Article R5121-107-2
…d, suspended or withdrawn by the Director General of the Agency. The period of suspension may not exceed one year. Decisions to refuse, amend, suspend or cancel registration shall state the reasons on…
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Showing 4471–4480 of 10563 articles for “Art. CE 27-9-2006 n° 285279”
…d, suspended or withdrawn by the Director General of the Agency. The period of suspension may not exceed one year. Decisions to refuse, amend, suspend or cancel registration shall state the reasons on…
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…
…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…
…relating to this change. On expiry of a period of sixty days from the date of the application, silence on the part of the Director of the Agency will be deemed to constitute acceptance of the applicat…
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…
…e application for registration and the expert reports are drawn up and signed by persons with the necessary qualifications and experience as mentioned in Article R. 5121-33.
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