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Showing 5701–5710 of 17893 articles for “Art. 515-5”
I. - The establishments or organisations mentioned in article L. 513-11-1 shall appoint a person responsible for the collection activity, who shall ensure compliance with the regulations relating to t…
In the event of agreement within the coordination group, referred to by the Director General of the Agence nationale de sécurité sanitaire de l'alimentation, de l'environnement et du travail or by ano…
Any wholesale distributor, where he is not the marketing authorisation holder, who imports a veterinary medicinal product from another Member State shall inform the marketing authorisation holder and…
Persons providing information by canvassing or prospecting for veterinary medicinal products, including medicated feedingstuffs, must meet one of the following qualification requirements: 1° Hold one…
The Director General of the Agence nationale de sécurité du médicament et des produits de santé may grant, under the conditions laid down in Article R. 5211-55 and Article 4 of Implementing Regulation…
The General Director of the Agence nationale de sécurité du médicament et des produits de santé regularly checks that the authorised body has the required skills and up-to-date knowledge of the medica…
The provisions of Section 2 of Chapter VII of Title II of Book I of this Part are applicable to the inspectors of the Agence nationale de sécurité sanitaire de l'alimentation, de l'environnement et du…
Notwithstanding the provisions of Article R. 5222-18-4, where the second-hand in vitro diagnostic medical device which is the subject of the transfer has never been put into service, the file consists…
By way of derogation from the provisions of article R. 5212-35-4, where the second-hand medical device being transferred has never been put into service, the file is composed solely of the following e…
The certificate of compliance with good practice relating to raw materials for pharmaceutical use is issued in accordance with Articles R. 5138-3 to R. 5138-6. When the inspection reveals serious brea…
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