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 ».
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Therefore EMVO kindly asks you to fill in your legal entity which a minimum of one and a maximum of three relating licenses in step 2.7 of the OBP On-boarding Portal. A full list of all the relating licenses will be requested when entering the technical on-boarding.