Parallel import

Publication of parallel imports

As of July 2013 all valid parallel imports licensed by the Federal Office for Safety in Healthcare are published online in the Austrian Medicinal Products 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

Parallel import license

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 F_Z10.

 

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/AGES MEA's 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:

ARGE-Pharma
Dr. Franz Latzko
Wirtschaftskammer Österreich
Wiedner Hauptstraße 63
1040 Wien
e-mail: latzko@fcio.at
Telefonnummer: +43 (0)5 90 900 -3367
 

Created: 16.07.2009 | Page last modified: 07.02.2018

© Austrian Federal Office for Safety in Health Care
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