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Article R5142-43 of the French Public Health Code

The establishments mentioned in article R. 5142-1 may not subcontract any of the activities defined in the same article, subject to the exceptions mentioned below: 1° Manufacturers of veterinary medicinal products mentioned in 1° of article R. 5142-1 may subcontract part of the manufacturing operations to other manufacturers of these veterinary medicinal products under a written contract which sets out their respective obligations, in accordance with the good practices provided…

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Article R5142-45 of the French Public Health Code

Manufacturers of veterinary medicinal products mentioned in 1° of article R. 5142-1 must justify, at all times, that all the products they use, manufacture and deliver comply with the characteristics to which they must conform and that the necessary controls have been carried out. Manufacturers of veterinary medicinal products which are the subject of a marketing authorisation referred to in article L. 5141-5 or a registration referred to in article…

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Article R5142-46 of the French Public Health Code

Each batch of veterinary medicinal products benefiting from a marketing authorisation referred to in article L. 5141-5 or a registration referred to in article L. 5141-9 is subject to control of the finished product when imported : 1° From a State which is not a member of the European Union and which is not a party to the Agreement on the European Economic Area ; 2° Or from another Member…

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Article R5142-46-1 of the French Public Health Code

For each batch of medicinal products referred to in articles R. 5142-45 and R. 5142-46, the pharmacist or veterinarian responsible shall release the batches and certify that each manufacturing batch complies with the provisions of the aforementioned articles on a register provided for this purpose or by any appropriate system which does not allow any modification of the data it contains after validation of their registration.

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Article R5142-47 of the French Public Health Code

A manufacturer and importer of veterinary medicinal products mentioned in 1° and 2° of article R. 5142-1 has one or more quality control departments. This department or these departments are placed under the authority of a suitably qualified person who is hierarchically independent of the other heads of department. The quality control department has one or more control laboratories with sufficient staff and equipment to carry out the necessary checks…

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Article R5142-48 of the French Public Health Code

A veterinary pharmaceutical establishment which manufactures medicinal products mentioned in 1° of article R. 5142-1 has a documentation system comprising specifications, manufacturing formulae, procedures and statements, reports and records, covering the various operations which it carries out. For veterinary medicinal products other than those subject to clinical trials, the documents relating to each batch are kept by the veterinary pharmaceutical establishment which manufactures it, for at least one year after…

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Article R5142-49-1 of the French Public Health Code

Pharmaceutical establishments carrying out one or more of the operations making up the operation must have a documentation system comprising the procedures and records covering the operations they carry out and keep them for at least five years after the batch has been released or at least one year after the expiry date of the batches concerned. The operator shall keep the certificate of release or any document attesting to…

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Article R5142-50 of the French Public Health Code

Any veterinary pharmaceutical establishment of a company mentioned in Article R. 5142-1 engaged in wholesale, free transfer or wholesale distribution shall keep, for each incoming and outgoing transaction, at least the following information: 1° The date of the transaction ; 2° The name of the veterinary medicinal product ; 3° The batch number and expiry date; 4° The quantity received or supplied; 5° The name and address of the supplier…

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Article R5142-50-1 of the French Public Health Code

Any wholesale distributor, where he is not the marketing authorisation holder, who imports a veterinary medicinal product from another Member State shall inform the marketing authorisation holder and notify the Agence nationale de sécurité sanitaire de l’alimentation, de l’environnement et du travail of his intention to proceed with this import. The Agence nationale de sécurité sanitaire de l’alimentation, de l’environnement et du travail and the holder of a marketing authorisation…

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