Book I: Pharmaceutical products

The Director General of the Agence nationale de sécurité du médicament et des produits de santé may require samples and mock-ups to be submitted when the medicinal product is marketed.

For public health reasons, the Agence nationale de sécurité du médicament et des produits de santé may require a company to submit samples of each batch of the bulk product and the finished product for its inspection before the batch is put into circulation when it operates : 1° A live vaccine ; 2° An immunological medicinal product used for the primary immunisation of young children or persons belonging to…

In the case of blood-derived medicinal products, the Agence nationale de sécurité du médicament et des produits de santé may, when examining the application for marketing authorisation, submit samples either of the bulk product and the finished product, or of one of them only. In the interests of public health, the Agence nationale de sécurité du médicament et des produits de santé may require a company exploiting a blood-derived medicinal…

The marketing authorisation holder shall submit to the Director General of the Agence nationale de sécurité du médicament et des produits de santé any proposed amendment to the labelling or package leaflet, other than amendments to the summary of product characteristics. If the Director General of the Agency has not made a decision within ninety days of the date of submission of the application, the applicant may proceed to implement…

When a medicinal product has obtained an initial marketing authorisation in accordance with Article L. 5121-8, any variation or extension, as provided for in Chapter I of Commission Regulation (EC) No 1234/2008 of 28 November 2008 concerning the examination of variations to the terms of a marketing authorisation for medicinal products for human use and veterinary medicinal products, is also subject to authorisation. All these authorisations are considered to be…

When a new indication is authorised by the Agence nationale de sécurité du médicament et des produits de santé, on the basis of preclinical and clinical studies considered significant during the scientific evaluation conducted with a view to this authorisation, for a medicinal product whose active substance has been in well-established medicinal use for at least ten years in France, in the European Community or in the European Economic Area,…

When a change in the classification mentioned in 1° of Article R. 5121-36 is authorised, on the basis of preclinical and clinical studies considered to be significant during the scientific evaluation conducted with a view to this authorisation, an application for authorisation of the same change for another medicinal product containing the same active substance may not refer to these studies for a period of one year. In this case,…

1° In the interests of patients or for any other public health reason and, where appropriate, at the request of the Minister for Health, the Director General of the Agence nationale de sécurité du médicament et des produits de santé may, by a reasoned decision setting out the appeal procedures and time limits, vary the marketing authorisation where it is necessary to update it in the light of scientific knowledge….

The Director General of the Agence nationale de sécurité du médicament et des produits de santé shall refuse the marketing authorisation on the grounds mentioned in Article L. 5121-9. The application for authorisation may only be rejected after the applicant has been invited to present his observations. Rejection decisions must state the reasons on which they are based and indicate the appeal procedures and time limits applicable.

The specific obligations which may be imposed pursuant to the third paragraph of Article L. 5121-9 and which must be mentioned in the risk management system are, in particular, the following: 1° The applicant must complete a trial programme within a period set by the Agency, the results of which will be used to reassess the benefit/risk balance of the medicinal product as defined in the first paragraph of article…