Brexit: Health and Social Care inquiry

Pharmacovigilance: (World Health Organization): the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other drug- related problem. (See Section 1 below).

  • Legal basis of the EU QPPV: As defined by EU Directive 2010/84/EU and Regulation 1235/20101 and outlined within Module 1 of Good Pharmacovigilance Practices2. As a key leader in the PV system, the EU/EEA QPPV has a very important role for Market Authorisation Holders (MAHs)i (or medicines licence holders) with extensive personal accountabilities in the legislation described further in the three appendices with the key points summarised in section 9.

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