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Showing 3831–3840 of 10604 articles for “Art. CA Paris 24-10-2024”
…e traditional herbal medicinal product is refused by the Director General of the Agency if the application does not comply with the provisions of Articles L. 5121-14-1, R. 5121-97, R. 5121-107-4 and R…
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…
Amendments to the terms of the registration decision and the registration dossier are submitted and examined under the conditions laid down in Chapters I and IIa of Commission Regulation (EC) No 1234/…
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…
Where a Community herbal monograph has been established or where the herbal medicinal product consists of herbal substances, preparations or combinations thereof included in the list drawn up by the C…
…ation system or the registration system for homeopathic medicinal products, he shall submit an application for a marketing authorisation or registration to the National Agency for the Safety of Medici…
…Communities, any registration of traditional herbal medicinal products containing this substance is cancelled by the Director General of the Agency, unless the holder requests a modification of the re…
I.-The period of traditional medical use provided for in 4° of Article L. 5121-14-1 is thirty years, including at least fifteen years in a Member State of the European Community or in another State pa…
I.-The Director General of the Agence nationale de sécurité du médicament et des produits de santé publishes, on the Agency's website, a reference database of medicinal products which are the subject…
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