The new Veterinary Regulation (Regulation (EU) 2019/6) has already been in use for some time in all EU Member States. Directive 2001/82/EC has been withdrawn and replaced by this Regulation.

One of the key changes introduced by Regulation (EU) 2019/6 in relation to variations to marketing authorisations is the simplification of variation classification. Under the previous system, variations were classified as Type IA, Type IB, or Type II. This has now been replaced by a new two-category system:

• Variations Not Requiring Assessment (VNRA) include all variations that were previously classified as Type IA, as well as certain variations that were previously considered Type IB.
• Variations Requiring Assessment (VRA) comprise most of the variations previously classified as Type IB, together with all Type II variations.

Variations Not Requiring Assessment (VNRA)

Under the new regulatory framework, VNRA are defined in the Commission Implementing Regulation (EU) 2021/17, which lists all eligible variations, along with the applicable conditions and required documentation.

Process for Submitting a VNRA

• The change must be recorded in the Union Product Database (UPD) within 30 days of implementation.
• Required documentation, as specified in the Implementing Regulation must be uploaded directly to the UPD.
• No application form or Common European Submission Portal (CESP) submission is required.

• The authority will review and either approve or reject the variation.
• The decision will be communicated to the MAH and CMS via both the UPD and email notification.

Further guidance is available in the CMDv Best Practice Guide for Variations Not Requiring Assessment.

Variations Requiring Assessment (VRA)

Any change not listed in Commission Implementing Regulation (EU) 2021/17 must undergo assessment and is therefore classified as a VRA.

To support implementation, the CMDv and EMA have published a detailed classification guideline: Guidance on the classification of variations requiring assessment according to Article 62 of Regulation (EU) 2019/6.

While the structure and categorisation of VRAs resemble those outlined in the previous Commission Regulation (EC) No 1234/2008, the new framework introduces several important changes and refinements.

Classification of VRA Categories

VRA changes are grouped into the following chapters:

• E. Administrative changes
• F. Quality changes
• G. Safety, efficacy, and pharmacovigilance changes
• H. VAMF or, PTMF changes
• I. Changes of active substance(s), strength, pharmaceutical form, route of administration or food producing target species

Additionally, Z-categories have been created to cover:

• Variations not explicitly listed in the classification guideline
• VNRA-type changes where the conditions outlined in the Implementing Regulation are not fulfilled

Timelines for VRA Evaluation

The new guidance outlines three distinct assessment timelines for VRAs, designed to reflect the complexity and regulatory impact of each proposed change:

• Standard (S) – 60 calendar days
• Reduced (R) – 30 calendar days
• Extended (E) – 90 calendar days

Submission Guidance

Further guidance is available in the CMDv has developed a comprehensive Best Practice Guide: Best Practice Guide for Variations Requiring Assessment.

Recommendation for the Classification of Unlisted Variations

A special procedure has been established for requesting a recommendation on the classification of variations that are not included in either the Commission Implementing Regulation (EU) 2021/17 or the EMA/CMDv Guidance on Variations Requiring Assessment.

For comprehensive guidance on this new procedure, please refer to the CMDv guideline titled:
“Procedural advice for requests for the classification of variations not already listed in Commission Implementing Regulation (EU) 2021/17.