Improving the
safety of medicines

Falsified Medicines Directive

Falsified medicines are 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; they may contain too much or too little of the active ingredient. This happens since they have not been properly evaluated to check their quality, safety and efficacy as required and directed by strict EU authorisation procedures. Thus, they could be detrimental to the health of people who take them. As falsifications become more sophisticated, the risk that falsified medicines reach patients in the EU increases every year.

Although falsified medicines have not been found to be common in Malta, there have been reports of fake medicines coming through legitimate supply channels in other countries, and so the risk cannot be ignored.