What are ‘falsified medicines’?

Falsified medicines are fake medicines that pass themselves off as real, authorised medicines. The term ‘falsified’ refers to all forms of falsification, while the term ‘counterfeit’ specifically refers to an infringement of intellectual property rights. Falsified medicines may contain ingredients, including active ingredients, which are of poor quality or in the wrong dose – either too high or too low. As they have not been properly evaluated to check their quality, safety and efficacy, as required by strict EU authorisation procedures, they could be detrimental to the health of patients who take them. As falsifications become more sophisticated, the risk that falsified medicines reach patients in the EU increases every year.

To date, the only counterfeit or fake medicines detected in Ireland have been bought from illegal websites . However, there have been reports of fake medicines coming through legitimate supply channels in other countries, including the UK, and so the risk cannot be ignored. 

The EU Falsified Medicines Directive (Directive 2011/62/EU) introduced a number of measures to prevent falsified medicines infiltrating the legal supply chain and ultimately from reaching European patients. These include:

  • 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, the pharmacy regulator, maintains the Internet Supply List for Ireland.
  • Safety features on medicines packs to enable the authenticity of the pack to be checked prior to dispensing.

Most prescription medicines placed on the market since February 2019 are required to carry the following ‘safety features’:

  • An anti-tamper device (similar to what you would see on a milk carton) so the person supplying it can be sure it hasn’t been interfered with.
  • A special 2D barcode containing information about the medicine, known as unique identifiers, i.e. product code, batch identifier, expiry date and serial number (unique to each pack). In some countries, national reimbursement codes have to be included in the barcode, but this is not the case in Ireland. 

Products that are in scope of the FMD are generally all prescription products with a few exceptions as specified in the Commission Delegated Regulation (EU) 2016/161. While non-prescription products are largely not in scope, there are a few exceptions.