News

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...

Draft EC guidelines on the details of the various categories of variations and operation of the procedures

26.06.2025.

Following the amended Variations Regulation No 1234/2008 (amended by Commission Delegated Regulation (EU) 2024/1701) applicable since 1 January 2025, the European Commission has now published a draft version of the new...

The Amended Variations Regulation No 1234/2008 enter into force on 1 January 2025

20.12.2024.

Please be advised that the amended Variations Regulation No 1234/2008 (amended by Commission Delegated Regulation (EU) 2024/1701) enter into force on 1 January 2025. Key changes concerning the preparation of variation...

Updated: Starting from January 1, 2025, changes in the procedures for declaring medicinal product prices will take effect

20.12.2024.

We would like to inform you that on July 23, 2024, amendments to Cabinet Regulation No. 803 of 25 October 2005 "Regulations Regarding the Principles of Pricing of Medicinal Products" (hereinafter - the Amendments) were...

On submission and approval of Risk minimization educational materials and Direct Healthcare Professional Communications at the State Agency of Medicines

06.08.2024.

Information for marketing authorisation holders The State Agency of Medicines (SAM) has published documents translated into English, which refer to the submission and approval of Risk minimization educational materials...