6322-4, the word "prefect" is replaced by the words "Director General of the Regional Health Agency" and f, the reference to the article: "L. 6111-1" is replaced by the reference to the article: "L. 6111-2".
Section D. 6322-48 is amended as follows:
1° The first paragraph is as follows:
"The compliance visit under section L. 6322-1 shall take place within two months after the licensee has informed the Director General of the Regional Health Agency that it is in a position to commission its facilities. It is carried out by at least three persons designated by the Director General of the Regional Health Agency among the persons referred to in sections L. 1421-1 and L. 1435-7. The Director General of the Regional Health Agency may also appeal to a person with special qualifications. »
2° The word "prefect" is replaced by the words "Director General of the Regional Health Agency".
In article R. 6324-1, after the words: "Public Health Inspectors" are inserted the words: "and inspectors of regional health agencies with the quality of a doctor".
Chapter V of Book III title II is amended as follows:
1° In article R. 6325-1, the words "prefect of the department" are replaced by the words: "Director General of the Regional Health Agency";
2° Section R. 6325-2 is amended as follows:
(a) In the first paragraph of II, the words: "and after the advice of the pharmacist Regional Public Health Inspector, the prefect" are replaced by the words: ", the Director General of the Regional Health Agency";
(b) In the second paragraph of II and III, the word "prefect" is replaced by the words "Director General of the Agency".
Are repealed:
1° Section 3 of chapter III of Book I, Part VI, Chapter V of Book I, Part VI, Part VI, Part VI, Part VI, Part VI, Part VI, Part VI, Part VI, Part VI, Part VI, Part VI, Part VI, Part VI, Part 6, Part VI, Part 6, Part 6, Part 6, Part 6, Part 6, Part 6, Part 6, Part 6, Part 6, Part 6, Part 6, Part II, Part 6, Sub-
2° On the date of publication of the decree establishing regional health agencies and no later than 1 July 2010, articles R. 6131-1 to R. 6131-16;
3° Within six months after the publication of the decree issued pursuant to Article L. 1432-2, in its writing from the Act No. 2009-879 of 21 July 2009 reforming the hospital and relating to patients, health and territories, and no later than 31 December 2010, articles R. 6122-8 to R. 6122-14.
Chapters III and VI of Book VII title I and Book VIII of the former regulatory part of the Public Health Code are repealed.
In article R. 131-4, the words: "and of 2° of Article L. 6111-2 of the Public Health Code are replaced by the words: "or in a health facility authorized to provide long-term care."
In article R. 232-32, the words: "indicated to a and b of the 1st of Article L. 6111-2 of the Public Health Code » are deleted.
I. ― Section R. 241-24 is amended as follows:
1° At 2°, after the words: "of the state" are inserted the words: "and of the regional health agency";
2° The words: "The departmental director of health and social affairs" are replaced by the words: "The departmental director responsible for social cohesion";
3° The words: "Departmental Director of Labour, Employment and Vocational Training" are replaced by the words: "Regional Director of Business, Competition, Consumption, Work and Employment";
4° The d is thus written:
"(d) The Director General of the Regional Health Agency or his representative; "
II. ― The provisions of 3° of I do not apply to the Ile-de-France region and its departments and in the overseas regions and departments.
The 1st of Article D. 247-5 is supplemented by a f as follows:
“(f) Officers of regional health agencies appointed by the Director General of each agency; "
Sub-section 2 of chapter II, section 2 of title I is amended to read:
1° Section R. 312-185 is amended as follows:
(a) After the words: "of the prefect of the region" are added the words: "or the director general of the regional health agency";
(b) The words: "Regional Directorate of Health and Social Affairs" are replaced by the words: "Regional Directorate of Youth, Sports and Social Cohesion";
(c) The second paragraph is supplemented by the words: "and by the regional health agency for establishments and services under its jurisdiction pursuant to b and article L. 313-3";
2° In article R. 312-189, after the words: "State agents" are inserted the words "of the regional health agency or".
Section 3 of Chapter II of Title I is amended as follows:
1° The unique subsection becomes subsection 1;
2° A sub-section 3 is inserted as follows:
"Subsection 3
" Consultation of the Regional Employment Coordination Committee
Training and Regional Council
"Art.D. 312-193-5.-The Regional Coordinating Committee for Employment and Vocational Training and the Regional Council shall issue a notice on the outlines mentioned in theArticle L. 1434-12 of the Public Health Code as they relate to the establishments referred to in Article L. 312-1, 5° I. »
Section R. 312-197 is repealed.
At 1° in D. 313-15-4, the word "prefect" is replaced by the words "Director General of the Regional Health Agency".
Sub-section 2 of chapter III, section 3, of title I is amended as follows:
1° In article D. 313-18, the words: "Department Prefect, after the advice of the Regional Health Insurance Fund" are replaced by the words: "Director General of the Regional Health Agency";
2° In article D. 313-23, the words "Department Prefect" are replaced by the words "Director General of the Regional Health Agency".
Section R. 313-26 is amended as follows:
1° In the first paragraph, the words: "and the inspectors of the regional health agency with medical quality" are inserted before the word: "sworn";
2° In the fourth paragraph, the words: "to the prefect" are replaced by the words: "to the authority under which the inspectors and the authority or authority has been issued" and the words: "as well as to the President of the General Council if he has only or jointly granted the authorization" are deleted.
The second paragraph of Article R. 314-1 is amended as follows:
1° The words: "related to the 2nd of Article L. 6111-2" are deleted;
2° At the end of the sentence, the words "authorized to provide long-term care".
Section R. 314-3 is amended as follows:
1° At 1° of the I, the words: "the prefect of the department in which they are located" are replaced by the words: "the representative of the State in the region or, for the establishments and services mentioned in b of Article L. 313-3, the director general of the regional health agency, or for the establishments and services mentioned in 4° of the I of Article L. 312-1 competent, the prefect of department,
2° At 3° of I, the words ", or double pricing" and the words ", IV or V" are deleted;
3° It is inserted in I a 4° so written:
« 4° The Director General of the Regional Health Agency and the President of the General Council of the Settlement Department are, each, the Pricing Authority of the establishments and services that are subject to joint pricing or double pricing, pursuant to the IV or V of section L. 314-1. » ;
4° II is repealed, II bis becomes II and II ter becomes II bis.
In R. 314-26, the 3° is replaced by the following:
« 3° The cost of care provided by health facilities other than those authorized to provide long-term care. »
In the first paragraph of Article R. 314-31, the words: "of the State, the prefect of the region" are replaced by the words: "of the state or regional health agency, the prefect of the region or the director general of the regional health agency".
Section R. 314-36 is amended as follows:
1° At 2° of I, the words "at 5° and 8°" are replaced by the words "at 5°, at 8° and at 13°";
2° At 5° of I, the words: "Departmental limiting endowments pursuant to the III of Article L. 314-3" are replaced by the words: "Restricting regional allocations under Article L. 314-3 II";
3° In the last paragraph of I, after the word "prefect" are inserted the words "or the Director General of the Regional Health Agency";
4° In II, the words: "at the regional health insurance fund and" are deleted.
Section R. 314-41 is repealed.
The second paragraph of Article R. 314-49 is repealed.
I. ― Paragraph 5 of subsection 1 of section 2 of chapter IV of title I is amended as follows:
1° Section R. 314-60 is amended as follows:
(a) The beginning of the first paragraph is as follows:
"When the director of the family allowance fund at the place of operation of the services referred to in section L. 361-1 I or section L. 361-2 funded in whole or in part by that organization, the services shall forward (the remainder without change)";
(b) The last paragraph is repealed;
2° Section R. 314-62 is amended as follows:
(a) The first paragraph of I is as follows:
"When an establishment or service with a fee for the state or regional health agency is experiencing operational and management difficulties, the department prefect may submit this facility or service to the examination of an investigative mission. » ;
(b) The words: "The Regional Director of Health and Social Affairs" are replaced by the words: "The Regional Director of Youth, Sports and Social Cohesion";
(c) The words: "The Regional Health Insurance Fund" are replaced by the words: "the Director General of the Regional Health Agency";
(d) The words: "the regional director and the departmental director of health and social affairs" are replaced by the words: "the regional director of youth, sports and social cohesion, the departmental director responsible for social cohesion";
(e) The words: "the departmental director of competition, consumption and the suppression of fraud" are replaced by the words: "the regional director of companies, competition, consumption, work and employment".
II. ― The provisions of the 2° I e do not apply to the Ile-de-France region and its departments and in the overseas regions and departments.
Paragraph 1 of subsection 2 of section 2 of chapter IV of title I is amended to read:
1° The last paragraph of Article R. 314-64 is repealed;
1° In R. 314-69, the words: "and are subject to the control of legality to provisions of Article L. 6145-6 of the Public Health Code » are deleted;
2° Section R. 314-72 is amended as follows:
(a) In the second paragraph, the words: "according to the procedure established by the order taken under the first paragraph" are deleted;
(b) In the third paragraph, the words "in accordance with the terms fixed by the same order" are deleted.
Subparagraph 3 of paragraph 4 of sub-section 2 of chapter IV, section 2 is amended to read:
1° Section R. 314-90 is amended as follows:
(a) In I, the words: "the competent authority is the representative of the specified state" are replaced by the words: "the competent authority is determined";
(b) In the first paragraph of the II, the words: "The representative of the competent State is the prefect of the department where" are replaced by the words: "The competent administrative authority is the prefect of the region or the director general of the regional health agency in whose jurisdiction";
(c) The second paragraph of the second paragraph is replaced by three paragraphs:
"If not, the competent authority is the Region Prefect or the Director General of the Regional Health Agency where the headquarters of the managerial body is located.
"In both cases, the Director General of the Regional Health Agency is the competent authority if the proceeds of the tariffing of establishments and services under the b of Article L. 313-3 are preponderant with respect to other funding from the State budget and health insurance referred to in I.
"By derogation from the above provisions, when the establishments and services referred to in 4° I of Article L. 312-1 under the management of the agency concerned receive more than half of the overall funding referred to in I, the competent authority is the prefect of the department where the establishments, together, receive the most important share of this overall funding. » ;
2° Section I R. 314-91 is amended as follows:
(a) In the first paragraph, the words "to the Prefect or the President of the General Council" are replaced by the words "to the administrative authority";
(b) In the second paragraph, the words "to the Prefect or the President of the General Council referred to in the first paragraph" are replaced by the words "to the competent administrative authority referred to in the first paragraph";
(c) In the third and fifth paragraphs, the words "the Prefect or the President of the General Council" are replaced by the words "the competent administrative authority determined under section R. 314-90".
In the XII of Article R. 314-105, the words: "as mentioned in 2° of Article L. 6111-2 of the Public Health Code are replaced by the words: "health authorized to provide long-term care".
In R. 314-110, the words "by the prefect of the implantation department" are replaced by the words "by the competent pricing authority".
In R. 314-114, the words: "or 2° of Article L. 6111-2 of the Public Health Code are replaced by the words: "and for health facilities authorized to provide long-term care."
Paragraph 7 of subsection 4 of section 2 of chapter IV of title I is amended to read:
1° In R. 314-140, the words: "the prefect of the implantation department" are replaced by the words: "the director general of the regional health agency in which they are located";
2° In R. 314-141, the words: "the department prefect" are replaced by the words: "the director general of the regional health agency";
3° In sections R. 314-142, R. 314-143 and R. 314-144, the word "prefect" is replaced by the words "Director General of the Regional Health Agency".
In article R. 314-150, the words "the department's prefect" are replaced by the words "the prefect of the region".
In article R. 314-158, the words: 2° of Article L. 6111-2 of the Public Health Code are replaced by the words: "health authorized to provide long-term care".
In article R. 314-168, the first is thus written: "1° Care provided by health facilities other than those authorized to provide long-term care."
In sections R. 314-177 and R. 314-178, the words "the region prefect" are replaced by the words "the director general of the regional health agency".
In R. 314-193-2, the words ", the regional health insurance fund" are replaced by the words "the pension and occupational health insurance fund".
In article R. 314-196, the words "reported to 2° of Article L. 6111-2 of the Public Health Code are replaced by the words: "health related to the Public Health Code authorized to provide long-term care."
In R. 314-204, the words: "or 2° of Article L. 6111-2 of the Public Health Code are replaced by the words: "and in health facilities authorized to provide long-term care."
In the first paragraph of Article R. 315-4, the words "prefect" are replaced by the words "competent authority".
Sub-section 1 of chapter V, section 2 of title I is amended to read:
1° In R. 315-15, after the words: "from the headquarters of the establishment. The words are inserted: "or the Director General of the Regional Health Agency where this office is located for establishments whose authorization falls within the competence of the Director General of the Regional Health Agency, either exclusive or joint with the President of the General Council. » ;
2° In R. 315-23-5, after the words: "or its delegate in the borough" are added the words: ", or to the Director General of the competent regional health agency pursuant to Article L. 315-14".
Paragraph 1 of subsection 3 of section 2 of chapter V of title I is amended to read:
1° In article R. 315-48, after the words: "prefect of the department" are inserted the words: "or to the director general of the competent regional health agency pursuant to article L. 315-14";
2° In article R. 315-49, after the word "prefect" are added the words "or to the Director General of the Regional Health Agency".
Section D. 316-3 is amended as follows:
1° At the end of 1, the words are added: ", a Director General of a Regional Health Agency";
2° In 4, the words "in articles L. 242-2 and L. 243-1" are replaced by the words "in article L. 241-5".
In article R. 331-7, after the words: "of article L. 313-14" are inserted the words: "or article L. 313-14-1".
Section R. 344-14 is amended as follows:
1° In the first paragraph, the words "prefect of the department" are replaced by the words "Director General of the Regional Health Agency";
2° In the second paragraph, the word "prefect" is replaced by the words "Director General of the Regional Health Agency".
In sections R. 344-29, R. 344-30, R. 344-32 and R. 344-33, after the word "prefect" are inserted the words "or the Director General of the Regional Health Agency".
In article D. 344-38, after the word "prefect" are inserted the words "or the director general of the regional health agency".
Section 1 of Chapter V of Title IV is amended as follows:
1° After article R. 345-1, an article R. 345-1-1 is inserted as follows:
"Art. R. 345-1-1. - When a multi-year contract of objectives and means is entered into pursuant to Article L. 313-12-2 by a management body of a shelter and social reintegration, the contract shall have the effect of the agreement provided for in Article L. 345-3 if it includes the references provided for in Article R. 345-1. » ;
2° In article R. 345-2, the words: "by theArticle L. 322-4-16 of the Labour Code are replaced by the words: "in articles L. 5132-1 to L. 5132-3 and L. 5132-16 of the Labour Code."
In article R. 345-7, after the word "prefect" are inserted the words "area".
In chapter VIII of title IV, after article D. 348-6, an article R. 348-6-1 is inserted as follows:
"Art. R. 348-6-1. - When a multi-year contract of objectives and means is entered into pursuant to Article L. 313-12-2 by a managerial body of a reception centre for asylum seekers, the contract shall have the effect of the agreement provided for in Article L. 348-4 if it includes the references set out in the regulatory provisions defining the content of such a convention. »
I. ― Section 1 of Part V is amended to read as follows:
1° It is inserted before article R. 351-4 an article D. 351-3-1 as follows:
"Art.D. 351-3-1.-Members appointed to serve in the interregional courts of health and social pricing under the 2nd of Article L. 351-2 shall be appointed in a list with at least eight names, proposed equally by two colleges, respectively:
"–the representatives of the health-care institutions and services and users of these institutions within the specialised commission of the care organization of the regional conference on health and autonomy;
"the representatives of the management bodies of social and medico-social institutions and services and the users of these institutions within the specialized commission of the regional conference of health and self-reliance competent for medical and social support and support.
"These colleges are gathered at the request of the president of the Interregional Health and Social Pricing Court within one month at least before the date of renewal of the term of the members of the court. They delibrate applications from the chairs of the specialized commissions and communicated to the members of these colleges at least five days before the date of the meeting. The majority vote shall be taken, if any, by vote of the members present at the uninominal majority vote on each nomination. The vote is secret. »
2° Article R. 351-4 is as follows:
"The appointment of qualified persons to serve in the interregional courts of health and social pricing under the 2nd of Article L. 351-2 comes after the opinion of the president of the interregional court of health and social pricing. »
II. I is applicable as of the next renewal of the interregional courts of health and social pricing.
Section 3 of Part V is amended as follows:
1° The last sentence of article R. 351-20 is deleted;
2° The last sentence of Article R. 351-21 is deleted.
Section R. 111-1 is replaced by the following provisions:
"Art.R. 111-1.-The organization of social security includes:
« 1° With regard to the general regime:
“(a) The National Health Insurance Fund for Employees and Primary Health Insurance Funds;
“(b) The National Fund for Family Allowances and Family Allowances;
"(c) The Caisse nationale d'assurance vieuxsse and, for the departments of Haut-Rhin, Bas-Rhin and Moselle, the Caisse régionale d'assurance vieuxsse des travailleurs wages de Strasbourg;
"(d) The Central Agency for Social Security Organizations and Unions for the Recovery of Social Security and Family Allowances Contributions;
“e) The Union des caisses nationales de sécurité sociale;
“(f) Pension and occupational health insurance schemes;
“(g) In overseas departments, general social security funds;
“(h) Unions or union federations;
« 2° With regard to the agricultural system, organizations of agricultural social mutuality including the Central Fund for Agricultural Social Mutuality, funds of agricultural social mutuality and their associations and groups of economic interest;
« 3° With regard to the social system of the independents, the National Fund for the Social Plan of Independents and the basic funds;
« 4° With respect to special plans to certain branches of activity or certain companies for all or part of the benefits, funds, agencies and services;
« 5° With respect to mandatory basic health insurance plans, the National Union of Health Insurance Funds;
« 6° With regard to the expatriate regime, the Caisse des Français de l' étrangers;
« 7° All other organizations and services that provide, in whole or in part, the responsibilities assigned to the organizations and services mentioned in 1° to 6°. »
In R. 114-17, the words: "and regional" are deleted and after the word: "illness" are inserted the words: "and pension and occupational health insurance funds".
In sections R. 122-3 and R. 122-4, the words "subject to sections L. 183-1 and" are replaced by the words "as mentioned in the article".
Sub-section 3 of section 2 of chapter III of title II is amended as follows:
1° In article R. 123-45-2, the 2° is repealed, the 3°, 4° and 5° respectively become the 2°, 3° and 4° and, in the last paragraph, the reference: "4°" is replaced by the reference: "3°";
2° In R. 123-47-6, the words: ", regional unions of health insurance funds" and the words: "as well as those of the director of regional unions of health insurance funds" are deleted;
3° The thirteenth paragraph of Article R. 123-47-7 is deleted;
4° In R. 123-47-10, the words: ", from those of the social regime of the independents and regional unions of the health insurance funds" are replaced by the words: "and the social regime of the independents".
Chapter I of title IV is amended as follows:
1° In R. 141-1, the words: "Department of Health and Social Affairs" are replaced by the words: "General of the Regional Health Agency", the words: ", the doctor-in-council of the Primary Health Insurance Fund or the Regional Health Insurance Fund" are replaced by the words: "or the doctor-in-council of the Primary Health Insurance Fund, the pension and health insurance plan at work,
2° In R. 141-2, the words: "or the regional health insurance fund" are replaced by the words: "health insurance or pension insurance and occupational health insurance";
3° In section R. 141-4, the words ", or committee," and the words "or committee" are deleted;
4° In section R. 141-7, the words: "or the regional health insurance fund" are replaced by the words: "health insurance, pension insurance and occupational health insurance, the basic plan of the independent social plan".
In R. 143-21, the words "regional health insurance" are replaced by the words "retirement and occupational health insurance";
Sub-section 1 of chapter VII, section 1, of title IV is amended as follows:
1° The second paragraph of section R. 147-2 is replaced by the following provisions:
"When the sanctioning procedure is initiated against a health care institution or a care facility for dependent elderly people, the director of the local health insurance agency simultaneously informs the director general of the regional health agency. » ;
2° In R. 147-3, the words: "from the regional agency for hospitalization" and "from the regional management of health and social affairs" are replaced by the words: "from the director general of the regional health agency".
Chapter III of title V is amended as follows:
1° In article R. 153-2, the words "of the regional agency for hospitalization with regard to health facilities within the meaning ofArticle L. 711-1 of the Public Health Code, and the department prefect in respect of social or medico-social establishments under the law of 30 June 1975 referred to above, are replaced by the words: "General of the regional health agency in respect of health facilities and establishments referred to in 8°, 13°, 14° and 15° of the I of Article L. 312-1 of the Code of Social Action and Families";
2° In R. 153-9, the words: "and regional health insurance" are replaced by the words: "health insurance, pension and occupational health insurance funds" and the words: ", special financial recipients" are replaced by the words: "or regional or departmental director of public finances".
In article R. 161-72, the words: ", good practice contracts and public health contracts referred to in articles L. 162-12-17, L. 162-12-18 and L. 162-12-20 respectively are replaced by the words "as mentioned in article L. 162-12-17".
Section 5 of Chapter II of Title VI is amended as follows:
1° Its title is replaced by the following title: "Health institutions";
2° In sections R. 162-28, R. 162-41-3, R. 162-41-5, R. 162-41-6, R. 162-42-4 and R. 162-42-14, the words "of the regional agency for hospitalization" are replaced by the words "general of the regional health agency";
3° Section R. 162-32-3 is replaced by the following provisions:
"Art.R. 162-32-3.-Without prejudice to the provisions set out in sections R. 162-42-10 and following for establishments referred to in Article L. 162-22-6, the procedures for the monitoring by regional health agencies of the performance of the legislative, regulatory or contractual obligations required by the establishments are:
« 1° The health facility provides all facilities necessary for the exercise of controls that are performed in the presence of the director of the institution or his representative. During the visit, no observation shall be made in the presence of the patient or his family, or in the presence of a third party, a staff member or not, except the director or his representative;
« 2° On-site inspection officers present useful observations to the management of the facility. They shall prepare, within two months of the last day of check, a report to the institution which may then make its observations known within one month. » ;
4° In R. 162-40, the words: "Representatives of regional hospitalization agencies" are replaced by the words: "Representatives of the regional health agency", the words: "Hospitalization" are replaced by the word "health" and the first sentence of the last paragraph is deleted;
5° Section R. 162-42-8 is replaced by the following provisions:
"Art.R. 162-42-8.-The control commission referred to in Article L. 162-22-18 is composed of two colleges:
« 1° Five representatives of the regional health agency, designated by its Director General;
« 2° Five representatives of local health insurance funds and medical services, appointed by the Director General of the National Health Insurance Union.
"The members of the commission are appointed for five years. An alternate number equal to that of the holders is designated under the same conditions. The replacement of a member of the commission, in the event of termination of office during the term, shall be carried out under the same conditions as his or her appointment and for the remainder of the term.
"The chair of the commission is designated by the director general of the regional health agency among the agency's representatives. He has a dominant voice in case of equal sharing of voices.
"The Commission can only give its opinion if at least three members of each of the two colleges are present.
“The members of the Commission are subject to the secrecy of the deliberations. They cannot sit when they have a personal or direct interest in the matter that is examined. » ;
6° Section R. 162-42-9 is replaced by the following provisions:
"Art.R. 162-42-9.-The control committee proposes to the Director General of the regional health agency the annual regional control program that it develops on the basis of a project prepared by the regional coordination unit of the external control placed with it. This unit coordinates the implementation of the controls decided by the Director General of the Regional Health Agency and prepares the annual performance of the control program.
"The Regional Coordination Unit for External Control is composed, for two thirds, of health insurance personnel designated by the Supervisory Board on the proposal of the members referred to in 2° of section R. 162-42-8 and, for one third, of personnel of the Regional Health Agency. The unit is composed by a majority of physicians and includes the regional health insurance physician for employed workers, the regional health insurance physician for the sickness and maternity insurance scheme for non-earmarked workers in non-agricultural occupations, and the regional coordinator of agricultural social welfare schemes or their representatives. » ;
7° In R. 162-42-10, the words "hospitalization" are replaced by the word "health";
8° In R. 162-42-11, the words: "executive agency of regional hospitalization" are replaced by the words: "control";
9° In R. 162-42-12, the words: "the executive commission of the regional agency for hospitalization" are replaced by the words: "the director general of the regional health agency on the advice of the supervisory board";
10° The third sentence of section R. 162-42-13 is replaced by the following provisions: "At the end of this period, the Director General seeks the advice of the supervisory board, including the amount of the penalty. It shall impose a penalty, notify the establishment within one month of any means to determine the date of receipt by indicating to the establishment the time limit and terms and conditions for payment of the amounts in question, and, where applicable, the reasons for which it did not follow the notice of the supervisory board. It shall send a copy of this notification to the control board and to the credit union referred to in Article L. 174-2-1 or L. 174-18. When he decides not to impose a penalty while the supervisory board was in favour of it, he shall, within fifteen days, communicate the reasons for his abstention to the supervisory board. » ;
11° In article R. 162-42-14, the word "executive" is replaced by the words "control" and the words: "executive commission may impose the penalty provided for in article L. 162-22-18" are replaced by the words: "a sanction referred to in the fourth paragraph of article L. 162-22-18 may be imposed on it".
Sub-section 1 of chapter II, section 6, of title VI is amended as follows:
1° In sections R. 162-48 and R. 162-50, the words "prefect of the department" are replaced by the words "Director General of the Regional Health Agency of the Region";
2° In R. 162-50, the word "prefect" is replaced by the words "Director General of the Regional Health Agency" and the last sentence of the second paragraph is deleted.
In R. 162-54-7, the words "regional unions of the caisses" are replaced by the words "primary funds".
In R. 165-18, the words "of the French Registry Institution" are replaced by the words "general of the biomedicine agency".
In R. 166-5, the words: "agricultural mutual aid" are replaced by the words: "agricultural social mutuality" and the words: "regional health and social affairs" are replaced by the words: "general of the regional health agency".
In R. 167-6, R. 167-7 and R. 167-31, the words "health and social affairs" are replaced by the words "social cohesion".
In R. 174-22, the words "hospitalization" are replaced by the word "health".
Paragraph 1 of subsection 2 of section 7 of chapter IV of title VII is amended as follows:
1° In sections R. 174-30 and R. 174-32 to R. 174-35, the words "hospitalization" are replaced by the word "health";
2° In R. 174-30, the word "Director" is replaced by the words "Director General";
3° In article R. 174-35, the words "of the executive commission" are deleted.
In R. 182-2-5, the second paragraph is deleted and, at the beginning of the third paragraph, the word "It" is replaced by the words "The Director General".
Section R. 211-1-2 is amended as follows:
1° In the fifth paragraph, the words: "service provided for in the penultimate paragraph of section L. 183-1" are replaced by the words: " negotiated with the Director General of the Regional Health Agency pursuant to theArticle L. 1434-14 of the Public Health Code » ;
2° The first sentence of the tenth paragraph is replaced by the following provisions: "The Director shall also, in conjunction with the Medical Control Service and the Regional Health Agency, implement the measures necessary to achieve the objectives set out in the contract negotiated with the Director General of the Regional Health Agency pursuant to theArticle L. 1434-14 of the Public Health Code. »
Chapter V of title I is amended as follows:
1° Its title is replaced by the following provisions: "Retirement and Occupational Health Insurance Funds";
2° Its subdivision in three sections is removed;
3° In R. 215-1, the words: "the old age of regional health insurance funds and the positions of divisional and chief of service specific to these services" are replaced by the words: "the manager of old-age insurance in pension and occupational health insurance funds".
In R. 215-4, the words "regional health insurance" are replaced by the words "retirement insurance and occupational health".
In R. 216-1, the words: "and regional health insurance" are replaced by the words: "health insurance, pension insurance and occupational health insurance".
In R. 217-9, the words "regional health insurance" are replaced by the words "retirement insurance and occupational health".
In R. 221-13, the words "local and regional" are replaced by the words "primary health insurance and pension and occupational health insurance funds".
In R. 222-1, the words "regional health insurance" are replaced by the words "retirement insurance and occupational health".
In R. 226-1, the words: "or regional health insurance" are replaced by the words: "health insurance or a pension and occupational health insurance fund" and the words: "regional health insurance funds" are replaced by the words: "a pension and occupational health insurance fund".
In R. 232-1, the words "regional health insurance" are replaced by the words "retirement insurance and occupational health".
In R. 241-1, the word "regional" is replaced by the words "retirement and occupational health insurance".
In R. 242-6-1, the words "regional health insurance" are replaced by the words "retirement insurance and occupational health".
In R. 243-1, the word "regional" is replaced by the words "retirement and occupational health insurance".
Section 1 of Chapter I of Title V is amended as follows:
1° In sections R. 251-7 and R. 251-7-2, the words "regional" are replaced by the words "health insurance and pension and occupational health insurance funds";
2° In R. 251-13, the words "regional health insurance" are replaced by the words "retirement and occupational health insurance".
In R. 251-23, the words "regional social security" and the words "regional health insurance" are replaced by the words "retirement insurance and occupational health".
Section 1 of Chapter II of Title V is amended as follows:
1° In R. 252-4, the word "regional" is replaced by the words "retirement and occupational health insurance";
2° In sections R. 252-12 and R. 252-13, the words "regional health insurance" are replaced by the words "retirement and occupational health insurance".
Section 2 of Chapter II of Title V is amended as follows:
1° In sections R. 252-16, R. 252-17 and R. 252-19 to R. 252-21, the words "regional health insurance" are replaced by the words "retirement and occupational health insurance";
2° In R. 252-18, the words "regional health insurance" are replaced by the words "retirement and occupational health insurance" and the word "regional" is deleted.
In R. 253-2, the words "regional health insurance" are replaced by the words "retirement insurance and occupational health".
In the first paragraph of R. 261-1, the words: ", regional and" are replaced by the words: "and the Caisse", after the word: "Schart," inserted the words: "retirement and occupational health insurance funds," and the words: ", taking into account the health and social equipment plan," are deleted.
Chapter II of title VI is amended as follows:
1° In R. 262-1, the words "regional and primary" are replaced by the words: "primary health insurance and each pension and occupational health insurance fund";
2° 2° of Article R. 262-1-1 is replaced by the following provisions:
« 2° To provide funds to regional health agencies and, in Saint-Pierre-et-Miquelon, to the General Social Security Fund, to fund actions of prevention, education and health information, under the conditions prescribed by theArticle L. 1434-6 of the Public Health Code ;
3° In sections R. 262-1-1 and R. 262-2-1, the words "regional" are replaced by the words "health insurance and every pension and occupational health insurance fund";
4° In sections R. 262-3 and R. 262-5, the word "regional" is replaced by the words "retirement and occupational health insurance";
5° In sections R. 262-4 and R. 262-8, the words "regional and primary health insurance" are replaced by the words "primary health insurance and pension and occupational health insurance funds";
6° In R. 262-5, the words "patient care" are replaced by the words "health with accommodation" and the words: "care without hospitalization" are replaced by the words "health without accommodation";
7° A Section R. 262-7, the words: ", within the meaning of section L. 711-1 of the Public Health Code," and the words: "under the law of June 30, 1975" are deleted, the words: "regional and primary health insurance" are replaced by the words: "primary health insurance and pension and health insurance funds at work", the words "regional hospitalization"
8° In R. 262-11, the words "regional health insurance" and the word "regional" are replaced by the words "retirement insurance and occupational health".
In R. 263-2, the words "regional and primary health insurance" are replaced by the words "primary health insurance and pension and occupational health insurance funds".
In R. 264-3, the word "regional" is replaced by the words "retirement and occupational health insurance" and the words "health insurance" are deleted.
In R. 265-1, the words "regional health insurance" are replaced by the words "retirement insurance and occupational health".
Chapter V of title I is amended as follows:
1° In article R. 315-1, the words "of the regional agency for hospitalization" are replaced by the words "general of the regional health agency" and the words "established in article L. 710-17 of the public health code" are deleted;
2° In R. 315-3, the words: "of all health insurance funds" are replaced by the words: "primary health insurance funds and pension and occupational health insurance funds" and the words: "at the regional union of health insurance funds, to the Regional Director of Health and Social Affairs" are replaced by the words: "to the Regional Director of Health"
3° In sections R. 315-3, R. 315-10 and R. 315-11, the words "regional health insurance" are replaced by the words "retirement and occupational health insurance";
4° In R. 315-9, the word "regional" and the word "regional" are replaced by the words "retirement and occupational health insurance" and the words "health insurance" are deleted;
5° In R. 315-10, the words: "Regional Director of Health and Social Affairs" are replaced by the words: "Minister for Social Security".
In section R. 322-5, the words: "local or otherwise the director of the regional health insurance fund" are replaced by the words: "primary health insurance, the basic credit union of the social plan of the independents or the farm social mutuality fund".
In sections R. 324-1 and R. 324-2, the words: "local or otherwise the director of the regional health insurance fund" are replaced by the words: "primary health insurance, the basic credit union of the social plan of the independents or the agricultural social mutuality fund".
I. - Title V is amended as follows:
1° In article R. 351-24, the words: "Departmental Work" are replaced by the words: "Regional Business, Competition, Consumption, Work and Employment";
2° In R. 355-3, the words "or regional health insurance" are replaced by the words: "health insurance, pension insurance and occupational health insurance";
3° In R. 355-4, the words "or regional health insurance" are replaced by the words "health insurance, pension insurance and occupational health insurance";
4° In R. 355-5, the words "regional or regional health insurance" are replaced by the words "health insurance, pension insurance and occupational health insurance funds".
II. ― The provisions of 1° of I do not apply to the Ile-de-France region and its departments and in the overseas regions and departments.
In R. 381-2, the words "regional health insurance" are replaced by the words "retirement insurance and occupational health".
In R. 412-2, the words "regional health insurance" are replaced by the words "retirement insurance and occupational health".
In R. 421-4, the words "regional" are replaced by the words "retirement and occupational health insurance".
I. ― Section 3 of Chapter I of Title II is amended as follows:
1° In article R. 421-11:
(a) The words: "regional health insurance" are replaced by the words: "retirement and occupational health insurance";
(b) The words: "work, employment and vocational training" are replaced by the words: "business, competition, consumption, work and employment";
2° In R. 421-12, the words "regional health insurance" are replaced by the words "retirement and occupational health insurance".
II. ― The provisions of the 1° of the I do not apply to the Ile-de-France region and its departments and in the overseas regions and departments.
In R. 422-1, the word "regional" is replaced by the words "retirement and occupational health insurance".
Section 2 of chapter II of title II is amended as follows:
1° Its title is replaced by the following provisions: "Assignments of pension insurance and occupational health insurance funds";
2° In sections R. 422-4 and R. 422-9, the word "regional" is replaced by the words "retirement and occupational health insurance";
3° In sections R. 422-6 to R. 422-8, the words "regional health insurance" are replaced by the words "retirement and occupational health insurance".
In R. 434-32, the word "regional" is replaced by the words "retirement and occupational health insurance".
In R. 434-33, the words "regional health insurance" are replaced by the words "retirement insurance and occupational health".
In R. 461-4, the word "regional" is replaced by the words "retirement and occupational health insurance".
In article R. 481-4, the references: "R. 323-33-1" and "R. 323-34" are replaced respectively by the references: "R. 5213-2" and "R. 5213-9", the words: "State representative in the" are replaced by the words: "prefect of", the words: "regional health insurance" are replaced by the words: d'assurance-2
In R. 611-65, the words: ", the regional union of health insurance funds and the Regional Director of Health and Social Affairs" are replaced by the words: "and the Director General of the Regional Health Agency".
In R. 862-17, the words "health and social affairs" are replaced by the words "youth, sports and social cohesion".
Section 3 of chapter II, title IV, of Book I, sub-section 2 of chapter II, section 10, of Book I, chapters III and IV of Book I, and articles R. 162-60, R. 162-65, R. 162-66, R. 215-2, R. 215-3 and R. 256-10 are repealed.
Section 5 of Chapter II of Title VI is amended as follows:
1° In sections D. 162-9, D. 162-13 and D. 162-15, the words "of the regional agency for hospitalization" are replaced by the words "general of the regional health agency";
2° In article D. 162-9, the words: ", the medical commission or the medical conference referred to in articles L. 6144-1, L. 6161-8 and L. 6161-2 of the Public Health Code and the commission or subcommission referred to in the last two paragraphs of Article L. 5126-5 of the same code are replaced by the words: "or the medical conference referred to in the articles L. 6144-1 and L. 6161-2 of the Public Health Code » ;
2° In sections D. 162-10, D. 162-14 and D. 162-16, the words "hospitalization" are replaced by the word "health";
3° In article D. 162-16, the words: "of the commission or subcommission referred to in both last paragraphs of Article L. 5126-5 of the Public Health Code » are deleted.
In section D. 174-2, the words: "Regional Health and Social Affairs" are replaced by the words: "General of the Regional Health Agency" and the words: "Head of the Regional Service for Labour Inspection, Employment and Agricultural Social Policy" are replaced by the words: "Regional Director of Food, Agriculture and Forestry".
In section D. 174-17, the words: "the regional health insurance fund" are replaced by the words: "the director general of the regional health agency", the words: ", or in case of refusal of approval, the prefect of the region fixes the amount of the endowment before April 30 of the year concerned, after notice of the regional health insurance fund, and notifies it to the latter as well as to"
In section D. 176-4, the word "regional" is replaced by the words "retirement and occupational health insurance" and the words "health insurance" are deleted.
Chapter V of title I is amended as follows:
1° Its title is replaced by the following provisions: "Retirement and Occupational Health Insurance Funds";
2° Its subdivision in three sections is removed;
3° In section D. 215-1 and its annex, the words "regional health insurance" are replaced by the words "retirement and occupational health insurance";
4° In the appendix to article D. 215-1, the words: "Regional de Strasbourg" are replaced by the words: "Alsace-Moselle".
In section D. 217-1, the word "regional" is replaced by the words "retirement and occupational health insurance".
In section D. 224-5, the words: "regional health insurance" are replaced by the words: "retirement and occupational health insurance" and the words "related to this branch" are deleted.
In section D. 253-1, the words "and regional health insurance" are replaced by the words "health insurance, pension insurance and occupational health insurance".
Chapter V of title II is amended as follows:
1° In sections D. 325-1-1 and D. 325-1-3, the words "regional or" are replaced by the words: "retirement and occupational health insurance or";
2° In article D. 325-4, the words "regional health insurance" are replaced by the words "health at work".
In article D. 381-6, the words "regional health insurance" are replaced by the words "retirement and occupational health insurance" and the words "in the Paris region or in the Strasbourg region" are replaced by the words "in Ile-de-France or Alsace-Moselle".
In section D. 412-9, the words "health insurance" are replaced by the words "retirement and occupational health insurance" and the word "regional" is deleted.
In sections D. 412-42 and D. 412-43, the words "health insurance" are replaced by the words "retirement and occupational health insurance" and the word "regional" is deleted.
In section D. 412-79, the words: "and regional health insurance" are replaced by the words: "health insurance, pension insurance and occupational health insurance".
In section D. 412-93, the words "regional health insurance" are replaced by the words "retirement insurance and occupational health".
In section D. 432-8, the words "regional health insurance" are replaced by the words "retirement insurance and occupational health".
Section 1 of Chapter I of Title IV is amended as follows:
1° In sections D. 441-1 and D. 441-2, the word "regional" is replaced by the words "retirement and occupational health insurance" and the words "health insurance" are deleted;
2° In section D. 441-1, the word "regional" is replaced by the words "retirement and occupational health insurance".
Chapter I of title VI is amended as follows:
1° In article D. 461-27, the words: "regional prefect on the proposal of the Regional Director of Health and Social Affairs" are replaced by the words: "Director General of the Regional Health Agency";
2° In section D. 461-30, the words "regional health insurance" are replaced by the words "retirement insurance and occupational health".
In section D. 542-4, the words: "regional health insurance" are replaced by the words: "retirement and occupational health insurance" and the words: "technical guidance and professional reclassification provided for in section L. 323-11 of the Labour Code" are replaced by the words: "the rights and autonomy of persons with disabilities".
In section D. 634-1, the words "regional health insurance" are replaced by the words "retirement insurance and occupational health".
I. ― Chapters III and IV of Book I VIII and sections D. 221-13 to D. 221-20 are repealed.
II. The last paragraph of articles D. 231-5 and D. 231-6 is deleted.
1° In R. 313-22 of the Code of Entry and Residence of Aliens and the Right of Asylum, the words: "Departmental Inspector of Public Health competent in respect of the place of residence of the person concerned" are replaced by the words: "physician of the competent regional health agency in respect of the place of residence of the person concerned, designated by the Director General. By derogation, in Paris, this doctor is designated by the police prefect. » ;
2° In R. 313-24, the first four subparagraphs are replaced by a paragraph as follows:
"The regional medical commission includes two doctors from the regional health agency and two hospital practitioners, appointed by the director general of the agency. » ;
3° In section R. 313-25, the words: "the regional public health inspector referred to in the 1st of section R. 313-24 or his alternate" are replaced by the words: "one of the doctors of the regional health agency member of the commission or his deputy; the president and his deputy shall be appointed by the director general of the agency";
4° In section R. 313-26, the words "Public Health Inspector" are replaced by the words "physician of the Regional Health Agency";
5° In R. 313-27, the words: "Public Health Inspector" are replaced by the words: "physician of the regional health agency referred to in the first paragraph of R. 313-22";
6° In section R. 313-29, the words "Public Health Inspector" are replaced by the words "physician of the regional health agency";
7° In R. 313-30, the words: "Public Health Inspector" are replaced by the words: "physician of the regional health agency referred to in the first paragraph of R. 313-22".
The general code of territorial authorities is amended as follows:
1° The second part of article R. 2213-1-3 is as follows:
« 2° To the officers of the regional health agency designated for this purpose by the Director General; » ;
2° In the fifth paragraph of article R. 2213-1-4, the words: "the departmental management of health and social affairs" are replaced by the words: "the regional health agency";
3° Article D. 2223-109 is amended as follows:
(a) The words: "by the Departmental Directorate of Health and Social Affairs (DDASS)" are replaced by the words: "by the Director General of the Regional Health Agency";
(b) The words: "to the Departmental Directorate of Health and Social Affairs" are replaced by the words: "to the Director General of the Regional Health Agency";
4° At 3° of article R. 4422-33, the words: "Departmental directions of the health and social action of Corse-du-Sud and Haute-Corse" are replaced by the words: "from the regional health agency";
5° 6° and 7° of Article D. 5334-3 are replaced by the following provisions:
« 6° The Departmental Director of Social Cohesion or the Departmental Director of Social Cohesion and Population Protection or their representative;
« 7° The departmental director of youth and sports and the departmental director of health and social affairs or their representative, in the departments of the Ile-de-France region and in overseas departments; "
The first paragraph of section R. 421-3 of the mutuality code is replaced by the following:
"Decisions relating to the allocation of loans and grants referred to in Article L. 421-1 are made by the High Council for Mutuality, which may delegate its jurisdiction to the commission referred to in Article R. 411-3, which is composed of members designated within it. These decisions are adopted after notice by the Director General of the Regional Health Agency. Its notice is deemed to have been rendered after a period of two months from its referral. »
In article D. 62 of the Code of Military Disability Pensions and War Victims, the words "regional agency for hospitalization" are replaced by the words "regional health agency".
The Code of Criminal Procedure is amended as follows:
1° Section R. 53-8-24 is replaced by the following:
"Art.R. 53-8-24.-I. ― Pursuant to the provisions of the 3rd of Article 706-53-7, may directly interrogate the file, by a secure telecommunications system, from the sole identity of a person who has applied for recruitment, assignment, authorization, approval or authorization for an activity or profession involving contact with minors or whose exercise of such activity or profession must be checked:
« 1° Prefectures or prefectures specially authorized by them for this purpose;
« 2° Heads of services or agents individually designated and specially authorized by them for this purpose by the following State administrations:
“(a) The Human Resources Management Directorate of the Ministry of National Education and Higher Education;
“(b) Rectorates and academic inspections;
"(c) The Youth Judicial Protection Directorate and its regional branches;
"(d) The Directorate of Prison Administration and the Interregional Directorates of Prison Services;
“e) The direction of youth and popular education and the direction of sports;
“(f) The regional branches of youth, sports and social cohesion, the departmental branches of social cohesion and the inter-ministerial departmental directorates responsible for social cohesion;
“(g) Departmental branches of work, employment and vocational training.
« 3° General directors of regional health agencies.
“II. ― The persons mentioned in I indicate the reason why they question the file. » ;
2° In 8 of article D. 348-2, the words "Public Health Inspector" are replaced by the words "registered physician in a regional health agency";
3° Article D. 368 reads as follows:
"Art.D. 368.-Diagnosis and care missions in prisons and coordination of health prevention and education activities are carried out by a hospital team under the medical authority of a hospital practitioner, within the framework of an outpatient counselling and care unit, in accordance with the provisions of sections R. 6112-14 to R. 6112-25 of the Public Health Code.
"In application of theArticle R. 6122-14 of the Public Health Code, the Director General of the Regional Health Agency designates, for each penitentiary institution in the region, the public health facility located near the penitentiary institution, which is responsible for implementing the tasks described in the first paragraph of this article.
"In application of theArticle R. 6112-15 of the Public Health Codewhere the public health institution designated by the Director General of the Regional Health Agency does not have a psychiatry service and that the penitentiary facility is not served by a regional medico-psychological service referred to in section D. 372, the Director General of the Regional Health Agency also designates, under the same conditions, the public health institution or the private health facility that is entitled to provide the public health service referred to in the public serviceArticle L. 6112-1 of the Public Health Codelocated nearby, which is responsible for providing psychiatric care to inmates. » ;
4° Article D. 369 reads as follows:
"Art.D. 369.-In application of provisions of Article R. 6112-16 of the Public Health Code, the procedure for the intervention of the public health institution referred to in Article R. 6112-14 of the same Code shall be determined by a protocol signed by the Director General of the Regional Health Agency, the Interregional Director of Prison Services, the Chief of the Penitentiary Institution and the Director of the relevant health institution, after notice of the Supervisory Board.
"The same is true with respect to the procedure for the intervention of the health care facility that may be designated under theArticle R. 6112-15 of the Public Health Code. In this case, the Director of the Public Health Institution referred to in theArticle R. 6112-14 of the Public Health Code is also a signatory to this supplementary protocol. » ;
5° In the last paragraph of section D. 384-1, the words: "to the public health inspector of the departmental management of health and social affairs" are replaced by the words: "to the doctor of the regional health agency designated by the Director General";
6° Article D. 571-5 is as follows:
"Art.D. 571-5.-The request for the issuance of the bulletin and the response of the criminal record shall be made through the following administrative authorities:
« 1° The director of the interdepartmental departmental management responsible for the social cohesion of the department in which is located the head office of the host organizer with regard to the receptions mentioned at the 1st of article D. 571-4, or the establishment, service or place of life and reception with regard to the places of life and reception mentioned at the 4th of the same article;
« 2° The Regional Director of Judicial Protection of Youth or, in overseas departments, the Departmental Director of Judicial Protection of Youth, territorially competent in the department where the establishment, service or place of life and reception is located, with regard to:
“(a) The establishments and services mentioned in the 2nd of Article D. 571-4;
“(b) The places of life and reception mentioned in the 3rd of Article D. 571-4;
« 3° The Director General of the Regional Health Agency for the establishments and services referred to in 6° of Article D. 571-4. »
The rural code is modified as follows:
1° In R. 231-38, the words: "Departmental Director of Health and Social Affairs" are replaced by the words: "Director General of the Regional Health Agency" and the words: "Departmental Director of Maritime Affairs" are replaced by the words: "Departmental Director of the Territories and the Sea";
2° In R. 231-39, the words: "Departmental Director of Health and Social Affairs" are replaced by the words: "Director General of the Regional Health Agency";
3° Section D. 723-134 is amended as follows:
(a) The words: "Regional union of health insurance funds and" are deleted;
(b) The words: "regional agency for hospitalization" are replaced by the words: "regional health agency";
4° Section D. 723-135 is amended to read:
(a) In the first paragraph, the words: "in accordance with the directions defined by the regional union of health insurance funds" are replaced by the words: "in accordance with the regional health program mentioned in theArticle L. 1434-14 of the Public Health Code » ;
(b) In the second paragraph, the words "of the regional union of insurance funds and all others" are replaced by the words "of all";
5° In R. 732-30, the words "regional union of health insurance funds" are replaced by the words "regional health agency";
6° In article R. 732-31, the words: "regional unions of health insurance funds or, in overseas departments, at the general social security fund" are replaced by the words: "regional health agencies, as well as the health agency Guadeloupe, Saint-Barthélemy and Saint-Martin mentioned at theArticle L. 1442-1 of the Public Health Code and the Indian Ocean Health Agency referred to in Article L. 1443-1 of the same code;
7° In R. 742-2, the words: "and regional health insurance" are replaced by the words: "health insurance and pension insurance and occupational health insurance";
8° At 1° of article R. 751-1, the words "and regional bodies" are deleted;
9° In the second paragraph of section R. 751-160, the words ", the regional health inspector, or their delegates," are replaced by the words "or his delegate, a doctor of the regional health agency designated by the Director General."
The tourist code is thus modified:
1° In R. 412-15, the words: "Health and social inspectors or public health inspectors" are replaced by the words: "Health and social inspectors, public health inspectors or inspectors of regional health agencies with a medical quality";
2° In section R. 412-16, the words: "a health and social inspector or a public health inspector" are replaced by the words: "a health and social inspector, a public health inspector or an inspector of the regional health agency with the quality of a doctor."
In article R. 6341-32 of the Labour Code, the words: "or departmental directorates of health and social affairs" are replaced by the words: "to interdepartmental departmental directorates responsible for social cohesion".
After the first paragraph of article R. 121-15 of the urban planning code, it is inserted a paragraph as follows:
"On receipt of the documents submitted to it, the environmental authority shall consult with the Minister of Health for the documents referred to in 1° to 3° of I of section R. 121-14 or the Director General of the Regional Health Agency for the other documents. This consultation is deemed to be carried out in the absence of a response from the Director General of this agency within one month of receipt by the agency of the environmental authority's request. In the event of an emergency, this authority may reduce this period without it being less than 10 working days. »
The above-mentioned decree of 14 March 1986 is thus amended:
1° In Article 1, the words: "Departmental Director of Health and Social Affairs" are replaced by the words: "Director General of the Regional Health Agency";
2° In Article 6, the words "Departmental Director of Health and Social Affairs" are replaced by the words "Departmental Director for Social Cohesion".
The above-mentioned decree of 7 April 1988 is amended:
1° In Article 10, the words: "the Regional Director of Health and Social Affairs" are replaced by the words: "the Director General of the Regional Health Agency";
2° In sections 13, 30 and 64, the words "regional prefect" are replaced by the words "Director General of the Regional Health Agency";
3° In sections 19, 41 and 70, the words "regional prefects" are replaced by the words "general directors of regional health agencies";
4° In Article 40, the words: "the (or) prefect (s) of the region" are replaced by the words: "the Director General of the Regional Health Agency or the Directors General of the Regional Health Agencies";
5° In sections 62 and 65, the word "prefect" is replaced by the words "Director General of the Regional Health Agency";
6° Section 68 is amended as follows:
(a) The words: "regional prefect" are replaced by the words: "Director General of the Regional Health Agency";
(b) The words: "the Regional Director of Health and Social Affairs" are replaced by the words: "the Director General of the Regional Health Agency";
7° Section 68-1 is amended as follows:
(a) The words: "prefects of regions" are replaced by the words: "general directors of regional health agencies";
(b) The words: "the Regional Director of Health and Social Affairs" are replaced by the words: "the Director General of the Regional Health Agency".
The above-mentioned decree of 19 October 1988 is thus amended:
1° Section 4 is amended as follows:
(a) In the second paragraph, the words: "regional prefect" are replaced by the words: "Director General of the Regional Health Agency";
(b) In the third and fourteenth paragraphs, the words: "Regional Directors of Health and Social Affairs" are replaced by the words: "Director General of Regional Health Agencies";
(c) In the thirteenth paragraph, the words "pharmacist" are replaced by the word "pharmacist";
2° Section 15 is amended as follows:
(a) The words: "regional prefects" are replaced by the words "general directors of regional health agencies";
(b) The words: "Regional Director of Health and Social Affairs" are replaced by the words: "Director General of the Regional Health Agency";
3° In sections 16 and 20, the words: "Regional Director of Health and Social Affairs" are replaced by the words: "Director General of the Regional Health Agency";
4° Section 39 is amended as follows:
(a) The words: "Regional Director of Health and Social Affairs" are replaced by the words: "Director General of the Regional Health Agency";
(b) The words: "regional directors of health and social affairs" are replaced by the words "general directors of regional health agencies".
The above-mentioned decree of 1 September 1989 is amended:
1° In Article 2, the words: "Prefect of the Region" are replaced by the words: "Director General of the Regional Health Agency";
2° Section 3 is amended as follows:
(a) The words: "prefect of the region" are replaced by the words: "Director General of the Regional Health Agency";
(b) The words: "Regional Directors of Health and Social Affairs" are replaced by the words: "The Directors General of Regional Health Agencies";
3° In Article 4, the words: "Regional Director of Health and Social Affairs under the authority of the prefect" are replaced by the words: "Director General of the Regional Health Agency";
4° In Article 6, the words "regional directors of health and social affairs" are replaced by the words "general directors of regional health agencies,"
5° In Article 7, the words: "Regional Director of Health and Social Affairs" are replaced by the words: "Director General of the Regional Health Agency".
In article 5 of the above-mentioned decree of 25 January 1990, the words: "prefects of the region" are replaced by the words: "Directors General of Regional Health Agencies".
In article 4 of the above-mentioned decree of October 26, 1990, the words: "regional prefect" are replaced by the words: "Director General of the Regional Health Agency".
In article 10 of the above-mentioned decree of August 19, 1994, the word "prefect" is replaced by the words "Director General of the Regional Health Agency".
In sections 41 and 47-2 of the above-mentioned Decree of 6 May 1995, the fifth paragraph of Article 41 and the first paragraph of Article 47-2, the words: "the departmental management of health and social affairs" are replaced by the words: "the regional health agency" and the words: "powered under the provisions of Article L. 3222-1" are replaced by the words: "specified in Article L. 3222-1".
The above-mentioned decree of 18 July 2003 is amended:
1° In Article 6, the words: "by order of the department's prefect" are replaced by the words: "by the director of the institution who manages it";
2° Section 7 is amended as follows:
(a) In the first paragraph, the words: "Departmental Director of Health and Social Affairs" are replaced by the words: "Director of the institution that manages it";
(b) In the second sentence of the second paragraph, the words: "choice from among government officials in the department of control of these establishments and falling under a category A body" are replaced by the words: "selected by the director of the institution who manages these departmental parity administrative commissions";
3° In the second paragraph of Article 11, the word "prefect" is replaced by the words "Director of the establishment that manages it";
4° In Article 16, the word "prefect of the department" is replaced by the words "director of the institution that manages it";
5° Section 22 is amended as follows:
(a) In the first paragraph, the words: "at the departmental management of health and social affairs" are replaced by the words: "at the institution that manages it";
(b) In the third paragraph, the words: "Departmental Director of Health and Social Affairs" are replaced by the words: "Director of the institution that manages it";
6° In the first paragraph of section 23, the word "prefect" is replaced by the words: "Director of the establishment who manages it";
7° In Article 24, the words: "in the departmental management of health and social affairs" are replaced by the words: "in the institution that manages it";
8° In the last paragraph of section 33, the words: "Departmental Director of Health and Social Affairs" are replaced by the words: "Director of the institution that manages it";
9° In the first paragraph of section 36, the words: "Departmental Director of Health and Social Affairs" are replaced by the words: "Director of the institution that manages it";
10° In section 42, the word "prefect" is replaced by the words "Director of the establishment that manages it";
11° In section 45, the words: "Departmental Director of Health and Social Affairs" are replaced by the words: "President of the Supervisory Board of the institution that manages it";
12° In the first paragraph of section 47, the words: "the departmental management of health and social affairs" are replaced by the words: "the establishment that manages it";
13° In section 52, the word "prefect" is replaced by the words: "Director of the establishment who manages it";
14° In the second paragraph of Article 57, the words: "relevant prefects" are replaced by the words: "Managers of institutions that manage them";
15° In the last paragraph of Article 60, the words: "relevant prefects" are replaced by the words: "Managers of institutions that manage them";
16° In the annex to the above-mentioned decree, in subgroup 1 of the CAP 2 single group, the words: "Principal care directors, second-class care directors" are deleted.
Article 167 of the above-mentioned Decree of 22 October 2003 is repealed.
The above-mentioned decree of 16 January 2004 is amended:
1° In articles 10, 17, 30 and 38, the words "regional prefect" are replaced by the words: "Director General of the Regional Health Agency";
2° Section 31 is replaced by the following:
"Art. 31.-When the choice of interns is made in the interregion Provence-Alpes-Côte d'Azur-Corse and the interregion of the Antilles-Guyane, the powers entrusted by this decree to the directors general of the regional health agencies are exercised jointly by the director general of the regional health agency Provence-Alpes-Côte d'Azur and by the director general » ;
3° Section 48 is replaced by the following:
"Art. 48.-In the Caribbean-Guyane interregion, the responsibilities entrusted to the Director General of the Regional Health Agency by articles 10 and 17 of this decree are exercised jointly by the directors general of the regional health agencies of Guyane and Martinique and the agency of Guadeloupe, Saint-Barthélemy and Saint-Martin. »
The above-mentioned decree of 25 March 2007 is amended:
1° In Article 4, the words "administrative authority" are replaced by the words "the Director General of the Regional Health Agency";
2° In Article 5, the words "prefect of the department" and the words "representative of the competent state" are replaced by the words: "Director General of the Regional Health Agency";
3° In sections 8 and 9, the words: "Regional Prefect" are replaced by the words: "Director General of the Regional Health Agency";
4° Section 10 is amended as follows:
(a) The words: "Department Prefect" are replaced by the words: "Director General of the Regional Health Agency";
(b) The last paragraph is deleted;
5° In article 11, the words: "prefect" and the words: "state representative" are replaced by the words: "Director General of the Regional Health Agency";
6° Section 12-1 is amended as follows:
(a) In the sixth, seventh, eighth, ninth, tenth and eleventh prefects, the words "regional prefect" are replaced by the words "Director General of the Regional Health Agency".
(b) In the thirteenth paragraph, the words "the department prefect checks, at the request of the region prefect", are replaced by the words "the director general of the regional health agency checks".
The above-mentioned decree of 15 May 2007 is amended:
1° In article 1, the words: "the Departmental Directorate of Health and Social Affairs" and the words: "the services of the Departmental Directorate of Health and Social Affairs" are replaced by the words: "the Director General of the Regional Health Agency";
2° In the 3rd of Article 4, the words: "the Departmental Directorate of Health and Social Affairs" are replaced by the words: "the Director General of the Regional Health Agency";
3° In the b of the 1st of Article 16, the words: "the Departmental Directorate of Health and Social Affairs" are replaced by the words: "the Director General of the Regional Health Agency".
In section 2 of the above-mentioned decree of October 3, 2007, the words: "regional prefect" are replaced by the words: "Director General of the Regional Health Agency".
The 2nd of Article 2 of the aforementioned Decree of 31 January 2008 is replaced by the following provisions:
« 2° Representatives of the deconcentrated services of the State and its administrative public institutions concerned:
“(a) Two representatives of the regional environmental, development and housing branches, jointly appointed by the ministers responsible for construction and the environment;
“(b) A representative of the regional directorates of companies, competition and consumption, work and employment, appointed by the ministers responsible for consumption and labour;
"(c) A representative of regional health agencies designated by the Minister for Health. »
In Article 3 of the above-mentioned Decree of 30 December 2008, the date: "January 1, 2011" is replaced by the date: "January 1, 2012".
In all regulatory texts, the words "Director of General Administration, Personnel and Budget in the Ministry of Health", "Director of General Administration, Personnel and Budget of the Ministry of Health", "Director of General Administration, Personnel and Budget in the Ministry of Health", "Director of General Administration, Personnel and Budget of the Ministry of Social Affairs, Health and the City" and "Director of the General Administration, Personnel and Budget"
The decrees of 19 October 1988, 1 September 1989, 31 January 2008 and 25 August 2009 correspond to the provisions of a simple decree.
The provisions of this decree that replace the Departmental Director of Health and Social Affairs or the Regional Director of Health and Social Affairs with the Departmental Director of Social Cohesion or the Regional Director of Youth, Sports and Social Cohesion do not apply to the Ile-de-France region and its departments and in the overseas regions and departments.
The provisions of this Decree, unless otherwise provided, come into force on the date of publication of the decree establishing regional health agencies and no later than 1 July 2010.
Minister of State, Minister of Ecology, Energy, Sustainable Development and the Sea, responsible for green technologies and negotiations on the climate, Minister of State, Guard of Seals, Minister of Justice and Freedoms, Minister of Interior, Overseas and Territorial Communities
A N N E X E
ANNEX 31-1 PUBLIC HEALTH CODE
International Health Regulation referred to in Article D. 3115-8 adopted by the fifty-eighth World Health Assembly on 23 May 2005
International Health Regulations (2005)
PART I
DEFINITIONS, OBJECT AND SCOPE,
RESPONSIBLE PRINCIPLES AND AUTORIES
Article 1
Definitions
1. For the purposes of the International Health Regulations (hereinafter referred to as the "IRSI" or "Rules"):
"aircraft" means an aircraft travelling internationally;
"airport" means an arrival and departure airport for international flights;
"affected" means persons, baggage, cargo, containers, means of transport, goods, postal parcels or human remains that are infected or contaminated, or that convey sources of infection or contamination, and thus constitute a risk to public health;
"entry" of a means of transport means:
(a) In the case of a sea vessel, arrival or anchorage in the defined area of a port;
(b) In the case of an aircraft, arrival at an airport;
(c) In the case of an inland navigation vessel carrying out an international voyage, from the arrival to an entry point;
(d) In the case of a train or road vehicle, from arrival to a point of entry;
"competent authority" means an authority responsible for the implementation and application of health measures taken under this Regulation;
"baggage" means the personal effects of a traveller;
"cargo" means goods transported in a means of transport or in a container;
"postal parcel" means an item or package with an address and transported by international postal or courier services;
"contamination" means the presence of an infectious or toxic agent or substance on the surface of the body of a person or animal, in or on a consumer product or on other inanimate objects, including means of transportation, that may constitute a risk to public health;
"container" means a transport equipment:
(a) Having a perennial character and thus being sufficiently resistant to allow its repeated use;
(b) Specially designed to facilitate the transport of goods, without load failure, by one or more modes of transport;
(c) Muni of devices that make it easier to handle, especially when transshipment from one means of transport to another; and
(d) Specially designed to be easy to fill and empty;
"decontamination" means a procedure that involves taking health measures to eliminate an infectious or toxic agent or substance on the surface of the body of a person or animal, in or on a consumer product or on other inanimate objects, including means of transport, that may constitute a risk to public health;
"departure" means, for a person, a baggage, a cargo, a means of transport or a commodity, the act of leaving a territory;
"deratization" means the procedure that involves taking health measures to control or eliminate rodent vectors of human diseases present in baggage, cargo, containers, means of transport, services, goods and postage parcels at the point of entry;
"disinfection" means the procedure that involves taking health measures to control or eliminate infectious agents present on the surface of the body of a person or animal or in or on baggage, cargo, containers, means of transport, goods and postal parcels by direct exposure to chemical or physical agents;
"disinsectisation" means the procedure that involves taking health measures to control or eliminate insect vectors of human diseases present in baggage, cargo, containers, means of transport, goods and postal parcels;
"Director General" means the Director General of the World Health Organization;
"personal data" means any information relating to an identified or identifiable natural person;
"scientific evidence" means information providing evidence based on established and accepted scientific methods;
"team" means persons on board a means of transport other than passengers;
"event" means a pathological manifestation or a fact that creates a risk of disease;
"medical examination" means the preliminary examination of a person by an authorized health officer or a person acting under the direct supervision of the competent authority, in order to determine whether the health status of that person poses a potential risk to public health; it may include the verification of health documents and a clinical examination if the circumstances so warrant;
"operating a means of transport" means the natural or legal person responsible for a means of transport, or his representative;
"infection" means the penetration and development or multiplication of an infectious agent in the body of people or animals that may constitute a risk to public health;
"inspection" means the examination by the competent authority or under its supervision of areas, baggage, containers, means of transport, installations, goods or postal parcels, as well as relevant information and documents, to determine whether there is a risk to public health;
"intrusive" means the embarrassment caused by close or intimate contact or close interrogation;
"invasive" means the effraction or cutaneous incision or the introduction of an instrument or foreign body into the body or examination of a cavity. For the purposes of this Regulation, the medical examination of the ear, nose or mouth, the taking of the temperature by means of an atrial, oral or skin contact thermometer, or by means of thermal imaging devices, the inspection, auscultation, external palpation, retinoscopy, the external collection of samples of urine, skeleton or its
"Isolation" means the removal of sick or contaminated persons or baggage, containers, means of transport, goods or postal parcels affected to prevent the spread of infection or contamination;
"free practice" means, for a vessel, authorization to enter a port, to embark on or disembark on boarding, unloading or loading cargo or provisions; for an aircraft, the authorization, after landing, to proceed with boarding or disembarking, unloading or loading of cargo or provisions; and, for a means of land transport, authorization, arrival, to proceed with boarding or disembarking, unloading or loading of cargo or provisions;
"healthy" means a person suffering or suffering from a physical disorder likely to pose a risk to public health;
"illness" means a human pathology or a condition, regardless of origin or source, having or likely to have significant adverse effects to the human being;
"goods" means tangible products, including animals and plants, transported during an international journey, especially to be used on a means of transport;
"health measure" means used to prevent the spread of disease or contamination; a health measure does not include enforcement or security measures;
"carriage means" means an aircraft, a vessel, a train, a road vehicle or any other means of transportation used for an international voyage;
"ship" means a sea ship or an inland navigation vessel that makes an international voyage;
"public health observation" means monitoring the health status of a traveller over time to determine the risk of disease transmission;
"Organization" or "WHO" means the World Health Organization;
"RSI contact point to WHO" means the service that, at any time, must be able to communicate with the RSI national focal point;
"entrance point" means a crossing point for the international entry or exit of passengers, baggage, cargo, containers, means of transport, goods and postal parcels as well as organizations and sectors providing services at the entrance or exit;
"RSI national focal point" means the national centre, designated by each State Party, which must be at any time in a position to communicate with RSI focal points to WHO for the purposes of this Regulation;
"port" means a seaport or an internal port where the ships on an international voyage arrive or depart;
"frontier" means a land entry point in a State Party, including a point used by road vehicles and trains;
"Scientific principles" means fundamental laws and facts accepted and known through scientific methods;
" quarantine" means the restriction of activities and/or the removal of suspected persons who are not ill or baggage, containers, means of transport or suspicious goods, so as to prevent the possible spread of infection or contamination;
"recommendation" and "recommended" refer to temporary or permanent recommendations issued under this Regulation;
"permanent recommendation" means the non-binding opinion issued by WHO under Article 16 concerning the systematic or periodic application of appropriate health measures in response to certain persistent risks to public health, in order to prevent or reduce the international spread of diseases by creating the minimum intrusions to international traffic;
"temporary recommendation" means the non-binding opinion issued by the WHO under Article 15 for the purposes of a time-limited and risk-based application to deal with an international public health emergency in order to prevent or reduce the international spread of diseases by creating the minimum intruder to international traffic;
"container" means an animal, plant or substance that normally hosts an infectious agent and whose presence may constitute a risk to public health;
"permanent residence" means in the sense determined by the internal law of the State Party concerned;
"provisional residence" means in the sense determined by the domestic law of the State Party concerned;
"risk for public health" means the probability of an event that can harm the health of human populations, particularly an event that can spread internationally or pose a serious and direct danger;
"monitoring" means the systematic and ongoing collection, compilation and analysis of public health data and the timely dissemination of public health information for the purpose of assessment and public health action, as appropriate;
" Suspects" means persons, baggage, cargo, containers, means of transport, goods or postal parcels that a State Party considers to have been exposed or may have been exposed to a risk to public health and may constitute a source of disease spread;
"international traffic" means the movement of people, baggage, cargo, containers, means of transport, goods or postal parcels that cross an international border, including international trade;
"International Public Health Emergency" means an extraordinary event to which it is determined, as set out in this Regulation:
(i) That it poses a risk to public health in other states because of the risk of international spread of diseases; and
(ii) May it require coordinated international action;
"vehicle" means an insect or any animal that normally carries an infectious agent that poses a risk to public health;
"land transport vehicle" means a motorized means of transport for ground transportation on an international journey, which includes trains, coaches, trucks and cars;
"road vehicle" means a ground transportation vehicle other than a train;
"audit" means the provision to the WHO by a State Party of information confirming an event on the territory or territories of that State Party;
"international travel" means:
(a) In the case of a means of transport, a journey between points of entry located on the territories of more than one State, or a journey between points of entry located on the territory or territories of the same State if, during its journey, the means of transport is in contact with the territory of any other State, but only for such contacts;
(b) In the case of a traveller, a journey involving the entry into the territory of a State other than the territory of the State from which the traveler leaves;
"traveller" means a natural person who travels internationally;
"affected area" means a specific geographic location for which health measures were recommended by the WHO under this Regulation;
"Container loading zone" means a place or facility reserved for containers used in international traffic.
2. Unless otherwise provided or unless the context is opposed, any reference to this Regulation shall also refer to the annexes thereto.
Article 2
Purpose and scope
The purpose and scope of this Regulation is to prevent the international spread of disease, protect, control and respond to it through a public health action that is proportionate and limited to the risks it presents to public health, avoiding unnecessary barriers to international traffic and trade.
Article 3
Principles
1. This Regulation is implemented in full respect of the dignity of persons, human rights and fundamental freedoms.
2. Implementation of this Regulation is guided by the Charter of the United Nations and the Constitution of the World Health Organization.
3. The implementation of this Regulation is guided by the concern of its universal application to protect the entire world population from the international spread of diseases.
4. Pursuant to the Charter of the United Nations and the principles of international law, States have the sovereign right to legislate and enact legislation for the implementation of their health policies. In doing so, they must promote the purposes of this Regulation.
Article 4
Responsible authorities
1. Each State Party shall establish or designate a national focal point RSI and the authorities responsible, in its own jurisdiction, for the implementation of the sanitary measures provided for in this Regulation.
2. RSI national focal points must be at any time in a position to communicate with RSI contact points to the WHO referred to in paragraph 3 of this article. RSI National Focal Points will include:
(a) To address the RSI points of contact to the WHO, on behalf of the State Party concerned, the urgent communications relating to the application of this Regulation, including those referred to in Articles 6 to 12; and
(b) To disseminate information to the relevant sectors of the administration of the State Party concerned, including the areas responsible for monitoring and reporting, entry points, public health services, clinics and hospitals and other public departments, and to collect the information provided by these sectors.
3. WHO designates RSI focal points that must be at any time in a position to communicate with RSI national focal points. RSI points of contact to WHO send urgent communications regarding the application of this Regulation, in particular the provisions of Articles 6 to 12, to the national RSI focal points of the States Parties concerned. WHO may designate RSI points of contact at the Organization's headquarters or at the regional level.
4. States Parties shall communicate to the WHO the coordinates of their national focal points RSI and WHO shall communicate to States Parties the coordinates of its RSI focal points. These coordinates are continuously updated and confirmed annually. WHO shall communicate to all States Parties the coordinates of the national RSI focal points that are communicated to it pursuant to this Article.
PART II
INFORMATION AND ACTION OF PUBLIC HEALTH
Article 5
Monitoring
1. Each State Party shall acquire, strengthen and maintain, as soon as possible but not later than five years after the entry into force of this Regulation with respect to that State Party, the capacity to detect, evaluate, notify and report events under this Regulation, as set out in Annex 1.
2. Following the assessment referred to in paragraph 2 of Annex 1, a State Party may report to the WHO on the basis of a justified need and action plan and, in so doing, obtain an additional two-year period to fulfil its obligation under paragraph 1 of this Article. In exceptional circumstances, and by submitting a new action plan, the State Party may request that the deadline be extended to the Director-General for a maximum of two years, taking into account the technical advice of the Committee established under Article 50 (hereinafter the "Review Committee"). After the period provided for in paragraph 1 of this article, the State Party that has obtained an additional period shall report annually to the WHO on progress made in the full implementation.
3. WHO assists States Parties, at their request, to acquire, strengthen and maintain the capacities referred to in paragraph 1 of this Article.
4. The WHO collects information on events within its monitoring activities, and assesses the risk of the international spread of diseases that they involve and the obstacles to international traffic that they can create. The information received by the WHO under this paragraph shall be processed in accordance with the provisions of articles 11 and 45 as appropriate.
Article 6
Notification
1. Each State Party shall assess the events occurring in its territory by means of the decision-making instrument set out in Annex 2. Each State Party shall notify the WHO, through the most effective means of communication available to it, through the national focal point RSI and within twenty-four hours of the assessment of public health information, of any events occurring in its territory that may constitute an international public health emergency under the decision-making instrument and any health measures taken to deal with these events. If the notification received by the WHO relates to the competence of the International Atomic Energy Agency (IAEA), the WHO immediately informs the IAEA.
2. After a notification, the State Party continues to provide the WHO with accurate and sufficiently detailed public health information, where possible, including case definition, laboratory results, source and type of risk, number of cases and deaths, factors affecting the spread of the disease and the health measures used; and indicates, if necessary, the difficulties encountered and the help it needs to cope with the possible international public health emergency.
Article 7
Communication of information
in case of unexpected or unusual events
If a State Party has elements indicating the occurrence of an unexpected or unusual event in its territory, regardless of origin or source, which may constitute an international public health emergency, it shall provide the WHO with all relevant public health information. In this case, the provisions of section 6 apply fully.
Article 8
Consultation
In the event that events on its territory do not require the notification provided for in Article 6, in particular events for which it does not have sufficient information to use the decision-making instrument, a State Party may nevertheless keep the WHO informed through its national focal point RSI and consult the WHO on the health measures to be taken. These communications are governed by the provisions of paragraphs 2 to 4 of Article 11. The State Party in the territory of which the event occurred may ask the WHO to assist it in verifying the epidemiological information it was able to obtain.
Article 9
Other reports
1. WHO may take into account reports from sources other than notifications or consultations and assess such reports in accordance with established epidemiological principles; it then discloses information on the event in question to the State Party on whose territory this event is supposed to occur. Before taking any action on the basis of these reports, the WHO shall consult with the State Party on the territory of which the event is supposed to occur and shall endeavour to verify this information with it in accordance with the verification procedures defined in Article 10. To this end, the WHO makes the information received available to the States Parties, knowing that, only in cases where this is duly justified, the WHO can preserve the confidential nature of the source. This information is used in accordance with the procedure provided for in Article 11.
2. States Parties, to the extent possible, shall inform the WHO within 24 hours of receipt of data establishing the existence, outside their territory, of a risk identified for public health that may be at the origin of the international spread of diseases, attested by the export or import:
(a) Human cases;
(b) Infection or contamination vectors; or
(c) Contaminated goods.
Article 10
Audit
1. The WHO, pursuant to Article 9, requests the State Party to verify reports from other sources than notifications or consultations, according to which events that may constitute an international public health emergency would occur in its territory. In such cases, the WHO shall inform the State Party concerned about the reports it seeks to verify.
2. In accordance with the provisions of the preceding paragraph and Article 9, each State Party, at the request of the WHO, shall conduct the necessary verifications and:
(a) Provides within 24 hours a first response or an acknowledgement of receipt of the WHO request;
(b) Provides within 24 hours the public health information available on the events referred to in the WHO request; and
(c) Provides information to the WHO in the context of the Article 6 assessment, including information described in this article.
3. When the WHO is informed of an event that could constitute an international public health emergency, it proposes to work with the State Party concerned to assess the risk of the international spread of diseases, the impetus to international traffic that could be created and the adequacy of the control measures. These activities may include collaboration with other standardization organizations and the offer to mobilize international assistance to assist national authorities in conducting and coordinating on-site assessments. At the request of the State Party, WHO provides information in support of this offer.
4. If the State Party does not accept the offer of collaboration, the WHO may, when justified by the magnitude of the risk to public health, communicate to other States Parties the information it has, while urging the State Party to accept the offer of collaboration of the WHO, taking into account the views of the State Party concerned.
Article 11
Communication of information by WHO
1. Subject to the provisions of paragraph 2 of this Article, WHO shall communicate to all States Parties and, as appropriate, to the relevant intergovernmental organizations, as soon as possible and by the most effective, confidential means, the public health information it has received in accordance with Articles 5 to 10 and which is necessary to enable States Parties to face a public health risk. WHO should provide other States Parties with information that could help prevent similar incidents.
2. The WHO shall use the information received pursuant to Articles 6 and 8 and paragraph 2 of Article 9 for verification, assessment and assistance under this Regulation and, unless otherwise agreed with the States Parties referred to in these provisions, it shall not generally communicate this information to other States Parties before:
(a) It is determined that the event constitutes an international public health emergency under Article 12; or
(b) Information on the international spread of infection or contamination was confirmed by the WHO in accordance with established epidemiological principles; or
(c) It is established that:
(i) Measures against international spread are unlikely to result due to the nature of contamination, pathogen, vector or reservoir; or
(ii) The State Party does not have sufficient operational capacity to implement the necessary measures to prevent further spread of the disease; or
(d) The nature and extent of the international movement of passengers, baggage, cargo, containers, means of transport, goods or postal parcels that may be affected by infection or contamination require the immediate implementation of international control measures.
3. The WHO shall consult with the State Party on whose territory the event occurred with respect to its intention to provide information under this article.
4. When communicating to States Parties, in accordance with this Regulation, information received under paragraph 2 of this Article, the WHO may also make this information public if further information concerning the same event has already been published and if the dissemination of reliable and independent information is required.
Article 12
Determination of the existence of an emergency
International Public Health
1. The Director-General shall determine, on the basis of the information he receives, in particular from the State Party in whose territory an event occurs, whether an event constitutes an international public health emergency under the criteria and procedure set out in this Regulation.
2. If the Director-General considers, on the basis of an assessment under this Regulation, that there is an international public health emergency, he shall consult with the State Party on the territory of which the event occurs with respect to this preliminary conclusion. If the Director General and the State Party agree with this conclusion, the Director General, following the procedure set out in Article 49, requests the views of the Committee established pursuant to Article 48 (hereinafter referred to as the "Emergency Committee") concerning the appropriate temporary recommendations.
3. If, following the consultation referred to in paragraph 2 above, the Director General and the State Party in whose territory the event occurs does not agree within 48 hours on whether the event constitutes an international public health emergency, a decision shall be taken in accordance with the procedure set out in Article 49.
4. To determine whether an event is an international public health emergency, the Director-General takes into account:
(a) Information provided by the State Party;
(b) of the decision instrument in Appendix 2;
(c) In the opinion of the Emergency Committee;
(d) Scientific principles and available scientific evidence and other relevant information; and
(e) An assessment of the risk to human health, the risk of international spread of diseases and the risk of intrusions to international traffic.
5. If the Director General, after consultation with the State Party on the territory of which the international public health emergency has occurred, considers that the international public health emergency has ended, it shall take a decision in accordance with the procedure set out in Article 49.
Article 13
Public health action
1. Each State Party shall acquire, strengthen and maintain, as soon as possible but not later than five years after the entry into force of this Regulation with respect to that State Party, the ability to react promptly and effectively in the event of a risk to public health and an international public health emergency in accordance with Annex 1. WHO publishes, in consultation with Member States, guidelines to assist States Parties to develop public health capacity.
2. Following the assessment referred to in paragraph 2 of Part A of Schedule 1, a State Party may report to the WHO on the basis of a justified need and action plan and, in so doing, obtain an additional two-year period to meet its obligation under paragraph 1 of this Article. In exceptional circumstances and with a new action plan, the State Party may request that the deadline be extended to the Director General for a maximum of two years, taking into account the technical advice of the Review Committee. After the period provided for in paragraph 1 of this article, the State Party that has obtained an additional period shall report annually to the WHO on progress made in the full implementation.
3. At the request of a State Party, WHO is working together on public health risk action and other events by providing technical advice and assistance and assessing the effectiveness of the control measures put in place, including, where appropriate, by mobilizing international teams of experts to provide on-site assistance.
4. If the WHO, in consultation with the States Parties concerned in accordance with Article 12, establishes that there is an international public health emergency, it may offer, in addition to the support indicated in paragraph 3 of this Article, additional assistance to the State Party, including an assessment of the seriousness of international risk and the adequacy of measures to combat. It can, under this collaboration, provide international assistance to assist national authorities in conducting and coordinating on-site assessments. At the request of the State Party, WHO provides information in support of this offer.
5. At the request of the WHO, the States Parties shall, to the extent possible, support the WHO coordinated action.
6. At their request, WHO provides appropriate advice and assistance to other States Parties affected or threatened by the international public health emergency.
Article 14
WHO cooperation with organizations
intergovernmental bodies and international bodies
1. WHO cooperates and, where appropriate, coordinates its activities with other intergovernmental organizations and relevant international bodies for the implementation of these Regulations, including similar agreements and arrangements.
2. In the event that the notification or verification of an event, or the action taken to deal with it, is primarily within the competence of other intergovernmental organizations or international organizations, WHO coordinates its activities with these organizations or organizations for the purpose of implementing measures to protect public health.
3. Notwithstanding the above, no provision of this Regulation shall prevent or limit the provision by WHO of advice, support or technical or other assistance for public health purposes.
PART III
RECOMMENDATIONS
Article 15
Temporary recommendations
1. If it has been established, in accordance with Article 12, that there is an international public health emergency, the Director General shall issue temporary recommendations in accordance with the procedure set out in Article 49. These temporary recommendations may be amended or extended, as the case may be, especially after it has been determined that an international public health emergency has ceased, after which other temporary recommendations may be issued, as appropriate, for the purpose of preventing or detecting resurgence.
2. Temporary recommendations may relate to health measures to be implemented by the State Party in which the international public health emergency occurs, or by other States Parties, with regard to persons, baggage, cargo, containers, means of transport, goods and/or postal parcels to prevent or reduce the international spread of diseases and to avoid unnecessary interference with international traffic.
3. Temporary recommendations may be cancelled at any time in accordance with the procedure set out in Article 49 and automatically expire three months after publication. They may be amended or extended for additional periods of up to three months. Temporary recommendations cannot be maintained beyond the Second World Health Assembly following the decision on the international public health emergency to which they relate.
Article 16
Permanent recommendations
WHO may make permanent recommendations for the systematic or periodic implementation of appropriate health measures, in accordance with Article 53. Such measures may be applied by States Parties in respect of persons, baggage, cargo, containers, means of transport, goods and/or postal packages in the event of persistent specific risks to public health in order to prevent or reduce the international spread of diseases and to avoid unnecessary obstacles to international traffic. The WHO may, under section 53, amend these recommendations or cancel them, if any.
Article 17
Criteria for recommendations
In formulating, modifying or cancelling temporary or permanent recommendations, the Director General shall take into account:
(a) views of States Parties directly concerned;
(b) In the opinion of the Emergency Committee or Review Committee, as appropriate;
(c) Scientific principles and evidence and available scientific information;
(d) Health measures that, on the basis of an assessment of the risks appropriate to the situation, do not interfere with international traffic and trade and are no longer intrusive to people than other reasonably available measures that would ensure the necessary health protection;
(e) Relevant international norms and instruments;
(f) Activities of other relevant intergovernmental and international organizations; and
(g) Other specific and appropriate information regarding the event.
With regard to temporary recommendations, the urgency of the situation may limit consideration by the Director-General of the elements referred to in subparagraphs (e) and (f) of this article.
Article 18
Recommendations on persons, baggage, cargo, containers, means of transport, goods and postal parcels
1. WHO recommendations to States Parties regarding individuals may include the following advice:
(a) No specific health measures are recommended;
(b) Review travel history in affected areas;
(c) Examine the evidence that a medical examination and laboratory analyses were performed;
(d) Requiring medical examinations;
(e) Examine evidence of vaccinations or other prophylactic measures;
(f) Require vaccination or prophylactic measures;
(g) Place suspicious persons for public health purposes;
(h) Quarantine suspected persons or apply other health measures;
(i) Isolate or treat affected persons if necessary;
(j) Search for contacts of suspected or affected persons;
(k) Refuse the entry of suspicious and affected persons;
(l) Refuse the entry of unaffected persons into affected areas; and
(m) Submit to screening people from affected areas and/or apply exit restrictions.
2. WHO recommendations to States Parties regarding baggage, cargo, containers, means of transport, goods and postal parcels may include the following advice:
(n) No specific health measures are recommended;
(o) Examine the manifest and the itinerary;
(p) Conduct inspections;
(q) Examine evidence of initial or transit measures to eliminate infection or contamination;
(r) Carry out the handling of baggage, cargo, containers, means of transport, goods, postal parcels or human remains to eliminate infection or contamination, including vectors and tanks;
(s) Apply specific health measures to ensure the safe handling and transport of human remains;
(t) Isolate or quarantine;
(u) Require, in the absence of effective processing or process, the seizure and destruction under control of baggage, cargo, containers, means of transport, goods or postal parcels infected, contaminated or suspected; and
(v) Refuse departure or entry.
PART IV
ITEMS
Article 19
General obligations
In addition to other obligations under this Regulation, each State Party shall:
(a) Ensure that the capabilities set out in Schedule 1 for designated entry points are acquired within the time limits set out in Article 5, paragraph 1, and Article 13, paragraph 1,;
(b) Please specify which competent authorities are at each designated entry point in its territory; and
(c) Provides to the WHO, to the extent possible when it requests it to address a potential public health risk, relevant data on sources of infection or contamination, including vectors and reservoirs, at its entry points, which may lead to the international spread of diseases.
Rule 20
Airports and ports
1. States Parties shall designate airports and ports to acquire and maintain the capacity set out in Annex 1.
2. States Parties shall ensure that certificates of exemption from ship health control and vessel health control certificates are issued in accordance with the requirements of Article 39 and the model in Annex 3.
3. Each State Party shall communicate to the WHO the list of ports authorized to propose:
(a) The issuance of ship health certificates and the provision of services referred to in Annexes 1 and 3; or
(b) Only the issuance of certificates of exemption from ship health control; and
(c) The extension of the certificate of exemption from ship health control for a period of one month until the vessel arrives in the port to which the certificate may be issued.
Each State Party shall inform the WHO of any changes in the status of the ports on the list. WHO publishes the information received under this paragraph.
4. The WHO may, at the request of the State Party concerned, do the necessary to certify, following an appropriate investigation, that an airport or port located in the territory of that State Party shall fulfil the conditions set out in paragraphs 1 and 3 of this article. WHO can periodically review these certifications, in consultation with the State Party.
5. WHO, in collaboration with relevant intergovernmental organizations and international bodies, develops and publishes the guidelines for the certification of airports and ports referred to in this article. WHO also publishes a list of certified airports and ports.
Article 21
Border posts
1. Where warranted in the light of public health, a State Party shall designate border crossings to acquire the capacity set out in Annex 1, taking into account:
(a) The volume and frequency of various types of international traffic at border crossings that could be designated by a State Party, compared to other entry points; and
(b) Risks to public health in areas where international traffic originates, or crosses, before arriving at a particular border post.
2. States Parties with common borders should consider:
(a) To conclude bilateral or multilateral agreements or arrangements concerning the prevention or control of the international transmission of diseases to border posts in accordance with Article 57; and
(b) To jointly designate adjacent border positions for the capabilities described in Appendix 1, pursuant to paragraph 1 of this section.
Article 22
Role of competent authorities
1. The competent authorities:
(a) Ensure that baggage, cargo, containers, means of transport, goods and postal parcels and human remains from and from affected areas are maintained in such a state that they are free from sources of infection or contamination, including vectors and tanks;
(b) Ensure, to the extent possible, that facilities used by passengers at ports of entry are maintained in good hygiene conditions and remain free from sources of infection or contamination, including vectors and tanks;
(c) Supervise the deratization, disinfection, decontamination or decontamination of baggage, cargo, containers, means of transport, goods, postal parcels, and human remains or sanitary measures applied to persons, in accordance with this Regulation;
(d) Notify operators of means of transportation, as long as possible, of their intention to apply control measures to a means of transport, and provide, where appropriate, written information on the methods to be used;
(e) Supervise the hygienic removal and disposal of contaminated water or food, as well as human or animal excrements, wastewater and any other contaminated material on board a means of transport;
(f) Take all possible measures consistent with this Regulation to monitor and prevent the release by vessels of wastewater, waste, ballast water and other potentially pathogenic substances that may contaminate water from a port, river or canal, strait, lake or other international inland waterway;
(g) Are responsible for the supervision of service providers for passengers, baggage, cargo, containers, means of transport, goods and postal parcels and human remains at ports of entry, including the conduct of medical inspections and examinations as required;
(h) Provide effective emergency arrangements to deal with an unforeseen event affecting public health; and
(i) Contact the RSI national focal point on relevant public health measures taken pursuant to this Regulation.
2. Health measures recommended by WHO for passengers, baggage, cargo, containers, means of transport, goods, postal parcels and human remains from an affected area may be applied again upon arrival if there are verifiable indications and/or evidence that the measures applied at the departure of the affected area have failed.
3. De-insectization, deratization, disinfection, decontamination and all other sanitary procedures are carried out in such a way as to avoid causing trauma and, as far as possible, discomfort to persons or damage to the environment that would affect public health, or damage to baggage, cargo, containers, means of transport, goods and postal parcels.
PART V
PUBLIC HEALTH MEASURES
Chapter I
General provisions
Article 23
Health measures on arrival and departure
1. Subject to applicable international agreements and relevant articles of this Regulation, a State Party may, for public health purposes, upon arrival or departure:
(a) For passengers:
(i) Ask them about their destination in order to be able to contact them;
(ii) Ask them about their route in order to check whether they have stayed in an affected area or nearby, or their other potential contacts with an infection or contamination prior to their arrival, and check the sanitary documents of such travellers if required under this Regulation; and/or
(iii) Require a non-invasive medical examination, i.e. the least intrusive examination possible to achieve the public health goal;
(b) Require inspection of baggage, cargo, containers, means of transport, goods, postal parcels and human remains.
2. On the basis of evidence of the existence of a public health risk obtained by applying the measures provided for in paragraph 1 of this article or by other means, States Parties may apply additional health measures in accordance with this Regulation, and in particular with regard to a suspicious or affected traveller may, on a case-by-case basis, carry out the least intrusive and least invasive medical examination possible to achieve the public health objective of
3. Travellers shall not be subjected to any medical examination, vaccination or health or prophylactic measures under this Regulation without their express and informed consent, or that of their parents or guardians, having been obtained in advance, except in accordance with article 31, paragraph 2, and in accordance with the international legislation and obligations of the State Party.
4. Travellers who must be vaccinated or to whom a prophylactic measure must be proposed in the application of this Regulation, or their parents or guardians, are informed of any risk associated with vaccination or non-vaccination, and the use or non-use of the prophylactic measure in accordance with the legislation and international obligations of the State Party. States Parties shall inform doctors of this obligation in accordance with the legislation of the State Party.
5. Any medical examination, medical act, vaccination or other prophylaxis that involves a risk of disease transmission is performed on a traveller or is administered only in accordance with national and international safety standards and principles, to minimize this risk.
Chapter II
Special provisions applicable to means
transport and transport operators
Article 24
Transport operations
1. States Parties shall take all possible measures consistent with this Regulation to ensure that operators of means of transport:
(a) Apply health measures recommended by WHO and adopted by the State Party;
(b) Inform travellers of the health measures recommended by WHO and adopted by the State Party for the purpose of their application on board; and
(c) Maintain the means of transport that they are responsible for free from sources of infection or contamination, including vectors and tanks. The application of measures to eliminate sources of infection or contamination may be required if signs of their presence are found.
2. The special provisions applicable to means of transportation and to operators of means of transportation under this section are listed in Appendix 4. The specific measures applicable to means of transportation and to operators of means of transportation for vector-borne diseases are listed in Appendix 5.
Rule 25
Ships and aircraft in transit
Subject to the provisions of articles 27 and 43 or unless the applicable international agreements authorize it, no health measures shall be applied by a State Party:
(a) A ship not from an affected area that borrows a canal or other maritime route located in the territory of that State Party towards a port located in the territory of another State. Such a ship is authorized to board, under the supervision of the competent authority, fuel, water, food and provisions;
(b) A ship that passes through waters under its jurisdiction without having to stop in a port or on the coast; neither
(c) At an aircraft in transit at an airport under its jurisdiction, such aircraft may nevertheless be confined to a particular area of the airport, without boarding or landing, or loading or unloading. However, such an aircraft is authorized to embark, under the supervision of the competent authority, on fuel, water, food and provisions.
Rule 26
Trucks, trains and coaches in transit
Subject to the provisions of Articles 27 and 43 or unless the applicable international agreements authorize it, no sanitary measures shall be applied to a civilian truck, train or coach from an affected area that passes through a territory without embarking or disembarking, or loading or unloading.
Rule 27
Means of transport affected
1. If clinical signs or symptoms and information based on facts or evidence that there is a risk to public health, including sources of infection and contamination, are discovered on a means of transport, the competent authority considers that the means of transport is affected and may:
(a) Disinfect, decontaminate, decontaminate or decontaminate this means of transport, as appropriate, or enforce these measures under its supervision; and
(b) Decide in each case the technique to be used to adequately control the risk to public health in accordance with this Regulation. If methods or materials are recommended by the WHO for these operations, they must be used, unless the competent authority considers that other methods are as safe and reliable.
The competent authority may take additional health measures, including isolating the means of transport, if necessary, to avoid the spread of a disease. These additional measures should be reported to the RSI national focal point.
2. If the competent authority at the point of entry is not in a position to apply the control measures prescribed by this Article, the means of transport affected may nevertheless be authorized to leave, provided that:
(a) The competent authority, at the time of departure, shall communicate to the competent authority at the next point of entry known the data referred to in paragraph b; and
(b) In the case of a vessel, the required signs and control measures are recorded in the vessel's health control certificate.
The means of transport in question is authorized to charge, under the supervision of the competent authority, fuel, water, food and supplies.
3. A means of transport that has been considered to be affected is no longer considered as such when the competent authority has acquired the conviction:
(a) The measures referred to in paragraph 1 of this article have been effectively implemented; and
(b) That there are no conditions on board that could pose a threat to public health.
Rule 28
Ships and aircraft at ports of entry
1. Subject to the provisions of section 43 or those of the applicable international agreements, a vessel or aircraft may not be prevented, for public health reasons, from stopping at a point of entry. However, if this entry point is not equipped to apply the sanitary measures provided for in this Regulation, an order may be given to the vessel or aircraft to continue its route, at its own risk, to the nearest appropriate entry point at its disposal, unless a technical problem makes this diversion dangerous.
2. Subject to the provisions of Article 43 or applicable international agreements, free practice may not be refused, for public health reasons, to a ship or aircraft by the States Parties; In particular, it cannot be prevented from embarking or disembarking, unloading or loading goods or supplies, or from embarking on fuel, water, food and provisions. States Parties may require the authorization of free practice to an inspection and, if a source of infection or contamination is discovered on board, disinfection, decontamination, decontamination, decontamination or deratization of the vessel or aircraft, or other measures necessary to prevent the spread of the infection or contamination.
3. Where possible, and subject to the provisions of the preceding paragraph, a State Party shall grant free practice to a ship or aircraft by radio or other means of communication where, based on information received from that ship or aircraft prior to arrival, the State Party considers that such arrival will not result in the introduction or spread of a disease.
4. The master of a vessel or the captain of an aircraft, or their representative shall inform the controllers of the port or airport as soon as possible prior to arrival at the port or airport of destination of any cases of indicative disease of an infectious nature, or evidence of the existence of a public health risk on board as soon as the master or commander is aware of such illness or public health risks. This information shall be transmitted immediately to the competent authority of the port or airport. In the event of an emergency, they shall be communicated directly by the master or commander to the competent authorities of the port or airport.
5. If, for reasons beyond the control of its captain or master, an aircraft or a suspicious or affected vessel lands elsewhere than on the scheduled airport, or is in a port other than the intended arrival port, the following provisions apply:
(a) The pilot-in-command of the aircraft or the master of the vessel, or any other person responsible for it, shall endeavour by all means to communicate promptly with the nearest competent authority;
(b) As soon as the competent authority has been informed of the landing or anchorage, it may apply the sanitary measures recommended by the WHO or other sanitary measures provided for in this Regulation;
(c) Unless the emergency or need for communication with the competent authority requires it, no traveller present on board the aircraft or vessel shall depart from it and no cargo shall be removed, unless the competent authority authorizes it; and
(d) Once all the sanitary measures prescribed by the competent authority are implemented, the aircraft or vessel may, with respect to these sanitary measures, continue its route either to the airport or to the port where it was to land or to wet, or, if technical reasons prevent it, to a convenient airport or port.
6. Notwithstanding the provisions of this section, the master of a vessel or the captain of an aircraft may take all emergency measures that may be necessary to protect the health and safety of passengers. It shall inform the competent authority as soon as possible of any action taken under this paragraph.
Rule 29
Trucks, trains and civil coaches at ports of entry
The WHO, in consultation with the States Parties, develops guidelines for the application of sanitary measures to civilian trucks, trains and coaches at ports of entry and crossing a border crossing.
Chapter III
Special provisions for travellers
Rule 30
Travellers for public health observation
Subject to the provisions of Article 43 or unless the applicable international agreements authorize it, a suspicious traveller who is placed on observation for public health purposes upon arrival may be authorized to continue an international voyage if it is not an imminent risk to public health and if the State Party informs the competent authority at the point of entry to the intended arrival of the traveller, if it knows it. Upon arrival, the traveller presents himself to this authority.
Rule 31
Health measures related to passenger entry
1. The entry of a traveller into the territory of a State Party is not subject to invasive medical examination, vaccination or other prophylaxis. Subject to the provisions of Articles 32, 42 and 45, these Regulations do not prohibit States Parties from requiring medical examination, vaccination or other prophylaxis or proof of vaccination or other prophylaxis:
(a) When necessary to determine whether there is a risk to public health;
(b) As a condition of entry for any traveller seeking temporary or permanent residence;
(c) As a condition of entry for any traveller, pursuant to Article 43 or Annexes 6 and 7; or
(d) Applicable under section 23.
2. If a traveller for whom a State Party may require a medical examination, vaccination or other prophylaxis under paragraph 1 of this article refuses to give consent, or refuses to provide the information or documents referred to in paragraph 1 (a) of Article 23, the State Party concerned may, subject to the provisions of Articles 32, 42 and 45, refuse entry to that traveller. If the existence of an imminent risk to public health is established, the State Party may, in accordance with its national legislation and to the extent necessary to combat this risk, oblige the traveller to, or advise him, in accordance with Article 23(3):
(a) To undergo the least invasive and intrusive medical examination possible to achieve the intended public health objective;
(b) immunization or other prophylaxis; or
(c) Apply to additional established health measures to prevent or reduce the spread of the disease, including isolation, quarantine or observation for public health purposes.
Rule 32
Traveller processing
When applying the health measures provided for in this Regulation, States Parties shall treat travellers in a manner that respects their dignity and fundamental human rights in order to minimize any discomfort or discomfort that may be associated with these measures, including:
(a) By treating all travellers with courtesy and respect;
(b) Taking into account the sex of the person and the religious or socio-cultural concerns of travellers; and
(c) By providing or making arrangements to provide travellers in quarantine or isolation, or subjected to medical examinations or other public health measures, food and water in sufficient quantity, adequate accommodation and clothing, protection for their baggage and other personal effects, appropriate medical treatment, means of communication if possible in a language they understand and any other appropriate assistance.
Chapter IV
Special provisions applicable to goods,
containers and containers
Rule 33
Goods in transit
Subject to the provisions of section 43 or unless the applicable international agreements authorize it, goods other than living animals that are in transit without transshipment are not subject to sanitary measures under this Regulation or retained for public health purposes.
Rule 34
Container containers and cargo areas
1. States Parties shall ensure, to the extent possible, that container loaders use, in international traffic, containers free from sources of infection or contamination, including vectors and tanks, especially during the shelling.
2. States Parties shall ensure, to the extent possible, that the container loading areas remain free from sources of infection or contamination, including vectors and tanks.
3. Where, in the opinion of the State Party, the volume of international container traffic is sufficiently important, the competent authorities shall take all possible measures consistent with this Regulation, including by conducting inspections, to assess the sanitary status of containers and container loading areas in order to ensure that the obligations set out in this Regulation are fulfilled.
4. To the extent possible, facilities are available in the container loading areas for inspection and isolation of containers.
5. Containers and container shippers are working to avoid cross-contamination when loading multiple-use containers.
PART VI
SANITARY DOCUMENTS
Rule 35
General rule
No health document other than those provided for in this Regulation or by WHO recommendations is required in international traffic, provided that this section does not apply to travellers seeking temporary or permanent residence permits, nor does it apply to documents relating to the state of goods or cargo entering international trade required by applicable international agreements. The competent authority may require travellers to complete information forms on their contacts and health questionnaires, provided that the conditions set out in section 23.
Rule 36
Vaccination certificates or other prophylaxis measures
1. Vaccines and prophylaxis measures administered to travellers pursuant to this Regulation or recommendations, and certificates thereof, shall be in accordance with the provisions of Schedule 6 and, where appropriate, Schedule 7 concerning certain diseases.
2. A traveller with a immunization certificate or certificate attesting to another prophylaxis measure issued in accordance with the provisions of Schedule 6 and, where applicable, of Schedule 7, may not be returned as a result of the disease covered by the certificate, even if it comes from an affected area, unless the competent authority has verifiable indications and/or evidence that the immunization or prophylaxis
Rule 37
Maritime Health Declaration
1. Before its first port of call in the territory of a State Party, the master of a ship shall ensure the state of health on board and, unless that State Party so requires, it shall fill and hand over to the competent authority of the port, upon arrival or before the arrival of the ship if the vessel is equipped with the necessary equipment and if the State Party requires that it be put on board the ship in advance, a Declaration against the vessel
2. The master or, if any, the on-board physician shall provide the competent authority with all information on the state of health on board during the international voyage.
3. The Marine Health Declaration must conform to the model set out in Appendix 8.
4. A State Party may decide:
(a) Not requiring all ships upon arrival to submit the Marine Health Declaration; or
(b) To require the submission of the Marine Health Declaration pursuant to a recommendation for vessels from affected areas or to require vessels that may otherwise be carrying a source of infection or contamination.
The State Party shall inform the operators of ships or their representatives of these requirements.
Rule 38
Part of the General Aircraft Declaration
on health issues
1. In flight or landing on the first airport in the territory of a State Party, the pilot-in-command of an aircraft or his representative shall fulfil his or her best and shall give to the competent authority of that airport, unless that State Party so requires, the part of the General Declaration of Aircraft on sanitary matters, which shall be in accordance with the model set out in Annex 9.
2. The pilot-in-command of an aircraft or its representative shall provide the State Party with all information it requests on the state of health on board during the international voyage and on any health measures that may be applied to the aircraft.
3. A State Party may decide:
(a) Not requiring all aircraft upon arrival to submit part of the General Aircraft Declaration on Health Issues; or
(b) To require the submission of the portion of the General Aviation Declaration on Health Issues pursuant to a recommendation on aircraft from affected areas or to require aircraft that may otherwise be carrying a source of infection or contamination.
The State Party shall inform aircraft operators or their representatives of these requirements.
Rule 39
Ship Health Control Certificates
1. Ship health certificates and ship health certificates are valid for up to six months. This validity period may be extended by one month if the required inspection or control measures cannot be carried out at the port.
2. If a certificate of exemption from ship health control or a valid ship health control certificate cannot be produced or if the existence on board a public health risk is established, the State Party may proceed as indicated in paragraph 1 of Article 27.
3. The certificates referred to in this section shall conform to the model in Appendix 3.
4. Whenever possible, the control measures are implemented when the vessel and the holds are empty. If the vessel is on ballast, they are carried out before loading.
5. When control measures are required and implemented satisfactorily, the competent authority shall issue a vessel health control certificate, in which signs and control measures are noted.
6. The competent authority may issue a certificate of exemption from ship health control in any port referred to in section 20 if it is satisfied that the vessel is free of infection and contamination, including vectors and tanks. Such a certificate is normally issued only if the vessel's inspection was carried out while the vessel and the holds were empty or contained only ballast or other equipment of such nature or arranged in such a way that a complete inspection of the holds was possible.
7. If the conditions under which the control measures are applied are such that, in the opinion of the competent authority of the port where the operation is carried out, a satisfactory result cannot be obtained, the competent authority shall include a note to that effect on the vessel's health control certificate.
PART VII
RIGHTS
Rule 40
Fees collected under sanitary measures
concerning travellers
1. Except for travellers seeking temporary or permanent residence authorization, and subject to paragraph 2 of this article, the State Party shall not receive other rights under this Regulation for the following public health protection measures:
(a) Any medical examination provided for in this Regulation, or any further examination, which may be required by the State Party to ensure the health of the traveller examined;
(b) Any vaccination or other measure of prophylaxis administered to a traveller upon arrival, which is not subject to a published prescription or has been subject to a published prescription less than ten days before the administration of immunization or other prophylaxis;
(c) Appropriate isolation or quarantine measures imposed on a traveller;
(d) Any certificate issued to the traveller stipulating the measures applied and the date of application; or
(e) Any medical measures concerning baggage accompanying passengers.
2. States Parties may collect rights for health measures other than those referred to in paragraph 1 of this article, including those applied primarily in the interest of the traveller.
3. If fees are collected for the application of these sanitary measures to travellers under this Regulation, there shall be only one tariff for each State Party, all of which:
(a) are in accordance with this tariff;
(b) Do not exceed the actual cost of the service provided; and
(c) Regardless of the nationality, domicile or place of residence of the passengers concerned.
4. The tariff, and any changes that may be made, is published at least ten days before the perception of any right contained therein.
5. Nothing in this Regulation shall prevent States Parties from seeking reimbursement of expenses incurred as a result of the sanitary measures referred to in paragraph 1 of this Article:
(a) With operators or owners of means of transport in respect of their employees; or
(b) With the insurers involved.
6. Passengers or operators of means of transport may not be denied the possibility of leaving the territory of a State Party pending the settlement of the rights referred to in paragraphs 1 and 2 of this article.
Rule 41
Fees collected on baggage, cargo, containers, means of transport, goods or postal parcels
1. If fees are collected for the application of sanitary measures to baggage, cargo, containers, means of transport, goods or parcels under this Regulation, there shall be in each State Party only one tariff for such rights, all of which:
(a) are in accordance with this tariff;
(b) Do not exceed the actual cost of the service provided; and
(c) Any nationality, flag, registration or owner of the baggage, cargo, containers, means of transport, goods or postal parcels concerned shall be collected. In particular, no distinction is made between luggage, cargo, containers, means of transport, goods or parcels of national and foreign postal goods.
2. The tariff, and any changes that may be made, is published at least ten days before the perception of any right contained therein.
PART VIII
GENERAL PROVISIONS
Rule 42
Implementation of health measures
Health measures taken under these Regulations are implemented and implemented without delay and implemented in a transparent and non-discriminatory manner.
Rule 43
Additional health measures
1. This Regulation does not prevent States Parties from applying, in order to address specific risks to public health or to international public health emergencies, health measures in accordance with their applicable national legislation and their obligations under international law which:
(a) Ensure a level of health protection identical to or above the WHO recommendations; or
(b) Article 25, Article 26, paragraphs 1 and 2 of Article 28, Article 30, paragraph 1 (c) of Article 31 and Article 33,
provided that these measures are otherwise compatible with these Regulations.
These measures should not be more restrictive for international traffic or more intrusive or invasive for people than other reasonably applicable measures that would ensure the appropriate level of health protection.
2. States Parties shall base their decision to apply the sanitary measures referred to in paragraph 1 of this Article or the other sanitary measures referred to in paragraph 2 of Article 23, paragraph 1 of Article 27, paragraph 2 of Article 28 and paragraph 2 (c) of Article 31 on:
(a) Scientific principles;
(b) Available scientific evidence indicating a risk to human health or, if insufficient, available information, including from WHO and other relevant intergovernmental organizations and international bodies; and
(c) Any specific advice or advice available from WHO.
3. A State Party that applies the additional health measures referred to in paragraph 1 of this article, which significantly hamper international traffic, shall provide the WHO with the public health reasons and scientific information that justify it. WHO communicates this information to other States Parties and communicates information on the health measures applied. For the purposes of this article, it is generally understood that the refusal to allow international travellers, baggage, cargo, containers, means of transport, goods and items assimilated, or to carry over 24 hours of their entry or departure.
4. After assessing the information provided pursuant to paragraphs 3 and 5 of this article and other relevant information, the WHO may request the State Party concerned to review the appropriateness of applying the measures.
5. A State Party that applies the additional health measures referred to in paragraphs 1 and 2 of this article that significantly impede international traffic shall inform the WHO, within 48 hours of their implementation, of these measures and their health justification unless they are subject to a temporary or permanent recommendation.
6. A State Party that applies a health measure under paragraph 1 or paragraph 2 of this article shall review it within three months, taking into account the WHO opinion and the criteria set out in paragraph 2 of this article.
7. Without prejudice to the rights conferred on it by article 56, any State Party that suffers the consequences of a measure taken under paragraph 1 or paragraph 2 of this article may request the State Party applying this measure to consult it to clarify scientific information and public health reasons behind the measure and to find an acceptable solution for both States Parties.
8. The provisions of this Article may apply to the implementation of measures concerning travellers taking part in important gatherings.
Rule 44
Collaboration and assistance
1. States Parties undertake to work together, to the extent possible, to:
(a) To detect and assess events and to deal with them in accordance with these Regulations;
(b) Ensure or facilitate technical cooperation and the provision of logistical support, in particular for the acquisition, strengthening and maintenance of public health capacity in accordance with these Regulations;
(c) Mobilizing financial resources to facilitate the implementation of their obligations under this Regulation; and
(d) Formulate bills and other legal and administrative provisions for the purposes of this Regulation.
2. WHO, to the extent possible, works with States Parties to:
(a) Assess and assess their public health capacities to facilitate the effective implementation of these Regulations;
(b) Ensure or facilitate technical cooperation and logistical support to States Parties; and
(c) Mobilizing financial resources that will help developing countries acquire, strengthen and maintain the capacity set out in Annex 1.
3. Collaboration under this Article can be implemented at multiple levels, including bilaterally, through regional networks and WHO regional offices, and through intergovernmental organizations and international organizations.
Rule 45
Processing of personal data
1. Sanitary information collected or received by a State Party of another State Party or WHO pursuant to this Regulation and relating to an identified or identifiable person shall be held confidential and treated anonymously as provided for in national legislation.
2. Notwithstanding paragraph 1, States Parties may disclose and use personal data if necessary to assess and manage a public health risk, but States Parties, in accordance with national legislation, and WHO shall ensure that such data:
(a) be treated impartially and with due respect for legality and not used in a manner incompatible with that purpose;
(b) Be adequate, relevant and do not exceed what is necessary for this purpose;
(c) be accurate and, where appropriate, updated; all reasonable arrangements shall be made to ensure that inaccurate or incomplete data are erased or corrected;
(d) Do not be kept longer than it is necessary.
3. The WHO shall, to the extent possible, provide to the interested party who makes the request for the personal data referred to in this article, in an intelligible form, without delay or excessive costs, and, if necessary, make corrections.
Rule 46
Transport and Handling of Biological, Reactive Substances
for diagnostic purposes
In accordance with national legislation and the applicable international guidelines, States Parties shall facilitate the transport, entry, exit, treatment and disposal of biological substances, diagnostic samples, reagents and other diagnostic materials for the verification and action required by this Regulation.
PART IX
RSI EXPERTS LIST,
URGENCE COMMITTEE AND EXAMEN COMMITTEE
Chapter I
List of RSI experts
Rule 47
Composition
The Director General shall prepare a list of experts from all relevant areas of competence (hereinafter referred to as the "IHR List"). Unless otherwise provided by this Regulation, the Director General shall appoint the members of the IHR List in accordance with the Regulations applicable to WHO Panels and Committees of Experts (hereinafter referred to as the "Regulation applicable to WHO Panels"). In addition, it appoints a member at the request of each State Party and, where appropriate, experts proposed by relevant intergovernmental organizations and regional economic integration organizations. The States Parties concerned shall communicate to the Director-General the qualifications and competence of each expert they propose. The Director General shall periodically inform States Parties and intergovernmental organizations and relevant regional economic integration organizations of the composition of the IHR List of Experts.
Chapter II
Emergency Committee
Rule 48
Mandate and composition
1. The Director General shall establish an Emergency Committee which, at the request of the Director General, shall give his opinion on:
(a) Whether an event is an international public health emergency;
(b) The question of whether an international public health emergency has ended; and
(c) The proposal to issue, amend, extend or cancel temporary recommendations.
2. The Emergency Committee is composed of experts selected by the Director General from among the members of the IHR List of Experts and, where appropriate, other expert tables of the Organization. The Director General determines the duration of the membership's mandate to ensure continuity of the review of a particular event and its consequences. The Director General selects the members of the Emergency Committee on the basis of the skills and experience required for a particular session and with due regard to the principles of equitable geographical representation. At least one member of the Emergency Committee should be an expert designated by a State Party in whose territory the event occurs.
3. The Director General may, on his own initiative or at the request of the Emergency Committee, appoint one or more technical experts to advise the Committee.
Rule 49
Procedure
1. The Director General shall convene the meetings of the Emergency Committee by selecting several experts from among those referred to in paragraph 2 of Article 48, depending on the areas of competence and experience that best correspond to the specific event that is happening. For the purposes of this Article, the Emergency Committee's "meetings" may designate electronic teleconferences, videoconferences or communications.
2. The Director General shall communicate to the Emergency Committee the agenda and any relevant information regarding the event, including information provided by the States Parties, as well as any temporary recommendation that the Director General propose to make.
3. The Emergency Committee shall elect its Chairperson and, after each meeting, shall prepare a brief report on its deliberations and deliberations in which it shall include its views on possible recommendations.
4. The Director General invites the State Party on whose territory the event occurs to present its views to the Emergency Committee. To this end, the Director General informs him as long in advance as necessary of the date and agenda of the Emergency Committee meeting. However, the State Party concerned cannot request the adjournment of the meeting of the Emergency Committee to explain its views.
5. The opinion of the Emergency Committee shall be communicated to the Director General for consideration. The Director-General finally decides.
6. The Director General shall inform the States Parties of its decision to declare that there is an international public health emergency or that it has terminated and shall notify them of any health measures taken by the State Party concerned, any temporary recommendations and their modification, extension or cancellation, and the opinion of the Emergency Committee. It also informs of these temporary recommendations, including their modification, extension or cancellation, operators of means of transport, through the States Parties and relevant international bodies. It then disseminates this information and recommendations to the general public.
7. States Parties on whose territory the event occurred may propose to the Director-General that an international public health emergency and/or temporary recommendations be terminated and may present a briefing to the Emergency Committee.
Chapter III
The Review Committee
Rule 50
Mandate and composition
1. The Director General shall establish a Review Committee which shall perform the following functions:
(a) To issue technical recommendations to the Director-General concerning amendments to this Regulation;
(b) Provide the Director-General with technical advice on the permanent recommendations and any changes or cancellations thereof;
(c) Provide technical advice to the Director-General on any matters before the Director-General concerning the operation of these Regulations.
2. The Review Committee shall be considered as an expert committee and shall be subject to the Regulations applicable to WHO expert tables, unless this section otherwise provides.
3. The members of the Review Committee are selected and appointed by the Director General from among the individuals listed on the IHR List of Experts and, where appropriate, from other expert tables of the Organization.
4. The Director General shall determine the number of members to be invited to a meeting of the Review Committee, as well as the date and duration of the meeting, and shall convene the Committee.
5. The Director General shall appoint the members of the Review Committee for the duration of the work of a session only.
6. The Director-General selects the members of the Review Committee on the basis of the principles of equitable geographical representation, gender parity, balanced representation of developed and developing countries, representation of different currents of thought, approaches and practical experiences in the various regions of the world, and appropriate interdisciplinary balance.
Rule 51
Conduct of work
1. The decisions of the Review Committee shall be taken by a majority of the members present and voting.
2. The Director General invites Member States, the United Nations and its specialized agencies and other relevant intergovernmental organizations or non-governmental organizations in official relations with the WHO to appoint representatives to attend the sessions of the Committee. These representatives may submit memorandums and, with the consent of the Chair, make statements on the topics under consideration. They don't have the right to vote.
Rule 52
Reports
1. For each session, the Review Committee shall prepare a report outlining its advice and advice. The report is approved by the Committee before the end of the session. These opinions and advice are not binding on the Organization and are presented in the form of advice addressed to the Director General. The text of the report cannot be amended without the Committee's consent.
2. If the findings of the Examining Committee are not unanimous, any member has the right to express one or more different professional opinions in an individual or group report, which indicates why a dissenting opinion is formulated and which is part of the Committee's report.
3. The report of the Committee is submitted to the Director General, who communicates the Committee's advice and advice to the Health Assembly or the Executive Council for consideration and action.
Rule 53
Procedure for standing recommendations
When the Director General considers that a permanent recommendation is necessary and appropriate in the face of a public health risk, he requests the views of the Review Committee. In addition to the relevant paragraphs of articles 50 to 52, the following provisions apply:
(a) The Director General or, through the Director General, States Parties may submit to the Review Committee proposals concerning the formulation, modification or cancellation of permanent recommendations;
(b) Any State Party may submit to the Review Committee relevant information for consideration;
(c) The Director General may request any State Party, intergovernmental organization or non-governmental organization in official relations with the WHO to make available to the Review Committee the information they have regarding the subject matter of the proposed permanent recommendations, as indicated by the Review Committee;
(d) The Director General may, at the request of the Review Committee or its own initiative, designate one or more technical experts to advise the Review Committee. These experts do not have the right to vote;
(e) Reports containing the advice and advice of the Review Committee on standing recommendations are forwarded to the Director General for consideration and decision. The Director General shall communicate the advice and advice of the Review Committee to the Health Assembly;
(f) The Director-General shall communicate to the States Parties the standing recommendations, as well as any changes made to or cancellation thereof, including the views of the Review Committee;
(g) The Director General shall submit the standing recommendations to the next Health Assembly for consideration.
PART X
FINAL PROVISIONS
Rule 54
Reporting and review
1. The States Parties and the Director General shall report to the Assembly of Health on the application of this Regulation as decided by the Assembly of Health.
2. The Health Assembly shall periodically review the operation of these Regulations. For this purpose, it may seek advice from the Review Committee through the Director General. The first of these examinations shall be held no later than five years after this Regulation comes into force.
3. WHO conducts periodic studies to review and evaluate the operation of Appendix 2. The first of these reviews shall be undertaken no later than one year after this Regulation comes into force. The results of these reviews are submitted, as appropriate, to the Health Assembly.
Rule 55
Amendments
1. Any State Party or Director-General may propose amendments to this Regulation. These amendments are submitted to the Health Assembly for consideration.
2. The text of any proposed amendment shall be communicated to all States Parties by the Director General at least four months before the Assembly of Health to which this amendment is submitted for consideration.
3. Amendments to this Regulation adopted by the Health Assembly in accordance with this Article shall enter into force with respect to all States Parties under the same conditions and subject to the same rights and obligations as provided for in Article 22 of the WHO Constitution and to Articles 59 to 64 of this Regulation.
Rule 56
Settlement of disputes
1. If a dispute arises between two or more States Parties concerning the interpretation or application of this Regulation, the States Parties concerned shall first endeavour to resolve it by negotiation or by any other peaceful means of their choice, including by resorting to good offices or mediation of a third party or conciliation. In the event of failure, the parties to the dispute shall continue their efforts to reach a settlement.
2. If the dispute is not resolved by the means set out in paragraph 1 of this article, the States Parties concerned may agree to submit the dispute to the Director-General, who makes every effort to resolve it.
3. A State Party may at any time declare in writing to the Director General that it agrees to submit to compulsory arbitration all disputes concerning the interpretation or application of this Regulation to which it is a party or a specific dispute opposing it to any other State Party that accepts the same obligation. Arbitration shall take place in accordance with the Optional Rules of the Permanent Court of Arbitration for Disputes between two States in force on the date of application for arbitration. States Parties that have agreed to accept arbitration as binding accept the arbitral award as binding and final. The Director General shall inform the Health Assembly if necessary.
4. None of the provisions of this Regulation shall affect the right of States Parties under any international agreement to which they are parties to the dispute settlement mechanisms established by other intergovernmental organizations or under an international agreement.
5. In the event of a dispute between WHO and one or more States Parties with respect to the interpretation or application of this Regulation, the matter shall be referred to the Health Assembly.
Rule 57
Relationship with other international agreements
1. States Parties recognize that RSI and other relevant international agreements should be interpreted to ensure their compatibility. The IHR provisions do not affect the rights and obligations of States Parties arising from other international agreements.
2. Subject to paragraph 1 of this rule, no provision of this Regulation shall prohibit States Parties that have certain common interests as a result of their health, geographic, social or economic situation from entering into separate treaties or arrangements to facilitate the application of this Regulation, including with respect to:
(a) The direct and rapid exchange of information on public health between neighbouring territories of different states;
(b) Sanitary measures applicable to international coastal traffic and international traffic in waters under their jurisdiction;
(c) Sanitary measures applicable in territories contiguous to different States on their common borders;
(d) Organization of the transport of affected persons or human remains affected by a specially adapted means of transport; and
(e) Deratization, disinsectization, disinfection, decontamination or any other treatment designed to make goods free from pathogens.
3. Without prejudice to their obligations under this Regulation, States Parties that are members of a regional economic integration organization shall apply the common rules in force within that organization in the context of their mutual relations.
Rule 58
International health agreements and regulations
1. Subject to the provisions of Article 62 and the following exceptions, this Regulation shall replace between the States it binds and between those States and WHO the provisions of the following international health agreements and regulations:
(a) International Health Convention, signed in Paris on 21 June 1926;
(b) International Convention for Air Navigation, signed at The Hague on 12 April 1933;
(c) International agreement on the suppression of health patents, signed in Paris on 22 December 1934;
(d) International arrangement concerning the abolition of consular visas on health patents, signed in Paris on 22 December 1934;
(e) Convention Amending the International Health Convention of 21 June 1926, signed in Paris on 31 October 1938;
(f) 1944 International Health Convention amending the Convention of 21 June 1926, opened for signature in Washington on 15 December 1944;
(g) 1944 International Air Navigation Convention amending the Convention of 12 April 1933, opened for signature in Washington on 15 December 1944;
(h) Protocol of 23 April 1946 extending the 1944 International Health Convention, signed in Washington;
(i) Protocol of 23 April 1946 extending the 1944 International Health Convention for Air Navigation, signed in Washington;
(j) 1951 International Health Regulations and Additional Regulations, 1955, 1956, 1960, 1963 and 1965; and
(k) 1969 International Health Regulations and 1973 and 1981 amendments.
2. The Pan American Health Code, signed in Havana on 14 November 1924, remains in force, with the exception of articles 2, 9, 10, 11, 16 to 53, 61 and 62, to which the relevant provisions of paragraph 1 of this article apply.
Rule 59
Entry into force;
deadline for formulating a refusal or reservation
1. The period provided for in Article 22 of the WHO Constitution to refuse this Regulation or to amend it or to make reservations shall be eighteen months from the date of notification by the Director General of the adoption of this Regulation or of the said amendment to this Regulation by the Health Assembly. A refusal or reservation received by the Director General after the expiry of this period will be without effect.
2. These Regulations come into force twenty-four months after the notification date referred to in paragraph 1 of this section, except in respect of:
(a) a State that has refused the Regulation or an amendment to it in accordance with Article 61;
(b) a State that has made a reservation, and in respect of which the Regulation comes into force as provided for in Article 62;
(c) A State that becomes a member of the WHO after the date of notification by the Director General referred to in paragraph 1 of this section and that is not already a party to this Regulation, in respect of which the Regulations come into force as provided for in Article 60; and
(d) Of a State not a member of the WHO but which accepts this Regulation and in respect of which it comes into force in accordance with Article 64, paragraph 1.
3. If a State is unable to adjust its national legislative and administrative provisions within the time limit provided for in paragraph 2 of this rule to bring them into full compliance with this Regulation, it shall forward to the Director-General within the time limit specified in paragraph 1 of this rule a declaration concerning the remaining adjustments and shall make such adjustments no later than twelve months after the entry into force of this Regulation in respect of that State Party.
Rule 60
New WHO Member States
Any State that becomes a Member of the WHO after the date of notification by the Director General referred to in paragraph 1 of Article 59, and that is not already a Party to these Regulations, may indicate that the Director General refuses or makes reservations within twelve months of the date of notification to the Director General after he became a Member of the WHO. Subject to the provisions of Articles 62 and 63, and except in case of refusal, this Regulation shall enter into force with respect to that State at the expiry of the period referred to above. This Regulation shall not enter into force in any case in respect of that State less than twenty-four months after the date of the notification referred to in paragraph 2 of Article 59.
Rule 61
Refus
If a State notify the Director General of its refusal of this Regulation or of an amendment to it within the time limit provided for in paragraph 1 of Article 59, this Regulation or the amendment concerned shall not enter into force with respect to that State. Any international health agreement or regulation referred to in article 58 to which that State is already a Party shall remain in force with respect to it.
Rule 62
Reservations
1. Any State may make reservations to the Regulation under this rule. Such reservations shall not be incompatible with the purpose and purpose of this Regulation.
2. Any reservation to this Regulation shall be notified to the Director General in accordance with the provisions of section 59, paragraph 1, and section 60, section 63, paragraph 1, or section 64, paragraph 1, as the case may be. A non-WHO State shall notify the Director General of any reservation it makes in its notification of acceptance of this Regulation. Any State that formulates reservations must convey its reasons to the Director-General.
3. A partial refusal of this Regulation or an amendment to it shall be equivalent to a reservation.
4. Pursuant to article 65, paragraph 2, the Director-General shall notify any reservation received under paragraph 2 of this article. Le Directeur général :
(a) If the reservation has been formulated prior to the entry into force of this Regulation, requests Member States that have not refused this Regulation to notify it within six months of any objection they would have to oppose this reservation; or
(b) If the reservation has been formulated after the entry into force of this Regulation, requests the States Parties to notify it within six months of any objection they would have to object to this reservation.
States that formulate an objection to a reservation must indicate the reasons to the Director-General.
5. After this period, the Director-General shall notify all States Parties of objections received concerning reservations. If, at the end of the six-month period from the date of notification referred to in paragraph 4 of this article, a third of the States referred to in paragraph 4 of this article did not object to the reservation, the reservation shall be deemed to be accepted and this Regulation shall enter into force with respect to the reserving State, with the exception of the provisions subject to the reservation.
6. If at least one third of the States referred to in paragraph 4 of this article object to a reservation before the expiration of the six-month period from the date of notification referred to in paragraph 4 of this article, the Director-General shall notify the reserving State of the reservation so that the reserving State may consider withdrawing its reservation within three months of the date of notification to it by the Director-General.
7. The reserving State continues to fulfil all obligations relating to the purpose of the reservation it has accepted under an international health agreement or regulation referred to in article 58.
8. If the State author of a reservation does not withdraw the reservation within three months of the date of notification by the Director General referred to in paragraph 6 of this article, and if the State author of the reservation so requests, the Director General shall request the opinion of the Review Committee. The Review Committee shall inform the Director-General, as soon as possible and in accordance with the provisions of section 50, of the practical impact of the reservation on the application of this Regulation.
9. The Director General shall submit the reservation and notice of the Review Committee, if any, to the Health Assembly for consideration. If the Assembly of Health, by a simple majority vote, opposes the reservation on the ground that it is incompatible with the object and purpose of this Regulation, the reservation is not accepted and this Regulation comes into force only after it has withdrawn its reservation in accordance with Article 63. If the Assembly of Health accepts the reservation, this Regulation shall enter into force with respect to the reserving State with that reservation.
Rule 63
Withdrawal of a refusal and a reservation
1. A refusal under Article 61 may, at any time, be withdrawn by a State with a notification addressed to the Director General. In such a case, the Regulation shall enter into force with respect to that State on the date of receipt by the Director General of the notification, unless the State issues a reservation when it withdraws its refusal, in which case the Regulation shall enter into force as provided for in article 62. In no case shall the Regulations come into force with respect to that State before a period of twenty-four months after the date of notification referred to in paragraph 1 of Article 59.
2. Any or part of a reservation may at any time be withdrawn by the State Party concerned with a notification addressed to the Director General. In this case, the withdrawal shall take effect from the date of receipt by the Director-General of the notification.
Rule 64
States not WHO Members
1. States not Members of the WHO, but which are Parties to an international health agreement or regulations referred to in Article 58 or to which the Director General has notified the adoption of this Regulation by the World Health Assembly, may become Parties to it by notifying their acceptance to the Director General. Subject to the provisions of section 62, such acceptance shall take effect on the effective date of this Regulation or, if notified after that date, three months after the day on which such notification was received by the Director General.
2. WHO non-Member States that have become Parties to these Regulations may at any time denounce their participation in these Regulations by a notification addressed to the Director General; this denunciation takes effect six months after receipt of the notification. The State that has denounced its participation shall, from that time on, apply the provisions of any international health agreement or regulation referred to in article 58 to which it was previously a Party.
Rule 65
Notifications by the Director-General
1. The Director-General shall notify the adoption of this Regulation by the Health Assembly of all WHO Member States and associate members, as well as other Parties to any international health agreement or regulation referred to in Article 58.
2. The Director-General shall also notify these States, as well as any other State that has become a Party to this Regulation or to any amendment to this Regulation, of any notification received by the WHO pursuant to Articles 60 to 64 respectively, and of any decision taken by the Health Assembly pursuant to Article 62.
Rule 66
Authentic texts
1. The Arabic, Chinese, English, French, Russian and Spanish texts of this Regulation shall also be authentic. The original texts of these Regulations are deposited in the WHO archives.
2. Certified true copies of this Regulation shall be sent by the Director-General to all Associate Members and Members, as well as to other Parties to any international health agreement or regulation referred to in Article 58, with the notification provided in paragraph 1 of Article 59.
3. At the time of the entry into force of these Regulations, the Director-General shall transmit certified copies thereof to the Secretary-General of the United Nations for registration, in accordance with Article 102 of the Charter of the United Nations.
A N N E X E 1
A. ― PRINCIPAL CAPACITIES REQUIRED
FOR MONITORING AND ACTION
1. States Parties shall use existing national structures and resources with a view to developing the key capacities required under this Regulation to:
(a) their monitoring, reporting, notification, verification, action and collaboration activities; and
(b) Their activities related to designated airports, ports and border crossings.
2. Each State Party shall, within two years after the entry into force of this Regulation with respect to that State Party, assess the capacity of existing national structures and resources to meet the minimum requirements of this Annex. As a result of this assessment, States Parties develop and implement action plans to ensure that these key capabilities are present and operate throughout their territory as stipulated in Article 5, paragraph 1, and Article 13, paragraph 1.
3. States Parties and WHO shall support, upon request, the evaluation, planning and implementation processes provided for in this annex.
4. At the local community level and/or at the primary level of public health action:
Capacity:
(a) To detect, in all areas of the State Party's territory, events involving morbidity or mortality above the expected levels for the period and place under consideration; and
(b) Immediately disclose all essential data available at the appropriate level of health action. At the community level, communications are addressed to local health care institutions or appropriate health personnel. At the primary level of public health action, communications are addressed at the intermediate or national level, depending on the organic structures. For the purposes of this annex, the essential data include the following information: clinical descriptions, laboratory results, sources and types of risks, number of human cases and deaths, conditions affecting the spread of the disease and the health measures applied; and
(c) Immediately apply preliminary control measures.
5. At the intermediate level of public health action:
Capacity:
(a) To confirm the nature of the reported events and immediately support or implement additional control measures; and
(b) To immediately assess the reported events and, if deemed urgent, to communicate all essential data at the national level. For the purposes of this annex, the criteria that determine the existence of an urgent event are its serious effects on public health and/or its unusual or unexpected character, with a high potential for spread.
6. At the national level:
Evaluation and notification. Capacity:
(a) Evaluate all urgent events reported within 48 hours; and
(b) Immediately notify the WHO, through the national focal point RSI, when the assessment indicates that the event must be declared pursuant to Article 6, paragraph 1 and Annex 2, and provide the WHO with the information requested in Article 7 and Article 9, paragraph 2.
Public health action. Capacity:
(a) Quickly determine the necessary measures to prevent the spread at the national and international levels;
(b) Provide support through the provision of specialized personnel, analysis at the sampling laboratory (at the national level or through the collaborating centres) and logistical assistance (material, supplies and transport);
(c) Provide, where appropriate, on-site assistance to complement local surveys;
(d) To ensure a direct operational link with senior health and other officials to accelerate the approval and implementation of the enforcement and control measures;
(e) Ensure direct liaison with other relevant departments;
(f) To ensure, through the most effective means of communication, the link with hospitals, clinics, airports, ports, border crossings, laboratories and other key operational areas, to disseminate, on the territory of the State Party and on that of other States Parties, information and recommendations from the WHO regarding the events that have occurred;
(g) To establish, implement and maintain a national emergency public health action plan, including the creation of multidisciplinary/multisectoral teams to respond to events that may constitute an international public health emergency; and
(h) Ensure the measures that precede 24 hours a day.
B. ∙ PRINCIPAL CAPACITIES REQUIRED OF AROPORTS,
SUSTAINABLE PORTS AND POSTS
1. All the time.
Capacity:
(a) To ensure access to an appropriate medical service, including diagnostic means, to enable the rapid examination and care of sick travellers; and to provide adequate personnel, equipment and premises;
(b) To provide the necessary equipment and appropriate staff to allow the transport of sick travellers to an appropriate medical service;
(c) To provide the services of qualified personnel for the inspection of means of transport;
(d) To ensure the hygiene of services used by travellers at the point of entry, including the provision of drinking water, restoration facilities, on-board catering services and public toilets, as well as the provision of solid and liquid waste disposal services and other potentially at-risk areas, by conducting, as appropriate, inspection programs; and
(e) To put in place to the extent that this is possible in practice a program led by qualified personnel to fight vectors and vector tanks at and near the entry points.
2. To address events that may constitute an international public health emergency.
Capacity:
(a) Organize appropriate action by establishing and maintaining a public health emergency response plan, including the designation of a focal point and focal point focal point and public and other health agencies and services involved;
(b) To ensure the examination and care of travellers or animals affected by agreements with local medical and veterinary services to allow their isolation and treatment and to provide other support services that may be required;
(c) Provide an appropriate space, separated from other travellers, for interviews with suspected or affected persons;
(d) To ensure the examination and, if necessary, the quarantine of suspicious travellers, preferably in facilities away from the point of entry;
(e) To apply the recommended measures to disinsect, deratize, disinfect, decontaminate or otherwise treat baggage, cargo, containers, means of transport, goods and postal parcels, including, if necessary, in places specially affected and equipped for this purpose;
(f) Submit travellers to arrival and departure to entrance and exit controls; and
(g) To ensure access to appropriately protected special equipment and qualified personnel to allow the transfer of passengers who may be carrying a source of infection or contamination.
You can consult the table in the
JOn° 77 of 01/04/2010 text number 22
You can consult the table in the
JOn° 77 of 01/04/2010 text number 22
You can consult the table in the
JOn° 77 of 01/04/2010 text number 22
You can consult the table in the
JOn° 77 of 01/04/2010 text number 22
You can consult the table in the
JOn° 77 of 01/04/2010 text number 22
You can consult the table in the
JOn° 77 of 01/04/2010 text number 22
A N N E X E 4
TECHNICAL REQUIREMENTS FOR TRANSPORT MEDITORIES AND EXPLANATORS
Section A
Transport operations
1. Transport operators will facilitate:
(a) Inspections of cargo, containers and means of transport;
(b) Medical examinations of persons present on board;
(c) The application of the other sanitary measures provided for in this Regulation; and
(d) The provision of public health information required by the State Party.
2. Operators of means of transport shall provide to the competent authority of the States Parties a valid certificate of exemption from health control, or ship health control, or a maritime declaration of health, or the sanitary part of the general declaration of aircraft, as required by this Regulation.
Section B
Transport
1. The measures applied under this Regulation to a baggage, cargo, container, means of transport or goods shall be implemented in such a way as to avoid any trauma or embarrassment to persons and any damage to baggage, cargo, container, means of transport or goods. The measures are applied, if possible and appropriate, when the means of transport and the holds are empty.
2. States Parties shall indicate in writing the measures applied to a cargo, container or means of transport, the processed parts, the methods used and the reasons for their application. This information is provided in writing to the person responsible for the aircraft and, in the case of a vessel, it is noted on the vessel's health control certificate. For other cargoes, containers or means of transport, States Parties shall submit this information in writing to shippers, consignees, carriers and the person responsible for the carriage or their agent.
A N N E X E 5
SPECIAL MEASURES
THE VECTORAL TRANSMISSION MALADIES
1. The WHO regularly publishes the list of areas from which any means of transport must be subject to de-insectization measures or other recommended vector control measures. These areas are defined in accordance with the procedures for temporary or permanent recommendations, as appropriate.
2. The means of transport leaving an entry point located in an area where vector control is recommended must be disinsected and maintained free of vectors. When the Organization advocates methods and materials for these operations, they must be used. The presence of vectors on transport and the control measures taken to eradicate them shall be recorded:
(a) In the case of an aircraft, in the health-related portion of the General Aircraft Declaration, unless the competent authority of the arrival airport grants a waiver to not complete that part;
(b) In the case of a vessel, on the vessel health certificate; and
(c) In the case of other means of transport, on a written certificate of treatment issued to the shipper, to the consignee, to the carrier, to the person responsible for the transport or to their agent.
3. States Parties shall accept measures of de-insectization, deratization and other vector control measures applied to means of transport by other States, if the methods and materials recommended by the Organization have been used.
4. States Parties shall establish programmes to combat vectors that may carry an infectious agent that poses a risk to public health within a perimeter of not less than 400 metres from the areas of the facilities at the point of entry that are used for passenger operations, means of transport, containers, cargoes and postal parcels, or even more if the vectors present have a greater radius of action.
5. If a supplementary inspection is required to determine the success of the applied vector control measures, the competent authorities of the next port or airport port port port port port port port of call authorized to conduct such an inspection must be informed in advance by the competent authority who makes the request. In the case of a vessel, this inspection must be recorded on the ship's health certificate.
6. A means of transport is considered suspect and must be inspected to detect the presence of vectors or tanks:
(a) If there is a possible case of vector-borne disease on board;
(b) If a possible case of vector-borne illness occurred on board during an international voyage; or
(c) If this means of transport left an affected area while the vectors present on board could still be carrying disease.
7. A State Party may not prohibit the landing of an aircraft at an airport in its territory or the arrival of a ship if the control measures referred to in paragraph 3 of this annex or otherwise recommended by the Organization are applied. However, aircraft or vessels from an affected area may be required to land at airports or diverted to other ports specially designated for this purpose by the State Party.
8. A State Party may apply vector control measures to a means of transport from an area where vector-borne disease occurs if the vectors of this disease are present in its territory.
A N N E X E 6
VACCINATION, PROPHYLAXIA AND CERTIFICATES
1. Vaccines or other prophylactic agents referred to in Schedule 7 or recommended in this Regulation shall be of satisfactory quality; vaccines and prophylactic agents prescribed by WHO must be submitted for approval. Upon request, the State Party shall provide the WHO with appropriate evidence of the adequacy of vaccines and prophylactic agents administered in its territory under this Regulation.
2. Persons to whom vaccines or other prophylaxis are administered under this Regulation receive an international vaccination certificate or a certificate certifying the administration of a prophylaxis (hereinafter referred to as the "certificate") in accordance with the model in this Annex. This model must be scrupulously respected.
3. The certificates referred to in this annex are valid only if the vaccine or prophylactic agent used has been approved by WHO.
4. Certificates must be signed by the clinician – doctor or other registered health officer – who supervises the administration of the vaccine or prophylactic agent; they must also bear the official stamp of the authorized centre which, however, cannot be considered to be held as a place of signature.
5. Certificates must be completed in English or French in full; They can also be in another language.
6. Any correction or rature on certificates or omission of any of the requested information may result in their nullity.
7. Certificates are individual and should not be used in a collective capacity. Children must be provided with separate certificates.
8. When the certificate is issued to a child who does not know how to write, a parent or guardian must sign it instead. The signature of an illiterate must be replaced, as it is used in such cases, by its mark authenticated by a third party.
9. If the clinician responsible is of the opinion that vaccination or the administration of a prophylaxis is counter-indicated for medical reasons, he shall give the person concerned a duly motivated counter-indication certificate, written in English or French and, where applicable, in another language in addition to English or French, that the competent authorities of the arrival place must take into account. The responsible clinician and the competent authorities shall inform the person concerned of any risk associated with the non-vaccination or non-use of prophylaxis in accordance with the provisions of section 23, paragraph 4.
10. An equivalent document issued by the armed forces to an active member of these forces will be accepted instead of an international certificate conforming to the model in this annex:
(a) If it contains medical information essentially identical to those required in the model; and
(b) If it indicates in English or French, and if applicable in another language in addition to English or French, the nature and date of vaccination or administration of prophylaxis, and if issued in accordance with this paragraph.
MODEL DE CERTIFICATE INTERNATIONAL DE VACCINATION OR CERTIFICATE ATTESTING THE ADMINISTRATION OF A PROPHYLAXIA
We certify that [name] born, sex
national identification document, if applicable
for signature
was vaccinated or received prophylactic agents on the date indicated against: (name of disease or affection)
in accordance with the International Health Regulations.
| 1. | | | | | |
| 2. | | | | | |
A N N E X E 7
VACCINATION REQUIREMENTS
OR THE PROPHYLAXIA AGAINST MALADIES
1. In addition to any recommendations regarding vaccination or the administration of prophylaxis, the entry of travellers to a State Party may be subject to the presentation of evidence of vaccination or the administration of prophylaxis against the following diseases expressly designated by this Regulation:
Yellow fever.
2. Considerations and requirements for yellow fever vaccination:
(a) For the purposes of this annex:
(i) The yellow fever incubation period is six days;
(ii) WHO-approved moor vaccines provide protection against infection that takes effect 10 days after vaccine administration;
(iii) This protection lasts 10 years; and
(iv) The validity of a yellow fever vaccination certificate is 10 years, beginning on the tenth day after the date of vaccination or, in the case of re-immunization during that 10-year period, from the date of re-accination.
(b) Yellow fever vaccination may be required from any traveller leaving an area in which the Organization has determined that there is a risk of yellow fever transmission.
(c) A traveller with an unsatisfactory amarile vaccination certificate may be allowed to leave, but the provisions of paragraph 2 h of this annex may be applied to the traveller upon arrival.
(d) A traveller with a valid yellow fever vaccination certificate must not be considered a suspect, even if it comes from an area in which the Organization has established that there is a risk of yellow fever transmission.
(e) In accordance with the provisions of Annex 6, paragraph 1, the amaril vaccine used shall be approved by the Organization.
(f) States Parties shall designate specific centres of amarile vaccination in their territory to ensure the quality and safety of the procedures and equipment used.
(g) Any person employed at a point of entry in an area in which the Organization has established that there is a risk of yellow fever transmission, as well as any member of the crew of a means of transport that uses this point of entry, must be provided with a valid yellow fever vaccination certificate.
(h) A State Party in the territory of which yellow fever vectors are present may require a traveller from an area in which the Organization has established that there is a risk of yellow fever transmission either, if it is not able to present a valid certificate of amarile vaccination, quarantined for a maximum of six days from the date of the last possible exposure to the infection, unless its certificate of vaccination became valid for a period of time.
(i) Travellers in possession of an Amarile Vaccine Exemption Certificate signed by an authorized physician or a registered health officer may nevertheless be allowed to enter the territory, subject to the provisions of the preceding paragraph of this annex and provided that they have received information on protection against yellow fever vectors. Travellers who have not been quarantine may be required to report any febrile symptoms or other symptoms relevant to the competent authority and placed under supervision.
You can consult the table in the
JOn° 77 of 01/04/2010 text number 22
ITEMS TO THE MODEL DECLARATION MARITIME DECLARATION
| | | | | | | | | | | | |
| | | | | | | | | | | | |
| | | | | | | | | | | | |
| | | | | | | | | | | | |
| | | | | | | | | | | | |
| (*) Indicate: 1) if the person has recovered, if he or she is still ill or if he or she has died; and 2) if the person is still on board, if it has been evacuated (name the port or airport), or if his body has been immersed. | |||||||||||
A N N E X E 9
THIS DOCUMENT PARTY OF THE GENERAL DECLARATION OF AERONEF PROMULGUED BY THE INTERNATIONAL ORGANIZATION OF CIVILE AVIATION
PART ON SANITARIES
OF THE GENERAL DECLARATION OF AERONEF (1)
Health statement
Cases of illness, excluding air injury or accidents (including people with symptoms or signs such as eruption, fever, chills, diarrhea), found on board or landed during the trip
Presence on other conditions that may cause the spread of a disease
Details relating to each insectization or other hygiene measure (place, date, time, method) practised during the flight. If there has been no insectization during the flight, please provide information on the most recent insectization
Signature (if necessary):
Member of the crew concerned
Done in Paris, March 31, 2010.
François Fillon
By the Prime Minister:
Minister of Health and Sports,
Roselyne Bachelot-Narquin
Minister of State, Minister of Ecology,
of energy, sustainable development and the sea,
green technologies
and climate negotiations,
Jean-Louis Borloo
The state minister, keep seals,
Minister of Justice and Freedoms,
Michèle Alliot-Marie
The Minister of the Interior,
the overseas and territorial authorities,
Brice Hortefeux
Minister of Labour, Solidarity
and the Public Service,
Eric Woerth
Minister of National Education,
Government spokesperson,
Luc Chatel
Minister of Higher Education
and research,
Valérie Pécresse
Minister of Defence,
Hervé Morin
Minister of Budget, Public Accounts
and state reform,
François Baroin
Minister of Food,
agriculture and fisheries,
Bruno Le Maire
The Minister of Immigration,
integration, national identity
and solidarity development,
Eric Besson
Minister of Rural Space
and landscaping,
Michel Mercier
The Minister to the Minister of Interior,
the overseas and territorial authorities,
loaded with the overseas,
Marie-Luce Penchard
