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Showing 421–430 of 3980 articles for “Art. 25 January 2005”
The investigator notifies the sponsor of all serious adverse events and serious incidents without delay after becoming aware of them. This notification is the subject of a written report and is follow…
The chairman and members of the commission are appointed by order of the Minister of Justice and the Minister of Health for a renewable period of five years. A number of alternates equal to the number…
The practitioner meeting the criteria mentioned in articles R. 2142-10 and R. 2142-11 carrying out sperm collection or oocyte retrieval with a view to donation is required : 1° Enquire about the gamet…
The company exploiting the medicinal product produces a follow-up report at the end of each programme or at the latest when it is renewed. The report is sent to the treating doctor, the prescribing do…
The Agence nationale de sécurité du médicament et des produits de santé is responsible for implementing haemovigilance and transfusion safety. It defines the guidelines, leads and coordinates the acti…
The task of preparing, labelling and storing labile blood products may only be carried out, under the supervision of the supervisory staff mentioned in II of article R. 1222-27, by a person holding at…
Tissues or their derivatives or cell therapy preparations are distributed under the responsibility of the responsible person referred to in Article R. 1243-12 or, where applicable, the person responsi…
Any training, research or health establishment which receives corpses for the purposes of medical teaching and research shall hold an authorisation issued by the ministers responsible for the establis…
The authorisations shall specify the elements listed in Annex II of Directive (EU) 2015/566. Authorisations issued in this way may be modified, suspended or withdrawn in whole or in part by the Direct…
The Scientific Advisory Board is convened by its Chairman, or at the request of the Managing Director, or at the motivated initiative of at least one third of its members, or at the request of the Boa…
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