Subsection 3: Examination and conditions of authorisation.

Any change in the marketing authorisation holder is subject to authorisation from the Director General of the Agence nationale de sécurité du médicament et des produits de santé.

The application must include the information specified in Article R. 5121-21 and must be accompanied by a dossier comprising :

1° A copy of the marketing authorisation, certified by the holder ;

2° The agreement of the marketing authorisation holder to the transfer of the marketing authorisation;

3° The designation of the manufacturing, testing and packaging sites;

4° An undertaking by the applicant to comply with all the conditions to which the marketing authorisation was subject and, in particular, to comply with the manufacturing and testing methods;

5° Reports on the controls carried out by the applicant in compliance with the said methods;

6° The preparation formula with, in particular, all relevant information on the container;

7° The capacity of new models intended for sale;

8° The proposed new labelling and, if applicable, the package leaflet;

9° A copy of the decisions authorising the manufacture of the speciality concerned and issued, as the case may be, either by virtue of the manufacturer's national legislation or in application of articles R. 5124-6, R. 5124-7 and R. 5124-10 or, where applicable, a copy of the receipts of the applications for authorisation if the said applications have not yet given rise to a decision;

10° Where applicable, the applicant's unique identification number.

In the event of a merger or partial transfer of assets, the companies concerned may submit an application for the transfer of marketing authorisations before the merger or transfer is definitively completed. In support of their application, they must provide the memorandum of understanding in principle concerning the merger or contribution. The transfer is granted subject to the suspensive condition of definitive completion, which is notified to the Director General of the Agence nationale de sécurité du médicament et des produits de santé.

The Director General of the Agence nationale de sécurité du médicament et des produits de santé will notify his decision within sixty days of receipt of the application. Failing this, silence on the part of the Director General of the National Agency for the Safety of Medicines and Health Products will be deemed to constitute authorisation on expiry of this period.