Preparation of Risk Management Plan (RMP) for a specific medicinal product usually is the responsibility of the Qualified Person Responsible for Pharmacovigilance (QPPV) and its team. Thus, QPPVs and their team’s should be familiar with legislation requirements for RMP preparation in different regions. Within this article, we will concentrate on the Eurasian Economic Union (EAEU) and identify specific conditions of EAEU countries as well as to try to understand the expectations of Competent Authorities in this region.
The EAEU currently units five countries from the Commonwealth of Independent States (CIS) region (1) and has its Good Pharmacovigilance Practices (GVP) (2), which is fully implemented and mandatory in Russia, Belarus, Armenia and Kyrgyzstan. Kazakhstan however, despite the fact of being a member of EAEU, currently has not fully implemented EAEU GVP. Other countries of the CIS region have national legislation of Pharmacovigilance based on EU GVP modules in general.
Module V: Risk management systems of EU GVP version 2 came into effect on 31 March 2017. The new template of RMP became mandatory to use for all RMP submissions on 31 March 2018, and it is very comprehensive with a lot of template text, especially for generic applications (3). However, Marketing Authorization Holder (MAH) having Marketing Authorization in EU is not able to submit RMP for EAEU countries without an update. EAEU legal requirements for RMP are based on EU format for RMP revision 1.
Currently, some of the CIS region countries (e.g. Ukraine) accept RMPs on EU-RMP template revision 1. Thus, EU MAH needs to review only the new information for the period between rev. 1 and rev. 2 of RMP templates. However, some other Competent Authorities (e.g. Belarus) have fully implemented requirements of EAEU GVP, which has specific demands for RMPs, even for generic applications which are the simplest.
The hugest differences between EU RMP template rev. 1 and EAEU RMP template for generic applications are requirements to fill Part II: Module SVI and Part II: Module SVII.
Modules SVI and SVII of RMP Part II require detailed description and additional analysis of „Additional requirements for the safety specification“ in the fields of the potential risk of overdose, the transmission of infectious agents, abuse and illegal use, medication errors, etc. and „Identified and potential risks“ including food-drug, drug-drug interactions and pharmacological class effects.
EAEU Competent Authorities expectations on information details are quite high. Therefore the QPPV, which is preparing RMP, should be ready for additional sources review, information collection from scientific literature, experience (e.g. PSUR) and analysis based on safety concerns.
Despite the dossier application type, Part V, „Risk minimization measures“ of RMP, has to be properly referenced to local Summary of Product Characteristics (SmPC) and Patient Leaflet (PL). Therefore, a native speaking person should review RMP before submission.
The main points you need to pay attention while preparing RMP for generic application in EAEU country are these:
- RMP template is based on the EU format for RMP revision 1. However, it may contain specific subsections e.g. „Specific aspects of paediatric use“ or „Predicted post-authorization use“.
- Part II: Module SVI and Part II: Module SVII are mandatory parts to be filled.
- The sources for filling above mentioned RMP fields may be used from the experience of MAH (e.g. PSUR) or referenced to scientific articles or other databases.
- A native-speaking person should review RMP before submission at least for the correct references to SmPC and PL.
Preparation and adaptation of Pharmacovigilance documents to local requirements may be quite a challenge for QPPV and its team. However, knowledge of local legislation requirements and practice makes these processes simple and smooth, and is the primary key to success.
If you want to get more information about the RMP preparation for EAEU and CIS region, contact us!
Ada Stelmakiene, MPharm, PhD
Senior Pharmacovigilance Specialist (EU-QPPV)