When a medicinal product is imported from other European countries, it is called parallel import. In the case of parallel imports, the medicinal product is marketed in Belgium by an importer who has not been designated by the holder of the original authorisation. Often, the same version (or practically the same version) of this medicinal product has already been authorised or registered in Belgium. This is known as the reference medicine.
The term "import" is used to refer to intra-Community trade, since it refers to trade between Member States of the European Union or between States participating in the Agreement on the European Economic Area (EEA).
The trade is "parallel" because it takes place outside the distribution network established by the manufacturers or by the original distributors, and in most cases in parallel.
Conditions, compilation and processing of files
The conditions for parallel imports, the compilation of a parallel import file and its processing are described in the Royal Decree dated April 19, 2001 (French version) regarding parallel import of medicines for human use and parallel distribution of medicines for human and veterinary use.
Further information can also be found in the document "Guide on how to request a parallel import authorisation, renew a parallel import authorisation, and submit a variation of a parallel import authorisation".