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Decree No. 2014 - 1367 14 November 2014 On Execution And Subcontracting Of Masterful And Officinal Preparations

Original Language Title: Décret n° 2014-1367 du 14 novembre 2014 relatif à l'exécution et à la sous-traitance des préparations magistrales et officinales

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Keywords

CODE OF THE PUBLIC HEALTH , CSP , PROFESSIONAL OF HEALTH , PHARMACY , PHARMACY , PHARMACY


JORF n°0265 of 16 November 2014 page 19318
text No. 21



Decree No. 2014-1367 of 14 November 2014 on the execution and subcontracting of master and informal preparations

NOR: AFSP1320938D ELI: https://www.legifrance.gouv.fr/eli/decret/2014/11/14/AFSP1320938D/jo/texte
Alias: https://www.legifrance.gouv.fr/eli/decret/2014/11/14/2014-1367/jo/texte


Public concerned: health professionals; pharmacists of offensive; pharmacists of pharmaceutical establishments authorized to make preparations on behalf of pharmacies for internal use or officin; regional health agencies.
Subject: modalities of execution and subcontracting of the execution of magistral and informal preparations.
Entry into force: this decree comes into force on the day after its publication.
Notice: the text, taken under the articles L. 5125-1 and L. 5125-1-1 the Public Health Code (CSP), sets out the terms and conditions for requesting authorization to subcontract the execution of the master and informal preparations provided for in the applicationCSP article L. 5125-1 and authorization for the execution of preparations that may pose a health risk as defined inCSP article L. 5125-1-1.
References: the text amended by this decree can be consulted, in its version, on the website Légifrance (http://www.legifrance.gouv.fr).
The Prime Minister,
On the report of the Minister of Social Affairs, Health and Women ' s Rights,
Vu le Public Health Codeincluding articles L. 5125-1, L. 5125-1-1 and L. 5125-32;
Vu la Act No. 2000-321 of 12 April 2000 the rights of citizens in their relations with administrations;
The State Council (Social Section) heard,
Decrete:

Article 1 Learn more about this article...


I. - The title of sub-section 9 of section 1 of chapter V of title II of Book I of the fifth part of the Public Health Code is replaced by the following title:
"Subsection 9. - Provisions relating to the execution of preparations that may pose a health risk."
II. - Section R. 5125-33-1 of the Public Health Code is amended as follows:
1° I is thus modified:
(a) The first paragraph is replaced by the following:
"I. - Authorization for the execution of preparations that may pose a health risk referred to in the second paragraph of Article L. 5125-1-1 is requested by the pharmacist who holds the offence concerned to the Director General of the Regional Health Agency. » ;
(b) In the second paragraph, the words "to be exercised" are replaced by the word "executing";
(c) The 1° is replaced by the following:
« 1° A photocopy of the professional card of the current year » ;
(d) At 2°, after the word "scheduled", the words "and the class(s) of preparations contained in the Order of the Minister for Health referred to in Article L. 5125-1-1" are added;
(e) The 9th is repealed;
2° II is replaced by the following:
“II. - Authorization for the execution of preparations that may pose a health risk is issued after investigation by an inspector of the regional health agency referred to in Article L. 5127-1. This authorization is subject to compliance with the good preparation practices referred to in Article L. 5121-5. The authorization decision indicates the pharmaceutical forms and the classes of preparations for which the authorization is issued, in accordance with the Order of the Minister for Health cited in section L. 5125-1-1. » ;
3° In the first paragraph of the III, the words "of the request" are replaced by the words "of the complete file";
4° In IV, the references: "1°, 2°, 3°, 4°, 5° and 6° of the I" are replaced by the references: "2°, 3°, 4° and 5° of the I" and the words: "at the regional inspection of the pharmacy" are replaced by the words: "at the director general of the regional health agency";
5° The V is thus modified:
(a) The first paragraph is replaced by the following:
"V. - The withdrawal or suspension, in whole or in part, of the authorization to perform preparations that may pose a health risk may be pronounced by the Director General of the Regional Health Agency, when it was established, after investigation by an inspector of the Regional Health Agency referred to in section L. 5127-1, that the offence no longer complies with good practices of preparation, does not respect the field of preparation » ;
(b) In the second paragraph, the words: "authorization to engage in subcontracting or" are deleted and the words: "sterile or dangerous" are replaced by the words: "may pose a health risk";
6° VI is replaced by the following:
"VI. - An annual quantitative assessment of preparations that may pose a health risk, classified by pharmaceutical forms and by categories, is carried out by the holder of the authorization to execute such preparations by March 31 of the following year. It is transmitted to the Director General of the Regional Health Agency upon request.
In the absence of transmission, the authorization may be withdrawn under the conditions specified in V."
7° It is added a VII as follows:
« VII. - Authorization to carry out the subcontracting activity referred to in the second paragraph of section L. 5125-1 for health-risk preparations is authorized to carry out such preparations under section L. 5125-1-1. »

Article 2 Learn more about this article...


I.-The title of sub-section 10 of chapter V, section 1, title II, of Book I, Part 5, of the Public Health Code is replaced by the following title:
"Subsection 10.-Dispositions relating to the subcontracting activity of the execution of preparations".
II.-Section R. 5125-33-2 of the Public Health Code is replaced by the following:


"Art. R. 5125-33-2.-I.-The authorization for the exercise of the subcontracting activity referred to in the second paragraph of section L. 5125-1 is requested by the pharmacist who holds the offence to the Director General of the territorially competent regional health agency.
When the application is submitted by a company or by several pharmacists together in co-ownership, it is signed by each partner or co-owner exercising in the offence.
The application is accompanied by a file containing the elements mentioned in 1° to 8° I of Article R. 5125-33-1.
II.-The authorization for the exercise of the subcontracting activity shall be issued after investigation by an inspector of the regional health agency referred to in section L. 5127-1. This authorization is subject to compliance with the good preparation practices referred to in Article L. 5121-5. The authorization decision refers to pharmaceutical forms and, where applicable, the classes of preparations referred to in 2° I of Article R. 5125-33-1 for which the authorization is granted.
III.-The failure to respond within the four-month period from the date of receipt of the complete file is tacit authorization for the activity that is the subject of it.
The Director General of the Regional Health Agency may request additional information from the applicant in the instruction of the application. In this case, the time limit provided for in the first paragraph of this III is suspended until such information is received.
IV.-A statement to the Director General of the Regional Health Agency shall be issued to the Director General of the Regional Health Agency any modification of the items referred to in 2°, 3°, 4° and 5° of the I of Article R. 5125-33-1. Compliance with this formality is exempt from making the declaration provided for in Article R. 5125-12.
V.-The withdrawal or suspension, total or partial, of the authorization to exercise the subcontracting activity may be pronounced by the Director General of the Regional Health Agency, when it has been established, after investigation by an inspector of the Regional Health Agency referred to in section L. 5127-1, that the offence no longer complies with good preparation practices, does not respect the scope of the authorization, authorization or
The decision to withdraw or suspend the authorization to exercise the subcontracting activity may only intervene after the proprietor or agent of the offence has been put in place to present within one month his observations.
In the event of an emergency, the Director General of the Regional Health Agency may, without prior procedure, issue an authorization suspension for a period not exceeding one month.
The withdrawal or suspension decision is notified by registered letter with a request for notice of receipt.
VI.-The written contract of subcontract referred to in the second paragraph of Article L. 5125-1 shall be established in accordance with the good preparation practices referred to in Article L. 5121-5.
VII.-An annual survey of subcontracting contracts indicating the contact details of order donors, the number of subcontracted preparations, the pharmaceutical forms of subcontracted preparations, the active substances they contain and, where applicable, the classes of preparations for which the authorization is issued is carried out by the holder of the authorization to carry out the subcontracting activity no later than March 31 of the following year. It is transmitted to the Director General of the Regional Health Agency upon request.
In the absence of transmission, the authorization may be withdrawn under the conditions set out in V."

Article 3 Learn more about this article...


I.-Subsection 11 of chapter V, section 1, title II, of Book I, Part 5, of the Public Health Code is repealed and subsection 12 "Subcontracting preparations to a pharmaceutical manufacturing facility" becomes subsection 11.
II.-Section R. 5125-33-3 is repealed. Section R. 5125-33-4 becomes section R. 5125-33-3 and is amended as follows:
1° At 1° of I, the words "European Community" are replaced by the words "European Union";
2° The 2° of I is replaced by the following:
« 2° Preparations that may pose a health risk referred to in the Minister's Health Order under section L. 5125-1-1. » ;
3° The 3° of I is repealed;
4° The III is replaced by the following:
"III.-An annual survey of the preparation subcontracts referred to in 2° of I indicating the contact details of the subcontractors, the categories and pharmaceutical forms of the subcontracted preparations as well as the active substances contained therein shall be carried out by the pharmacist who holds the offensive no later than March 31 of the following year. It is transmitted, upon request, to the Director General of the Regional Health Agency by the pharmacist who holds the offence on whose behalf the subcontract is carried out. »


Transitional provisions

Article 4 Learn more about this article...


I. - Valid authorization within the meaning ofArticle R. 5125-33-1 of the Public Health Code in its writing from this decree the authorizations for the execution of dangerous or sterile preparations mentioned inArticle L. 5125-1 of the Public Health Code, issued to the informals pursuant to Article R. 5125-33-1 in its writing before this decree, for the preparations they mention and to the extent that they fall under the order set out in the orderArticle L. 5125-1-1 of the Public Health Code.
II. - Valent authorization within the meaning ofArticle R. 5125-33-2 of the Public Health Code in its drafting of this decree the authorizations for the exercise of the subcontracting activity issued to the informals pursuant to article R. 5125-33-1 in its writing prior to this decree for the preparations they mention.
III. - Officin pharmacists who, at the date of entry into force of this decree, are preparing for a health risk referred to in the order provided for in Article L. 5125-1-1 and who do not have an authorization under Article R. 5125-33-1 in its earlier drafting of this Order have a period of six months to comply with the provisions of this Order.

Article 5 Learn more about this article...


The Minister of Social Affairs, Health and Women's Rights is responsible for the execution of this decree, which will be published in the Official Journal of the French Republic.


Done on 14 November 2014.


Manuel Valls

By the Prime Minister:


Minister of Social Affairs, Health and Women ' s Rights,

Marisol Touraine


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