Article R5121-126
After it has been issued, the parallel import authorisation may be suspended or withdrawn by the Director General of the Agence nationale de sécurité du médicament et des produits de santé if the medi…
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Showing 1891–1900 of 6191 articles for “Art. n° 12-22.637”
After it has been issued, the parallel import authorisation may be suspended or withdrawn by the Director General of the Agence nationale de sécurité du médicament et des produits de santé if the medi…
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…
The holder of a parallel import authorisation notifies the holder of the marketing authorisation for the proprietary medicinal product in the Member State of origin of the marketing in France of the p…
When the marketing authorisation for the proprietary medicinal product that has been granted a marketing authorisation in France is amended by the Director General of the Agence nationale de sécurité…
For each parallel import operation, 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 author…
The proprietary medicinal product benefiting from a parallel import authorisation is subject to the provisions of the marketing authorisation for the proprietary medicinal product which obtained the m…
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…
The closure of a pharmaceutical establishment belonging to the companies and organisations mentioned in 1° to 3° of R. 5124-2 must be notified to the Agence nationale de sécurité du médicament et des…
A person who fulfils the conditions laid down in the first paragraph of article L. 5125-2 and intends to practise pharmacy concurrently with one of the professions of doctor, dental surgeon, midwife o…
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…
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