Title III: Other regulated pharmaceutical products and substances

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.

The Director General of the Agence nationale de sécurité du médicament et des produits de santé keeps an up-to-date list of authorisation holders and authorised persons. These lists are accessible at all times to the Ministers of Foreign Affairs, Defence and the Interior and to the Ministers of Agriculture, the Budget, Customs, the Environment, Research and Health.

The holder of an authorisation must send the Director General of the Agence nationale de sécurité du médicament et des produits de santé, by 15 February each year at the latest, an annual statement of the stocks held at 31 December of the previous year. The Director General of the Agency may request a statement of the stocks held by the authorisation holder at any time. The authorisation holder must…

For the purposes of this chapter, “establishment” means any place or site where one or more operations involving micro-organisms and toxins or products containing them are carried out.

The authorisation holder shall inform the Director General of the Agency of the commencement of the activity covered by the authorisation. He shall also inform him of the definitive cessation of this activity. The authorisation document is then returned to the Agency. The authorisation is also returned to the Director General of the Agency when it has been withdrawn in accordance with the provisions of article R. 5139-8 and article…

The authorisation holder shall record any acquisition, transfer, import or export of micro-organisms and toxins or products containing them in a special register or by any appropriate computer system. This register or these records must be kept for a period of forty years from the date of the last operation mentioned therein in order to be produced at the request of the competent authorities. This period is reduced to ten…

The establishment in which the operations for which authorisation has been granted are carried out operates in compliance with the rules of good practice laid down under the conditions referred to in 3° of Article R. 5139-20 and designed to guarantee biological safety and security. The following definitions apply 1° Biological safety: all measures and practices aimed at protecting people and the environment from the consequences of infection, intoxication or…

The transmission of information referred to in Articles R. 5139-4, R. 5139-5, R. 5139-12 and R. 5139-14 may be carried out electronically after affixing an electronic signature in accordance with the provisions of Decree No. 2017-1416 of 28 September 2017 on electronic signatures. The decision to refuse, suspend or withdraw an authorisation may also be sent under these conditions in urgent cases.