Chapter IX: Micro-organisms and toxins

Any production, manufacture, transport, import, export, possession, offer, transfer, acquisition or use of the micro-organisms and toxins on the list drawn up in application of article L. 5139-1 and products containing them is subject to an authorisation issued by the Director General of the Agence nationale de sécurité du médicament et des produits de santé, without prejudice to the provisions of Title III of Book V of the Environmental Code…

The authorisation referred to in article R. 5139-1 : 1° Operations relating to proprietary medicinal products for human use, proprietary medicinal products for veterinary use, experimental medicinal products for human use, veterinary medicinal products intended for experimentation and autovaccines for veterinary use which contain micro-organisms or toxins which have been inactivated or reduced to a level which ensures a sufficient level of safety for public health, as described in the…

Any technical file accompanying the application for authorisation must include the following information: 1° A list of the persons whom the applicant proposes to authorise to contribute, under his authority, to the operations covered by the authorisation; 2° Proof that the applicant and the persons he proposes to authorise have the necessary training and professional experience; 3° An undertaking by the director of the establishment that the operation(s) involving micro-organisms…

I. – Before issuing the authorisation applied for, the Director General of the Agence nationale de sécurité du médicament et des produits de santé (French National Agency for the Safety of Medicines and Health Products) will request from the Ministry of Justice the bulletin no. 2 of the criminal record or any equivalent document from the administration concerned, concerning the applicant for the authorisation, the persons authorised by the applicant…

The application for authorisation shall be sent to the Director General of the Agence nationale de sécurité du médicament et des produits de santé by registered letter with acknowledgement of receipt or lodged with the Agency in return for a receipt.

The application for authorisation is deemed to be complete if, within 30 days of receipt, the Director General of the Agence nationale de sécurité du médicament et des produits de santé has not informed the applicant, by registered letter with acknowledgement of receipt, of the list of missing or incomplete documents. If the documents required to examine the application are missing or incomplete, the Director General of the Agency will…

The Director General of the Agence nationale de sécurité du médicament et des produits de santé will notify the applicant of his decision within 90 days of the date on which the application is deemed to be complete. At the end of this period, the absence of a decision from the Director General will constitute an implicit decision to refuse authorisation. When he considers it necessary to examine the application…

When the application for authorisation concerns all or part of the micro-organisms or toxins or products containing them, intended for veterinary use, the Director General of the Agence nationale de sécurité du médicament et des produits de santé first obtains the opinion of the Director General of the Agence nationale de sécurité sanitaire de l’alimentation, de l’environnement et du travail. The absence of a response from the latter within 30…

I. – In addition to the cases mentioned in article R. 5139-3-1, authorisation is also refused if the operation or operations envisaged in the application present or are likely to present a risk to public health. II – Authorisation is suspended or withdrawn by the Director General of the Agency in the following cases: 1° When the use of the micro-organisms and toxins or products containing them mentioned in this…

The decision to refuse, suspend or withdraw an authorisation must be substantiated and notified to the authorisation holder by registered letter with acknowledgement of receipt. In the event of an implied refusal, the applicant may at any time request the reasons which led the Director General of the Agency to refuse the authorisation applied for. Except in cases of urgency, a decision to suspend or withdraw an authorisation may only…