As of the 1st of April, 2017, the legislation of the Federal Service for Supervision in the Health Care Sector ("Roszdravnadzor") dated February 15, 2017 No. 10711, came into force, which approves the procedure for pharmacovigilance earlier described GVP of EAEU (Eurasian Economic Union) - Here.
The main highlights of the legislation are:
- Provision of the EAEU QPPV (QPPV) who must reside in one of the 5 member states (RU, BY, KZ, AM, KY) and there can be only 1 EAEU QPPV in each PHV system of MAH. In addition to the appointment of QPPV, the authorized bodies of the member states may require the appointment of the local contact person for PV at the national level, subordinated to the EAEU QPPV (in countries where the product is marketed). LQPPV can perform functions of QPPV.
- Submission of periodic aggregate reports with the following schedule to follow from the date of the first registration:
- Every 6 months for the first 2 years
- Once per year in the next 2 years
- After that, every 3 years
- ICSR submission:
- In case of marketed product, non-serious adverse events
- Within 15 days from date of the receipt of the minimum criteria for the case
- In the next 15 days any other information gathered on the case which can state any risk benefit profile of the product for the population
- In case of a product undergoing clinical trials
- In case of death cases and serious adverse events within 7 days with minimum information about the case
- The rest of the information on the case in the next 15 days including the 7 days above.
- All other cases – 15 days
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