Section 10: Special provisions.

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The authorisation may be modified, suspended for a maximum period of one year or withdrawn by the Director General of the Agence nationale de sécurité sanitaire de l’alimentation, de l’environnement et du travail where it appears : 1° That there is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…

Decisions to authorise, modify, renew, suspend or withdraw authorisation for the preparation of autovaccines are made public in an extract on the website of the Agence nationale de sécurité sanitaire de l’alimentation, de l’environnement et du travail.

The labelling of self-vaccines for veterinary use and, where appropriate, the accompanying information sheet must include, in addition to the words: “self-vaccine for veterinary use” in clearly visible characters, the following information: 1° The name of the pathogen ; 2° The qualitative composition in active substances and adjuvants and constituents of the excipient, knowledge of which is necessary for correct administration of the medicinal product, as well as the volume…

Monitoring self-vaccines for veterinary use consists of the authorisation holder recording the following information in chronological order: 1° The name and address of the owner of the animal or farm from which the pathogen was taken; 2° The date of receipt of the pathogen sampled; 3° The name and address of the prescribing veterinarian; 4° The pathogen from which the autovaccine was prepared; 5° The date of manufacture ; 6°…