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Showing 3681–3690 of 8145 articles for “Art. 1352-9”
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I.-The registration of the medicinal products mentioned in article L. 5121-13 may be refused, amended, suspended or withdrawn by the Director General of the Agency.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…
Where, following the establishment of a new Community herbal monograph, the revision of an existing monograph or the revision of the list drawn up by the European Commission in application of Article…
The Director General of the Agency may automatically vary, suspend or cancel a registration in the same cases and according to the same procedures as those laid down for a marketing authorisation in A…
Following the establishment of a new Community herbal monograph or the revision of an existing monograph, the registration holder shall submit a request for amendment of the registration dossier to th…
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