Counterfeit Medicines

The Irish Medicines Verification Organisation (IMVO) is a new organisation set up to protect Irish patients from the threat of falsified medicines being supplied through legitimate channels.

Counterfeit medicinal products are now officially known as ‘falsified medicinal products’ under EU medicines legislation. Falsified medicines may contain ingredients which are of poor quality or in the wrong dose. As they have not undergone the standard quality, safety and efficacy checks that apply to all legitimate medicines, they could be harmful to patients who take them. As falsifications become more sophisticated, the risk that falsified medicines reach patients in the EU increases every year.

The HPRA, in partnership with Revenue’s Customs Service, An Garda Síochána and regulatory and law enforcement agencies worldwide, revealed in June 2016 that they had detained, in Ireland, 60,000 falsified/counterfeit and other illegal medicines worth €350,000 as part of the Interpol coordinated Operation Pangea IX. Globally, the total value of illicit medicines seized and detained during Operation Pangea IX was estimated at approximately US$ 53 million approximately.

New EU legislation (Directive 2011/62/EU - the ‘Falsified Medicines Directive’) was finalised in 2011 to introduce new harmonised, pan-European measures to prevent falsified medicines infiltrating the legal supply chain and ultimately from reaching patients. The new measures include:

  • Requirements for medicine packs to have an anti-tamper device (e.g. foil seal, breakable cap) and a barcode containing ‘unique identifiers’ (including a serial number) to enable the authenticity of the pack to be checked prior to dispensing.
  • A common, EU-wide logo to identify legal online medicines suppliers, making it easier to distinguish them from illegal operators. The Pharmaceutical Society of Ireland maintains the register of online retailers in Ireland.

Further EU legislation (Commission Delegated Regulation (EU) 2016/161) sets out the detailed technical requirements for unique identifiers and national databases or ‘repositories’ where they will be stored and set a deadline of 9th February for implementaion. The repositories referred in this legislation must be set up and managed by not-for-profit organisations funded by pharmaceutical manufacturers. The Irish Medicines Verification Organisation (IMVO) - has been established by the key players in the medicines supply chain in Ireland - pharmaceutical manufacturers, wholesalers, parallel distributors, and community pharmacists - as part of this EU-wide series of measures to tackle the growing problem of fake or ‘falsified’ medicines. www.imvo.ie