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Showing 4691–4700 of 13081 articles for “Art. 7 sept. 2017”
Any practice of prescribing a medicinal product outside the scope of its marketing authorisation may be reported by electronic means to the Director General of the Agency, to enable him to assess the…
I.-The compassionate access authorisation may be renewed. Renewal is the subject of a request from the holder of this authorisation addressed to the Director General of the Agence nationale de sécurit…
…ws up a draft summary of each report, with a view to publication as provided for in Article R. 5121-76-10, and sends it to the Agency with the report. III. - Prescribers and pharmacists are required t…
…otocol; 3° Where applicable, summaries of the periodic summary reports mentioned in article R. 5121-74-6. II.-The Ministers for Health and Social Security publish, on their websites, the list of medic…
Where the application for registration concerns a product which has been the subject of a Community herbal monograph established by the Committee for Herbal Medicinal Products of the European Medicine…
Where the therapeutic use and patient monitoring protocol so provides, the holder of the exploitation rights for a medicinal product benefiting from a compassionate access authorisation or, where appl…
The compassionate prescribing framework drawn up by the Director General of the Agence nationale de sécurité du médicament et des produits de santé states in particular, for each medicinal product: 1°…
The data referred to in II and III of Article R. 5121-201-5 and a copy of the administration record referred to in Article R. 5121-201-6 shall be kept by the establishments referred to in Article R. 5…
The société de participations financières de profession libérale de pharmaciens d'officine shall inform the director general of the regional health agency, in whose area of jurisdiction the registered…
For the application of the provisions mentioned in article R. 5125-33-6, the pharmacist shall respect the confidentiality of discussions with the patient. To this end, he must have at his disposal pre…
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