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Showing 391–400 of 26972 articles for “Art. CE 16-4-2012 n° 323592”
…f its members and after consultation with the chairman of the Executive Council, for a period not exceeding two days.
…a medicinal product or a product mentioned in Article R. 5121-150 shall implement a pharmacovigilance system in order to fulfil its pharmacovigilance obligations, and in particular to collect and sci…
…erved during a post-authorisation study; 2° To report, electronically, to the European "Eudravigilance" database: a) Any suspected serious adverse reaction occurring in a Member State of the European…
…t or a product referred to in Article R. 5121-150 has at its disposal on a permanent basis the services of a person responsible for pharmacovigilance residing and practising in a Member State of the E…
…oduct referred to in Article R. 5121-150 may not communicate information relating to pharmacovigilance to the general public about this medicinal product or product without sending it, beforehand or,…
…have an impact on the marketing authorisation; 2° A scientific evaluation of the risk-benefit balance of the medicinal product or product based on all available information, including that resulting…
…the European Parliament and of the Council in order to request the setting of European Union reference dates or a change in the frequency of submission of periodic safety update reports, for reasons o…
…nisation exploiting a medicinal product or a product mentioned in Article R. 5121-150 implements procedures to obtain accurate and verifiable information for the scientific evaluation of suspected adv…
…y the investigators of the research mentioned in 1° of article L. 1121-1. Its implementation and procedures are determined under the conditions defined by Law no. 78-17 of 6 January 1978 relating to i…
…s, in the order of the trades carried out:1° The date of the transaction;2° The purchase or sale price or, failing that, the unit purchase price;3° The number of shares purchased or sold at each price…
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