Chapter I: General provisions.

Any proprietary medicinal product or any other medicinal product manufactured industrially or by a method involving an industrial process, as well as any generator, kit or precursor which is not the subject of 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…

Once the authorisation provided for in Article L. 5121-8, the Agence nationale de sécurité du médicament et des produits de santé may, under conditions laid down by decree in the Conseil d’Etat, require the holder of the authorisation to carry out, within a period set by the Agency: 1° Post-authorisation safety studies if there are concerns about the safety risks presented by an authorised medicinal product; 2° Post-authorisation efficacy studies…

Inclusion on the list defined in article L. 1121-15 of clinical trials prior to the granting of marketing authorisation is compulsory.

The authorisation provided for in article L. 5121-8 is refused if it appears that the assessment of the positive therapeutic effects of the medicinal product or product with regard to the risks to patient health or public health associated with its quality, safety or efficacy is not considered to be favourable, or that it does not have the qualitative and quantitative composition declared, or that the therapeutic effect announced is…

Where a medicinal product is authorised in another Member State of the European Union or a State party to the Agreement on the European Economic Area, but is not the subject in France of either the marketing authorisation provided for in Article L. 5121-8 or an application under examination for such authorisation, the Agence nationale de sécurité du médicament et des produits de santé may, on justified public health grounds,…

The company or organisation exploiting a medicinal product or health product shall immediately notify the National Agency for the Safety of Medicines and Health Products of any prohibition or restriction imposed by the competent authority of any country in which the medicinal product for human use is marketed and of any other new information likely to influence the evaluation of the benefits and risks of the medicinal product for human…

In order to be able to continuously assess the benefit/risk balance of the medicinal product as defined in the first paragraph of Article L. 5121-9, the Agence nationale de sécurité du médicament et des produits de santé may at any time ask the marketing authorisation holder to submit data demonstrating that this balance remains favourable.

The holder of a marketing authorisation for a medicinal product shall immediately inform the Agence nationale de sécurité du médicament et des produits de santé, specifying the reasons, of any action taken, in France or in another Member State of the European Union, to suspend or stop the marketing of this medicinal product, to request the withdrawal of this authorisation or not to apply for its renewal, specifying in particular…

For a generic or hybrid medicinal product defined in 5° of Article L. 5121-1, the marketing authorisation may be granted before the expiry of the intellectual property rights attached to the reference medicinal product concerned. The applicant for this authorisation must inform the holder of these rights at the same time as the application is submitted. Where the Agence nationale de sécurité du médicament et des produits de santé has…

A generic medicinal product may not be marketed until ten years have elapsed following the initial marketing authorisation of the reference medicinal product. However, this period is extended to eleven years if, during the first eight years following the authorisation of the reference medicinal product, the holder of the latter obtains authorisation for one or more new therapeutic indications considered, during the scientific evaluation carried out with a view to…