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Showing 8791–8800 of 59899 articles for “Art. R 134-1”
Private individuals may only import a medicinal product in a quantity compatible with personal therapeutic use for a period of treatment not exceeding three months under normal conditions of use, or f…
The certificates referred to in Article L. 5124-11 are issued by the Director General of the Agence nationale de sécurité du médicament et des produits de santé. These certificates are valid for three…
For pharmaceutical products with a parallel import authorisation, Customs officers check the import authorisation number on the packaging. If this number does not appear on the packaging at the time o…
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…
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…
After it has been issued, the parallel import authorisation may be suspended or withdrawn by the Director General of the Agence nationale de sécurité du médicament et des produits de santé if the medi…
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…
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 regional pharmacovigilance centres inform the Agence nationale de sécurité du médicament et des produits de santé on the same day of the reports of adverse reactions likely to be due to a blood-de…
When a medicinal product is subject to the restricted prescription conditions laid down in section 8 of chapter I of this title, it may only be advertised to prescribers authorised to draw up the pres…
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