Commission Implementing Regulation (EU) No 520/2012 of 19 June 2012 on the performance of pharmacovigilance activities provided for in Regulation (EC) No 726/2004 of the European Parliament and of the Council and Directive 2001/83/EC of the European Parliament and of the Council (Text with EEA relevance)
When the UK left the EU, legislation.gov.uk published EU legislation that had been published by the EU up to IP completion day (31 December 2020 11.00 p.m.). On legislation.gov.uk, these items of legislation are kept up-to-date with any amendments made by the UK since then.
Point in time view as at 31/01/2020.
There are currently no known outstanding effects by UK legislation for Commission Implementing Regulation (EU) No 520/2012, Article 11.
1.Specific quality system procedures and processes shall be in place in order to ensure the following:
(a)the continuous monitoring of pharmacovigilance data, the examination of options for risk minimisation and prevention and appropriate measures are taken by the marketing authorisation holder;
(b)the scientific evaluation by the marketing authorisation holder of all information on the risks of medicinal products, as referred to in the second subparagraph of Article 101(1) of Directive 2001/83/EC;
(c)the submission of accurate and verifiable data on serious and non-serious adverse reactions to the Eudravigilance database within the time limits provided for in the first and second subparagraphs respectively of Article 107(3) of Directive 2001/83/EC;
(d)the quality, integrity and completeness of the information submitted on the risks of medicinal products, including processes to avoid duplicate submissions and to validate signals in accordance with Article 21(2);
(e)effective communication by the marketing authorisation holder with the national competent authorities and the Agency, including communication on new risks or changed risks, the pharmacovigilance system master file, risk management systems, risk minimisation measures, periodic safety update reports, corrective and preventive actions, and post-authorisation studies;
(f)the update of product information by the marketing authorisation holder in the light of scientific knowledge, including the assessments and recommendations made public via the European medicines web-portal, and on the basis of a continuous monitoring by the marketing authorisation holder of information published on the European medicines web-portal;
(g)appropriate communication by the marketing authorisation holder of relevant safety information to healthcare professionals and patients.
2.Where a marketing authorisation holder has subcontracted some of its pharmacovigilance tasks, it shall retain responsibility for ensuring that an effective quality system is applied in relation to those tasks.
All content is available under the Open Government Licence v3.0 except where otherwise stated. This site additionally contains content derived from EUR-Lex, reused under the terms of the Commission Decision 2011/833/EU on the reuse of documents from the EU institutions. For more information see the EUR-Lex public statement on re-use.
