Article R5121-74-5
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…
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Showing 6331–6340 of 19551 articles for “Art. CE 28-5-2010 n° 330567”
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°…
…or therapeutic interest referred to in article L. 5111-4, marketing authorisation holders and pharmaceutical companies exploiting medicinal products shall, under their responsibility, draw up and impl…
…or party to the Agreement on the European Economic Area and are manufactured or imported in accordance with the requirements of Directive 2003/94/EC and by an establishment authorised under Article 13…
…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 medicinal product…
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.
For 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 t…
…ary or who manages a mutualist or miner's aid pharmacy, participating in the same coordinated practice within the systems mentioned in articles L. 1411-11, L. 1434-12, L. 6323-1-10 and L. 6323-3 as th…
…tional medicinal products shall ensure that all manufacturing operations are carried out in accordance with the information provided by the sponsor in the application for authorisation referred to in…
…plicable, the decision of the competent professional body referred to in article R. 5125-24-4. On receipt of this document, the Registrar will register the company and inform the President of the Asso…
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