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Showing 1661–1670 of 9666 articles for “Art. CE 16-11-1988 n° 47685-47741”
…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…
…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…
…s) of the companies or organisations mentioned in 1° and 2° of article R. 5124-2 must provide evidence of at least two years' practical experience in one or more establishments authorised to manufactu…
…R. 5122-15 may be taken in the event of misuse, as defined in article R. 5121-153, or drug dependence or abuse, as defined in article R. 5132-97, of the medicinal product being advertised.
A private practice company may not operate more than one pharmacy.
The internal-use pharmacy may only operate at each of its sites in the presence of the pharmacist in charge or his replacement or an assistant pharmacist mentioned in article R. 5125-34 practising in…
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