Risk Management Plan (RMP) for a generic medicinal product

Risk Management Plan (RMP) for a generic medicinal product

Poster

Nikolay Avramov, Sava Ognyanov, Kalina Andreevska
Faculty of Chemistry and Pharmacy, Sofia University "Saint Kliment Ohridski", Bulgaria

Introduction: Medicinal products are authorized for use on the basis that in the indicated indications, at the time of authorization, the risk-value balance is assessed as positive for the target population. However, some of the ADRs will be discovered and characterized afterwards. The aim of the RMP is to document the risk management system (RMS) which is required to identify, characterize, and minimize important risks for a medicinal product. Aim: The purpose is to investigate the legislative framework and current guidelines related to the preparation of a Risk Management Plan (RMP), and more precisely – what are the specifications for the preparation of an RMP for a generic medicinal product. Method: Document analysis and content analysis were used. Results: The risk management plan prepared by the MAH should contain the following elements: Identification or characterization of the medicine’s safety profile; Guidance on how to continue characterizing the safety profile of the relevant medicine; Documentation of the measures to limit or minimize the risks associated with it; Documentation of the obligations of the MAH after the MA is granted. Conclusion: While a reference medicine’s RMP should include all parts, for a generic one some of the parts can be omitted. Parts 1, 3 and 6 include all items, but in Part 2 many of the sub-parts may be left blank depending on whether the original product has an RMP and what the safety hazards are. The same applies to part 5. Part 4 can be omitted completely (with a few exceptions).
Keywords: RMP, risk management plan, medicinal products, safety profile