Application may be made for a marketing authorisation for the parallel import of a medicinal product, if the original product already has a valid marketing authorisation in Finland. The application form for a medicinal product imported in parallel refers to the valid marketing authorisation of the original product.
The prerequisites for the application of a marketing authorisation for a parallel-imported medicinal product are laid down in the Finnish Medicines Agency Administrative Regulation Parallel Import of Medicinal Products.
In addition, the application must comply with the Finnish Medicines Agency Administrative Regulation Applying for and maintaining a marketing authorisation and registration for a medicinal product and the Finnish Medicines Agency Administrative Regulation Labelling and package leaflet for medicinal products.
An application for a marketing authorisation for a medicinal product for parallel import is made on a form that can be obtained from Fimeas web page. The marketing authorisation shall be applied by the parallel importer of the medicinal product (a natural person or legal person). The future holder of a marketing authorisation for a medicinal product for parallel import must, at the time of the application, hold an authorisation for wholesale distribution in Finland.
A marketing authorisation for parallel-imported medicinal products must be renewed on the authorisation holders initiative in accordance with the same provisions as the marketing authorisation for other medicinal products.
The European Medicines Agency (EMA) processes all applications which concern parallel distribution of medicinal products for which a marketing authorisation has been obtained through the centralised procedure.
- Laakso Merja Coordinator for Marketing Authorisations custom-phone email@example.com