Article R5121-201-4
…the good practices provided for in Article L. 1245-6, or those relating to blood and its components as provided for in Articles R. 1221-36 et seq, as well as in the good practices mentioned in Article…
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Showing 2521–2530 of 23743 articles for “Art. Cass. 13 March 2008 – counterfeit as dispossession”
…the good practices provided for in Article L. 1245-6, or those relating to blood and its components as provided for in Articles R. 1221-36 et seq, as well as in the good practices mentioned in Article…
…ufacturing or exploiting blood-derived medicinal products which are aware of information likely to cast doubt on the quality of blood or plasma intended for fractionation inform each other. Blood tran…
…te a system ensuring the traceability of advanced therapy medicinal products prepared on an ad hoc basis. II - Establishments which prepare punctually prepared advanced therapy medicinal products shal…
…the data relating to the traceability of advanced therapy medicinal products prepared on an ad hoc basis are transferred to the establishment or organisation authorised under the same article, with wh…
…cle R. 5121-201-6 shall be kept by the establishments referred to in Article R. 5121-201-5 for at least thirty years after the expiry date of the advanced therapy medicinal product prepared on an ad h…
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…
Organisations or companies exploiting blood-derived medicinal products which have knowledge of adverse reactions likely to be due to these medicinal products inform the Director General of the Agence…
…ay be due to a blood-derived medicinal product, he/she shall report it immediately, even if he/she has not personally prescribed, dispensed or administered the medicinal product in question. The repor…
…the purposes of this sub-section, army hospitals and the army blood transfusion centre are regarded as public health establishments and blood transfusion establishments respectively.
…the economic, financial, social and environmental elements required to understand the accounts and assess the company's situation.
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