Assistant pharmacists or veterinary surgeons entrusted with the release of batches must have at least six months’ professional experience under the conditions set out in article R. 5142-16 before taking on this role.
For each establishment belonging to companies mentioned in 1°, 2° and 3° of Article R. 5142-1, the number of assistant pharmacists or veterinarians is set as follows, depending on the number of staff calculated under the conditions set out in Article R. 5142-40: 1° One assistant pharmacist or veterinary surgeon for a workforce of between 20 and 35 people ; 2° A second assistant pharmacist or veterinarian for a workforce…
For each establishment belonging to companies mentioned in 4° to 10° of Article R. 5142-1, the number of assistant pharmacists or veterinarians is set as follows, depending on the number of staff calculated in accordance with the conditions laid down in Article R. 5142-40: 1° One assistant pharmacist or veterinarian for a workforce of between 40 and 100 people ; 2° A second assistant pharmacist or veterinarian for a workforce…
For the purposes of calculating the number of staff referred to in articles R. 5142-38 and R. 5142-39, account is taken of persons engaged in the following operations: 1° Manufacturing and import operations and all related controls ; 2° Procurement, warehousing, order preparation and packaging; 3° Batch monitoring, complaints handling, product withdrawals and returns, pharmacovigilance operations.
When a pharmacist or assistant veterinarian recruited in application of article R. 5142-37 is absent or replaces the pharmacist or veterinarian in charge for a period of more than one month, he is replaced.
Veterinary pharmaceutical establishments operate in accordance with the good practices mentioned in article L. 5142-3 which are applicable to them. In particular, they have : 1° Premises fitted out, arranged and maintained according to the pharmaceutical operations carried out there; 2° The staff and equipment required to carry out these activities. Each year, they send the Director General of the Agence nationale de sécurité sanitaire de l’alimentation, de l’environnement et…
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…
The establishments referred to in article R. 5142-1 shall take all necessary measures to ensure that veterinary medicinal products are transported and delivered under conditions which guarantee their proper conservation, integrity and safety.
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…
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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75001, Paris France
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is a Registered Trademark of
PETROFF LAW FIRM (SELARL LEGASTRAT)
182, rue de Rivoli
75001, Paris France
RCS Paris n°814433470
Paris Bar Registration n° (Toque) C2396
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