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General | Onboarding Process - OBP Organisation Type, General Explanation
General | Onboarding Process - OBP Organisation Type, General Explanation
Updated over a week ago

EMVO is not in the position to define the certain organisation type of an OBP.

This is solely the responsibility of the On-boarding Partner (OBP). However, as EMVO tries to provide as much support as possible, you can find the definitions of an Original Pack Manufacturer (OPM) and a Parallel Distributor (PD) below:

The Original Pack Manufacturer is a pharmaceutical company holding a marketing authorisation (MA) and is placing medicines on a given market. In the context of batch release the company uploads product codes and pack data into the EMVS.

The Parallel Distributor or Parallel Import company is an independent company purchasing medicines in one market and โ€“ after repackaging - placing these medicines on a different market (the market of destination) under a license obtained under its name from the NCA of the destination market (parallel import license) or of comparable permits issued by EMA for centrally approved medicines (EMA parallel distribution notice).

Parallel distributors must repackage the product, which they handle in order to comply with the labelling and other regulatory and trademark requirements of the destination market; this constitutes (partial) manufacturing and is subject to a manufacturing authorisation.

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