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On the 12 January 2016, the European Medicines Agency (“EMA”) published an overview of comments in response to a public consultation regarding a “Draft revision of EudraVigilance access policy for medicines for human use“.


EudraVigilance is a data processing network and management system for reporting and evaluating suspected adverse drug reactions (“ADR”) during the development, and in the post-marketing authorisation phase of medicinal products in the European Economic Area (“EEA”). It was launched in 2001 as a joint effort between the EMA and National Competent Authorities (“NCA”) to strengthen the conduct of pharmacovigilance in the EEA. EudraVigilance facilitates the process of risk management at several levels including all aspects of risk detection, assessment, minimisation and communication.

The EudraVigilance Access Policy is a definition of the overall principles for the provision of access to EudraVigilance data in line with the EU legal framework and the interest in use of the data among other stakeholders.

A public consultation regarding EudraVigilance Access Policy started on 4 August 2014 and concluded one year later with a final draft document titled “Collection of key information on medicines”. In September 2015, a final draft document was provided to the EudraVigilance working group for information. After the final draft document was agreed upon by the European Medicines Agency (EMA)’ Committee for Human Medicinal Products (“CHMP”) and the Co-ordination group for Mutual recognition and Decentralised procedures (“CMD-h”) it was adopted by EMA Management Board 17. December 2015.

These consultations were issued in response to criticism, after significant changes of the EudraVigilance Access Policy were made in August 2014.

Proposed changes draft revision of EudraVigilance access policy for medicines for human use

In light of the Draft revision of EudraVigilance access policy for medicines for human use, general public and professionals would have access to Individual Case Safety Reports (“ICSR”) data for all medicinal products subject to a marketing authorisation in the EU. Access would be made available by means of easy to use retrieval functions provided through EMA’s adrreports.eu portal.

Marketing authorisation holders (“MAH”) would also have access to defined ICSR data element sets in support of their signal detection, validation and other pharmacovigilance obligations. Academic professionals would also have access to ICSR data sets in support of their research activities and requests.

The draft document also provides that the World Health Organisation (“WHO”) Uppsala Monitoring Centre (“UMC”) would receive regular electronic data outputs for ICSRs originating from within the EEA.

Medicines regulatory authorities in third countries would also be entitled to obtain data outputs on an ad-hoc basis on the grounds of the same data elements as shared with the abovementioned WHO-UMC.

The document also underlines that technical and organisational measures would be adopted to protect processed data against unauthorised or unlawful access, disclosure, dissemination, alteration, destruction or accidental loss.

The data elements for ICSRs have also been reviewed and updated in line with the ISO ICSR standard and the ICH E2B (R3)/EU ICSR Implementation Guide.

Stakeholders’ comments

392 interested stakeholders provided feedback on the draft EudraVigilance Access Policy. All stakeholders’ comments were reviewed by the EMA and combined in the final document published on 12 January 2016.

Respondents to the public consultation made a number of comments in relation to the following changes:

– The EMA’s right to view any publication submitted to EudraVigilance database before submission. The EMA would have six weeks to provide revisions to “incorrect analyses, unsupported inferences, misleading statements or the protection of personal data must be addressed to the satisfaction of the Agency before submission for publication“;
– “A standard Agency disclaimer must be added to the manuscript. The Agency reserves the right to reword the disclaimer to the manuscript in cases of unresolved disagreement over the interpretation of the data. The manuscript or its conclusions must not be disseminated in any way without the disclaimer

At the date of this blog, the date by which the revisions to the EudraVigilance access policy for medicines for human use is unknown. We will, however, continue to monitor any developments in relation to this revision of EudraVigilance access policy for medicines for human use.