Article R5141-35
…5141-5, any variation or extension, as provided for in Chapter I of Commission Regulation (EC) No 1234/2008 of 28 November 2008 concerning the examination of variations to the terms of a marketing a…
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Showing 12611–12620 of 15302 articles for “Art. 12 al. 2”
…5141-5, any variation or extension, as provided for in Chapter I of Commission Regulation (EC) No 1234/2008 of 28 November 2008 concerning the examination of variations to the terms of a marketing a…
The application for registration must be accompanied by a dossier containing : 1° The scientific name, or other name appearing in a pharmacopoeia, of the homeopathic stock or stocks, mentioning the va…
The marketing authorisation is granted by the Director General of the Agence nationale de sécurité sanitaire de l'alimentation, de l'environnement et du travail. It is accompanied by the summary of pr…
…10° A special warning, if required for the medicinal product; 11° The manufacturing batch number; 12° The registration number.
…Title II of Book I of Part One of this Code, including the clinical trials mentioned in article L. 1124-1, ensure that the provisions of article L. 513-11-4 are complied with. For the importation of f…
…II variations and extensions as defined in 3° and 4° of Article 2 of Commission Regulation (EC) No 1234/2008 of 28 November 2008 concerning the examination of variations to the terms of a marketing a…
…3° For applications for extensions as defined in 4° of Article 2 of Commission Regulation (EC) No 1234/2008 of 28 November 2008 concerning the examination of variations to the terms of a marketing a…
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…
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…
…f technical and scientific progress under the conditions laid down in Commission Regulation (EC) No 1234/2008 of 28 November 2008 concerning the examination of variations to the terms of a marketing a…
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