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Showing 10791–10800 of 36632 articles for “Art. al. 5”
Articles R. 4234-18 to R. 4234-22 are applicable in New Caledonia and French Polynesia in the version published in Decree no. 2022-381 of 16 March 2022.
…ional medicinal products are prepared in accordance with the good practices mentioned in article L. 5121-5. The information appearing on the labelling must be written at least in French. The labelling…
The standards and methods applicable to the testing of medicinal products are set, on a proposal from the Director General of the Agence nationale de sécurité du médicament et des produits de santé, b…
…s "common name" and by route of administration. The information which, in application of article R. 5125-55, must be included in a prescription under a non-proprietary name is specified in the directo…
…ns that comply with the provisions of Commission Delegated Regulation (EU) 2016/161 of 2 October 2015 supplementing Directive 2001/83/EC of the European Parliament and of the Council by laying down de…
The provisions of the French pharmacopoeia and the European pharmacopoeia are made mandatory by decision of the Director General of the Agence nationale de sécurité du médicament et des produits de sa…
…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…
Decisions to include a medicinal product in the register of generic groups, to amend these decisions and to remove a medicinal product from this register, governed by this section, are published on th…
…ept where there is a risk to patients' health, the proprietary medicinal products mentioned in b of 5° of Article L. 5121-1 which are presented in a modified-release oral pharmaceutical form different…
…f the Agency. In this case, the Director General of the Agency, if the conditions laid down in b of 5° of Article L. 5121-1 are met, informs the holder of the marketing authorisation issued for this m…
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