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Showing 9481–9490 of 60179 articles for “Art. R 145-29-1”
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After it has been issued, the parallel import authorisation may be suspended or withdrawn by the Director General of the Agence nationale de sécurité du médicament et des produits de santé if the medi…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…
When, in application of the second paragraph of Article L. 5124-11, the Director General of the Agence nationale de sécurité du médicament et des produits de santé intends to prohibit the export of a…
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…
Withdrawal of the approval provided for in the third paragraph of Article L. 5122-9 is decided by the Director General of the Agence nationale de sécurité du médicament et des produits de santé after…
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