Articles R. 5121-51 to R. 5121-51-4 are applicable to homeopathic medicinal products subject to the registration referred to in article L. 5121-13. This sub-section does not apply to homeopathic medicinal products subject to the marketing authorisation referred to in article L. 5121-8.
The Director General of the Agence nationale de sécurité du médicament et des produits de santé or the applicant for marketing authorisation may refer the matter to the European Medicines Agency 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 divergent decisions concerning the authorisation, variation, suspension or withdrawal…
In specific cases of interest to the European Union, the Director General of the National Agency for the Safety of Medicines and Health Products or the applicant shall refer the matter to the European Medicines Agency for application of the Community arbitration procedure before a decision is taken on the granting, variation, suspension or withdrawal of the marketing authorisation. The Director General of the Agence nationale de sécurité du médicament…
At the end of the Community arbitration procedure implemented in accordance with the provisions of Articles R. 5121-51-8 and R. 5121-51-9, the Director General of the Agence nationale de sécurité du médicament et des produits de santé shall grant, vary, suspend or revoke the marketing authorisation within a period of thirty days, in accordance with the decision taken by the European Commission at the end of this procedure.
Each year, the Director General of the Agence nationale de sécurité du médicament et des produits de santé sends the coordination group referred to in Article 27 of Directive 2001/83/EC of the European Parliament and of the Council a list of medicinal products for which he considers it necessary to harmonise the summaries of product characteristics.
Where a marketing authorisation issued by the European Union pursuant to Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency provides that the medicinal product is subject to prescription, the Director General of the Agence nationale de sécurité du médicament…
The Director General of the Agence nationale de sécurité du médicament et des produits de santé will arrange for the Agency’s inspectors to take samples of proprietary medicinal products to ensure that they comply with the declared formulation. The samples taken are placed in bags bearing a label specifying the name and batch number of the medicinal product, the date of sampling, the reason for sampling and the name of…
Exceptionally, the Director General of the Agence nationale de sécurité du médicament et des produits de santé may, at the reasoned request of the marketing authorisation holder, authorise him to present several proprietary medicinal products, each of which has obtained a marketing authorisation, in a single pack.
I.-The application for authorisation to obtain the early access provided for in Article L. 5121-12 is sent by electronic means, by the holder of the exploitation rights or his authorised representative, simultaneously to the Haute Autorité de Santé and to the Ministers for Health and Social Security and, where the application concerns a medicinal product mentioned in 1° of II of the aforementioned Article, to the Agence nationale de sécurité…
When the application for early access authorisation concerns a medicinal product composed, in whole or in part, of genetically modified organisms, the holder of the exploitation rights, or his authorised representative, sends the Agence nationale de sécurité du médicament et des produits de santé an application for authorisation to market the genetically modified organism underArticle L. 533-5 of the Environment Code. The provisions of article R. 533-49 of the same…
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is a Registered Trademark of
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75001, Paris France
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