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Showing 4461–4470 of 11432 articles for “Art. CE 17-10-1990 n° 56991”
…s laid down in Chapters I and IIa of Commission Regulation (EC) No 1234/2008 of 28 November 2008 concerning the examination of variations to the terms of a marketing authorisation for medicinal produc…
…e application for registration and the expert reports are drawn up and signed by persons with the necessary qualifications and experience as mentioned in Article R. 5121-33.
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…
…rbal 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 Commission of the Eur…
If, after a traditional herbal medicinal product has been registered, the proprietor considers, on the basis of new data available to him, that, given its characteristics, the medicinal product is now…
When a herbal substance, a herbal preparation or a combination of substances is withdrawn from the list drawn up by the Commission of the European Communities, any registration of traditional herbal m…
…unity or in another State party to the European Economic Area, as attested by bibliographical evidence or expert reports; thirty-year medical use is established even if the product has not been market…
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…
…d, suspended or withdrawn by the Director General of the Agency. The period of suspension may not exceed one year. Decisions to refuse, amend, suspend or cancel registration shall state the reasons on…
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…
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