Key Benefits:
Publics concerned: pharmaceutical laboratories and manufacturers of medical devices (or their agents) wishing to apply for the registration of a pharmaceutical specialty or medical device on the list mentioned in first paragraph of Article L. 162-22-7 of the Social Security Code.
Subject: modalities for filing an application with ministers responsible for social security and health on the list referred to as the "additional list".
Entry into force: the text comes into force on the day after its publication.
Notice: This Order sets out the terms and conditions for applying for a therapeutic indication of a pharmaceutical specialty, product or benefit on the list referred to in first paragraph of Article L. 162-22-7 of the Social Security Code. The application for registration is sent electronically or by mail to the hospital board, which is responsible for issuing a recommendation on this application.
References: the provisions of Social Security Code Amended by this decree may be consulted, in their drafting, on the website Légifrance (http://www.legifrance.gouv.fr).
The Prime Minister,
On the report of the Minister of Finance and Public Accounts and the Minister of Social Affairs, Health and Women's Rights,
Vu le Social Security Codeincluding articles L. 162-21-2, L. 162-22-7, L. 162-16-6, L. 165-2 and R. 162-22,
Decrete:
After article D. 162-16 of the Social Security Code, an article D. 162-16-1 is inserted as follows:
"Art. D. 162-16-1. - The inclusion of a therapeutic indication of a pharmaceutical specialty, product or benefit on the list referred to in the first paragraph of Article L. 162-22-7 may be requested from the ministers responsible for health and social security by the company that operates the pharmaceutical specialty, the product or the benefit concerned.
"The application for registration shall be sent, by way of dematerialisation or by post, to the board of hospitality referred to in Article L. 162-21-2, which shall acknowledge and inform the Ministers concerned. The date of receipt of the application by the Board of Hospitalization is the starting point for the one hundred and eighty-day period referred to in the first paragraph of Article L. 162-16-6 and the last paragraph of Article L. 165-2.
"The application for registration is accompanied by a file that contains the information necessary to assess the conditions for listing the therapeutic indication of specialty, product or service. As such, it shall include the final opinion of the Transparency Commission referred to in theArticle L. 5123-3 of the Public Health Codefor a pharmaceutical specialty, or the final opinion of the National Medical Devices and Health Technologies Review Board referred to in section L. 165-1, for a product or service. It may also be accompanied by foreign prices, budgetary impact elements and, where applicable, the maximum compensation amount referred to in L. 162-16-5-1. »
The Minister of Finance and Public Accounts, the Minister of Social Affairs, Health and Women's Rights and the Secretary of State responsible for the budget are responsible, each with regard to him, for the execution of this decree, which will be published in the Official Journal of the French Republic.
Done on April 30, 2015.
Manuel Valls
By the Prime Minister:
Minister of Social Affairs, Health and Women ' s Rights,
Marisol Touraine
Minister of Finance and Public Accounts,
Michel Sapin
The Secretary of State in charge of the budget,
Christian Eckert
