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Parliamentary questions
21 June 2017
E-002925/2017
Answer given by Mr Andriukaitis on behalf of the Commission

EU legislation relating to medicinal products for human use relies on the scientific assessment performed by the scientific committees of the European Medicines Agency (EMA) for its decision making process. In the case of the Human papillomavirus (HPV) vaccines review, in particular the Pharmacovigilance Risk Assessment Committee (PRAC) and the Committee for Medicinal Products for Human Use (CHMP) were involved. Patients’ representatives were also extensively involved during the evaluation so that scientific experts could understand the views of those affected by the two conditions under assessment. Extensive measures are in place, including rules on handling potential conflicts of interests of scientific committee members, to ensure that the committees reach their scientific conclusions in an impartial way without any undue outside pressure particularly while the procedure is ongoing. Once the procedure is completed, a summary of the scientific recommendation enters the public domain. This published assessment report (European public assessment reports(1)) contains a comprehensive summary of the data assessed.

Further explanation regarding the EMA review process is publicly available in the EMA's response to the questions raised by the Nordic Cochrane Centre(2).

After a marketing authorisation is granted, medicines in the EU, including the HPV vaccines, are subject to a post-marketing surveillance. New emerging safety information including pharmacovigilance reports and published studies, regardless of their origin, are appropriately considered. The pharmacovigilance reports on suspected adverse drug reactions of all centrally authorised medicines are collected in the EU centralised database(3).

(1)http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/landing/epar_search.jsp&mid=WC0b01ac058001d125
(2)http://www.ema.europa.eu/docs/en_GB/document_library/Other/2016/07/WC500210543.pdf
(3)http://www.adrreports.eu

Last updated: 28 June 2017Legal notice