Variations / Changes according to § 4 (4) TAMG
VNRA
VNRAs are listed, including the relevant conditions and documentation to be submitted, in Commission Implementing Regulation (EU) 2021/17 of 8 January 2021.
VRA
Changes to the terms of the marketing authorisations that are not listed in Commission Implementing Regulation (EU) 2021/17 of 8 January 2021 require an assessment.
Information on VRAs is provided in the EMA-CMDv 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.[GDC2]
Changes with regard to the legal status of supply of the veterinary medicinal product (prescription-only, pharmacy-only, product for general sale) are also VRAs. These may relate to the classification according to Article 34 of Regulation (EU) 2019/6 or the categorisation according to § 41 of the Veterinary Medicinal Products Act (Tierarzneimittelgesetz, TAMG).
Variations not already listed
Where a particular variation is neither listed in Commission Implementing Regulation (EU) 2021/17 of 8 January 2021 nor in the EMA-CMDv 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 CMDv in consultation with the EMA may deliver, upon request, a recommendation concerning the type of variation, the classification code and conditions and documentation requirements as relevant.
Guidance on the classification recommendation process is available in the Procedural advice for requests for the classification of variations not already listed in Commission Implementing Regulation (EU) 2021/17 or EMA/CMDv Guidance on the details of the classification of variations requiring assessment according to Article 62 of Regulation (EU) 2019/6. [GDC4]
The corresponding request form is also available under the above links.
Changes according to § 4 (4) TAMG
According to § 4 TAMG, veterinary medicinal products for certain pets can be exempted from the obligation to obtain a marketing authorisation. The holder of an exemption must notify the BVL, without delay, of any changes to the information required for the Union product database, the labelling or the package leaflet of the veterinary medicinal product.
In the event of a change in the following provisions, the holder of an exemption shall apply for a new exemption:
- the target species in which the veterinary medicinal product is to be used,
- the indication of the veterinary medicinal product,
- the route of administration of the veterinary medicinal product,
- the active substance
- the dosage,
- the pack size.
Further notes
VNRA are recorded in the Union product database (UPD) by the marketing authorisation holder.
VRA must always be submitted with the following documents:
- electronic variation application form, cf. https://esubmission.ema.europa.eu/eaf/
- documentation as applicable according to the relevant requirements (e.g. amended product texts, copy of the request letter of the amendment by BVL, updated expert reports, scientific documentation).
Further details can be found in the CMDv Best Practice Guide for variations requiring assessment as well as the EMA-CMDv 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, cf. https://www.hma.eu/578.html.