Parallel Distributors (PD) are no Marketing Authorisation Holders in the matter of EU law, they functionally take a comparable role. The parallel importer, or distributor, does not hold a Marketing Authorisation in the terms of the community law. Instead, the parallel importer is holder of specific product authorisations issued by national competent authorities in an abbreviated procedure. These national authorisations may be regarded under the respective national rules as « marketing authorisations » and he holder of such authorisations is, for example in Germany, a pharmaceutical entrepreneur comparable in legal status to any brand manufacturer.
In the case of centrally approved products, the product can by definition circulate in the entirety of the EEA market, when it enters parallel distribution, the EMA only issues a so called « distribution notice ».
In addition, PDs must repackage the product which they handle in order to comply with the labelling and other regulatory and trademark requirements of the destination market, and repackaging is a manufacturing activity regulated by GMP. The FMD correspondingly speaks of „manufacturing authorisation holders“ when it means on the one hand marketing authorisation holders and on the other parallel distributors.
For these reasons, parallel distributors connect to the EU Hub, comparable to other (normal) manufacturers. Therefore, EMVO kindly asks you, to fill in your legal entity with a minimum of one and a maximum of three relating licenses in Step 2.7 of the OBP Portal. A full list of all the relating licenses will be requested when entering the technical On-boarding.