Title II: In vitro diagnostic medical devices

Applications for authorisation to advertise the in vitro diagnostic medical devices referred to in Article L. 5223-3 must be sent to the Director General of the Agence nationale de sécurité du médicament et des produits de santé by the person on whose behalf the advertising is to be disseminated, by registered letter or by electronic means with acknowledgement of receipt or by delivery against receipt. Each application for authorisation must…

The Director General of the Agence Nationale de Sécurité du Médicament et des Produits de Santé may require the communication of all information essential for checking the accuracy of the advertised characteristics and performances.

The Director General of the Agence nationale de sécurité du médicament et des produits de santé will notify the applicant of his prior authorisation decision within two months of the date of receipt of the complete dossier. Authorisation is deemed to have been granted in the absence of a decision by the Director General of the Agency within this period. If the applicant’s documents are not complete, the Agence nationale…

The authorisation is issued for a period of five years. At the request of the holder, submitted no later than two months before the normal expiry date, the initial authorisation is renewed for a period of five years.

Any project to modify the elements mentioned in 1° and 2° of article R. 5223-5 is the subject of a new application for authorisation submitted and examined under the same conditions as the initial application for authorisation. The authorisation continues to run until its initial expiry date.

The authorisation may be suspended or withdrawn by reasoned decision of the Director General of the Agence nationale de sécurité du médicament et des produits de santé where the advertising of the in vitro diagnostic medical device no longer complies with the conditions laid down by the provisions of Articles L. 5223-2 and L. 5223-4, and by the provisions of this chapter. Suspension or withdrawal may only take place after…

In an emergency, the Director General of the Agence nationale de sécurité du médicament et des produits de santé may suspend the authorisation of an advertisement for a maximum period of three months.