CMDh/HMA: New Update of the Q&A List on Variations

A new version (Rev. 62) of the "Q&A - List for the submission of variations for human medicinal products according to Commission Regulation (EC) 1234/2008" was created in May 2024 and published on the HMA (Heads of Medicines Agencies) website. General topics regarding variation procedures and their submissions for human medicinal products are listed and answered in this document.

The new version of the Q&A catalogue now includes the following question and its answer:

3.32. How should a change to update the SmPC section 5.1 to include EUCAST breakpoints be submitted?

Answer:
The Guideline on the evaluation of medicinal products indicated for treatment of bacterial infections (CPMP/EWP/558/95) indicates that a link to the EUCAST breakpoints published on EMA's website should be included in the SmPC section 5.1. For this purpose a heading and text to be inserted in section 5.1 of the SmPC in all EU languages can be found on EMA's website under "Evaluation of medicinal products indicated for treatment of bacterial infections - Scientific guideline". If no upcoming variation is planned the change can be applied for as a type IA variation under category C.I.z with reference to the article 5 recommendation "Change(s) in the SmPC, labelling or package leaflet of human medicinal products in order to adapt to a recommendation of a competent authority, e.g. a Core SmPC, following the assessment of an Urgent Safety Restriction etc.". In cases where the SmPC wording has to be adapted the change should be submitted as a type IB variation under category C.I.z.

No further changes or updates have been made.

The new version of the Q&A-List for the submission of variations for human medicinal products according to Commission Regulation (EC) 1234/2008" - with and without change tracking can be found on the HMA website.