On 10 June 2026, representatives of the State Agency of Medicines (SAM) participated in the European Medicines Agency (EMA) information event “ePI Open Day”, dedicated to the implementation of electronic Product...
The State Agency of Medicines (SAM) announces that on June 12, 2026, amendments to Cabinet Regulation No. 803 “Regulations Regarding the Principles for the Determination of the Price of Medicinal Products” will take...
On 15 January 2026, the new Variation Guidelines (including updated variation classifications) came into force. All variations submitted after this date should follow the new guideline. If, unexpectedly, a MAH identifies...
To facilitate and speed up the permit issuance process, and following the example of other countries, the State Agency of Medicines informs that starting from January 1, 2026, import and export permits for controlled...
