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Volumn 34, Issue 3, 2011, Pages 187-197

Strengthening and rationalizing pharmacovigilance in the EU: Where is Europe heading to?: A review of the new EU legislation on pharmacovigilance

Author keywords

Legislation; Pharmacovigilance; Postmarketing surveillance.

Indexed keywords

ADVERSE DRUG REACTION; DECISION MAKING; DRUG INDUSTRY; DRUG LEGISLATION; DRUG SAFETY; DRUG SURVEILLANCE PROGRAM; EUROPEAN UNION; HEALTH PRACTITIONER; HUMAN; INFORMATION PROCESSING; INFORMATION RETRIEVAL; METHODOLOGY; PRIORITY JOURNAL; PROFESSIONAL STANDARD; PUBLIC HEALTH; REVIEW; RISK ASSESSMENT; RISK MANAGEMENT;

EID: 79951788370     PISSN: 01145916     EISSN: 11791942     Source Type: Journal    
DOI: 10.2165/11586620-000000000-00000     Document Type: Review
Times cited : (83)

References (11)
  • 4
    • 84855629523 scopus 로고    scopus 로고
    • Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the community code relating to medicinal products for human use. 2001L0083-EN-3012.2008-006.001-1 [online] [Accessed 2010 Apr 23]
    • Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the community code relating to medicinal products for human use. 2001L0083-EN-3012.2008-006.001-1 [online]. Available from URL:http://ec.europa.eu/enterprise/sectors/pharmaceuticals/files/ eudralex/vol-1/dir-2001-83-cons/dir2001-83-cons-200812 30-en.pdf [Accessed 2010 Apr 23]
  • 7
    • 84855622604 scopus 로고    scopus 로고
    • European Commission [online] [Accessed 2010 Apr 23]
    • European Commission. Citizen's summary: legal proposals on pharmacovigilance [online]. Available from URL: http://ec.europa.eu/enterprise/ sectors/pharmaceuticals/files/ pharmacos/pharmpack-12-2008/pharmacovigilance/en- su mmary-phvg-en.pdf [Accessed 2010 Apr 23]
    • Citizen's Summary: Legal Proposals on Pharmacovigilance
  • 8
    • 84855637947 scopus 로고    scopus 로고
    • Council of the European Union 10779/10 [online] [Accessed 2010 Sep 21]
    • Council of the European Union. Proposal for a Regulation of the European Parliament and of the Council amending, as regards pharmacovigilance of medicinal products for human use, 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 and proposal for a Directive of the European Parliament and of the Council amending, as regards pharmacovigilance, Directive 2001/83/EC on the Community code relating to medicinal products for human use. 10779/10 [online]. Available from URL: http://register.consilium.europa.eu/pdf/en/10/ st10/st10779.en10.pdf [Accessed 2010 Sep 21]
  • 9
    • 84855639259 scopus 로고    scopus 로고
    • The European Parliament and the Council of the European Union [online] [Accessed 2011 Jan 24]
    • The European Parliament and the Council of the European Union. Regulation (EU) No 1235/2010 of the European Parliament and of the Council of 15 December 2010 amending, as regards pharmacovigilance of medicinal products for human use, 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, and Regulation (EC) No 1394/2007 on advanced therapy medicinal products [online]. Available from URL: http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri= OJ:L:2010:348:0001:0016: EN:PDF [Accessed 2011 Jan 24]


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.