State Medicines Control Agency (SMCA) published a notice regarding medicinal products that may be subject to the “sunset clause.”

The agency compiled a list of medicinal products authorised in Lithuania that have not been supplied to the market for more than three years, based on market monitoring data.

Sunset Clause Application

According to Article 14 of the Law on Pharmacy, if a medicinal product has not been supplied to the market for a specified period, the validity of its marketing authorisation may be withdrawn.

However, in exceptional cases and in the interest of public health, the SMCA may decide not to revoke the marketing authorisation.

Request from Marketing Authorisation Holders

Marketing Authorisation Holders who wish to maintain the validity of their authorisation must submit a justified request to the SMCA.

This request should include sufficient justification to support a decision not to apply the sunset clause.

Submission Deadline

The SMCA will review reasoned requests submitted by Marketing Authorisation Holders or their representatives until 10 May 2026.

After this deadline, the marketing authorisations for the listed medicinal products will be revoked if no request is submitted or accepted.

Submission Method

Requests should be submitted via email to:
[email protected]

For more information: Regarding medicinal products for which „sunset clause“ may already be applied

Supporting Regulatory Processes

Regulatory requirements such as maintaining marketing authorisation validity and responding to provisions like the sunset clause require continuous monitoring and compliance with regulatory obligations.
Support in regulatory strategy and lifecycle management can be explored here:
https://www.baupharma.com/services-categories/regulatory-affairs/#Regulatory-affairs-services