| Author (Corporate) | European Commission |
|---|---|
| Series Title | COM |
| Series Details | (2016) 498 final (8.8.16) |
| Publication Date | 08/08/2016 |
| Content Type | Policy-making, Report |
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In the European Union medicinal products for human use are subject to strict testing and assessment of their quality, efficacy and safety before being authorised either at Member State or EU level. Once placed on the market they continue to be monitored through pharmacovigilance activities. Pharmacovigilance, as defined by the World Health Organisation (WHO), is ‘the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other drug-related problem’. Some side effects or ‘adverse reactions’ may not be seen until a large number of people have in real-life use received the medicine. It is therefore vital that the safety of all medicines is monitored throughout their use in healthcare practice. The EU legal framework of pharmacovigilance for medicinal products for human use is provided for in Regulation (EC) No 726/2004 and Directive 2001/83/EC. The legislation was amended in 2010 and 2012. Article 29 of Regulation (EC) No 726/2004 and Article 108b of Directive 2001/83/EC require regular reporting on the performance of pharmacovigilance tasks by the European Medicines Agency (EMA) and the Member States respectively. This report and the accompanying Staff Working Document describe the activities of the EU’s networked and collaborative system for monitoring and controlling the safety of human medicines and is focused on activities since the start of operation of new legislation in 2012 until the end of 2014, but also includes information on some tasks and processes initiated up to July 2015. |
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| Source Link | http://eur-lex.europa.eu/legal-content/EN/TXT/?uri=COM:2016:498:FIN |
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| Subject Categories | Business and Industry, Health |
| Countries / Regions | Europe |
