Article R5141-107
The declaration and reporting obligations laid down in this section apply without prejudice to those laid down for veterinary medicinal products authorised by the European Medicines Agency in Regulati…
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Showing 3811–3820 of 11432 articles for “Art. CE 17-10-1990 n° 56991”
The declaration and reporting obligations laid down in this section apply without prejudice to those laid down for veterinary medicinal products authorised by the European Medicines Agency in Regulati…
The procedures and standard form for the declarations and the periodic pharmacovigilance update report mentioned in articles R. 5141-103 to R. 5141-105-1 are laid down by decision of the Director Gene…
Without prejudice to the conditions laid down when the marketing authorisation is granted pursuant to the provisions of the fourth paragraph of Article L. 5141-5, the company operating the veterinary…
…company operating veterinary medicinal products has at its disposal, on a permanent basis, the services of a person, pharmacist or veterinarian, responsible for veterinary pharmacovigilance residing i…
The creation, organisation and funding of veterinary pharmacovigilance centres, as well as the conditions under which they carry out the tasks entrusted to them by the Agence nationale de sécurité san…
Where the initial authorisation was granted after the Director General of the Agence nationale de sécurité du médicament et des produits de santé or the Prefect had been informed in accordance with th…
Where a medical device is not intended for use in a specific part of the body, it must be considered and classified according to the most critical use as specified. Where more than one rule applies to…
…r the conditions laid down in article L. 5143-7, the regional prefect of the group's registered office approves the animal health programmes and grants approval to the groups mentioned in article L. 5…
…in application of article L. 5145-2-1 or article L. 5145-2-2 is published on the website of the Agence nationale de sécurité sanitaire de l'alimentation, de l'environnement et du travail.
…4° of article R. 5222-3 and any blood transfusion establishment shall appoint a local reactovigilance correspondent.The local reactovigilance correspondent is a doctor or pharmacist with experience i…
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