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
How does the Falsified
Medicines Directive tackle this threat?
A requirements for medicine packs to
carry specialsafety features in the
form of 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 theregister of online retailers in Ireland.