Key Benefits:
Publics concerned: holders of marketing authorization; companies or establishments manufacturing, distributing, important, exporting, operating or carrying out brokerage activities related to medicines or raw materials for pharmaceutical use; health professionals; patients; approved patient associations; pharmaceutical establishments.
Subject: Prevention of the introduction of falsified medicines in the legal supply chain and supervision of the sale by internet of medicines by pharmacy pharmacies.
Entry into force: the text comes into force on the day after its publication, subject to the following transitional provisions as provided for in Article 8:
- the provisions relating to the declaration that the manufacturer of the pharmaceutical specialty has verified that the manufacturer of the active substance has complied with good manufacturing practices by conducting audits are applicable to applications for marketing authorization submitted as of the day after the publication of this text;
- the provisions relating to safety devices carried by the packaging of drugs and the controls exercised by the actors of the pharmaceutical circuit on these devices are applicable three years after the date of publication of the last of the delegated acts adopted by the European Commission on the basis of Article 54 bis of Directive 2001/83/EC of the European Parliament and the Council of 6 November 2001 establishing a Community Code on Human Drugs. This effective date is found by order of the Minister for Health;
- the provisions on persons engaged in drug brokering activities come into force on April 1, 2013;
– the provisions for persons engaged in the manufacture, import or distribution of active substances come into force on April 1, 2013. Persons who regularly carry out these activities on the date of the publication of this Order may continue to do so until the intervention of the National Drug Safety Agency's decision on their application for authorization;
― the provisions relating to the common logo to be displayed on the websites proposing drugs for sale come into force one year after the date of publication by the European Commission of the last acts of execution provided by the 20 of Article 1 of Directive 2011/62/EU of the European Parliament and of the Council of 8 June 2011 amending Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 establishing a community code on medicines for human use, This effective date is found by order of the Minister for Health;
― the import terms for active substances are applicable as of July 2, 2013.
Notice: The purpose of this text is to transpose the above-mentioned Directive 2011/62/EU. It aims to secure the legal supply chain of medicines.
It provides a safety device on certain drugs whose purpose is to verify their authenticity, their individual identification and their integrity. It reinforces the obligations of the operators of the legal supply chain of medicines and provides for the reporting and exercise of the drug brokers. It introduces new obligations related to activities related to raw materials for pharmaceutical use. Finally, it regulates electronic drug trade by officin pharmacies, with the Internet being designed as a possible dispensation of medicines.
References: the provisions of Public Health Code Amended by this decree may be consulted, in their writing resulting from this amendment, on the website Légifrance (http://www.legifrance.gouv.fr). This text transposes Directive 2011/62/EU of the European Parliament and of the Council of 8 June 2011 amending Directive 2001/83/EC establishing a Community code on human-use drugs, with regard to the prevention of the introduction into the legal supply chain of falsified drugs.
The Prime Minister,
On the report of the Minister of Social Affairs and Health,
Considering Directive 2011/62/EU of the European Parliament and of the Council of 8 June 2011 amending Directive 2001/83/EC establishing a Community Code for Human-Use Drugs, with regard to the prevention of the introduction into the legal supply chain of falsified medicines;
See?Order No. 2012-1427 of 19 December 2012 the strengthening of the safety of the supply chain of medicines, the supervision of the sale of drugs on the internet and the fight against the falsification of drugs;
Vu le Criminal codeincluding its article R. 610-1;
Vu le Public Health Code ;
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. 2004-575 of 21 June 2004 modified for confidence in the digital economy;
Considering the opinion of the Autorité de la concurrence dated 13 December 2012;
The State Council (Social Section) heard,
Decrete:
Chapter I of Title II of Book I of Part 5 of the Public Health Code is thus amended:
1° Article R. 5121-25 is amended as follows:
(a) The 8° to 13° respectively become the 9° to 14°;
(b) After the 7° it is inserted a new 8° as follows:
« 8° A statement certifying that the manufacturer of the pharmaceutical specialty has verified that the manufacturer of the active substance has respected good manufacturing practices by conducting audits.
"This statement mentions the date of the audit and certifies that the results obtained indicate that manufacturing is consistent with good manufacturing practices. » ;
2° Section R. 5121-118 is amended as follows:
(a) The first paragraph is replaced by the following:
"The labelling and packaging of the pharmaceutical specialty with a parallel import permit are identical to those of the pharmaceutical specialty that obtained the marketing authorization in France, except in that they include:"
(b) It is added a 5° as follows:
« 5° Security devices equivalent to those of the pharmaceutical specialty that obtained the marketing authorization in France. » ;
3° In R. 5121-132-1, the words "and the National Agency for the Safety of Medicine and Health Products" are replaced by the words ", to the National Agency for the Safety of Medicine and Health Products and to the European Agency for Drugs";
4° After section R. 5121-138, insert items R. 5121-138-1, R. 5121-138-2, R. 5121-138-3 and R. 5121-138-4 as follows:
"Art. R. 5121-138-1.- Drugs subject to mandatory prescription are equipped with safety devices described in Article R. 5121-138-2, unless they are exempted because of their presence on the list established for this purpose by delegated act of the European Commission pursuant to Article 54 bis of Directive 2001/83/EC of the European Parliament and the Council of 6 November 2001 establishing a human code.
Non-mandatory prescription drugs are not equipped with these safety devices unless, by exception, they are listed for this purpose by delegated act of the European Commission, after a falsification risk has been identified.
"By derogation from the two preceding paragraphs, medications that are repayable by mandatory health insurance plans are equipped with such safety devices.
"Art. R. 5121-138-2.-The labelling of the outer packaging or, if not external packaging, the labelling of the primary packaging of the drugs referred to in R. 5121-138-1 carries safety devices, whether visible or not, that allow people whose activity is the wholesale distribution of drugs or the retail dispensation of drugs:
« 1° To verify the authenticity of the drug;
« 2° Identify individual boxes of medicines.
"Art. R. 5121-138-3. -All drugs have a device to verify the integrity of their outer packagings.
"Art. R. 5121-138-4.-Safety devices can only be replaced by equivalent safety devices to verify authenticity, identify and demonstrate illicit handling of the drug. This replacement shall be made without opening the primary packaging as defined in 3° of Article R. 5121-1 and in accordance with the good practices referred to in Article L. 5121-5.
“Safety devices are considered equivalent if:
« 1° They meet the requirements set out in the delegated actions taken by the European Commission on the basis of Article 54 bis, paragraph 2, of Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 establishing a Community Code on Human Drugs;
« 2° They allow to verify authenticity and identify medications, with the same efficiency, and to demonstrate the illicit handling of drugs. »
Chapter IV of Title II of Book I of the fifth part of the Public Health Code is thus amended:
1° Section R. 5124-3 is amended as follows:
(a) The first paragraph is supplemented by a sentence as follows:
"They verify for this purpose by any means that these establishments are authorized as pharmaceutical establishments and that they respect the good practices referred to in Article L. 5121-5 that apply to them. » ;
(b) A second preambular paragraph was added:
"When the drug is obtained through a broker, the pharmaceutical establishment verifies that the broker has declared himself to the National Drug and Health Products Safety Agency in accordance with section L. 5124-20. » ;
2° Article R. 5124-6 is supplemented by a last paragraph as follows:
"The opening authorization granted to a company or agency for the activities mentioned in 1°, 3° and 5° of Article R. 5124-2 is recorded in the European Union data bank. » ;
3° Section R. 5124-36 is amended as follows:
(a) After 8°, a 9° and 10° are added:
« 9° It ensures, in the case of drugs intended to be marketed in the European Union, that the safety devices referred to in R. 5121-138-1 have been affixed to the packaging under the conditions set out in R. 5121-138-1 to R. 5121-138-4;
« 10° It reports to the National Agency for the Safety of Medicine and Health Products any placing on the national market of a drug that it considers falsified within the meaning of the provisions of section L. 5111-3, of which it ensures the manufacture, operation and distribution. » ;
(b) In the last paragraph, the reference: "7°" is replaced by the reference: "10°";
4° After the article R. 5124-48-1, an article R. 5124-48-2 is inserted as follows:
"Art. R. 5124-48-2.-When the companies and organizations referred to in section R. 5124-2 are aware of a falsification or suspicion of falsification of drugs that they provide for the manufacture, operation or distribution, whether these products are distributed via the legal supply chain or by illegal means, including the illegal sale by means of the holder of the information society, they » ;
5° After the article R. 5124-49-1, two articles R. 5124-49-2 and R. 5124-49-3 are inserted as follows:
"Art. R. 5124-49-2.-The manufacturers of medicines referred to in Article R. 5124-2 shall verify that the active substances used are from manufacturers, importers or distributors or are authorized by the National Drug Safety Agency and Health Products when they operate in the national territory or registered with the competent authority of the Member State in which they are established.
"Art. R. 5124-49-3.- Pharmaceutical manufacturers must be able to document the measures they have taken to ensure compliance by their suppliers of excipients with good practices under the conditions laid down in Article L. 5138-3. » ;
6° After the article R. 5124-54, an article R. 5124-54-1 is inserted as follows:
"Art. R. 5124-54-1.-The pharmaceutical establishment that ensures the manufacture of medicines shall verify, before removing or recovering partially or completely the safety devices provided for in section R. 5121-138-2, that the drug concerned is authentic and that it has not undergone unlawful handling. » ;
7° In R. 5124-58, after the word: "exit" are inserted the words: "including when using a broker";
8° After the article R. 5124-60, an article R. 5124-60-1 is inserted as follows:
"Art. R. 5124-60-1.-The pharmaceutical establishment of a company or organization referred to in Article R. 5124-2 engaged in wholesale sale, free disposal or wholesale distribution shall verify that the drugs received have not been falsified by controlling the security devices mentioned in Articles R. 5121-138-2 and R. 5121-138-3, according to the European Commission » ;
9° After chapter IV of title II of Book I of the fifth part of the same code, a chapter IV bis is inserted as follows:
“Chapter IV bis
"Art. R. 5124-74. - The declaration provided for in section L. 5124-20 is addressed to the National Agency for the Safety of Medicine and Health Products by the person carrying out the brokerage activity or by the legal representatives of the company by any means to acknowledge receipt.
"The declaration includes the administrative information relating to the company including the name of the legal representatives of the company, the company or, in the case where the company is the property of a company, its legal form, its corporate name and the address of the company's head office.
"The form and content of the document with the list of administrative information shall be determined by decision of the Director General of the Agency.
"The director general of the agency may require any additional information.
"A change in administrative information shall be notified to the agency without delay by any means to acknowledge receipt.
"The cessation of activity of the establishment is communicated without delay in the same forms.
"Art. R. 5124-75. - In the event of non-compliance with the obligations referred to in Article L. 5124-20 and in this chapter, as applicable following an inspection, the Director General of the Agency may prohibit, for a maximum period of six months, the exercise of the brokerage activity.
"With the exception of an emergency, the decision to ban the exercise can only take place after the person carrying out the drug brokerage activity has been invited to submit their observations.
"When, at the end of the prohibition period, the person carrying out the drug brokerage activity did not comply with the applicable rules, the Director General of the agency may issue a new prohibition under the same conditions.
"Art. R. 5124-76. - The agency shall render the administrative information referred to in R. 5124-74, except for the name of the legal representatives of the undertaking, and any temporary prohibition of exercise, accessible to the public.
"Art. R. 5124-77. - The obligations referred to in sections R. 5124-48-2, R. 5124-58 and R. 5124-60 apply to persons carrying out the drug brokerage activity referred to in L. 5124-19. »
I. ― At the 1st of the article R. 5125-26 of the Public Health Code, after the words: "of an informal", the words are inserted: ", as well as the creation of an official website" and after the reference: "R. 4235-52", are inserted the words: "the address of the website of the officine,".
II. ― After chapter V of title II of Book I of the fifth part of the Public Health Code, a chapter V bis is inserted as follows:
“Chapter V bis
"Art. R. 5125-70. - The e-commerce website of the pharmacy offence is created or operated by pharmacists mentioned in article L. 5125-33 in sections A, D and E of the national order of pharmacists.
"The website contains the contact information of the National Drug Safety Agency and Health Products, a hyperlink to the website of the national order of pharmacists and the Ministry of Health, as well as the common logo set up at the community level, which is displayed on each page of the website that deals with electronic drug trade.
"Art. R. 5125-71. - The application for authorization for electronic commerce of medicines and the creation of an e-commerce website of medicines provided for in Article L. 5125-36 is addressed by the pharmacists mentioned at 1° and 2° of Article L. 5125-33 to the Director General of the regional health agency in the spring of which the offence is located, by any means allowing to acknowledge receipt.
"The application includes:
« 1° The name of the pharmacist who holds the offer or manages a mutualist or mine rescue pharmacy responsible for the site;
« 2° The certificate of admission to the order of pharmacists of the pharmacist holder of the offence or manager of a mutualist or mine rescue pharmacy;
« 3° The name and address of the official or mutualist pharmacy or mine rescue;
« 4° The address of the website used for e-commerce purposes;
« 5° All information necessary to identify the website;
« 6° Description of the site and its features to ensure compliance with existing legislation and regulations;
« 7° The description of the conditions for the installation of the offence prescribed by section R. 5125-9.
"The application is deemed to be accepted in the absence of a decision by the Director General of the Regional Health Agency within two months of the date of receipt of the application.
"Within fifteen days from the date of explicit or implicit authorization, the Officin licensee shall inform the board of the order of the pharmacists to whom it is responsible for the creation of its electronic drug business website and shall transmit to that effect a copy of the application to the regional health agency and, where appropriate, a copy of the express authorization.
"Art. R. 5125-72. - In the event of a substantial change in the elements of the authorisation referred to in R. 5125-71, the pharmacist who holds the offence or manages a mutualist or mine rescue pharmacy shall promptly inform the pharmacist, by any means to acknowledge receipt, the director general of the territorially competent regional health agency and the council of the order of the pharmacists to which he reports.
"Art. R. 5125-73. - In the event of suspension or termination of operation of its website, the pharmacist who holds the offence or manages a mutualist pharmacy or mine rescue shall promptly inform the director general of the regional agency of territorially competent health and the advice of the pharmacists to whom he reports.
"Art. R. 5125-74. - The national order of pharmacists keeps up to date a list of websites of authorized pharmacy depositors and makes it available to the public on its website. This list is also available on the Ministry of Health website.
"The website of the national order of pharmacists and the Ministry of Health contain information on the legislation applicable to the electronic commerce of medicines by an officin pharmacy, the risks associated with drugs illegally provided on the internet, as well as the common logo established at the community level. »
Section 1 of Chapter VIII of Title III of Book I of Part 5 of the Public Health Code is amended as follows:
1° Its title is replaced by the following title: "Authorization of the manufacturing, import and distribution of active substances";
2° Sections R. 5138-1 and R. 5138-2 are replaced by the following:
"Art. R. 5138-1.-I. ― The application for authorization under section L. 5138-1 is addressed to the National Agency for the Safety of Medicine and Health Products by the legal representatives of the establishment by any means to acknowledge receipt, at least sixty days before the date for the commencement of the activity.
“II. ― It includes the following information:
« 1° The administrative information relating to the establishment including the name, social reason and address of the head office to which the establishment belongs, the name of the legal representatives of the establishment and the address of the establishment that operates the manufacturing, import or distribution of active substances;
« 2° Active substances to be imported, manufactured or distributed;
« 3° The characteristics of the premises and technical equipment used as part of their activity;
« 4° Technical information relating to the manufacture, import or distribution of active substances, including the list of such activities, the quality assurance processes and systems used to carry them out, as well as potential subcontractors.
"The form and contents of the document containing the list of administrative information and technical information are determined by decision of the Director General of the agency.
"For the manufacturers mentioned in the 1st of Article R. 5124-2 and 1st of Article R. 5142-1, which, for their own use, replenish, by restricting itself to the purchase or storage operations of the active substances, the mention of this activity in the condition provided for in Article R. 5124-46 or Article R. 5142-42 shall be reported as the distribution.
"III. ― The Director General of the agency may request any information or conduct an on-site inspection to ensure that the site is in compliance with the existing repositories for the purpose of starting their activity. For these purposes, it may extend the period referred to in paragraph 1 for a period of sixty days. In this case, the applicant shall notify the applicant of this extension decision.
"If, within sixty days of receipt of the application for authorization, the Director General of the Agency has not notified the applicant that an inspection will be carried out, the authorization is implicitly granted and the applicant may commence its activity.
"IV. ― Any modification that may affect the quality or safety of pharmaceutical raw materials manufactured, imported or distributed is notified by any means and without delay to the agency.
"Another modification of one of the elements of the file is communicated to the agency by any means to acknowledge receipt, in the form of a summary annual statement, the terms of which are set by decision of the director general of the agency.
"The cessation of activity of the establishment is communicated without delay in the same forms.
"V. ― The Director General of the Agency may refuse to authorize all or part of the activity that is the subject of the original application or any subsequent modification that may affect the quality or safety of the active substances manufactured, imported or distributed.
"It may also suspend the authorization following an inspection that has found non-compliance with the obligations referred to in sections L. 5138-1 and below and in this chapter.
"With the exception of an emergency, the suspension decision can only intervene after the person engaged in the manufacturing, import or distribution of active substances has been invited to submit their observations.
"Art. R. 5138-2.-The elements mentioned in 1° to 3° of Article R. 5138-1, with the exception of the name of the legal representatives of the establishment, are registered in the European Union data bank. » ;
3° After section 1, a section 1 bis is inserted as follows:
“Section 1 bis
"Art. R. 5138-2-1. - The declaration provided for in section L. 5138-1 is addressed to the National Agency for the Safety of Medicine and Health Products by a person authorized to enter the company to which the establishment is owned by any means to acknowledge receipt. It includes the following information:
« 1° The name or name and address of the company to which the establishment belongs and the address of the establishment that carries out the manufacturing, import or distribution activity of excipients;
« 2° The name and function of the declarant;
« 3° The nature of the activity(s) submitted to report by the establishment.
"For the manufacturers mentioned in 1° of Article R. 5124-2 and 1° of Article R. 5142-1 that import excipients for their own use, the mention of this activity in the state provided for in Article R. 5124-46 or Article R. 5142-42 is a declaration for import.
"A change in the information contained in the statement shall result in a new statement, immediately communicated to the agency by any means to acknowledge receipt.
"The cessation of activity of the establishment must be communicated immediately in the same forms.
"Art. R. 5138-2-2. - The descriptive record provided for in section L. 5138-1 and accompanying the statement is sent to the National Agency for the Safety of Medicine and Health Products by any means to acknowledge receipt. It contains the following information and information:
« 1° Administrative information relating to the establishment where the activity of manufacture, import or distribution of excipients, its internal organization, and, where appropriate, its other activities and the certifications it holds under its activities;
« 2° Technical information relating to the production, import or distribution of excipients, including the list of such activities, the premises, equipment, processes and quality assurance system used to exercise them, as well as potential subcontractors.
"The list of administrative information and technical information is determined by decision of the Director General of the agency.
"The changes to the descriptive file are communicated to the agency by any means that will allow it to be acknowledged in the form of a summary annual statement, in accordance with the terms set out in the above decision. » ;
4° After section 2 bis, a section 3 is inserted as follows:
“Section 3
"Art. R. 5138-7. - Active substances may only be imported from a third country to the European Union if they are accompanied by a written confirmation from the competent authority of the third country exporter stating that:
« 1° The standards of good manufacturing practices applicable to the establishment that manufactures the active substances exported are at least equivalent to those defined by the European Union;
« 2° The manufacturing establishment concerned is subject to regular, strict and transparent controls and effective enforcement of good manufacturing practices, including repeated and unannounced inspections, ensuring public health protection at least equivalent to that provided by the European Union;
« 3° If a non-compliance is found, the information relating to this finding will be immediately communicated to the European Union by the third-country exporter.
"Art. R. 5138-8. - The written confirmation referred to in Article R. 5138-7 is not to be provided when the imported active substances come from a country mentioned in the list provided for in Article 111 ter of Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 establishing a Community Code for Human Drugs.
"Art. R. 5138-9. - In exceptional circumstances and in case of necessity, in order to ensure the availability of drugs, when an establishment for the manufacture of an active substance for export and located in a third country, has been inspected by a member State and has been in accordance with the principles and guidelines for good manufacturing practices, the requirement referred to in Article R. 5138-7 may be waived for a period not exceeding the validity of the certificate of good manufacturing practices issued. If the National Agency for the Safety of Medicine and Health Products uses this provision, it shall inform the European Commission in accordance with Article 46 ter of Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 establishing a Community Code for Human Drugs. »
In chapter II of Book III title I of the fifth part of the Public Health Code (regulatory provisions), a single section is created as follows:
« Single Section
"Medicine Warning and Warning Device
"Art. A. 5312-1.-For the implementation of the monitoring and warning device referred to in section L. 5312-4, the National Drug and Health Products Safety Agency ensures the receipt and treatment of reports of suspected falsified drugs and quality defects suspected of affecting drugs.
"This device also covers recalls of medications made by companies or organizations that provide for the operation and withdrawal of medicines from the market ordered by the agency to the relevant actors of the supply chain, during and outside normal working hours. The device also allows medication reminders to patients who received these medications, if any with the assistance of health professionals.
"If the drug in question is suspected of presenting a serious risk to public health, the agency shall promptly transmit a notification of early warning to all Member States and all stakeholders in the supply chain. If this medication has been delivered to patients, public releases for its recall are issued urgently within 24 hours. These releases contain sufficient information on the alleged lack of quality or falsification and the risks involved. »
Chapter III of Title I of Part 5, Part 5, of the Public Health Code is amended to read:
1° After the first sentence of the first paragraph of article R. 5313-3, a sentence is inserted as follows:
"The form and content of this report are defined by the Director General of the agency in cooperation with the European Agency for Drugs. » ;
2° Section R. 5313-4 is replaced by the following provisions:
"Art. R. 5313-4.-In order to control the application of the laws and regulations relating to human-use drugs, the inspectors of the National Agency for the Safety of Medicine and Health Products or, in the case provided for in section L. 5313-3, the inspectors of the regional health agencies referred to in section L. 5127-1 shall, in particular, carry out the risk of affecting the quality or safety of the pharmaceutical products,
"Manufacturers, importers, wholesalers, wholesale distributors of drugs and operators are subject to regular inspections.
"The inspections may also take place in the premises of the holders of a drug marketing authorization, a drug dealer and in customs warehouses. » ;
3° Section R. 5313-5 is amended as follows:
(a) In the first paragraph, after the word "pharmaceous", the words "or an establishment for the manufacture, import and distribution of raw materials for pharmaceutical use" are inserted, the words "pharmacists inspectors for public health" are replaced by the words "the inspectors of the regional health agencies referred to in Article L. 5127-1", after the reference: "L. 5121-5", are inserted the words "pharmacy and pharmacy"
(b) In the last paragraph, after the words: "if the drug" are inserted the words: "or the raw material for pharmaceutical use";
(c) It is added a paragraph to read:
"The certificate of conformity for pharmaceutical raw materials is issued in accordance with articles R. 5138-3 et seq. of this Code. »
Chapter VIII of Title III of Part Five of the Public Health Code is amended to read:
1° Section R. 5438-1 is replaced by the following provisions:
"Art. R. 5438-1.-The act for the manufacturer, importer or distributor of excipients as defined in section L. 5138-2 to carry out his or her activity without having reported to the National Drug Safety Agency and Health Products pursuant to and under the conditions laid down in section L. 5138-1 shall be punished by the fine provided for contraventions of the fifth class. » ;
2° In R. 5438-3, after the words: "contents" are added the words: "amongst the documents requested for authorization or".
I. ― provisions of Article R. 5121-25 of the Public Health Code in its writing from this decree are applicable to applications for marketing authorization submitted from the day after its publication.
II. ― The provisions of articles R. 5121-138-1 to R. 5121-138-4, R. 5124-36, R. 5124-54-1 and R. 5124-60-1 of the Public Health Code are applicable three years after the date of publication of the last of the delegated acts adopted by the European Commission on the basis of Article 54 bis of Directive 2001/83/EC of the European Parliament and the Council of 6 November 2001 establishing a Human Code. This effective date is found by order of the Minister for Health.
III. The provisions of sections R. 5124-74 to R. 5124-76 of the Public Health Code come into force on April 1, 2013.
IV. ― provisions of articles R. 5138-1 and R. 5138-2 of the Public Health Code, in their drafting of this decree, come into force on 1 April 2013. Persons who regularly carry out these activities on the date of the publication of this Order may continue to do so until the intervention of the National Drug Safety Agency's decision on their application for authorization.
V. ― The provisions of articles R. 5125-70 and R. 5125-74 of the Public Health Code relating to the common logo come into force one year after the date of publication by the European Commission of the last of the acts of execution provided for in Article 1 of the Directive 2011/62/EU of the European Parliament and of the Council of 8 June 2011 amending Directive 2001/83/EC of the European Parliament and the Council of 6 November 2001 introducing a This effective date is found by order of the Minister for Health.
VI. ∙ The provisions of sections R. 5138-7 to R. 5138-9 of the Public Health Code are applicable as of 2 July 2013.
The guard of the seals, Minister of Justice, and the Minister of Social Affairs and Health are responsible, each with regard to it, for the execution of this decree, which will be published in the Official Journal of the French Republic.
Done on 31 December 2012.
Jean-Marc Ayrault
By the Prime Minister:
Minister of Social Affairs
and Health,
Marisol Touraine
The guard of the seals,
Minister of Justice,
Christiane Taubira
