Article R5141-10
…s : 1° The identity of the investigator(s) or investigator(s), their qualifications, experience and duties ; 2° The dates and places where the trial was conducted; 3° For the medicinal product undergo…
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Showing 5781–5790 of 34927 articles for “Art. Aut. conc. n° 22-D-10 du 12 Apr 2022”
…s : 1° The identity of the investigator(s) or investigator(s), their qualifications, experience and duties ; 2° The dates and places where the trial was conducted; 3° For the medicinal product undergo…
…ns laid down in this section apply without prejudice to those laid down for veterinary medicinal products authorised by the European Medicines Agency in Regulation (EC) No 726/2004 of the European Par…
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…
Under the conditions laid down in article L. 5143-7, the regional prefect of the group's registered office approves the animal health programmes and grants approval to the groups mentioned in article…
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…
All in vitro diagnostic medical devices imported, placed on the market or put into service must bear the CE mark. However, CE marking is not required for devices undergoing a performance evaluation or…
Decisions of the Board of Directors are 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…
…nt and to the quality management of the sterile medical device circuit, in accordance with the procedures defined by order of the Minister for Health. It includes, where applicable, the actions requir…
…health insurance organisations and to the regional health agencies, in a form and according to procedures which are set by order of the ministers responsible for health and social security, following…
Without prejudice to the provisions of article R. 6123-32-9, the provisions of this section do not apply to the health establishments mentioned in the first paragraph of article L. 3211-1 and article…
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