Article R5121-105
A medicinal product or a series of medicinal products mentioned in Article L. 5121-13 may only be registered if the applicant is established in a Member State of the European Community or a party to t…
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Showing 5461–5470 of 25404 articles for “Art. Cass. 3e civ. 17-9-2008 n° 07-16.973”
A medicinal product or a series of medicinal products mentioned in Article L. 5121-13 may only be registered if the applicant is established in a Member State of the European Community or a party to t…
The application file for registration of a medicinal product or a series of medicinal products mentioned in article L. 5121-13 is sent to the Agency. It includes the following information and document…
I.-The registration of the medicinal products mentioned in article L. 5121-13 may be refused, amended, suspended or withdrawn by the Director General of the Agency. The period of suspension may not ex…
The principles of good veterinary pharmacovigilance practice to which veterinarians, pharmacists and members of the other health professions mentioned in 4° of article R. 5141-93 are subject are defin…
Veterinary pharmacovigilance centres are responsible for : 1° Receiving reports sent, in application of article R. 5141-103, by veterinarians, pharmacists and any member of a health profession or any…
The poison control centres referred to in article L. 6141-4 and the regional pharmacovigilance centres referred to in article R. 5121-167 shall transmit, without delay, to the Agence nationale de sécu…
A 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…
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…
The provisions mentioned in Article L. 541-1 are applicable to New Caledonia subject to the following adaptations: 1° A l'article L. 512-2, the words: "and breaches are recorded" are replaced by the w…
…n 28 September 1994 and by its third amendment signed in Paris on 11 July 2001, approved by the loi n° 2002-1305 du 29 octobre 2002 and published by the decree no. 2002-1500 of 20 December 2002;b) Agr…
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