Article 31: Summary of the risk management plan

1.   The summary of the risk management plan to be made publicly available in accordance with point (c) of Article 106 of Directive 2001/83/EC and Article 26(1)(c) of Regulation (EC) No 726/2004 shall include key elements of the risk management plan with a specific focus on risk minimisation activities and, with regard to the safety specification of the medicinal product concerned, important information on potential and identified risks as well as missing information.

2.   Where a risk management plan concerns more than one medicinal product, a separate summary of the risk management plan shall be provided for each medicinal product.