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Showing 2681–2690 of 39320 articles for “Art. L 134-10”
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…
The procedures and standard form for the declarations and the periodic pharmacovigilance update report mentioned in articles R. 5141-103 to R. 5141-105-1 are laid down by decision of the Director Gene…
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 the initial authorisation was granted after the Director General of the Agence nationale de sécurité du médicament et des produits de santé or the Prefect had been informed in accordance with th…
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…
Any establishment mentioned in 4° of article R. 5222-3 and any blood transfusion establishment shall appoint a local reactovigilance correspondent.The local reactovigilance correspondent is a doctor o…
The service provider and the equipment distributor provide a comprehensive service comprising all the elements defined by order of the Minister for Health. Depending on the category of equipment, its…
…re taken by a majority of votes of the members present or represented. The members of the Board, including the Chairman, each have one vote, with the exception of the State representatives mentioned i…
On the basis of and within the limits of the data supplied by practitioners and transmitted by the doctor responsible for medical information under the conditions laid down inarticle R. 6113-8, the re…
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