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Showing 5641–5650 of 17809 articles for “Art. 758-5”
The Director General of the Regional Health Agency shall issue a certificate to candidates deemed suitable by the jury, certifying that they have passed the knowledge verification tests and that they…
The regional directorate for youth, sport and social cohesion provides the committee's secretariat.
Generic herbal medicinal products are covered by the provisions of articles R. 5121-6 and R. 5121-7.
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…
The detailed summaries of the tests accompanying the application for registration and the expert reports are drawn up and signed by persons with the necessary qualifications and experience as mentione…
I.-The granting of a compassionate access authorisation is subject to the establishment by the Agence nationale de sécurité du médicament et des produits de santé of a therapeutic use and patient moni…
The compassionate prescribing framework drawn up by the Director General of the Agence nationale de sécurité du médicament et des produits de santé states in particular, for each medicinal product: 1°…
I.-For the medicinal products of major therapeutic interest referred to in article L. 5111-4, marketing authorisation holders and pharmaceutical companies exploiting medicinal products shall, under th…
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…
Before removing or partially or totally covering the safety features provided for in article R. 5121-138-2, the pharmaceutical establishment which manufactures medicinal products shall check that the…
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