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Showing 10741–10750 of 36632 articles for “Art. al. 5”
In the absence of agreement within the coordination group, the Community arbitration procedure provided for in articles 32 to 34 of Directive 2001/83/EC of the European Parliament and of the Council a…
…médicament et des produits de santé or by another State : 1° In the case provided for in Article R. 5121-51-1, the Director General of the Agency will notify the States concerned and the marketing aut…
By way of derogation from 2° of Article R. 5121-25, for the medicinal products mentioned in this Article, the dossier attached to the marketing authorisation application is compiled under the followin…
Exceptionally, the Director General of the Agence nationale de sécurité du médicament et des produits de santé may, at the reasoned request of the marketing authorisation holder, authorise him to pres…
…n or restriction intended to ensure the safe and effective use of the medicinal product or product; 5° The existence of an adequate pharmacovigilance system; 6° The performance of post-authorisation e…
The experts referred to in Article L. 5121-20 shall have the following qualifications and experience, as set out in a summary of the curriculum vitae attached to the marketing authorisation applicatio…
…sation makes this necessary, the holder of the early access authorisation referred to in Article L. 5121-12 will take all necessary steps, in particular with stockholders, to stop distributing the med…
…for health and social security and, for the medicinal products mentioned in 1° of II of article L. 5121-12, to the Agence nationale de sécurité du médicament et des produits de santé, at intervals la…
…n a medicinal product has obtained an initial marketing authorisation in accordance with Article L. 5121-8, any variation or extension, as provided for in Chapter I of Commission Regulation (EC) No 12…
…he national number identifying the presentation of the medicinal product provided for in Article R. 5121-4. It indicates, where applicable, the classification of the medicinal product in the following…
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