A risk management plan (hereinafter – RMP) is a detailed description of the risk management system that is part of the registration dossier of a medicinal product. The RMP must contain a non-confidential part intended for publication for the public, namely the RMP summary.
Pursuant to paragraph 9 of Chapter 4 of Section V of the Procedure for Pharmacovigilance approved by MoH order of December 27, 2006 No. 898 (as amended by MoH order of September 26, 2016 No. 996): the RMP summary is posted on the Center's website.
Publication of the RMP summary is another step toward increasing transparency and improving public access to information on medicinal products, as required by pharmacovigilance legislation.
After the RMP is approved by the Center within the registration, re-registration, or variation procedure, in order to publish the RMP summary for the public on the Center's website, the RMP summary must be sent within 30 calendar days in PDF format together with a cover letter to the Center's e-mail address: rmppublic@dec.gov.ua.
Regarding previously approved RMPs whose RMP summaries have not been published on the Center's website, please send the summary of the latest approved version of the RMP for publication on the Center's website to the e-mail address indicated above.
Recommendations for completing the letter on publishing the RMP summary on the Center’s website are available at the link
Recommendations for preparing the RMP summary when compiling an RMP are available at the link
