Recommendations for preparing the Risk Management Plan summary

Information on publication of the Risk Management Plan summary for the public

The risk management plan (hereinafter – RMP) is a detailed description of the risk management system, which is part of the registration dossier of a medicinal product.

The PSUR may be prepared in accordance with the structure given in Annex 14 to the Pharmacovigilance Procedure approved by MoH order of 27 December 2006 No. 898 (as amended by MoH of Ukraine order of 26 September 2016 No. 996) (hereinafter – the Pharmacovigilance Procedure), or another structure containing modules, parts and sections similar to those set out in Annex 14 to the Pharmacovigilance Procedure, including information on risk minimization measures, the PSUR summary, and the pharmacovigilance plan.

If the PSUR concerns more than one medicinal product, vaccine, or tuberculin, a summary is prepared for each medicinal product, vaccine, or tuberculin.

The RMP summary should be submitted:

• for all registration applications, except where submission of an RMP is not provided for;
• for PSUR updates in the post-registration period.

The RMP summary must be updated to reflect any important changes in the RMP and to be consistent with other parts/modules of the RMP.

If the RMP is prepared in English, the RMP summary must be submitted translated into Ukrainian.

The translation of the RMP summary must be an accurate Ukrainian translation of part VI of the approved RMP in English, avoiding omissions and/or additions of sentences, terms or paragraphs.

The translation of the PAR summary must be of high quality. This applies not only to the conformity of the translation with the original, but also to the stylistic and grammatical correctness of the use of specialized medical terminology.

In addition, automatic translation should be avoided, in which a program takes the source text and, without human intervention, generates text in the target language, for example in Google Translate; in this way it is often impossible to achieve a high-quality translation by translating the English text word for word.

If the text contains references to literature and the applicant considers it necessary to include references in this section, they must be presented in full rather than in abbreviated form, since an ordinary citizen has no opportunity to consult the information presented in the corresponding annex to the public assessment report. It is also necessary to avoid using abbreviations in the text; it is better to use the full wording or provide an explanation, since the target audience of the summary of the public assessment report is the general public.

The RMP summary must be in Ukrainian, without headings or footers related to the general document, and without the “Confidential” stamp.