Guidance for the application of Article 34 of Regulation (EU) 2019/6 - prescription status

Consideration of whether a product is subject to veterinary prescription or not is an outcome of product assessment and therefore requires detailed consideration. Regulation (EU) 2019/6 of the European Parliament and of the Council of 11 December 2018 on veterinary medicinal products and repealing Directive 2001/82/EC establishes, in Article 34, the legal framework for the classification of veterinary medicinal products. Whilst some of the provisions in Article 34 of Regulation (EU) 2019/6 are relatively clear-cut, some others will benefit from further elaboration. It is the intention of the guideline to provide clear guidance for the practical application of the provisions in Article 34 of Regulation (EU) 2019/6. To ensure a consistent implementation and a harmonised EU approach, the assessment principles for the various provisions of Article 34 of Regulation (EU) 2019/6 are laid out.

Keywords: VMP Regulation implementation, classification of veterinary medicinal products, veterinary prescription, non – Prescription Only Medicine – Veterinary (non-POM-V)

Current version

Guideline on the application of Article 34 of Regulation (EU) 2019/6

AdoptedReference Number: EMA/CVMP/273040/2022

Document history

Overview of comments received on CVMP guideline on NVR Art 34 for the classification of VMPs

Reference Number: EMA/CVMP/855384/2022

Concept paper on the elaboration of guidance for the application of Article 34 of Regulation (EU) 2019/6

Consultation dates: 25/03/2022 to 30/04/2022Draft: consultation closedReference Number: EMA/CVMP/65618/2022Summary:

Consideration of whether a product is subject to veterinary prescription or not is an important component of product assessment that merits detailed consideration. Article 34 of Regulation (EU) 2019/6 sets out criteria according to which veterinary medicinal products shall be subject to a veterinary prescription. While some of the provisions in Article 34 for the classification of veterinary medicinal products are clear-cut, some others require further elaboration. Therefore, the CVMP captured as an activity the development of guidance on the application of Article 34 of Regulation (EU) 2019/6 in the CVMP 2022 workplan. This concept paper has been prepared with the aim to develop guidance that ensures a consistent implementation and a harmonised EU approach in implementing Article 34 both for initial marketing authorisation applications and variations to change the legal status of a veterinary medicinal product.