EMA Publication regarding New Safety Features for Medicines sold in the EU

15 febbraio 2019 – As of 9 February 2019, new safety features for medicines sold in the EU are being implemented through a delegated regulation under the Falsified Medicines Directive (2011/62/EU). Accordingly, most prescription medicines and some over-the-counter medicines for human use supplied in the EU 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. Moreover, a new reporting form is available on EMA’s website to be used by pharmaceutical companies when notifying EMA of any suspected falsification of their centrally authorised medicines (see https://www.ema.europa.eu/en/news/new-safety-features-medicines-sold-eu).