Parallel importation marketing authorisation

A company can apply for a marketing authorisation for parallel importation of a veterinary medicinal product from one of the other Member States of the European Economic Area (EEA). This veterinary medicinal product must be virtually identical to the veterinary medicinal product for which a marketing authorisation has been granted in the Netherlands.

The requirements that apply to parallel importation of immunological veterinary medicinal products differ from the requirements that apply to pharmacological veterinary medicinal products.

This is stated in Article 3.14 of the Veterinary Medicinal Products Decree. The price of a veterinary medicinal product might be lower in the other member state, making it economically attractive to market the product in the Netherlands via parallel importation.

Different rules apply for parallel importation of immunological and pharmacological veterinary medicinal products. These can be found in the document Information for the processing of applications for a marketing authorisation for parallel importation. Please read this document before filling in the application form.

Parallel distribution

Information about parallel importation of veterinary medicinal products that have obtained a (European) marketing authorisation via the centralised procedure of the European Medicines Agency (EMA) can be found on the page about parallel distribution.