uputstva za nosioca dozvole - Rules

Responsibilities of marketing authorization holders in the area of pharmacovigilance are defined by the Law on medicines 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:

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