All medicines - including parallel-distributed ones - are strictly regulated by either national authorities or by the European Medicines Agency (EMEA) . Parallel distribution itself is a highly regulated and safety-conscious industry.
Parallel distributors who are members of the EAEPC operate in some of high quality, state of the art facilities, and are subject to regular inspections. All products marketed are approved by the relevant regulatory agencies, national or European. Parallel distributors employ pharmacists who, in close cooperation with the relevant regulatory authority, check every product according to common industry safety rules and operating procedures, which include recording batch numbers and expiry dates
Every parallel distributed product has in fact been approved twice:
- its producer obtains a marketing authorisation to place it on the market
- each parallel distributor requires an abbreviated marketing authorisation to sell it
In addition, any distributor that repackages or re-labels parallel distributed products has a manufacturing authorisation - similar to that needed by original manufacturers like Bayer, laxoSmithKline and Pfizer, employs a legally-responsible EU Qualified Person in accordance with EU regulations, and is subject to binding guidelines and periodic inspection from the regulators.
In practice, these operations ensure that parallel distribution helps to improve the level of safety in the European pharmaceutical market by providing an additional layer of product control.
This additional step in the supply chain ensures the medicine receives a second "quality control" check. Parallel distributors adhere to strict requirements which oblige them to destroy any "not-fit-for-sale" products and redundant packaging. They often find faulty products in the supply chain and quarantine the relevant medicine. Without this additional check these medicines would stay in the system and, ultimately, be dispensed to the patient.
But it is not only the regulators who review parallel distribution. Parallel importers are required by ECJ case law to make available to the original trademark owner (in the importing member state) the complete product sample before being allowed to market the product.
When problems with original product occur and are alerted by the manufacturer, parallel distributors perform all product recalls as efficiently, promptly and comprehensively as any other pharmaceutical distributor.
Parallel distribution is not an entry point for counterfeit medicines into the supply chain. The German Federal Ministry of Health and Social Security, in a written answer on 14 July 2003 to questions from German members of the Bundestag, responded:
"The Federal government does not know of any case where medicines with counterfeit contents were brought on the market by an importer since the introduction of imported medicines. The labelling and packaging of medicines is regulated in the relevant authorisation procedures and is under the surveillance of the responsible state authority. Deviations from the authorisation notice are not admissible and are subject to prosecution by the competent authority."
Other EU countries have similar records, including Sweden, where the Swedish Medical Products Agency says that there have never been any counterfeit products detected.