The procedure for not applying Sunset Clause is determined by Regulation No 376 of 9 May 2006, “Procedures for the Registration of Medicinal Products” (hereinafter – Regulation No 376).
Additional information about non-application of Sunset Clause is available on the Agency’s website here: Information on the non-application of Sunset Clause.
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.
Information on the decisions made by the Agency regarding non-application of Sunset Clause, starting in January 2023.
Information regarding decisions made before 1 January 2023 can be found in Archive.
