Article R5121-100-1
…concerning the examination of variations to the terms of a marketing authorisation for medicinal products for human use and veterinary medicinal products, in accordance with the amendment envisaged in…
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Showing 4021–4030 of 39275 articles for “Art. Décret 2013-392 du 10-5-2013”
…concerning the examination of variations to the terms of a marketing authorisation for medicinal products for human use and veterinary medicinal products, in accordance with the amendment envisaged in…
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I.-The registration of the medicinal products mentioned in article L. 5121-13 may be refused, amended, suspended or withdrawn by the Director General of the Agency.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…
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…
When the holder of the surgical oncology authorisation implements a hybrid practice of surgical oncology management with the administration of a systemic cancer drug treatment intraoperatively or in t…
…ted if the holder has access, on site or by agreement, to medical biology tests and labile blood products within a timeframe that is compatible with the safety of treatment.
…s. In this case, an agreement is drawn up between the authorisation holders for each site. When the duty of care is provided for several sites, the agreement referred to in the 2nd paragraph specifies…
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