New pharmacovigilance legislation, July 2012

In July 2012, new pharmacovigilance legislation come into effect across the EU as a result of changes set out in:

Regulation (EU) No1235/2010 (external link)

Directive 2010/84/EU  (external link)

The changes introduced by the Directive will be transposed into UK law in the Human Medicines Regulations 2012, which also consolidate nearly all other UK medicines legislation. In February 2012, we published a formal consultation on our proposals for transposition (MLX 374). The MHRA’s response to this consultation presents a summary of the responses we received to MLX 374 and key issues raised. It also highlights significant changes we made in response:

Public consultation (MLX 374): Transposition of Pharmacovigilance Directive 2010/84/EU - The MHRA’s responsePDF file (opens in new window) (50Kb)

The legislation will be underpinned by an EC Implementing Measures Regulation and a series of modules on Good Pharmacovigilance Practice.

Find out more about the implementation of the legislation in the introduction page below. 

We have developed a series of questions and answers (Q&As) (below), from the MHRA’s perspective, to support marketing authorisation holders (MAHs) with the introduction of the new legislation. Information is grouped into six themes. This information will be developed over the coming weeks and months, and MAHs are advised to keep an eye out for updated information.

A Q&A document on the new Pharmacovigilance legislation is also available from the European Medicines Agency (EMA) (external link)

For further questions or comments specifically regarding MHRA’s implementation of the new legislation, email Please note, however, that not all enquiries will be answered directly and may instead be used to develop further questions and answers on this webpage. The EMA also has an email for enquiries regarding the legislation:


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This page provides information about the new pharmacovigilance legislation.
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European database of suspected adverse drug reaction reports

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The European Medicines Agency (EMA) has launched a new European database of suspected adverse drug reaction reports. The information initially published on the website relates to approximately 650 medicines and active substances authorised through the centralised procedure. Within a year, the EMA aims to also publish suspected side-effect reports for common drug substances used in nationally-authorised medicines.
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Watch our video explaining the impact of the new legislation

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Questions and answers

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This section provides questions and answers about the new pharmacovigilance legislation.

2012 pharmacovigilance legislation changes: implications for marketing authorisation holders

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This page provides information on the implications of the new pharmacovigilance legislation for marketing authorisation holders.
Page last modified: 16 July 2013