As of July 2013 all valid parallel imports licensed by the Federal Office for Safety in Healthcare are published online in the Austrian Medicinal Product Index.
Please enter a suffix *P* in the field “MA number” to create a result list. The product information (SmPC and PIL) can be found at the Austrian reference marketing authorisation. Therefore a new search with the name of the medicinal product or the MA number without suffix can be done.
For example: MA number: parallel import 1-123456-P01 -> reference MA 1-123456
1. the parallel imported product is essentially similar to a already authorised reference product in Austria
For this purpose the rules of § 10c Medicines Act apply. Please use form Parallelimport (F_Z10). Form Parallelimport (F_Z10) can be found below in the Downloads section.
2. parallel distribution of centrally authorised medicinal products in accordance with Regulation (EC) No 726/2004
Notifications of parallel distribution is not under the responsibility of the Federal Office. For this purpose the procedures and rules of EMA shall apply.
For BASG FAQs click here.
For FAQs, related documents and further information of the EMA click here.
Please mind additional (national) requirements according to § 10c (4) and (5) of Austrian's Medicines Act.
Information about the Austrian "Pharmazentralnummer" (PZN) can be found here:
Dr. Franz Latzko
Wiedner Hauptstraße 63
Telefonnummer: +43 (0)5 90 900 -3367
- Form: Parallelimport (F_Z10)| 67 KBAntrag auf Genehmigung für den Vertrieb im Parallelimport05/09/2022