Posted by Michael Wonder on 08 Feb 2019
New safety features for medicines sold in the EU
8 February 2019 - As of 9 February 2019, most prescription medicines and some over-the-counter medicines for human use supplied in the European Union are required to have a unique identifier (a two-dimension barcode) and an anti-tampering device on their outer packaging.
The anti-tampering device is a safety feature that shows whether the packaging has been opened or altered since it left the manufacturer, thereby ensuring that the content of the packaging is authentic.
These mandatory safety features are a key measure of the Falsified Medicines Directive which is part of the EU’s strategy to strengthen the security of the supply chain of medicines. The safety features are implemented through a delegated regulation that comes into application on 9 February 2019. It will apply in all EU/EEA Member States, except for Greece and Italy, who have until 2025 to update their already existing tracking systems.
