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Article R5142-35 of the French Public Health Code

With a view to applying the rules laid down in the interests of public health, the pharmacist or veterinary surgeon in charge shall carry out the following duties insofar as they correspond to the activities of the company in which he works: 1° He/she organises and supervises all the pharmaceutical operations of the company, and in particular the supply, manufacture, advertising, information, pharmacovigilance, release, monitoring and withdrawal of batches, distribution,…

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Article R5142-35-1 of the French Public Health Code

When the pharmacist or veterinary surgeon responsible for an establishment engaged in the manufacture, import or use of veterinary medicinal products, other than those subject to clinical trials, becomes aware, after a batch of veterinary medicinal products has been marketed, of an incident or accident which has occurred during the manufacture or distribution of that batch and which is likely to involve a risk to public health, it shall immediately…

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Article R5142-36 of the French Public Health Code

If the competent body terminates the appointment of a pharmacist or veterinary surgeon as pharmacist or veterinary surgeon in charge, or refuses to renew the appointment when it expires, the pharmacist or veterinary surgeon may refer the matter to the central council of the competent section of the national order of pharmacists or the regional council of the order of veterinary surgeons, as appropriate. After hearing the views of both…

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Article R5142-37 of the French Public Health Code

Pharmacists and veterinary surgeons who assist the pharmacist or veterinary surgeon in charge are known as assistant pharmacists and veterinary surgeons. They are registered respectively in section B, C or E of the Ordre des Pharmaciens or in the Roll of the Ordre des Vétérinaires. Their diplomas are registered under the conditions set out in article L. 4221-16 or article L. 241-1 of the Rural and Maritime Fishing Code, as…

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Article R5142-38 of the French Public Health Code

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…

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Article R5142-39 of the French Public Health Code

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…

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Article R5142-40 of the French Public Health Code

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.

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Article R5142-42 of the French Public Health Code

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…

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