Article R5139-13
The Director General of the Agence nationale de sécurité du médicament et des produits de santé keeps an up-to-date list of authorisation holders and authorised persons. These lists are accessible at…
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Showing 3281–3290 of 9794 articles for “Art. CJEU – C-64/21 – 13 Oct. 2022”
The Director General of the Agence nationale de sécurité du médicament et des produits de santé keeps an up-to-date list of authorisation holders and authorised persons. These lists are accessible at…
Advertising to the public for a product or object defined in article R. 5134-11 may not include any element which : 1° Suggest that the effect of the product or object is guaranteed or that it has no…
The application for marketing authorisation for a veterinary medicinal product shall be sent to the Director General of the Agence nationale de sécurité sanitaire de l'alimentation, de l'environnement…
Any modification concerning the elements and documents mentioned in Article R. 5141-130 is submitted for authorisation to the Director General of the Agence nationale de sécurité sanitaire de l'alimen…
Decisions to authorise, modify, renew, suspend or withdraw authorisation for the preparation of autovaccines are made public in an extract on the website of the Agence nationale de sécurité sanitaire…
The labelling of self-vaccines for veterinary use and, where appropriate, the accompanying information sheet must include, in addition to the words: "self-vaccine for veterinary use" in clearly visibl…
The authorisation holder shall inform the Director General of the Agence nationale de sécurité sanitaire de l'alimentation, de l'environnement et du travail of the date on which the activity of prepar…
…ns declared in the application which gave rise to the authorisation provided for in article R. 5141-130 or modified under the conditions set out in article R. 5141-131. Except in an emergency, these d…
The authorisation holder sends the renewal application to the Director General of the Agence nationale de sécurité sanitaire de l'alimentation, de l'environnement et du travail ninety days before the…
In the event of a change of ownership of a veterinary pharmaceutical establishment, the authorisation to open is transferred to the new owner on application made jointly by the two responsible pharmac…
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