# 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 32: Updates of the risk management plan

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

1. Where the marketing authorisation holder updates a risk management plan, it shall submit the updated risk management plan to the national competent authorities or the Agency as appropriate. After agreement with the national competent authorities or the Agency as appropriate, the marketing authorisation holder may submit only the modules concerned by the update. If necessary, the marketing authorisation holder shall provide the competent authorities or the Agency with an updated summary of the risk management plan.
2. Each submission of the risk management plan shall have a distinct version number and shall be dated.

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Source: https://www.legislation.gov.uk/eur/2012/520/article/32 (the official version)
Page: https://openlegislation.uk/eu-regulation-2012-520/article-32
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.