The Parallel import policy document (MEB 14) has been clarified on a number of points, particularly regarding the following:
- It has been added to the introduction that, for centrally authorised products, an application for parallel distribution is handled by the EMA.
- It has been stated in the introduction that the parallel product receives the legal status of supply assigned to the Dutch reference product. Chapter 2.3 describes which documents should be submitted if the legal status of supply of the Dutch reference product has changed.
- Information has been added regarding the assessment framework for parallel products whose active ingredient is a complex biological active substance.
- For parallel products for which the Dutch reference product is no longer authorised, the SmPC of another medicinal product may henceforth serve as the guiding principle for keeping the package leaflet of the parallel product up to date. It has been clarified in the policy document that it is not intended to align the full text of the parallel package leaflet with the package leaflet of this other medicinal product.
- An instruction has been added for situations where the Dutch reference product has a Controlled Access Program (CAP) or a Controlled Distribution System.
- For situations where the parallel product and the Dutch reference product are not part of the same MRP/DCP, a declaration regarding the relationship between the proposed holder of the parallel marketing authorisation and the marketing authorisation holder of the medicinal product in the country of origin must henceforth be included in the application dossier.