Part five: Health products

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 II – Authorisation is suspended or withdrawn by the Director General of the Agency in the following cases: 1° When the use of the micro-organisms and toxins or products containing them mentioned in this…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…

I. – Authorisation is issued to a natural person for all or part of a strain of micro-organism or a type of toxin and for one or more of the operations mentioned in the first paragraph of Article R. 5139-1 carried out within a specific establishment. Authorisation may not be issued to a legal entity. It is not transferable. Authorisations are valid for a maximum of five years. II –…

I. – Any change of establishment or use of premises intended to receive micro-organisms and toxins or products containing them, or any modification of the operations provided for in the authorisation, must first be the subject of a new application for authorisation addressed to the Director General of the Agence nationale de sécurité du médicament et des produits de santé under the conditions mentioned in Articles R. 5139-3 to R….

The authorisation holder keeps the list provided for in 1° of Article R. 5139-3 up to date and sends it to the Agence nationale de sécurité du médicament et des produits de santé by 15 February each year at the latest. Any change to this list during the year is immediately notified to the Director General of the Agency.