In this section the State Agency of Medicines (hereinafter – the Agency) publishes up-to-date information on the decisions made by the Agency of the granting of exemptions from the Sunset Clause.
The procedure for the granting of exemptions from the Sunset Clause is determined by Regulation No 376 of 9 May 2006, “Procedures for the Registration of Medicinal Products” (hereinafter – Regulation No 376).
In accordance with Sub-Paragraph 1253 of Regulation No 376 the State Agency of Medicines shall publish information regarding the decision not to apply the norm referred to in Sub-paragraphs 125.1 and 125.2 of this Regulation (Sunset Clause) for a period of one to three years, taking into account the application of the registration owner based on public health protection considerations, on the website without delay.
Additional information regarding the granting of exemptions from the Sunset Clauseis available on the Agency’s website here: Information on granting exemptions from the Sunset Clause.
Information regarding decisions made before 1 January 2023 can be found in Archive.
