Instructions for marketing authorisation holders
Responsibilities of marketing authorization holders in the area of pharmacovigilance are defined by the Law on Medicinal Products and Rulebook on the manner of collecting of data and reporting and monitoring adverse reactions to medicines for use in human medicine. In line with the Law on medicines, Guidelines on Good Pharmacovigilance Practice are applied in this area and they are available on the website of the European Medicines Agency (EMA).
Additionally, responsibilities of marketing authorization holders are more closely defined by the following instructions:
- Instruction on the manner of submitting the summary of PSMF (updated 1.6.2026.)
- Instruction on the manner of submitting ADR report (updated 13.12.2021.)
- Instruction on the manner of sending letters to health professionals (updated 13.12.2021.)
- Instruction on the manner of submitting periodic safety update report (updated 13.12.2021.)
- Instruction on the manner of submitting risk management plan (RMP) (updated 16.6.2025.)
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