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Showing 10531–10540 of 36632 articles for “Art. al. 5”
…equirements, the conditions for granting or monitoring the authorisation referred to in Articles R. 5121-212 and R. 5121-213, or where it appears, particularly following evaluation, that the benefit/r…
…ncerning the tissues and cells removed and the products and materials coming into contact with them;5° Data relating to the quality of the medicinal product concerning the active substance and the fin…
…application for authorisation or renewal of authorisation provided for in 12° and 13° of Article L. 5121-1 shall be sent by registered post with acknowledgement of receipt or lodged against receipt wi…
The correspondent mentioned in article R. 5121-181 who receives the report provided for in article R. 5121-196 immediately forwards it to the regional pharmacovigilance centre. If he is otherwise awar…
The declarations and the periodic safety update report referred to in Articles R. 5121-161, R. 5121-168 and R. 5121-170 are drawn up in accordance with the procedures and standard form laid down by th…
Advertising for a medicinal product to the healthcare professionals mentioned in Article L. 5122-9 is tailored to the target audience. It specifies the date on which it was drawn up or last revised an…
…named medical prescription. When medicines are dispensed, the information referred to in article R. 5121-187 is recorded in a special register which is listed and initialled by the mayor or police com…
…al establishments, including those managed by public health establishments mentioned in articles R. 5124-68 to R. 5124-73 for their production, hospital preparation and magistral preparation activitie…
…uest, refer the matter to the Committee for Medicinal Products for Human Use referred to in Article 56 of Regulation (EC) No 726/2004 of the European Parliament and of the Council or to the coordinati…
I.-Any company or organisation exploiting a medicinal product or a product mentioned in article R. 5121-150 is required to transmit electronically to the European Medicines Agency a periodic safety up…
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