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Showing 3521–3530 of 24607 articles for “Art. CA Douai 12-5-2016 n° 15/03664”
If the Director General of the Agence nationale de sécurité du médicament et des produits de santé remains silent for a period of forty-five days from the date of receipt of the complete application a…
…mple of the product, as it will be placed on the market, to the Agence nationale de sécurité du médicament et des produits de santé, which ensures that it complies with the marketing authorisation in…
…thorisation in France is amended by the Director General of the Agence nationale de sécurité du médicament et des produits de santé, the Director General will notify the holder of the parallel import…
…the authorisation holder notifies the Director General of the Agence nationale de sécurité du médicament et des produits de santé of the batch numbers of the authorised medicinal product being impor…
…mmary of product characteristics, with the exception of the stability period and special storage precautions, which are those provided for in the marketing authorisation obtained in the country of ori…
Pursuant to Article L. 5122-1, an application for an advertising approval for a medicinal product, as provided for in Article L. 5122-9, is made for any form of information, as defined by Article L. 5…
…ealth Agency. In addition to documents proving that the required conditions have been met, the application must include a copy of the undertaking on honour, attached to the application for registratio…
An in-house pharmacy may be authorised to have premises located on several separate sites belonging to one or more of the establishments, services or organisations mentioned in Article R. 5126-1, prov…
…rmines the amount and terms of payments to be made by audited bodies to cover the costs incurred in carrying out the audit.
For seafarers, the authorisations referred to in article R. 5523-10 are issued by the maritime authority under the conditions laid down in the Maritime Labour Code.
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