DOH EXPLAINS FMD…
The Falsified Medicines Directive (FMD) went live on 9 February 2019. At the time, PiF’s survey of pharmacists showed that no one had done anything to even begin the process. Now it’s serious…
Northern Ireland Protocol of the UK/EU Withdrawal Agreement (NI Protocol), NI is still having to comply with FMD even though the rest of Great Britain doesn’t.
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To date, there has been a ‘wait and see’ approach to FMD, with many pharmacy contractors not complying with it, but now that there is certainty, the Department of Health (DoH) is going to start insisting on full compliance.
To clarify matters, PiF contacted the DoH to clarifymatters for everyone and to ensure that everyonewas well aware of the implications of FMD.
What exactly is the law for pharmacies? The EU Falsified Medicines Directive (2011/62/EU) was adopted in 2011 to prevent the entry into the EU’s legal supply chain of falsified medicinal products.
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ince 9 February 2019, concerns over FMD have been more than overtaken by COVID-19, but, unfortunately, due to the
What support is offered by DoH and what issues are they currently trying to resolve? Since 9 February 2019, pharmacies were offered the opportunity to avail of grants at this time to purchase equipment to assist with compliance to this regulatory change.
There are currently no known short-term issues in relation to FMD as the UK and EU have agreed to a twelve-month pragmatic approach to the supply of medicines into NI from GB, including FMD requirements. During this period, medicines entering the UK will not be decommissioned from EU supply chain to enable end users in NI, such as community pharmacies, to meet their legal obligations.
What are the deadlines/grace period? The implementation of FMD came into effect from 9 February 2019 with no grace periods. From 1 January 2021, the NI Protocol came into force and the EU pharmaceutical regulatory
framework will therefore continue to apply in Northern Ireland. This includes FMD and the Delegated Regulation, meaning there is no phased-in approach for end users in NI and therefore community pharmacies in NI must continue to comply with FMD.
Will there be an inspection regime? FMD is incorporated within the current inspection regime by the Medicines Regulatory Group. During an inspection, pharmacy inspectors have been reviewing and assessing FMD compliance.
What are the penalties for non- compliance? Enforcement action is usually only taken when repeated non-compliance has been uncovered or when failure to comply with an improvement/ enforcement notice. Non-compliance can result in a fine and/or up to two years imprisonment as laid out in regulation 255A of the Human Medicines Regulations 2012. A referral to the Pharmaceutical Society of NI may also be considered for non-compliance.
NON-COMPLIANCE CAN RESULT IN A FINE AND/OR UP TO TWO YEARS IMPRISONMENT AS LAID OUT IN THE HUMAN MEDICINES REGULATIONS 2012
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