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Decree No. 2015 - 509 Of 6 May 2015 Relating To Simplification Of Schemes Of Authorisations For Preparatory Activities, Conservation, Distribution, Transfer, Import Or Export Of Fabrics, Their Derivatives, Cells And...

Original Language Title: Décret n° 2015-509 du 6 mai 2015 relatif à la simplification des régimes d'autorisations concernant les activités de préparation, conservation, distribution, cession, importation ou exportation de tissus, de leurs dérivés, des cellules et des...

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Keywords

HEALTH , HEALTH , PUBLIC HEALTH CODE , CSP , HEALTH PRODUCT , CELLULAR THERAPI , CELLULAR THERAPI , CELLULAR THEIR , CONSERVATION , DISTRIBUTION , CESSION , IMPORTATION , EXPORTATION , TISSUS


JORF n°0107 du 8 mai 2015 page 7907
text No. 16



Decree No. 2015-509 of 6 May 2015 on the simplification of licensing regimes for the preparation, conservation, distribution, disposal, import or export of tissues, derivatives, cells and cell therapy preparations, derived from the human body, used for therapeutic purposes

NOR: AFSP1428071D ELI: https://www.legifrance.gouv.fr/eli/decret/2015/5/6/AFSP1428071D/jo/texte
Alias: https://www.legifrance.gouv.fr/eli/decret/2015/5/6/2015-509/jo/texte


Publics concerned: institutions seeking from the National Agency for the Safety of Medicine and Health Products an authorization to prepare, preserve, distribute, dispose, import or export tissues, their derivatives, cells and cell therapy preparations from the human body for therapeutic purposes.
Subject: simplification of the procedure for authorizing the activities of tissue and cell banks.
Entry into force: the text comes into force on the day after its publication.
Notice: theArticle 122 of Act No. 2012-387 of 22 March 2012 simplified procedures and decisions, previously distinct, relating to the activities of tissue and cell banks. This decree adapts accordingly the provisions of Public Health Code related to these procedures for the preparation, conservation, distribution, disposal, import or export of tissues, their derivatives, cells and cell therapy preparations from the human body for therapeutic purposes.
References: the decree is taken for the application of theArticle 122 of Act No. 2012-387 of 22 March 2012 on the simplification of the law and the reduction of administrative procedures. The provisions of Public Health Code Amended by this decree can be consulted in the drafting resulting from this amendment 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,
Considering Directive 2004/23/EC of the European Parliament and of the Council of 31 March 2004 on the establishment of quality and safety standards for the donation, obtaining, controlling, processing, conservation, storage and distribution of human tissues and cells;
In light of Commission Directive 2006/17/EC of 8 February 2006 implementing Directive 2004/23/EC of the European Parliament and the Council on certain technical requirements relating to the donation, obtaining and controlling of tissues and cells of human origin;
In light of Commission Directive 2006/86/EC of 24 October 2006 on the implementation of Directive 2004/23/EC of the European Parliament and the Council on traceability requirements, notification of serious adverse reactions and incidents, as well as certain technical requirements for the codification, transformation, conservation, storage and distribution of tissues and cells of human origin;
Vu le Public Health Codeincluding articles L. 1243-2, L. 1243-9 and L. 1245-5;
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...


Sub-section 1 of Chapter III, Chapter III, Title IV, Book II of the Public Health Code is amended as follows:
1° At the beginning of the first paragraph of article R. 1243-1, it is inserted an I;
2° The second paragraph of the same article shall be replaced by the following provisions:
“II. - The use for therapeutic purposes includes the research referred to in Article L. 1121-1. Pursuant to section L. 1245-4, the provisions of subsections 3 and 4 of this section apply to such research. » ;
3° At the beginning of the third paragraph of the same article, it is inserted a III;
4° Section R. 1243-3 is amended as follows:
(a) In the first paragraph, after the words: "must be authorized", the words are inserted: ", pursuant to article L. 1243-2,";
(b) The last paragraph is deleted.

Article 2 Learn more about this article...


I. - Section R. 1243-4 of the same code is replaced by the following:


"Art. R. 1243-4. - I. - The application for authorization under section L. 1243-2 is addressed to the Director General of the National Agency for the Safety of Medicine and Health Products by the legal person who requests this authorization, by any means to acknowledge receipt. This application specifies, for each institution or organization and, where applicable, for each site of the establishment, the activities for which the authorization is sought and, for each activity, the tissues, their derivatives, the cells or cell therapy preparations concerned.
“II. - This application can only be considered if it is accompanied by a supporting documentation that is specified in the form and content by decision of the Director General of the National Agency for the Safety of Medicine and Health Products, taken after notice by the Biomedicine Agency, published on the website of the National Agency for the Safety of Medicine and Health Products.
"This file includes:
« 1° Information on premises, equipment and materials, personnel, procedures and conventions with third parties;
« 2° Information on tissue and cell sampling;
« 3° Information on the preparation process implemented;
« 4° Information on the finished product;
« 5° The list of products and materials in contact with tissues, derivatives, cells and cell therapy preparations;
« 6° Preclinical data, based on the product that is the subject of the application, as well as clinical data, including results of clinical trials and claimed therapeutic indications;
« 7° Where applicable, information relating to the establishment of the procedures referred to in R. 1243-17;
« 8° When the application comes from a health institution, a copy of the letter and the notice of receipt accompanying it, certifying that the director(s) of the relevant regional health agencies in the area where the sites of the institution are located, were informed of the application for authorization to implement the activities referred to in R. 1243-1, as well as, where appropriate, a copy of any mail indicating the possible regional observations
"III. - The file is deemed to be complete if, within one month of its receipt, the Director General of the National Drug Safety Agency and Health Products did not notify the applicant, by any means to ensure a certain date, of the missing or incomplete information and mentioning the deadline to provide it. »


II. - In the second paragraph of article R. 1243-5 of the same code, the words "three months" are replaced by the words "two months".
III. - Article R. 1243-6 of the same code is amended as follows:
(a) In the first and second paragraphs, the words "six months" are replaced by the words "four months";
(b) The fourth preambular paragraph is replaced by the following:
"The authorizations specify the address of the establishment or organization and, where appropriate, the address of the site, the type of authorized activities, the category of tissues and their derivatives, cells or cell therapy preparations, mention the agreements between an establishment and third parties for the conduct of these activities, the preparation and conservation processes implemented and the recognized therapeutic indications. » ;
(c) The fifth preambular paragraph is replaced by the following:
"The Director General of the National Drug Safety Agency and Health Products transmits the authorizations granted to the Director General of the Biomedicine Agency and to the Director General of the Regional Health Agency where the establishment or authorized site is located. »
IV. - Section R. 1243-7 of the same code is replaced by the following:


"Art. R. 1243-7. - I. - Are subject to prior written authorization from the Director General of the National Agency for the Safety of Medicine and Health Products, following the advice of the Director General of the Agency for Biomedicine, the substantial amendments to the authorization referred to in R. 1243-6.
“These are considered to be substantial changes to:
« 1° The types of activities and categories of tissue, derivatives, cells or cell therapy preparations referred to in R. 1243-1;
« 2° Changes in premises that have an impact on the conditions of operation;
« 3° The creation of new premises in which authorized activities are carried out;
« 4° To products or their preparation and preservation processes that are likely to have an impact on the quality, safety and efficacy of the product and, as such, are listed by decision of the Director General of the National Agency for the Safety of Medicine and Health Products published on the website of the National Agency for the Safety of Medicine and Health Products.
“II. - The application specifies the nature of the requested amendment. It is accompanied by a technical record, the form and content of which are specified by a decision of the Director General of the National Agency for the Safety of Medicine and Health Products, following the advice of the Director General of the Agency for Biomedicine, published on the website of the National Agency for the Safety of Medicine and Health Products.
"III. - The application is addressed to the Director General of the National Agency for the Safety of Medicine and Health Products by the legal person who requests this authorization, by any means to acknowledge receipt.
"IV. - The file is deemed to be complete if, within one month of its receipt, the Director General of the National Drug Safety Agency and Health Products did not disclose to the applicant the missing or incomplete information and mentioning the deadline for providing it.
"V. - The provisions of Article R. 1243-5 are applicable.
"VI. - The decision of the Director General of the National Drug Safety Agency and Health Products comes within four months of the date the file is deemed complete.
« VII. - If the Director General of the National Agency for the Safety of Medicine and Health Products considers that additional information is necessary to allow him to decide on the application, he may interrupt the examination of the drug until the missing information is received within a period of four months. In this case, the applicant must notify the applicant of the reasons for this interruption and specify the time limit for which such information is to be sent. This request for additional information suspends the deadline mentioned in VI.
« VIII. - The lack of response within the deadlines mentioned in VI and VII is a rejection of the amendment request.
« IX. - The Director General of the National Drug Safety Agency and Health Products informs the Director General of the Biomedicine Agency and the Director General of the Regional Health Agency of the establishment or site authorized to amend the authorization. »


V. - Article R. 1243-8 of the same code is amended as follows:
(a) At 1°, after the words: "or the organism", the words are inserted: ", if any of the site";
(b) At the 4th, after the words: "at the 5th of Article R. 1243-4", the words are added: "as long as this modification is without consequence on the product";
(c) After the 6°, a 7° and an 8° are inserted:
« 7° When the establishment or organization and site are closed;
« 8° The process and product that are not substantial changes, as such, is listed by decision of the Director General of the National Agency for the Safety of Medicine and Health Products, published on the website of the National Agency for the Safety of Medicine and Health Products. » ;
(d) In the ninth preambular paragraph, the words: "with a recommended fold with a request for a notice of receipt or filed against receipt" are replaced by the words: "by any means to acknowledge receipt".
VI. - Article R. 1243-10 of the same code is amended as follows:
(a) In the first paragraph, after the words: "especially in case of", the words are inserted: " danger to public health or to the environment or";
(b) In the fifth paragraph, the words "of fifteen days" are replaced by the words "fixed by the Director General of the National Drug Safety Agency and Health Products";
(c) A seventh preambular paragraph added:
"These decisions are made public. »
VII. - Section R. 1243-11 of the same code is amended as follows:
(a) In the second paragraph, the words "or its renewal" are deleted;
(b) In the third paragraph, the words: "authorized under section R. 1243-6" are deleted and the word "biomedical" is replaced by the words "as mentioned in section L. 1121-1".

Article 3 Learn more about this article...


I. - In the second sentence of article R. 1243-22 of the same code, after the words: "Biomedicine Agency" are inserted the words: ", published on the website of the National Drug Safety Agency and Health Products. "
II. - In the second and third paragraphs of article R. 1243-25 of the same code, the reference "L. 1243-5" is replaced by the reference "L. 1243-2".

Article 4 Learn more about this article...


Section R. 1245-2 of the same code is replaced by the following provisions:


"Art. R. 1245-2.-Any import or export operation, excluding transit, is subject to the affixing of the information defined by order of the Minister for Health and the Minister for Research pursuant to Appendix IV 1.7 of Directive 2006/17/EC of the Commission of 8 February 2006 implementing Directive 2004/23/EC of the European Parliament and the Council on certain technical requirements relating to the donation,
"The package is accompanied, where applicable, by the Minister for Research and the Director General of the National Drug Safety Agency and Health Products.
"Products imported or exported for therapeutic purposes are accompanied by the document referred to in R. 1211-19 or R. 1211-22-2. »

Article 5 Learn more about this article...


I.-Subsection 1 of chapter V, section 2 of title IV of Book II of the same code is amended as follows:
1° The title of subsection 1 is replaced by the title: "Authorization of import and export from or to third countries to the European Union and the European Economic Area";
2° Subdivision 1 in paragraphs shall be deleted;
3° Section R. 1245-8 is repealed.
II.-Section R. 1245-3 of the same code is replaced by the following:


"Art. R. 1245-3.-I.-The application for authorization to import or export for therapeutic purposes, as provided for in the second paragraph of section L. 1245-5, is addressed by the establishment or agency authorized under section L. 1243-2 to the Director General of the National Agency for the Safety of Medicine and Health Products by the physical or legal person who requests such authorization, by any means permitting such authorization.
"II.-The application is accompanied by a file that includes:
« 1° A copy of the authorization issued under Article L. 1243-2 and that of the authorization issued by the competent authorities of the suppliers and their translation into French;
« 2° Any information or document to establish that the requirements referred to in section R. 1245-15 are met by the applicant establishment or organization;
« 3° The name and address of each supplier or recipient;
« 4° Description of the means in place to ensure traceability of products, conservation methods and conditions of transport of products;
« 5° The precise designation of the product;
« 6° Information on tissue and cell sampling, the preparation process implemented, products and materials in contact with tissues, derivatives, cells and cell therapy preparations, and, for finished products, information on the finished product, preclinical and clinical data, including clinical test results and claimed therapeutic indications.
"III.-A decision by the Director General of the National Agency for the Safety of Medicine and Health Products, following the advice of the Director General of the Agency for Biomedicine, specifies the form and content of the file, as well as the list of documents and additional information required for the instruction of the application. It is published on the website of the National Drug Safety Agency and Health Products.
"IV.-The file is deemed to be complete if, within one month of its receipt, the Director General of the National Agency for the Safety of Medicine and Health Products has not made known to the applicant, by any means to ensure a certain date, the missing or incomplete information and mentioning the deadline to provide it. »


III.-In the second paragraph of section R. 1245-4 of the same code, the words: "when it is an application for authorization and deemed to be granted in the terms of the previous authorization when it is a renewal application" are deleted.
IV.-The first paragraph of section R. 1245-5 of the same code is replaced by the following:
"The authorities specify the type of authorized activity and the category of products imported or exported. »
V.-The first paragraph of article R. 1245-6 of the same code is amended as follows:
1° After the words: "or origin of the products", the words are inserted: "and the substantial modifications mentioned in the 4th of article R. 1243-7 do";
2° The words: ", without effect on the duration of it" are deleted.
VI.-Article R. 1245-7 of the same code is amended as follows:
1° The first paragraph is supplemented by the following sentence:
"This list is made public. » ;
2° In the second paragraph, the word "nature" is replaced by the word "category".

Article 6 Learn more about this article...


Sub-section 2 of chapter V, section 2 of Book II, title IV, of the same code is replaced by the following:


"Subsection 2
" Provisions relating to the import of products from the Member States of the European Union or a party to the European Economic Area not authorized in their country of origin


"Art. R. 1245-9.-I.-The application for authorization under the third paragraph of Article L. 1245-5 for products originating from the Member States of the European Union or a party to the European Economic Area that do not have the authorization provided for in 2 of Article 6 of Directive 2004/23/ EC on the establishment of quality and safety standards for the donation, obtaining, controlling, processing, conservation, storage and distribution of human tissues and cells is addressed to the Director General of the National Agency for the Safety of Medicine and Health Products, along with a supporting record, by the legal person who requests such authorization by any means that would allow for the acknowledgement of receipt.
"II.-This file contains a copy of the authorisation issued under Article 6 (1) of Directive 2004/23/EC by the competent authorities of the suppliers, together with its translation into French, as well as the elements mentioned in Article 1245-3, 5° and 6°. Its form and content are specified by a decision of the Director General of the National Drug and Health Products Safety Agency, following the advice of the Director General of the Biomedicine Agency, published on the website of the National Drug and Health Products Safety Agency.
"III.-The file is deemed to be complete if, within one month of its receipt, the Director General of the National Agency for the Safety of Medicine and Health Products has not made known to the applicant, by any means to ensure a certain date, the missing or incomplete information and mentioning the deadline to provide it.
"IV.-The Director General of the National Agency for Drug Safety and Health Products shall forward a copy of the file to the Director General of the Agency for Biomedicine, who shall notify the Agency within one month. The lack of response within this period is a favourable opinion.


"Art. R. 1245-10.-I.-The Director General of the National Drug and Health Products Safety Agency shall notify the applicant of its decision within three months of the date on which the file is deemed complete.
"II.-He may request, by any means to ensure certain date, any additional information that he considers necessary. In this case, the period provided for in the previous paragraph is suspended until the additional information required has been provided.
"III.-The absence of a response to the expiry of this period is a rejection of the application.
"IV.- Authorities specify the category of imported products.
"V.-The authorizations so issued may be amended, suspended or withdrawn in whole or in part by the Director General of the National Agency for the Safety of Drugs and Health Products under the conditions set out in section L. 1245-1. A copy of the authorization, suspension or withdrawal decisions is forwarded to the Minister of Health, the Minister of Customs and the Biomedicine Agency.
"VI.-Any modification of the elements in the original authorization application file, concerning the nature or origin of the products and the substantial amendments referred to in the 4th of section R. 1243-7, shall be subject to an authorization issued by the Director General of the National Drug Safety Agency and Health Products. The application for amendment shall be filed and investigated under the same conditions as the original application.
" VII.-Any modification of the other elements in the original file is the subject of a statement to the Director General of the National Drug Safety Agency and Health Products.
" VIII.-The list of authorizations issued to institutions and organizations under section R. 1245-9 is regularly updated and communicated by the Director General of the National Drug Safety Agency and Health Products to the Minister for Health, the Minister for Customs and the Agency for Biomedicine. This list is made public. It specifies the names and addresses of authorized establishments and agencies and the category of products that each of them is authorized to import. »

Article 7 Learn more about this article...


I. - The title of sub-section 3 of section 2 of chapter V of title IV of Book II of the same code is replaced by the title: "Product export provisions that do not benefit from the authorization referred to in section L. 1243-2. »
II. - Section R. 1245-11 of the same code is amended as follows:
1° The first paragraph is deleted;
2° II is deleted and the reference: "L. 1243-5" is replaced by the reference: "L. 1243-2";
3° The last paragraph is replaced by the following:
"A decision by the Director General of the National Agency for Drug Safety and Health Products after the advice of the Director General of the Biomedicine Agency specifies the form and content of the file, as well as the list of additional parts and information required to study this file. It is published on the website of the National Drug Safety Agency and Health Products. »

Article 8 Learn more about this article...


Article R. 1245-13 of the same code is amended as follows:
1° In the first paragraph, after the words: "health products", the words are inserted: "by any means to acknowledge their receipt,"
2° In the second paragraph, the words: "Decision of the Minister for Health on Proposal" are replaced by the word: "Decision" and, after the words: "health products" are inserted the words: "published on the website of the National Agency for the Safety of Medicine and Health Products. » ;
3° The second paragraph is supplemented by the following:
"This file includes the name of the patient, the precise description of the product and the number of units, the name and address of the supplier or recipient, and the essential information on the process implemented and the product obtained. » ;
4° The third fourth preambular paragraph was replaced by the following:
"The authorization decision, made after notice by the Director General of the Biomedicine Agency, includes the name and address of the supplier establishment, establishment or agency that imports or exports, the initials of the patient, the nature of the product or element that is the subject of the authorization, its identification code, the number of units of the item or product being transported and its duration of the product. » ;
5° In the fifth preambular paragraph, the reference: "R. 1245-8" is replaced by the reference: "R. 1245-15".

Article 9 Learn more about this article...


In section 2 of chapter V of Book II title IV of the same code, a sub-section 5 is re-established as follows:


"Subsection 5
" Provisions common to imports and exports for therapeutic purposes


"Art. R. 1245-15.-The establishment or organization that imports or exports elements or products of the human body or their derivatives referred to in R. 1245-1 for therapeutic purposes, including biomedical research within the meaning of L. 1121-1, does not disclose any information that would identify the donor and the receiver. It ensures compliance with the provisions mentioned in the second paragraph of Article R. 1245-1.
"The establishment or organization that imports or exports elements or products referred to in the first paragraph shall ensure that they have been taken or collected in accordance with protection standards at least as demanding as the sanitary safety rules referred to in section L. 1211-6.
"The establishment or organization that imports products referred to in section R. 1245-1 shall ensure that they are taken and prepared in accordance with rules at least equivalent to the rules of good practice referred to in section L. 1245-6.


"Art. R. 1245-16.-Seuls may be imported or exported the products referred to in R. 1245-1 that meet the requirements of Directive 2004/23/EC, the provisions of the first paragraph of Article L. 1211-4 and the provisions of this section. »

Article 10 Learn more about this article...


Article R. 1245-19 of the same code is amended as follows:
1° In the first paragraph, the word "sixth" is replaced by the word "fifth";
2° In the fifth paragraph, the words "decision of the Minister for Health on Proposal" are replaced by the word "decision" and, after the words "health products" are inserted, the words "published on the website of the National Agency for the Safety of Medicine and Health Products".

Article 11 Learn more about this article...


Article R. 1245-20 of the same code is amended as follows:
1° In the first paragraph, the word "seventh" is replaced by the word "sixth";
2° At 1°, the words: "analysis" are deleted.

Article 12 Learn more about this article...


In R. 1235-1 of the same code, the words "section 5" are replaced by the words "section 3".

Article 13 Learn more about this article...


Section 2 of chapter III of Book II title IV of the same code is repealed.

Article 14 Learn more about this article...


The first two paragraphs of section R. 1418-19 of the same code are replaced by the following:
"The agency's guidance board includes, in addition to its president, thirty members:
« 1° Four deputies and four senators appointed by their respective assembly; "

Article 15 Learn more about this article...


I. - Authorizations for activities and products issued prior to the publication of this Order in Council pursuant to Articles R. 1243-6 and R. 1243-35 in their earlier drafting remain valid until May 1, 2017 or until their normal due date if this deadline is after May 1, 2017.
II. - Are deemed to have been obtained under section R. 1245-5 in its drafting by this decree:
1° Authorities granted for import activity prior to the date of publication of this Order, provided that the products were also authorized under Article R. 1245-9 in its writing prior to this Order;
2° Authorizations granted for export activity prior to the date of publication of this Order, provided that the products meet the requirements set out in section R. 1245-11 in its writing before this Order.
III. - It is decided on applications for authorization in the course of instruction filed before the date of publication of this decree, according to the nature of the application, under the conditions provided for in articles R. 1243-5 and R. 1243-6, or R. 1243-34 and R. 1243-35 or R. 1245-4 or R. 1245-9, in their writing prior to that of this decree. The authorisations granted under articles R. 1243-6 and R. 1243-35 in their earlier writings are granted for a period of five years. The authorisations granted under articles R. 1245-5 and R. 1245-9 in their writing prior to that of this decree are for an indefinite period.

Article 16 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 May 6, 2015.


Manuel Valls

By the Prime Minister:


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

Marisol Touraine


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