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Showing 3691–3700 of 8936 articles for “Art. 9 Mar 2004”
…her in 3° of Article R. 5121-25 and Article R. 5121-37-2, or in Article 6 of Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Community procedures…
…cation of Article 16f of Directive 2001/83/EC, a herbal medicinal product which is the subject of a marketing authorisation now falls wholly or partly under the registration system, the holder sends t…
…ncel a registration in the same cases and according to the same procedures as those laid down for a marketing authorisation in Article R. 5121-47. It shall immediately inform the European Medicines Ag…
Following the establishment of a new Community herbal monograph or the revision of an existing monograph, the registration holder shall submit a request for amendment of the registration dossier to th…
The detailed summaries of the tests accompanying the application for registration and the expert reports are drawn up and signed by persons with the necessary qualifications and experience as mentione…
Where the application for registration concerns a herbal substance, a herbal preparation or a combination thereof included in the list drawn up for use in traditional herbal medicinal products by the…
…cognition procedure or the decentralised procedure under the same conditions as those laid down for marketing authorisation in articles R. 5121-51 to R. 5121-51-7.
…data available to him, that, given its characteristics, the medicinal product is now covered by the marketing authorisation system or the registration system for homeopathic medicinal products, he sha…
When a herbal substance, a herbal preparation or a combination of substances is withdrawn from the list drawn up by the Commission of the European Communities, any registration of traditional herbal m…
…evidence or expert reports; thirty-year medical use is established even if the product has not been marketed with a specific authorisation or if the number of components of the product or their dosage…
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