Classification of Type “C” Variations – Safety Variations, Efficacy Variations, Pharmacovigilance Variations

The State Institute for Drug Control (SÚKL) hereby informs marketing authorisation holders of changes in the classification of certain Type C variations, in particular those whose classification, prior to the entry into force of the new classification guideline applicable as of 15 January 2026, had been determined in accordance with Article 5 of Commission Regulation (EC) No 1234/2008 on the examination of variations to the terms of marketing authorisations for medicinal products for human use. The classification of these variations is now directly included in the list of variations in the classification guideline, and all of the variations listed below are classified under category C.3:

• Changes to the Summary of Product Characteristics (SmPC), labelling and/or package leaflet (PL) of medicinal products for human use intended to implement the outcome of a procedure relating to the assessment of a Periodic Safety Update Report (PSUR) or a Post-Authorisation Safety Study (PASS), or the outcome of an assessment carried out by the competent authority pursuant to Articles 45 or 46 of Regulation (EC) No 1901/2006, shall be classified as variations from category C.3.
• Changes to the SmPC, labelling and/or PL of medicinal products for human use intended to implement the outcome of a signal assessment procedure within the framework of a recommendation of the Pharmacovigilance Risk Assessment Committee (PRAC signal recommendation) shall be newly classified as variations from category C.3.
• Changes to the SmPC, labelling and/or PL of medicinal products for human use in accordance with the Core SmPC or based on the assessment of an Urgent Safety Restriction (USR) shall be classified as variations from category C.3.

General rules for the submission of specific variation types within the given category:

Type IA_IN variation – Variations for which the implementation of the approved wording does not require the submission of additional supplementary information and does not require further regulatory assessment (official translations have been approved and may be incorporated into the existing texts without further modification).

Type IB variation – Variations for which the implementation of the approved wording requires further regulatory assessment (e.g. where official translations have not yet been approved).

Type II variation – Variations for which new additional data must be generated, substantiated and submitted by the marketing authorisation holder.

Further information may also be obtained in the document “Q&A LIST FOR THE SUBMISSION OF VARIATIONS ACCORDING TO COMMISSION REGULATION (EC) No 1234/2008” available on the CMDh website.