Falsified medicines are fake versions of genuine medicines that fall short of the usual high standards required. These are potentially dangerous to patients for the following reasons:
- they may contain low quality active ingredients, or incorrect doses
- they may be deliberately or fraudulently mislabelled as to identity or source
- they may have fake packaging or the wrong ingredients.
Increasing sophistication on the part of manufacturers of falsified medicines has raised concerns about the risks they present. This is being addressed at EU level under a new regime, based on the Falsified Medicines Directive, to tackle the presence of these fake medicines on the market.
The final element of this reform comes into effect 9 February. As explained in our earlier blog, the new requirements will introduce two different safety features for medicinal products. These are:
- a unique identifier (a 2D data matrix code and human readable information) which will be placed on medical products that can be scanned at fixed points along the supply chain
- tamper evident features (anti-tampering devices) on the pack.
Implementation in the UK comes in the form of a series of amendments to the Human Medicines Regulations 2012. The changes cross-refer to the EU Delegated Regulation giving specific details of the required safety features.
Those affected include marketing authorisation holders, but also other groups such as manufacturers, wholesale dealers and parallel importers. Failure to comply with the new scheme will lead at first to enforcement notices requiring compliance within specified periods. Non-compliance with an enforcement notice can amount to a criminal offence, punishable by a fine or prison sentence of up to two years.
MHRA guidance on how different stakeholders can achieve compliance with the regime is available here.