French Public Health CodeIn force
Section 3: Generic specialities
Article R5121-5-3
Generic herbal medicinal products are covered by the provisions of articles R. 5121-6 and R. 5121-7.
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Showing 5671–5680 of 18481 articles for “Art. CE 5-5-2010 n° 301419”
Generic herbal medicinal products are covered by the provisions of articles R. 5121-6 and R. 5121-7.
…5121-10, hybrid medicinal products are identified by a decision of the Director General of the Agence nationale de sécurité du médicament et des produits de santé mentioning the corresponding referen…
…e application for registration and the expert reports are drawn up and signed by persons with the necessary qualifications and experience as mentioned in Article R. 5121-33.
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…
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