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Showing 10541–10550 of 36632 articles for “Art. al. 5”
…d in an advertisement which, prior to the reassessment, was endorsed in accordance with articles L. 5122-8 or L. 5122-9, the operator must obtain a new endorsement in order to resume advertising. In t…
…t outside healthcare establishments or the establishments and organisations mentioned in article R. 5121-192, he/she affixes a detachable label from the immediate packaging of the unit administered to…
The withdrawal of the visa provided for in the third paragraph of Article L. 5122-8 is decided by the Director General of the Agence nationale de sécurité du médicament et des produits de santé after…
…arried out under the responsibility of the marketing authorisation holder referred to in article L. 5121-8, who is responsible for their management and checks that they are properly funded. These stud…
If the coordination group agrees, at the end of the single assessment procedure for periodic safety update reports provided for in Article 107g(1) of Directive 2001/83/EC of the European Parliament an…
By way of derogation from the provisions of Article R. 5121-168, any company or organisation exploiting an authorised or registered medicinal product or product, in accordance with the procedure laid…
…f adverse reactions suspected to be due to a medicinal product or a product mentioned in article R. 5121-150, including cases of overdose, misuse, abuse and medicinal errors as defined in article R. 5…
…rketing a medicinal product shall set up an advertising department within the meaning of article L. 5122-1, under the supervision of the pharmacist responsible, which shall ensure compliance with the…
…d for in this paragraph take the place of the transcriptions and recordings mentioned in article R. 5132-10.
…s which do not have an in-house pharmacy, the stock of medicinal products referred to in article R. 5126-108 may only contain blood-derived medicinal products if the establishment has designated a cor…
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