Chapter I: General provisions

The Director General of the Agence nationale de sécurité du médicament et des produits de santé will notify the applicant of his decision within a maximum of one hundred and twenty days from the date of receipt of the complete application. If no decision has been taken by the end of this period, the application will be rejected. If the Director General of the Agence nationale de sécurité du médicament…

The authorisation may be subject to special conditions requiring the beneficiary of the authorisation to implement a plan for monitoring the efficacy and safety of the medicinal product, including the periodic collection of information concerning efficacy and adverse reactions and the transmission of this information to the Director General of the Agence nationale de sécurité du médicament et des produits de santé.

A request for authorisation must be submitted for any changes which have an impact on the quality, safety and efficacy of the medicinal product. This application must be accompanied by a technical dossier, the model for which is laid down by decision of the Director General of the National Agency for the Safety of Medicines and Health Products. The decision of the Director General of the Agency is taken within…

In the event of failure to comply with the legislative and regulatory requirements, the conditions for granting or monitoring the authorisation referred to in Articles R. 5121-212 and R. 5121-213, or where it appears, particularly following evaluation, that the benefit/risk balance of the medicinal product is not favourable or that the claimed therapeutic effect is lacking, or in the event of danger to public health, the authorisation may be suspended…

The Agence de la biomédecine is informed of the decisions taken in application of Article R. 5121-212.