Article R5121-74-5
…ate 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 monitoring protocol. This protocol…
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Showing 6741–6750 of 21091 articles for “Art. CA Paris 20-5-2009 n° 08-2432”
…ate 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 monitoring protocol. This protocol…
…e 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° The therapeutic…
…erapeutic interest referred to in article L. 5111-4, marketing authorisation holders and pharmaceutical companies exploiting medicinal products shall, under their responsibility, draw up and implement…
…ially 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 medicinal product conce…
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.
…investigational medicinal products, the documents relating to each batch are kept by the pharmaceutical establishment which manufactures it, for at least five years after the end of the trial or the e…
…r 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 application for author…
…joint representative appointed by the partners shall send to the clerk of the court where the application for registration has been filed a copy of the application for registration with the professio…
…tions as the full member. Alternates may attend meetings of the Regional Employment, Training and Vocational Guidance Committee with the full members. They may only deliberate in the absence of the fu…
A statutory auditor shall certify the annual accounts of the fund referred to in the second paragraph of II of Article L. 6131-4.
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