Regarding medicinal products for which „sunset clause“ may already be applied
The State Medicines Control Agency (SMCA) on based on market monitoring data has compiled the list of medicinal products authorized in the Republic of Lithuania which more than for three years had not been supplied to the Lithuanian market.
We hereby remind you that in accordance with Part 7 Article 14 of the Law on Pharmacy, in exceptional cases and in the interests of public health, the SMCA may not withdraw the validity of the marketing authorisation of the medicinal product which according to the Part 6 of this Article has not been supplied to the market.A Marketing Authorisation Holder seeking that the validity of marketing authorisation would not be withdrawn according to Part 6 Article 14 of the Law on Pharmacy has to submit to the SMCA a request with motivation on the basis of which the SMCA could accept the decision not to revoke the validity of marketing authorisation of the medicinal product.
SMCA upon receipt of a reasoned request from the Marketing Authorisation Holder or its representative by 10 May 2026, will consider whether not to apply the “sunset clause” to the specific medicinal product.. After that date the validity of marketing authorisations of the medicinal products listed in the table will be revoked.
Please submit reasoned requests by email to [email protected]