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Showing 9791–9800 of 29733 articles for “Art. CE 8-4-2022 n° 447694”
…the marketing authorisation must state the reasons on which it is based and indicate the appeal procedures and deadlines. Except in cases of urgency, the decision may only be taken after the marketin…
The Director General of the Agence nationale de sécurité sanitaire de l'alimentation, de l'environnement et du travail may automatically vary a marketing authorisation for a veterinary medicinal produ…
…modify or withdraw authorisations and as a precautionary measure, the Director General of the Agence nationale de sécurité sanitaire de l'alimentation, de l'environnement et du travail may prohibit…
…relating to the trials to the Ministers of Agriculture and Health, the Director General of the Agence nationale de sécurité sanitaire de l'alimentation, de l'environnement et du travail and the inspe…
The procedures for submitting and examining applications for authorisation to open, for modification of initial authorisations and for transfer of authorisations to open, as provided for in articles R…
…ackaging; 3° Batch monitoring, complaints handling, product withdrawals and returns, pharmacovigilance operations.
A veterinary pharmaceutical establishment which manufactures medicinal products mentioned in 1° of article R. 5142-1 has a documentation system comprising specifications, manufacturing formulae, proce…
…armacist 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.
…ng to veterinary medicinal products. This control is carried out by the importer's veterinary pharmaceutical establishment in a Member State or party to the Agreement on the European Economic Area or…
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, a…
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