Applications for variations to marketing authorisations for veterinary medicines

Applications for variations are provided for in the Regulation (EU) 2019/6 of the European parliament and of the council.

Types of application

Variations are classified either as variations not requiring assessment or as variations requiring assessment. In the Commission implementing regulation (EU) 2021/7 the variations not requiring assessment are listed and classified. CMD(v) and EMA have published a classification guidance for variations requiring assessment.

Variations not requiring assessment (VNRA)

Variations not requiring assessment must be recorded by the MAH in the Union Product Database (UPD) within 30 days following implementation.

Variations requiring assessment (VRA)

Variations requiring assessment are divided into three types according to the timetable:

• Reduced timetable, VRA-R
• Standard timetable, VRA-S
• Extended timetable, VRA-E

Variations requiring assessment are classified in the guideline Guidance on the details of the classification of variations requiring assessment according to Article 62 of Regulation (EU) 2019/6 for veterinary medicinal products and on the documentation to be submitted pursuant to those variations.

The fee for variations requiring assessment depends on the timetable.

Transfer of marketing authorisations to a new holder

 

Applications for transferring a marketing authorisation to a new holder are national variation applications for which no application form is needed. The processing time for these applications is 120 days. There is a separate fee specified for transfers of marketing authorisations to a new holder.