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 5651–5660 of 29557 articles for “Art. 5 janv. 1983 + Cass. 3e civ.”
Generic herbal medicinal products are covered by the provisions of articles R. 5121-6 and R. 5121-7.
…w 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 Agenc…
…p and signed by persons with the necessary qualifications and experience as mentioned in Article R. 5121-33.
…reactions; 4° The classification of the medicinal product in the categories mentioned in article R. 5121-36, if different from that indicated in the marketing authorisation. It specifies its period 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…
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…
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.
…blishments importing investigational medicinal products under the conditions set out in articles R. 5124-57-3 and R. 5124-57-4 hold these documents and keep them for the same period of time. When the…
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…
For each representative, an alternate is appointed under the same conditions as the full member. Alternates may attend meetings of the Regional Employment, Training and Vocational Guidance Committee w…
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