Article R5121-107-13
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…
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Showing 4101–4110 of 47060 articles for “Art. CJUE ord. 10-2-2022 aff. 191/21”
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…
When a herbal substance, a herbal preparation or a combination of substances is withdrawn from the list drawn up by the Commission of the European Communities, any registration of traditional herbal m…
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…
Where the application for registration concerns a product which has been the subject of a Community herbal monograph established by the Committee for Herbal Medicinal Products of the European Medicine…
In the event of a serious adverse reaction likely to be due to a tattooing product, the persons responsible for placing a tattooing product on the market, the health professionals who have observed it…
Tattoo products are subject to vigilance designed to monitor undesirable effects occurring under normal conditions of use of the product or resulting from misuse. This vigilance is applied to all thes…
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