Protecting Your Health

How the Law Protects You

The Falsified Medicines Directive (FMD) is a new initiative to combat the growing problem of the sale of falsified and, as a result, ineffective or unsafe medicines, including online.

All medicine suppliers and manufacturers in the EU have to comply with detailed legislation to ensure medicine safety. However, unauthorised online pharmacies often supply products that have been sourced from outside this regulated supply chain. This means that, as consumers, we have to take care and be sure that we buy from the authorised source. That is the only guarantee that the medicines we take are effective and safe.

The FMD is working to clean up the supply chain, to ensure that customers know that the medicines they are buying are authentic.

1            Focusing on Falsified Medicines

The FMD is targeting the growing problem of falsified medicines, which it defines as medicine that misleads the purchaser by:

  • claiming that it contains an active ingredient that it does not;
  • containing potentially harmful ingredients that are not mentioned on the labelling;


Definition of Falsified Medicinal Products from the FMD

Any medicinal product with a false representation of:

a) its identity, including its packaging and labelling, its name or its composition as regards any of the ingredients including those added to bulk it up or change its form and the strength of those ingredients;

b) its source, including its manufacturer, its country of manufacturing, its country of origin or its marketing authorisation holder; or

c) its history, including the records and documents relating to the distribution channels used.

  • falsely claiming that it was manufactured or supplied in a particular country, factory or supply chain.
Last updated on 16/12/2020