# 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), Article 30: Content of the risk management plan

Extent: E+W+S+N.I.

1. The risk management plan established by the marketing authorisation holder shall contain the following elements:
(a) an identification or characterisation of the safety profile of the medicinal product(s) concerned;
(b) an indication of how to characterise further the safety profile of the medicinal product(s) concerned;
(c) a documentation of measures to prevent or minimise the risks associated with the medicinal product, including an assessment of the effectiveness of those interventions;
(d) a documentation of post-authorisation obligations that have been imposed as a condition of the marketing authorisation.
2. Products containing the same active substance and belonging to the same marketing authorisation holder may be subject, where appropriate, to the same risk management plan.
3. Where a risk management plan refers to post-authorisation studies, it shall indicate whether those studies are initiated, managed or financed by the marketing authorisation holder voluntarily or pursuant to obligations imposed by the national competent authorities, the Agency or the Commission. All post-authorisation obligations shall be listed in the summary of the risk management plan together with a timeframe.

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Source: https://www.legislation.gov.uk/eur/2012/520/article/30 (the official version)
Page: https://openlegislation.uk/eu-regulation-2012-520/article-30
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.