Parallel imports are original European supply. The products have been sourced in another country of the EU or EEA and fully adapted to the destination market. Safety of these medicines is fully ensured, as parallel traders are subject to the same regulatory requirements as the original manufacturers of branded or generic pharmaceuticals, and they must undergo regular inspections by the national competent authorities.
Parallel distributors must have an EU or EEA wholesale distributor license and apply internal supply and quality controls. This includes product verification, supplier verification and audits. For a company to get the license, it must meet the requirements set in the EU Good Distribution Practice guidelines that ensure that the quality and integrity of medicines is preserved in the supply chain. For companies that repackage products, compliance with Good Manufacturing Practice guidelines is also required.
With the introduction of the Falsified Medicines Directive (FMD), parallel imported medicines must carry both unique identifiers (2D barcodes) and anti-tampering devices, like all other medicines. Affordable Medicines Europe works together with regulators and stakeholders in the implementation of the Falsified Medicines Directive, rolling out, monitoring and developing this advanced end-to-end verification system to ensure that only safe medicines reach patient via the legal supply chain in Europe.
Affordable Medicines Europe is one of the five founding members of the European Medicines Verification Organisation (EMVO) that was founded in 2015 to ensure the functioning of the EMVS, whose mission is to ensure that the supply chains of medicines are free from falsified medicines. The other founders are representatives of the industry, the wholesalers and the pharmacists (EFPIA, GIRP, Medicines for Europe, and PGEU). You can read more about the functioning of EMVO from the organisation’s website.
Within EMVS and in its daily functions, Affordable Medicines Europe is committed to halt the entry of any counterfeit or falsified pharmaceutical products into the European market. The products imported by parallel importers must have a marketing authorisation and be obtained from authorised EU wholesalers or manufacturers in other EEA countries. The destinations of the medicines are always authorised wholesalers, registered pharmacies or other persons entitled to sell pharmaceutical products to the general public.
Affordable Medicines Europe’s members are not only dedicated to preserve the safety in the supply chain by blocking the entry of falsified medicines but frequently are also the ones who detect them and alert the authorities when counterfeit products circulate in Europe, also in situations of theft of medicines that might illegally circulate in the market after the theft. Because of their vast repackaging and relabeling experience, independent distributors are able to remove suspicious packages before they are put in the market and potentially harming patients. The difference between the original package and the falsified one is often very subtle, but parallel importers have experts who meticulously compare the packs with the original information provided by the marketing authorisation holder and report any possibility of counterfeit.
In addition to the requirements introduced by the Falsified Medicines Directive, all members of Affordable Medicines Europe must follow a strict and long-standing Code of Operational conduct, the Good Parallel Distribution Guidelines. These guidelines are Affordable Medicines Europe’s own code of conduct that every member of the association commits to. As an association, we also run our own Audit Scheme, in which members must comply with further requirements aimed at ensuring best practices in independent distribution of medicines.
