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Showing 1011–1020 of 34670 articles for “Art. R. 145-10”
The Director General of the Agence nationale de sécurité du médicament et des produits de santé provides all relevant information to the European Medicines Agency, as well as to the International Narc…
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…
…State of the European Union; 3° Annually for the following two years; 4° Every three years thereafter. After the marketing authorisation has been granted, the company responsible for the operation of…
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 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…
Under 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…
The animal health decision taken 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'environn…
All in vitro diagnostic medical devices imported, placed on the market or put into service must bear the CE mark. However, CE marking is not required for devices undergoing a performance evaluation or…
…aid down by the provisions of Articles L. 5213-2 and L. 5213-4, and by the provisions of this chapter. Suspension or withdrawal may only take place after the holder has been invited, by any means enab…
…aid down by the provisions of Articles L. 5223-2 and L. 5223-4, and by the provisions of this chapter. Suspension or withdrawal may only take place after the holder has been invited, by any means enab…
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