Article R5121-147
The marketing authorisation holder must comply with the good package leaflet practices established by decision of the Director General of the Agence nationale de sécurité du médicament et des produits…
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Showing 10661–10670 of 36632 articles for “Art. al. 5”
The marketing authorisation holder must comply with the good package leaflet practices established by decision of the Director General of the Agence nationale de sécurité du médicament et des produits…
By way of derogation from the provisions of Article R. 5121-138, when the medicinal products or products are contained in an outer packaging that complies with the requirements of the said Article, th…
At the time of each parallel distribution operation, the company responsible for the parallel distribution of the medicinal product notifies the Director General of the Agence nationale de sécurité du…
…subject to the specific provisions relating to them respectively, which are set out in articles R. 5132-27 and R. 5132-86.
The application for a parallel import authorisation is accompanied by a dossier comprising : 1° A sample of the proprietary medicinal product which has obtained marketing authorisation in France and a…
…gency for the Safety of Medicines and Health Products under the conditions laid down in Articles R. 5121-21 and R. 5121-97 respectively.
…progress. Any resulting changes must first be registered under the conditions set out in article R. 5121-100-1.
…healthcare professionals concerned must not constitute advertising within the meaning of Article L. 5122-1. These measures are subject to the prior opinion of the Agence nationale de sécurité du médic…
…imary packaging on which it is impossible to include all the information provided for in Article R. 5121-146-2 may bear only the information provided for in a, c, d and h of 1° of Article R. 5121-146-…
…primary packaging on which it is impossible to include all the information specified in Article R. 5121-138 may bear only the following information: 1° The name of the medicinal product or product, t…
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