What is the company type?
Written by Tracy Slosse
Updated over a week ago

There are two company types:

  • 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 EU Hub.

  • The Parallel Distributor or Parallel Import company is an independent company purchasing medicines in one market and – after repackaging - placing these medicines on a different market (the market of destination) under a license obtained under its name from the National Commitment Authority (NCA) of the destination market (parallel import license) or of comparable permits issued by European Medicines Agency (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.

Did this answer your question?