The Global Language of Business

Extension of FMD Use and Learn Period

Published: 3 September 2019
From: Department of Health

Extension of FMD Use and Learn period Ireland beyond September 2019

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 9th February. Taking all factors into account, the group has decided that the use and learn period will be further extended to allow additional time for the system to stabilise and to ensure that everyone is ready when it becomes mandatory to investigate and close out all alerts before supplying the packs. The use and learn period will end on a phased basis, and a detailed plan as to how this will be done, including dates, will be published at the end of September.

In the meantime, pharmacies, hospitals, wholesalers and manufacturers/MAHs are asked to continue following the instructions given to them when the use and learn period was last extended in May -

Please see full details provided in the below document;

Source:  Department of Health