The Council of the Eurasian Economic Commission adopted a decision of November 3, 2016 No. 87 on the approval of the rules of good practice for pharmacovigilance of the Eurasian Economic Union. Within the framework of these rules, a risk management plan should be formed. The risk management plan (hereinafter — RMP) contains information that must meet the following requirements:
a) determine and characterize the safety profile of the medicinal product;
b) indicate how the further characteristics of the safety profile of the medicinal product can be supplemented;
c) documentary evidence of the adoption of measures to prevent or minimize the risks associated with the use of the medicinal product, including an assessment of the effectiveness of these measures;
d) documentary confirmation of the fulfillment of post-registration obligations to ensure the safety of use introduced during registration of the medicinal product.
The preparation of a RMP (risk management plan) is a rather laborious task that requires appropriate skills, experience, qualified personnel. Therefore, often the preparation of an RMP (risk management plan) is made to order by individual organizations.
If the RMP is prepared for several medicinal products, a separate part should be provided for each of the medicinal products.
To comply with the requirements specified in clause 6.2.3.1 of these Rules, the information contained in the RSP, including if the preparation of the RSP (risk management plan) is made by third-party organizations to order, must include:
a) description of known and unknown information about the safety profile of the medicinal product;
b) an indication of the degree of confidence that the effectiveness of the drug, demonstrated in the target populations during clinical trials, will be achieved in daily medical practice, and documenting the possible need for efficacy studies in the post-marketing period;
c) an indication of the planned method for assessing the effectiveness of measures to minimize risks.
The RMP is a dynamically changing, independent document that must be updated throughout the entire life cycle of a medicinal product. For medicinal products that require a PSAR, some (parts of) the RMP modules can be used to compile a PSAR. The preparation of a RMP (Risk Management Plan) to order is currently a highly demanded service in the market for writing periodically updated reports on the safety of medicines.