Article R5138-6
The Agence nationale de sécurité du médicament et des produits de santé shall transmit to the European Medicines Agency, for recording in the Community database, the certificates of good manufacturing…
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Showing 4571–4580 of 42579 articles for “Art. L 136-6”
The Agence nationale de sécurité du médicament et des produits de santé shall transmit to the European Medicines Agency, for recording in the Community database, the certificates of good manufacturing…
Where the Director General of the Agence nationale de sécurité sanitaire de l'alimentation, de l'environnement et du travail considers that the application or the accompanying dossier is incomplete, h…
Any change of registration holder is subject to authorisation from the Director General of the Agence nationale de sécurité sanitaire de l'alimentation, de l'environnement et du travail. The applicati…
After registration has been granted, the manufacturing methods and control techniques set out in the dossier provided for in Article R. 5141-64 are modified in line with scientific and technical progr…
The registration includes the registration number and the data mentioned in Article R. 5141-63 as approved by the Director General of the Agence nationale de sécurité sanitaire de l'alimentation, de l…
Amendments concerning the data mentioned in the application and dossier provided for in articles R. 5141-63 and R. 5141-64 are submitted for approval to the Director General of the Agence nationale de…
The provisions relating to full-time practice and replacement contained in articles R. 5142-20 and R. 5142-22 to R. 5142-30 do not apply to the pharmacist or veterinarian mentioned in article R. 5142-…
The necessary measures are taken to prevent contamination of other food categories by medicated feed and contamination of medicated feed during manufacture, import, distribution or transport.
Medicated premixes and medicated feeds are stored in locked premises or in hermetically sealed containers separated by category and specially designed for the conservation of these products.
Authorised bodies shall inform the Director General of the Agence nationale de sécurité du médicament et des produits de santé of all certificates issued, modified, supplemented, suspended, withdrawn…
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