Variations for veterinary medicines
A variation is a change to the terms of a marketing authorisation. Guidance is available from the European Medicines Agency (EMA) for marketing authorisation holders for centrally authorised veterinary medicines on the different types of variation procedure.
There are two types of variation under Regulation (EU) 2019/6:
- Variations not requiring assessment, which have minimal or no impact on the quality, safety or efficacy of the medicine, as listed in Commission Implementing Regulation (EU) 2021/17.
- Variations requiring assessment.
A number of historical variation procedures are no longer applicable because of changes in European law. They took place under Regulation (EC) No 1234/2008 and Regulation (EU) No 712/2012.
The names of these historical procedures are listed below, for reference:
- Type IA variation: a minor variation that only has a minimal impact, or no impact at all, on the quality, safety or efficacy of the veterinary medicinal product, and did not require prior approval before implementation (“Do and Tell” procedure).
- Type IB variation: a minor variation which was not a Type IA variation, a Type II variation or an extension.
- Type II variation: a major variation which was not an extension and which may have a significant impact on the quality, safety or efficacy of a medicinal product.
- Extension application: certain changes to a marketing authorisation considered to fundamentally alter the terms of this authorisation.
The outcomes of a number of these historical variation procedures, and references to them, are available on this website.