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°…
Within the meaning of article L. 5141-2, the veterinarian may only prescribe an auto-vaccine for veterinary use under the conditions of 4° of article L. 5143-4, prepared from a pathogen which he himself has collected. The holder of the authorisation provided for in article L. 5141-12 may only sell an auto-vaccine for veterinary use to the prescribing veterinarian or to any other veterinarian who has declared, at the time of…
The agreements referred to in article L. 5141-13-1 between veterinary surgeons or veterinary students and the companies referred to in article L. 5142-1 are forwarded by the company to the Conseil national de l’ordre des vétérinaires provided for inarticle L. 242-3-1 of the code rural et de la pêche maritime for its opinion, by any means that can be used to give it a date certain, before they are signed…
The file requesting the opinion shall include the following information: 1° For agreements concerning the research and scientific evaluation activities referred to in the third paragraph of Article L. 5141-13-1 : a) The unsigned agreement, indicating the name, company name and registered office address of the company proposing it; b) The amount and method of calculating the remuneration of veterinary surgeons or the allowance of veterinary students and, where applicable,…
I.-The National Council of the Order of Veterinary Surgeons has two months from the date of receipt of the application to give its opinion. If the National Council of the Order of Veterinary Surgeons finds that the application is incomplete, it will immediately notify the company, by any means that confirms the date of receipt, of the list of missing documents or information. The deadline is then suspended until the…
Companies shall inform the Conseil national de l’ordre des vétérinaires of the implementation of the agreements referred to in Article L. 5141-13-1 within one month of their implementation.
The provisions of articles R. 5141-143, R. 5141-144, R. 5141-145 and R. 5141-146 apply to agreements between pharmacists or students training to become pharmacists and the companies mentioned in article L. 5142-1. Where the agreement concerns a pharmacist or a student, it is forwarded to the departmental council of the pharmacist’s place of practice or the student’s place of training. Where the agreement concerns two or more pharmacists or students,…
The provisions of articles R. 5141-143 to R. 5141-146 apply to military veterinarians and military veterinary students covered by the provisions of article L. 4138-2 of the French Defence Code. The provisions of article R. 5141-147 apply to armed forces pharmacists and military students covered by the provisions of article L. 4138-2 of the Defence Code who are studying to become pharmacists. However: 1° For the military professionals and students…
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is a Registered Trademark of
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75001, Paris France
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