A veterinary medicinal product that is authorised pursuant to the centralised procedure has a community marketing authorisation. This authorisation isvalid in all EU Member States. A distributor may also market a community marketing authorization. He can do this independently of the marketing authorization holder. This is called parallel distribution.
Parallel distribution applies to all community marketing authorisations. Do you intend to purchase, repackage and distribute a veterinary medicinal product that has a community marketing authorization from one or more Europese Member states – to one or more Member States? Then you must submit an application via the European Medicines Agency (EMA). Regulation (EC) No. 726/2004 describes the rules for (parallel distribution of) a centrally authorised medicinal product (CAP). Purchasing and distribution within the same Member State is not covered by parallel distribution.
In that case, the marketing authorisation holder for distribution remains unchanged and naturally also retains the responsibility under community law.The community marketing authorisation contains, by definition:
- all language versions of the labelling and the package leaflet;
- all available permitted package sizes.
The product information (SPC), and the conditions under which the product may be marketed, must not change. Although no further marketing authorisation is necessary, the the EMA must be informed that this parallel distribution is taking place. This is essential in order to allow the EMA to check whether the conditions of the community marketing authorisation are being met (such as the text on the label and package leaflet)
Application for parallel distribution
The EMA website describes the requirements that an application for parallel distribution must meet.
The parallel distribution approval of the EMA states:
- From which EU Member State you may import the veterinary medicinal product
- What the permitted packaging sizes are
- In which EU Member State you may market the veterinary medical product (after repacking)
The EMA website contains additional information about parallel distribution, including the obligations of a parallel distributor.
The EMA Parallel Distribution Register contains the (veterinary) medicinal products that have been granted approval for parallel distribution.