Title IV: Veterinary medicinal products

The Director General of the Agence nationale de sécurité sanitaire de l’alimentation, de l’environnement et du travail may issue to veterinary pharmaceutical establishments exporting medicated feedingstuffs a certificate stating : 1° The name or company name and address of the establishment holding the authorisation to open as provided for in Article L. 5142-2 under 11°, 12°, 13° or 14° of Article R. 5142-1 ; 2° The name of the medicated…

Autovaccines are prepared under the responsibility of a qualified person, who has obtained the authorisation provided for in article L. 5141-12, in facilities which may, where appropriate, be made available by an organisation or company in which this person has technical responsibilities. The qualified person is a pharmacist or a veterinarian. They are registered, depending on the case, in section B or E of the national order of pharmacists or…

I.-The qualified person shall send the application for authorisation provided for in Article L. 5141-12 to the Director General of the Agence nationale de sécurité sanitaire de l’alimentation, de l’environnement et du travail. The application must include 1° The name of the applicant ; 2° The address of the place of preparation ; 3° The name of the company or organisation providing the facilities, where applicable; 4° The list of…

The Director General of the Agence nationale de sécurité sanitaire de l’alimentation, de l’environnement et du travail will notify the applicant of his decision within one hundred and twenty days from the date of receipt of the complete application. Silence on the part of the Director General will be deemed to constitute refusal of authorisation on expiry of this period.

The authorisation is issued for a period of five years; it is renewable for five-year periods under the conditions laid down in article R. 5141-137 of the same code. It mentions the surname, first name and position of the authorisation holder, the name of the company or the name of the organisation which, where applicable, provides the facilities and the address of the preparation site. It specifies the pathogens by…

The authorisation holder shall inform the Director General of the Agence nationale de sécurité sanitaire de l’alimentation, de l’environnement et du travail of the date on which the activity of preparing autovaccines for veterinary use commences. It shall also inform him of the definitive cessation of this activity.

After the authorisation provided for in Article L. 5141-12 has been issued, the preparation methods and control techniques mentioned in a, c and d of the technical dossier provided for in 3° of II of Article R. 5141-130 are modified in line with scientific and technical progress.

Any modification concerning the elements and documents mentioned in Article R. 5141-130 is submitted for authorisation to the Director General of the Agence nationale de sécurité sanitaire de l’alimentation, de l’environnement et du travail, accompanied by the corresponding supporting documents. The Director General notifies the applicant of his decision within thirty days of receipt of the complete application. If the Director General remains silent, the authorisation will be refused on…

The authorisation may be modified, suspended for a maximum period of one year or withdrawn by the Director General of the Agence nationale de sécurité sanitaire de l’alimentation, de l’environnement et du travail where it appears : 1° That there is one or more immunological veterinary medicinal products with a marketing authorisation for the species in question containing one or more of the pathogens listed on the authorisation to prepare…

The authorisation holder sends the renewal application to the Director General of the Agence nationale de sécurité sanitaire de l’alimentation, de l’environnement et du travail ninety days before the authorisation expires. This application for renewal includes : 1° A summary analysis of the pharmacovigilance data drawn up on the basis of the reports provided for in Article R. 5141-105; 2° Depending on the case, either an updated dossier taking account…