Parallel importer alerts authorities to suspicious Celebrex
The product in question raised suspicions at a licenced UK parallel importer as part of the company's routine procedures. The importer, which is a member of the British Association of European Pharmaceutical Distributors (BAEPD), immediately alerted Pfizer, the MHRA and other parallel distributors across the European Economic Area. This led to the recall by the MHRA reproted in your online publication. Contrary to your report, however, the product was not packed for the Libyan market,but for the French market, bearing the French market authorisation number. Quite why a French product was destined for a non-Francophone country such as Libya is however open to debate. The BAEPD member company had been offered the product by an established licenced wholesaler in France. Why and how the product was diverted from Libya to France remains the subject of investigation.
This incident is evidence of both effective controls carried out by licenced parallel importers, and of successful communication and cooperation between parallel importers and the competent authorities.
At the same time, the incident also demonstrates that full-line wholesalers should be subject to the same stringent requirements as parallel importers when engaging in cross-border distribution, in particular the obligation to record incoming and outgoing batch numbers. Celebrex from this suspect batch was also imported into UK by full-line wholesalers - without holding the product-specific marketing authorisations, without performing incoming product inspections and without ensuring full product traceability. The medicines were then repackaged after importation in UK. If full-line wholesalers had to play by the sames rules as parallel importers, all affected packs would have been accounted for, and the recall initiated by MHRA unnecessary.
The BAEPD and its European umbrella group, the European Association of Euro-Pharmaceutical Companies (EAEPC) have repeatedly recommended to national regulators and to the European Commission in Brussels that all cross-border distribution of medicines within the EEA should be regulated under Good Manufacturing Practice (GMP), as is the case for our member companies.
We call on regulators and policymakers to act on our recommendation.
Richard Freudenberg, Secretary-General, BAEPD & President, EAEPC
