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Showing 4001–4010 of 24422 articles for “Art. Cass. com. – 20 Sept. 2011 – no. 10-21.623”
The request for an opinion from the Agence nationale de sécurité du médicament et des produits de santé by the ministers responsible for health and social security, on the order mentioned in the last…
The Agence nationale de sécurité du médicament et des produits de santé publishes on its website : 1° The initial compassionate prescribing framework, the protocol for therapeutic use and patient foll…
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…
…examined under the conditions 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 author…
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…
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When a herbal substance, a herbal preparation or a combination of substances is withdrawn from the list drawn up by the Commission of the European Communities, any registration of traditional herbal m…
I.-The registration of the medicinal products mentioned in article L. 5121-13 may be refused, amended, suspended or withdrawn by the Director General of the Agency. The period of suspension may not ex…
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…
The following changes to the authorisation to open a pharmaceutical establishment must be declared, pursuant to the second paragraph of Article L. 5124-3: 1° Change in the corporate name of the compan…
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