A wholesale distributor can apply for a marketing authorisation for parallel trade in a veterinary medicinal product originating from another Member State of the European Economic Area (EEA) on the condition that this veterinary medicinal product is identical to a veterinary medicinal product for which a marketing authorisation has been issued in the Netherlands.
Article 102 of the Veterinary Medicinal Products Regulation describes parallel trade in veterinary medicinal products. Parallel trade is a new term in the Veterinary Medicinal Products Regulation. It was previously referred to as parallel import.
The pricing for a veterinary medicinal product could be lower in another Member State. It could therefore be economically appealing to bring the product to market in the Netherlands through parallel trade.
What requirements must be met in order to obtain an authorisation for parallel trade?
If you are a wholesale distributor and wish to bring a veterinary medicinal product from another EEA Member State to the Netherlands or vice versa via parallel trade, you will need to fulfil the requirements set out in Article 102, paragraphs 1, 2, 5 and 6 of the Veterinary Medicinal Products Regulation. These are:
When applying for a marketing authorisation for parallel trade in a veterinary medicinal product, we recommend that you refer to the following guidance: Verkrijgen en onderhouden van een vergunning voor parallelhandel in een diergeneesmiddel (Obtaining and maintaining marketing authorisation for parallel trade in a veterinary medicinal product).
This document describes and explains:
- The statutory provisions governing parallel trade laid down in Article 102 of the Veterinary Medicinal Products Regulation (Regulation (EU) 2019/6) and Article 2.5 of the Veterinary Medicines Regulations 2022;
- the case law of the Court of Justice of the European Union;
- All the information given in the CMDv Best Practice Guid (BPG) for parallel trade in veterinary medicinal products.
If you are able to fulfil all the requirements, you can apply for a marketing authorisation for parallel trade in a veterinary medicinal product.
You can apply for an authorisation-, a variation- or withdrawal of an existing parallel trade authorisation by using the form ‘Application form for an authorisation-, a variation- or withdrawal of an existing parallel trade authorisation’. You can also apply for the withdrawal of a parallel import license using this form.
You can add attachments to this form, including:
- a MS Word version of the European form prepared by the CMDv. This CMDv form contains some overlapping questions. The questions that have already been answered in the application form do not need to be filled in again in the CMDv form.
Information has been included in the Verkrijgen & onderhouden van een vergunning voor parallelhandel in een diergeneesmiddel guidance.
If you have any questions, please contact with the Veterinary Medicinal Products Unit.