How safe is it?

All medicines - including parallel-traded ones - are strictly regulated by either national authorities or by the European Medicines Agency (EMEA) .

Every parallel traded product has in fact been approved twice - its producer obtains a marketing authorisation to place it first on the market and then each parallel trader requires an abbreviated marketing authorisation to sell it. In addition, any trader that repackages or re-labels parallel trade has a manufacturing authorisation, employs a legally-responsible EU Qualified Person, and is subject to Good Manufacturing Practice regulations and periodic government inspection.



Of course, any medicine has a potential to cause unwanted side effects as well as beneficial effects, but no case of damage to patient health from medicines merely because they are in parallel trade form has ever been reported.

The European Court has played a key role in establishing and regulating parallel trade. The most important case to establish the regulatory position arose in the Netherlands in the early 1970s - the de Peijper case. This clarified the fact that Member States could not block imports, except in very specific circumstances.