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Showing 10651–10660 of 36632 articles for “Art. al. 5”
After it has been issued, the parallel import authorisation may be suspended or withdrawn by the Director General of the Agence nationale de sécurité du médicament et des produits de santé if the medi…
…e for registration of a medicinal product or a series of medicinal products mentioned in article L. 5121-13 is sent to the Agency. It includes the following information and documents 1° The name and a…
A medicinal product or a series of medicinal products mentioned in Article L. 5121-13 may only be registered if the applicant is established in a Member State of the European Community or a party to t…
…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…
In order to be able to continuously assess the benefit/risk balance of the medicinal product, the Director General of the Agence nationale de sécurité du médicament et des produits de santé may at any…
…onale de sécurité du médicament et des produits de santé has the prerogatives set out in Article R. 5121-34. II.- As soon as a first request for authorisation for compassionate access for a medicinal…
I.-The labelling of the medicinal products mentioned in 1° of II of article L. 5121-12 includes at least the following information: 1° The name of the medicinal product or, where appropriate, its code…
…sible for the operation of the proprietary medicinal product within the meaning of 3° of Article R. 5124-2. It invites the person responsible for the notification to report this adverse reaction to th…
…marketing authorisation in France of any serious adverse reaction, within the meaning of Article R. 5121-153, concerning the imported medicinal product, as soon as he is aware of it. It will also info…
Classification in the category of medicinal products reserved for hospital use may only take place if the restrictions on prescribing, dispensing and administration of the medicinal product are justif…
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