26-04-2024
Regarding medicinal products for which „sunset clause“ may already be applied
The State Medicines Control Agency on the ground of 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 here with remind that following Part 7 Article 14 of the Law on Pharmacy in the exceptional cases and for the interests of public health the State Medicines Control Agency 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.
Marketing Authorisation Holder seeking that the validity of marketing authorisation would not be withdrawn according to Part 6 Article 14 of the Law on Pharmacy has to submit to the Agency a request with motivation on the basis of which the Agency could accept the decision not to revoke the validity of marketing authorisation of the medicinal product.
The State Medicines Control Agency after receipt of motivated request from Marketing Authorisation Holder or its representative by 24 May 2024 will consider whether not to apply „sunset clause“ for specific medicinal product. After that date the validity of marketing authorisations of the medicinal products listed in the table will be revoked.
Motivated requests please send by email: [email protected]