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Showing 1351–1360 of 4074 articles for “Art. no 16-26395”
The dental surgery student gives the employer of the dental assistant being replaced an authorisation issued by the departmental council of the dental surgeons' association of the department in which…
Investigational medicinal products are prepared in accordance with the good practices mentioned in article L. 5121-5. The information appearing on the labelling must be written at least in French. The…
…urring in a Member State of the European Union or a State party to the Agreement on the European Economic Area or a third country are accessible in the "Eudravigilance" database.
The doctor, dental surgeon, midwife, pharmacist or nurse shall immediately report any adverse reaction suspected of being due to a medicinal product or to a product mentioned in article R. 5121-150 of…
Any company or organisation exploiting a medicinal product or a product mentioned in Article R. 5121-150 shall implement a pharmacovigilance system in order to fulfil its pharmacovigilance obligations…
…urring in a Member State of the European Union or a State party to the Agreement on the European Economic Area or a third country, of which it is aware, whether these reactions have been reported spon…
…tising in a Member State of the European Union or a State party to the Agreement on the European Economic Area, and providing evidence of appropriate qualifications in pharmacovigilance. The identity,…
…or organisation 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…
…able information, including that resulting from biomedical research for indications and populations not authorised by the marketing authorisation; 3° All information concerning the sale, prescription…
…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 coordination group referred to i…
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