Key Benefits:
The Prime Minister,
On the report of the Minister of Health, Youth and Sports,
Having regard to Regulation (EC) No. 726/2004 of the European Parliament and Council of 31 March 2004 establishing community procedures for authorisation and monitoring of drugs for human use and veterinary use, and establishing a European Agency for Drugs;
Having regard to Commission Regulation (EC) No. 1084/2003 of 3 June 2003 on the review of amendments to the terms of a marketing authorization issued by the competent authority of a Member State for human-use drugs and veterinary medicines;
Having regard to Directive 2004/27/EC of the European Parliament and of the Council of 31 March 2004 amending Directive 2001/83/EC of the European Parliament and the Council of 6 November 2001 establishing a Community Code on Human Drugs;
Vu le Public Health Codeincluding articles L. 5121-8 and L. 5121-20;
The State Council (Social Section) heard,
Decrete:
In section 5 of chapter I of title II of Book I of Part V of the Public Health Code, after section R. 5121-21-21, an article R. 5121-21-1 is inserted as follows:
"Art. R. 5121-21-1. - Where a drug, already authorized or subject to an application for an authorization to place on the market in the course of instruction in another Member State of the European Community or a party to the agreement on the European Economic Area, is the subject of an application for authorization to place on the market in France without complying with the provisions of subsection 3 bis of this section, the Director General of the French Health Agency immediately informs the applicant of »
In the same section, after R. 5121-50, a sub-section 3 bis is inserted as follows:
"Subsection 3 bis
“ Mutual Recognition Procedure and Decentralized Procedure
“paragraph 1
“General provisions
"Art. R. 5121-51. - To obtain an authorization to market a drug that does not fall within the scope of the marketing authorization procedure issued by the European Commission pursuant to Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004, in more than one Member State of the European Community or a party to the European Economic Area Agreement, the applicant shall submit to one of the two procedures set out in this subsection:
"—the mutual recognition procedure when a marketing authorization has already been issued for this drug in one of these states;
"—or decentralized procedure if the drug is not allowed in any of them.
"A request made pursuant to one of these procedures shall include a list of the States concerned and a certificate certifying that the records filed in each of these States are identical.
"A request to amend a marketing authorization issued under one of these procedures shall be submitted by the licensee to all States that have authorized the drug concerned. These requests for amendments are reviewed in accordance with the Commission's European Regulation (EC) No. 1084/2003 on the review of the amendments to the terms of a marketing authorization issued by the competent authority of a Member State for human-use drugs and veterinary medicines.
“Paragraph 2
“ Mutual Recognition Procedure
"Art. R. 5121-51-1. - To obtain the recognition, by at least one other Member State of the European Community or a party to the agreement on the European Economic Area, of a marketing authorization issued by the Director General of the French Health Safety Agency, France acting as a reference State, the licensee shall request that the latter update or prepare the evaluation report of the drug; it transmits any supplements to the file the agency has.
"The Director General of the Agency shall transmit this evaluation report, together with a summary of the characteristics of the product, the labelling and the notice, to the States concerned and to the licensee of the marketing authorization within 90 days of the receipt of the complete record:
« 1° In the event of the approval of these documents by each of the States concerned within ninety days, the Director General of the agency shall notify the agreement to these States and the holder of the authorization to market.
« 2° If there is no agreement within the time limit mentioned in 1°, the Director General of the Agency shall refer the coordination group referred to in Article 27 of Directive 2001/83/EC of the European Parliament and the Council.
"Art. R. 5121-51-2. - To obtain the recognition in France of a marketing authorization issued by another so-called State of Reference, a member of the European Community or a party to the agreement on the European Economic Area, the holder of this authorization shall apply for a marketing authorization to the Director General of the French Health Products Agency.
"From the receipt of the drug assessment report, accompanied by a summary of the characteristics of the product, the labelling and the notice, transmitted by the reference State, the director general of the agency has a period of ninety days to decide:
« 1° If the director general of the agency approves these documents, he informs the reference state. In the event of an agreement between all the States concerned, notified by the reference State, it shall issue a marketing authorization in accordance with the assessment report so approved within thirty days of the receipt of this notification.
« 2° If the director general of the agency does not approve these documents because it considers that the drug concerned presents a serious potential risk to public health within the meaning of the guidelines referred to in Article 29.2 of Directive 2001/83/EC of the European Parliament and the Council, it immediately makes known its opposition motivated to the reference State, to the other States concerned, to the applicant and to the coordination group referred to in Article 27 of the above directive.
“Paragraph 3
“Decentralized procedure
"Art. R. 5121-51-3. - To obtain a marketing authorization in France and in at least one other Member State of the European Community or part of the European Economic Area Agreement, for a drug that is not authorized in the European Community or in the European Economic Area, the applicant shall apply for a marketing authorization to the Director General of the French Health Products Agency.
« 1° If the applicant designates France as the reference State, the application shall be instructed under the conditions set out in articles R. 5121-34 and R. 5121-35. The Director General of the Agency shall transmit to the States concerned and to the applicant a draft evaluation report of the drug, if any unfavourable, accompanied by the draft summaries of the characteristics of the product, labelling and notice, within a period of one hundred and twenty days from the receipt of the complete package.
"If these documents are approved by each of the States concerned within ninety days, the Director General of the Agency shall notify the agreement to these States and the applicant. In accordance with the approved assessment report, it shall issue or refuse the marketing authorization within thirty days of such notification.
"If there is no agreement between the States concerned within the ninety-day period referred to in the preceding paragraph, the Director General of the Agency shall refer to the coordination group referred to in Article 27 of Directive 2001/83/EC of the European Parliament and the Council.
« 2° If the applicant designates another Member State of the European Community or a party to the Agreement on the European Economic Area as a reference State, the Director General of the Agency shall, from the date of receipt of the draft assessment report, together with the draft summaries of the characteristics of the product, of the labelling and notice transmitted by the reference State, have a period of ninety days to decide.
"If the director general of the agency approves these documents, he informs the reference state. In the event of an agreement between all the States concerned, notified by the reference State, it shall issue or refuse a marketing authorization in accordance with the assessment report so approved within thirty days of the receipt of the notification.
"If the director general of the agency does not approve these documents because it considers that the drug concerned presents a serious potential risk to public health within the meaning of the guidelines referred to in Article 29.2 of Directive 2001/83/EC of the European Parliament and the Council, it immediately discloses its opposition motivated to the reference State, to the other States concerned, to the applicant and to the coordination group referred to in Article 27 of the above-mentioned directive.
“Paragraph 4
“ Provisions common to both procedures
"Art. R. 5121-51-4. - In the event of an agreement within the coordination group, seized by the Director General of the French Health Safety Agency or by another State:
« 1° In the case provided for in R. 5121-51-1, the Director General of the Agency shall notify the agreement to the States concerned and to the holder of the marketing authorization. In accordance with the approved assessment report, it amends or withdraws, if any, the marketing authorization within 30 days of the notification.
« 2° In the case provided for in the 1st of Article R. 5121-51-3, the Director General of the Agency shall notify the States concerned and the applicant of the agreement. In accordance with the approved assessment report, it shall issue or refuse the marketing authorization within 30 days of this notification.
« 3° In the cases provided for in Article R. 5121-51-2 and 2° of Article R. 5121-51-3, the Director General of the agency shall issue or refuse the authorization to place on the market in accordance with the assessment report so approved within thirty days of the notification of the agreement by the reference State.
"Art. R. 5121-51-5. - In the absence of agreement within the coordination group, the Community Arbitration Procedure provided for in sections 32 to 34 of Directive 2001/83/EC of the European Parliament and the Council shall apply. When France is the reference State, it is up to the Director General of the French Health Products Agency to initiate this procedure by informing the European Agency of the drugs of this disagreement.
"The director general of the agency issues, refuses, amends or withdraws the authorization to market the drug concerned in accordance with the decision taken by the European Commission following this procedure within thirty days.
"Waiting the decision of the European Commission, the director general of the agency may, upon request of the applicant, issue a marketing authorization. After the intervention of this decision, the authorization is, if necessary, amended or withdrawn under the conditions set out in the preceding paragraph.
"Art. R. 5121-51-6. - At the end of the procedures provided for in this subsection, the issuance or modification of the authorization to place on the market by the Director General of the French Health Safety Agency of the health products intervenes within 30 days after the notification of the agreement by the reference State or by the European Commission, subject to the provision by the applicant of a French translation of the summary of the characteristics of the product, the notice and the relevant product.
"Art. R. 5121-51-7. - Articles R. 5121-51 to R. 5121-51-4 are applicable to homeopathic medicines subject to registration referred to in L. 5121-13.
"This subsection is not applicable to homeopathic drugs subject to market authorization referred to in section L. 5121-8.
“Paragraph 5
“Other applications of the procedure
Community arbitration
"Art. R. 5121-51-8. - The Director General of the French Health Products Safety Agency or the applicant for the marketing authorization may apply to the European Agency for Drugs with a view to the application of the Community Arbitration Procedure provided for in Articles 32 to 34 of Directive 2001/83/EC of the European Parliament and of the Council when a drug has been subject, on the part of Member States of the European Community or parties to the agreement on the European Union's decision
"Art. R. 5121-51-9. - In particular cases of community interest, the Director General of the French Health Products Agency or the applicant shall refer the European Medicines Agency to the application of the Community Arbitration Procedure before a decision is made on the issue, amendment, suspension or withdrawal of the marketing authorization, including on the basis of pharmacovigilance data.
"Art. R. 5121-51-10. - When the Director General of the French Health Products Agency considers that the modification, suspension or withdrawal of a marketing authorization issued by the Director General of the French Health Products Agency following a mutual or decentralized recognition procedure is necessary for the protection of public health, he immediately informs the European Agency of the drugs for the application of the Community Arbitration procedure.
"In exceptional cases, when the Director General of the French Health Products Agency urgently decides to suspend or remove from the market a drug to protect public health until a final decision is made pursuant to the Community Arbitration Procedure, he shall inform the European Commission and other Member States of the European Community or parties to the agreement on the European Economic Area of the reasons for this measure not later than the first day of the decision.
"Art. R. 5121-51-11. - At the end of the community arbitration procedure implemented in accordance with the provisions of Articles R. 5121-51-8 to R. 5121-51-10, the Director General of the French Health Products Safety Agency issues, amends, suspends or withdraws the authorization to market within thirty days, in accordance with the decision taken by the European Commission at the end of this procedure. »
“Paragraph 6
“Community Harmonization
"Art. R. 5121-51-12. - The Director General of the French Health Products Agency transmits annually to the coordination group referred to in Article 27 of Directive 2001/83/EC of the European Parliament and the Council a list of medicines for which he considers it necessary to harmonize summaries of the product characteristics. »
Sections R. 5121-43 and R. 5121-44 are repealed.
The Minister of Health, Youth and Sports is responsible for the execution of this decree, which will be published in the Official Journal of the French Republic.
Done in Paris, December 26, 2007.
François Fillon
By the Prime Minister:
The Minister of Health,
youth and sports,
Roselyne Bachelot-Narquin
