Naudingos nuorodos
Legislation of the "grace period"

In order to create conditions for the uninterrupted supply of medicinal products to the market of the Republic of Lithuania, the postponement of the implementation of changes to the conditions of the registration certificate (hereinafter - Changes) is legalized in Lithuania (except for cases related to the safety of medicinal products).

For that purpose, the order of State Medicines Control Agency under the Ministry of Health of the Republic of Lithuania no. 1A-233 “On the sale of packages of medicinal products” (24th of March, 2011) had been changed. After legalizing the proposed changes, marketing authorisation holders will have the opportunity to smoothly and continuously supply medicinal products to the Lithuanian market in packages labelled in the Lithuanian language with Lithuanian package leaflets.

The practice of postponing the implementation of changes will significantly reduce the administrative burden of marketing authorisation holders - after each change approval, they will not be asked to submit a report on the quantities of batches and packages of the medicinal product on the market of the Republic of Lithuania and/or produced and released on the market of the Republic of Lithuania before the conditions of the registration certificate of the medicinal product were changed. The practice of delaying the implementation of changes is also applied in other EU countries.

You can find the current version of the order by clicking here.