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Showing 3751–3760 of 8963 articles for “Art. 9 sept. 2020”
The creation, organisation and funding of veterinary pharmacovigilance centres, as well as the conditions under which they carry out the tasks entrusted to them by the Agence nationale de sécurité san…
…icles 81, 84 and 85, the first seven paragraphs of Article 88, the first two paragraphs of Article 89, the first five paragraphs of Article 90 and Articles 92, 97 to 99 of the aforementioned Decree of…
Where, following the establishment of a new Community herbal monograph, the revision of an existing monograph or the revision of the list drawn up by the European Commission in application of Article…
The Director General of the Agency may automatically vary, suspend or cancel a registration in the same cases and according to the same procedures as those laid down for a marketing authorisation in A…
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…
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…
…of Medicines and Health Products under the conditions laid down in Articles R. 5121-21 and R. 5121-97 respectively.
When a herbal substance, a herbal preparation or a combination of substances is withdrawn from the list drawn up by the Commission of the European Communities, any registration of traditional herbal m…
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