Article R5121-9-10
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…
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Showing 3091–3100 of 33452 articles for “Art. Cass. com. 5-10-1999 n° 1443”
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…
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/…
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…
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…
I.-The registration of the medicinal products mentioned in article L. 5121-13 may be refused, amended, suspended or withdrawn by the Director General of the Agency.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…
Non-compliance with the provisions governing the formation and operation of sociétés de participations financières de profession libérale de pharmaciens d'officine by pharmacists who are members of su…
The Board comprises : 1° Four representatives of the State, including the Regional Prefect and three representatives appointed by him from among those mentioned in 2° of Article R. 6123-3-3, including…
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