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Showing 10701–10710 of 36632 articles for “Art. al. 5”
…and according to the same procedures as those laid down for a marketing authorisation in Article R. 5121-47. It shall immediately inform the European Medicines Agency. Decisions to refuse, vary, suspe…
…irector General of the Agency if the application does not comply with the provisions of Articles L. 5121-14-1, R. 5121-97, R. 5121-107-4 and R. 5121-107-5, or if at least one of the following conditio…
…cases, to his marketing authorisation, his early access authorisation under 1° of II of article L. 5121-12-12-1 or the compassionate access authorisation under II of article L. 5121-12-1 or the compa…
…for the persons carrying out, in these establishments, the responsibilities mentioned in article L. 5126-6; 3° The medicinal product may only be administered as part of hospitalisation or care in a ho…
…nal transport, they are exempt from import authorisation under the conditions set out in article L. 5124-13. A sports team doctor who personally transports a medicinal product or who imports a medicin…
For finished products, defined as medicinal products that have undergone all stages of manufacture, including packaging, an import authorisation is required for each import operation. For medicinal pr…
By way of derogation from the provisions of article R. 5121-99, the registration lapses if it appears that it is not followed by the marketing of the medicinal product on the national territory within…
…t des produits de santé shall register the homeopathic medicinal products referred to in Article L. 5121-13 and the traditional herbal medicinal products referred to in Article L. 5121-14-1 on the bas…
…s who have been awarded a specialist qualification under the conditions set out in decree no. 2004-252 of 19 March 2004 relating to the conditions under which doctors of medicine may obtain a speciali…
When presenting a prescription for a medicinal product classified in one of the categories of medicinal products subject to restricted prescription, the pharmacist must ensure, in accordance with the…
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