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Showing 10611–10620 of 36632 articles for “Art. al. 5”
The holder of a parallel import authorisation notifies the holder of the marketing authorisation for the proprietary medicinal product in the Member State of origin of the marketing in France of the p…
The importation of a proprietary medicinal product constitutes a parallel import with a view to placing it on the market in France: 1° Which comes from another Member State of the European Community o…
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…
I.-The registration of the medicinal products mentioned in article L. 5121-13 may be refused, amended, suspended or withdrawn by the Director General of the Agency.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…
Registration of homeopathic medicinal products and traditional herbal medicinal products, as well as suspension and withdrawal of registration, are made available to the public by the Director General…
…f the risk-benefit balance of the medicinal product as defined in the first paragraph of article L. 5121-9 in the case of traditional herbal medicinal products. In this case, the additional renewal ta…
…up protocol; 3° Where applicable, summaries of the periodic summary reports mentioned in article R. 5121-74-6. II.-The Ministers for Health and Social Security publish, on their websites, the list of…
…labelling of the immediate packaging of a medicinal product or a product referred to in Article L. 5121-8, must include the following information, written in such a way as to be easily legible, clear…
…of the authorisation to import by a means other than personal transport, referred to in article R. 5121-109, or a copy of the compassionate access authorisation under II of article L. 5121-12-1 grant…
…ve days from the date of receipt of the complete application and dossier referred to in Articles R. 5121-111 and R. 5121-112. The time limit mentioned in the previous paragraph is extended by fifteen…
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