j res pharm

Marmara Pharmaceutical Journal

1309-0801

Marmara University

The new pharmacovigilance legislation and impact on observational studies

Gülmez

Sinem

03 07 2014

17 2 61 64 03 07 2014

1985

Marmara Pharmaceutical Journal

ABSTRACTBACKGROUND: After the publication of the Regulation (EU) No 1235/2010 and Directive2010/84/EU on 31st of December 2010, the new legislation on pharmacovigilance came intooperation for the better protection of public health through a further strengthened EU systemfor medicines safety.REMARKS: The main changes include the new definition of adverse reactions, Eudravigilancebecoming the single receipt point for all pharmacovigilance information through theEU, the Pharmacovigilance Risk Assessment Committee, and strengthened PASS/PAES, andrequirement of a risk management planning for all new medicines. The possible increase inPA(E)SS may be a concern in terms of access to appropriate data and so obtaining necessaryauthorisations without delays.CONCLUSION: The new legislation will provide good vigilance practice standards with increasedtransparency of pharmacovigilance data. The communication will improve with theinvolvement of patient and public. With better access to real-life data, better protection ofpublic health will be ensured.KEYWORDS: pharmacovigilance legislation, pharmacoepidemiology, observational study,regulations, European Directive

GİRİŞ: 1235/2010 sayılı yeni tüzük ve 2010/84/EU sayılı yeni farmakovijilans yö nergesi, Avrupa Birliği (AB) Resmi Gazetesi’nde 31 Aralık 2010 tarihinde yayımlandıktan sonra yü rü rlü ğ e girdi. Yeni düzenlemelerle AB, halk sağlığı ve ilaç güvenliliğine daha sıkı bir takip getirmiş oldu

pharmacovigilance legislation pharmacoepidemiology observational study regulations European DirectiveThe new pharmacovigilance legislation

ANAHTAR SÖZCÜKLER: Farmakovijilans yönetmeliği farmakoepidemiyoloji farmakovijilans yasal düzenlemeler

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Directive 2010/84/EU of the European Parliament and of the Council of 15 December 2010. Official Journal of the European Union dated 31.12.2010. L 348/74-99. PDF document. http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2010:348:0074:0099:EN:PDF [Accessed: November 15th, 2012]

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