A community marketing authorisation is issued for the marketing of a veterinary medicinal product that is authorised pursuant to the centralised procedure. This authorisation is, by definition, valid in all Member States.
Veterinary medicinal products marketed in one Member State may then also be marketed, independent from the marketing authorisation holder, in any other part of the community by a distributor (“parallel distributor").
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 community (in practice, the European Medicines Agency) and national authority (in the Netherlands, the MEB) must be informed that this parallel distribution is taking place. This is essential in order to:
- allow the European Medicines Agency to check whether the conditions of the community marketing authorisation are being met (such as the text on the label and package leaflet)
- allow the national authority to monitor the market (batch identification, pharmacovigilance, etc.) and supervise the market.
Application for parallel distribution
The EMA website describes the requirements that an application for parallel distribution must meet.
A letter can be sent to the MEB Agency, stating for which centrally authorised product you have submitted an application for parallel distribution to the European Medicines Agency.
As soon as the EMA notifies the MEB of its approval, you will receive a marketing authorisation number (REG NL) and the legal status of supply from the MEB. These are the same as the marketing authorisation number (REG NL) and the legal status of supply provided to the marketing authorisation holder. You must list both of these in the “Blue Box” on the packaging.
The approval for parallel distribution from the EMA states, among other things, which EU Member States the veterinary medicinal product may be procured from, the permitted pack sizes and in which EU Member States the veterinary medicinal product may be marketed (after re-packaging).
The EMA website contains additional information about parallel distribution, including the obligations of a parallel distributor after obtaining approval for parallel distribution, which includes:
- Annual reporting to the EMA about whether the veterinary medicinal product has been marketed.
- Amended labels and package leaflets must be submitted following dossier variations. If the parallel distributor does not meet the requirements, the approval will be given a so-called "dormant status".
- Packaging, labelling and package leaflet texts must be the same as the approved product text in the language of the destination country, as published on the EMA website.
The EMA Parallel Distribution Register contains the (veterinary) medicinal products that have been granted approval for parallel distribution.