Please be informed that due to planned technical work, some users may experience temporary disruptions when accessing the website of the State Agency of Medicines over the next few days. The work is being carried out...
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...
Applications for available time slots for DCP (with Latvia acting as RMS) and national authorisation procedures in 2027 will open on 15 July 2026. As the Agency continues to receive a significant number of requests to...
Ensuring the availability of medicines, monitoring their safety, and supporting the development of new treatment options in Latvia were the State Agency of Medicines (SAM) key priorities in 2025. During the past year...
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...
Please be informed that due to technical issues, today after 20.00 the website of the State Agency of Medicines may experience disruptions. Our specialists are actively working to restore the website’s full functionality...
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...
