Article R5121-164
…party to the Agreement on the European Economic Area, and providing evidence of appropriate qualifications in pharmacovigilance. The identity, position and contact details of this person are communic…
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Showing 2101–2110 of 7791 articles for “Art. CA Paris – 26 June 2019 – no. 16/23435”
…party to the Agreement on the European Economic Area, and providing evidence of appropriate qualifications in pharmacovigilance. The identity, position and contact details of this person are communic…
…ation exploiting a medicinal product or a product referred to in Article R. 5121-150 may not communicate information relating to pharmacovigilance to the general public about this medicinal product or…
…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 update report containing : 1° All informati…
…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 coordination group referred to in Ar…
…dicinal product or a product mentioned in Article R. 5121-150 participates in the detection of duplicates in the reports of suspected adverse reactions, in particular by reporting to the Agence nation…
…ions 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 manufacture or import medicinal products…
For reasons relating to the protection of public health, the measures provided for in article R. 5122-15 may be taken in the event of misuse, as defined in article R. 5121-153, or drug dependence or a…
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…
The hourly amount of the flat-rate assistance for training costs mentioned in article R. 5522-14 is set at 7.62 euros.
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