Safety Features – Extension of the ‘Use & Learn’ Phase in Ireland until September 9th 2019

News Category: Regulatory news

Date: 08/05/2019

As outlined in our previous update in February, the Falsified Medicines Directive safety feature requirements came into effect on 9th February. 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 until 9th September 2019 to allow additional time for the system to stabilise. The situation will be reviewed again at that stage.  For more details, and for important updates for MAHs, manufacturers and wholesalers, see below

Extension of FMD Use and Learn Period, Ireland, May 2019

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