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SOCIAL QUESTIONS|health|pharmaceutical industry
an Coiste Cógas-Aireachais um Measúnú Rioscaí Tagairt "Rialachán (AE) 658/2014 maidir le táillí is iníoctha leis an nGníomhaireacht Leigheasra Eorpach chun gníomhaíochtaí cógas-aireachais a dhéanamh i ndáil le táirgí íocshláinte lena n-úsáid ag an duine, CELEX:32014R0658/GA Faomhadh an téarma seo mar chuid de Thionscadal Lex"
ga
Ausschuss für Risikobewertung im Bereich der Pharmakovigilanz | Beratender Ausschuss für Risikobewertung im Bereich der Pharmakovigilanz
de
Pharmacovigilance Risk Assessment Committee | PRAC | Pharmacovigilance Risk Assessment Advisory Committee | PRAAC
en
Sainmhíniú committee, forming part of the European Medicines Agency, which is responsible for providing recommendations to the Committee for Medicinal Products for Human Use and the coordination group (set up by Article 27 of Directive 2001/83/EC on the Community code relating to medicinal products for human use) on any question relating to pharmacovigilance activities in respect of medicinal products for human use and on risk management systems and responsible for monitoring the effectiveness of those risk management systems Tagairt "COM-EN, based on: Article 56(1)(aa) of Regulation (EC) No 726/2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency (consolidated text: CELEX:02004R0726-20130605/EN ), inserted by Regulation (EU) No 1235/2010, CELEX:32010R1235/EN"
comité pour l’évaluation des risques en matière de pharmacovigilance | comité consultatif pour l’évaluation des risques en matière de pharmacovigilance
fr
Sainmhíniú "comité chargé de présenter des recommandations au comité des médicaments à usage humain [IATE:843393] et au groupe de coordination sur toute question relative aux activités de pharmacovigilance" Tagairt "Règlement (UE) nº 1235/10 modifiant, en ce qui concerne la pharmacovigilance des médicaments à usage humain, le règlement (CE) n ° 726/2004 (...), et le règlement (CE) n ° 1394/2007 (...), CELEX:32010R1235/FR"
PRAC
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