Announcement of extension to FMD ‘use and learn’ period in Ireland

Decision to extend ‘use and learn’ phase

On Saturday 09th February the European Commission’s Delegated Regulation (EU) 2016/161 on Safety Features on Medicinal Products for Human Use, came into operation across Europe. The Delegated Regulation supplements the Falsified Medicines Directive 2011/62/EU, by setting out detailed rules for the safety features appearing on the packaging of medicinal products for humans. During this time, the system in Ireland has been in ‘use and learn’ phase to ensure the continuity of safe supply of medicines to patients while all parties gained a better understanding of the new system. The national Safety Features Oversight Group comprising the Irish Medicines Verification Organisation (IMVO), the Department of Health, the Health Products Regulatory Authority (HPRA), the Pharmaceutical Society of Ireland (PSI), the Health Service Executive (HSE) and the Private Hospitals Association (PHA) has been closely monitoring progress since go live on 09th February. Taking all factors into account, the group has decided that the use and learn period will be further extended until 09th September 2019 to allow additional time for the system to stabilise. The situation will be reviewed again at that stage.

For more information please see the IMVO website: