According the the MHRA the counterfeit product entered the British market through parallel market imports from France. The MHRA noted in its alert that the European Medicines Agency (EMEA) has allowed 40 UK parallel market distributors to supply this product to the British market but did not clarify if this counterfeit product entered the market through one of these parallel market distributors.

Parallel medicines and health care products may legally be sold in the parallel market within the European Union. Britain recognizes two forms of parallel trade in such products based on the authorizing agency. Parallel distributed products have a marketing authorization issued by the EMEA and parallel imported products have a marketing authorization issued by the MHRA. In both cases the repacking and relabelling are inspected by the MHRA but the importation and/or distribution takes place outside the original manufacturer’s supply chain.