Applications for remaining time slots for DCP (with Latvia acting as RMS) s in 2027 will open on 4 August 2026 – January 1 slot, July – 1 slot, September – 1 slot, October – 1 slot. The Agency has reviewed the...
The CMDh has agreed to delete the requirement to provide cover letters for type IA variations, starting from 1 July 2026. The following guidance documents have been updated to reflect the change: Requirements on...
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...
Due to a significant increase in changes submitted within already approved DCP time slots, applications for available time slots for the assessment of medicinal product authorization applications for 2027 will be opened...
Dear Clients of the State Agency of Medicines, We sincerely thank you for your continued cooperation and for the valuable feedback you provide each year on the work of the State Agency of Medicines (the Agency). We...
To better accommodate applicants’ preferred submission dates, to improve transparency of information and to optimise the Agency’s time and resources management, future applicants are advised to request time slots for...
