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Showing 2501–2510 of 39773 articles for “Art. R. 145-5”
With a view to their inclusion in the register of hybrid groups mentioned in the last paragraph of Article L. 5121-10, hybrid medicinal products are identified by a decision of the Director General of…
Where batches of investigational medicinal products come from another Member State of the European Community or party to the Agreement on the European Economic Area and are manufactured or imported in…
By way of derogation from the provisions of the first sub-section, the provisions of this sub-section apply to the manufacture and importation of investigational medicinal products.
The manufacturer or importer of investigational medicinal products shall ensure that all manufacturing operations are carried out in accordance with the information provided by the sponsor in the appl…
A statutory auditor shall certify the annual accounts of the fund referred to in the second paragraph of II of Article L. 6131-4.
Subsection 4 of Section 4 of Chapter I of Title III of Book III of this Part shall not apply to Mayotte.
Any wholesale distributor, where he is not the marketing authorisation holder, who imports a veterinary medicinal product from another Member State shall inform the marketing authorisation holder and…
The provisions of Section 2 of Chapter VII of Title II of Book I of this Part are applicable to the inspectors of the Agence nationale de sécurité sanitaire de l'alimentation, de l'environnement et du…
The authorisation holder has an organisation, set up where appropriate jointly with other cancer treatment authorisation holders, which ensures that each patient is informed of the proposed therapeuti…
Authorisation for A6 breast oncology surgery may only be granted if the health care establishment is organised in such a way as to enable it: 1° To prepare for oncology surgery, to have access to : a)…
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