Book II: Pharmacy and medical physics professions

Any application for the authorisation provided for in article L. 4211-6 shall be submitted to the Director General of the Agence nationale de sécurité du médicament et des produits de santé by the person preparing and supplying allergens specially prepared for a single individual. The Director General makes his decision on the basis of a file containing : 1° The name of the person preparing and supplying the allergens ;…

As soon as the request is received, the Director General of the Agency will refer the matter to the Académie nationale de médecine for an opinion. In the absence of a response within sixty days of the date of receipt of the request for an opinion, the opinion is deemed to have been issued.

If the Director General of the Agency does not respond to an application for authorisation within six months of the submission of a complete and regular application, this will be deemed to constitute a rejection decision.

The authorisation is issued for a period of five years and is renewable under the conditions set out in article R. 4211-9. It mentions the surname, first name and position of the person preparing and supplying allergens, as well as the address of the place of preparation. It specifies the pharmaceutical forms and routes of administration of the allergens. It also includes the list of parent preparations as defined in…

The authorisation holder shall inform the Director General of the Agency of the date of commencement of the allergen preparation and supply activity. He shall also inform him of the definitive cessation of this activity.

After the authorisation provided for in Article L. 4211-6 has been issued, the manufacturing and preparation methods and the control techniques mentioned in 5° and 6° of Article R. 4211-1 are modified in line with scientific and technical progress.

Any changes to the information and documents mentioned in Article R. 4211-1 must be authorised by the Director General of the Agency. The application for authorisation must be accompanied by the corresponding supporting documents. If the Director General of the Agency remains silent on an application for authorisation for more than four months from the date of submission of a complete and regular application, this will be deemed to constitute…

The authorisation may be amended ex officio, suspended or withdrawn by the Director General of the Agence nationale de sécurité du médicament et des produits de santé where it appears : 1° That one or more of the parent products mentioned in the authorisation are harmful under normal conditions of use or are likely to present a risk to human health ; 2° That the conditions of manufacture of the…

The authorisation provided for in article L. 4211-6 may be renewed at the request of the holder, submitted no later than three months before the expiry date. This application for renewal must include : 1° A summary analysis of the pharmacovigilance data drawn up on the basis of the reports provided for in article R. 5121-176 drawn up during the previous five-year period ; 2° An updated dossier and certification…

Decisions to authorise, modify, renew, suspend or withdraw authorisation are published on the Agency’s website.