News

Changes in the Issuance of Import and Export Permits for Controlled Narcotic and Psychotropic Substances and Medicines in Latvia

08.01.2026.

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...

Booking of time slots for DCP (Latvia as RMS) and national authorization procedures will commence in the second half of 2026

16.12.2025.

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...

Survey of the clients of the State Agency of Medicines

07.11.2025.

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...

Time slot allocation tool for DCP (LV as RMS) and national marketing authorisation procedure

03.11.2025.

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...

Strongly recommended use of web-based Human variations electronic Application Forms (eAFs) for non-CAPs

01.10.2025.

24 September 2025 EMA launched the human variations web-based electronic Application Form (eAF) for optional use for non-CAPs* in February, and recommended use in May. From 29 September 2025, the use of web-based eAF is...

Guidance on the application of the revised variations framework

26.09.2025.

Following the revision of the Variation Regulation applicable since 1 January 2025, the European Commission (EC) has now adopted and published the final version of the EC guidelines on the details of the various...

As of 16 August, Marketing Authorization Certificates are published on the SAM website

19.08.2025.

On 16 August 2025, amendments to Cabinet Regulation No. 376 of 9 May 2006, “Procedures for the Registration of Medicinal Products,” adopted on 12 August 2025, entered into force. The amendments are intended to simplify...

Information for Marketing Authorisation applicants

08.07.2025.

We kindly remind applicants, when preparing responses to requests related to national marketing authorisation procedures, to observe the following: please submit a summary of responses both in PDF format under Module 1...

Ensuring Safe and Effective Medicinal Products: 2024 in Review

27.06.2025.

In 2024, as in previous years, the State Agency of Medicines of Latvia (SAMLV) has remained steadfast in its mission: to ensure the availability of safe, effective, and high-quality medicines and medical devices for the...