HDA UK welcomes ‘risk-based’ wholesaler verification in Falsified Medicines Directive Delegated Regulation

10th February 2016 London: The Healthcare Distribution Association (HDA UK) welcomes the fact that ‘risk-based’ wholesaler verification has been enshrined in the Delegated Regulation of the Falsified Medicines Directive (FMD), which was published on 9th February 2016. This issue was the biggest area of concern for HDA member companies, as alternatives would have placed unnecessary burdens on the supply chain, including delays in being able to supply life-saving medicines speedily to patients. Thanks to the efforts of the European Healthcare Distribution Association (GIRP), with whom the HDA works closely in Brussels, this threat has now been averted. ‘End-to-end verification’ has now been mandated throughout the EU, with the manufacturers of prescription medicines having to place ‘safety-features’ on all their medicines sold in the EU and those who dispense to patients will verify these ‘safety features’ before patients receive them.

Following this publication, the UK now has three years to implement the Falsified Medicines Delegated Regulation, with all new measures having to be in place by early 2019. The HDA will utilise the technical expertise of its Responsible Persons’ Committee to ensure its members adhere to the highest standards when putting the required technical changes into place and will also coordinate with the wider supply chain representatives on the HDA Members’ Liaison Group to ensure the sector is aware of the business changes brought about by the Falsified Medicines Directive.

Martin Sawer, Executive Director of the HDA noted:

“It is good news to finally see the publication of the Delegated Regulation that sets the clock ticking in the UK and other EU member states. ‘Risk-based’ wholesaler verification was crucial in securing a credible and sustainable solution to secure the European medicines supply chain. We look forward to working with our supply chain partners to ensure the Delegated Regulation is implemented to the highest standards so that patients can continue to benefit from a safe medicines distribution sector.”

The HDA has been working alongside fellow supply chain stakeholders to agree the foundation of the UK’s Medicines Verification Organisation (UK MVO), which will manage the UK data repository and verification system. The UK’s MVO will be created this year and is aiming to select the IT database provider for the UK by the end of 2016.

The focus of all those working on FMD will now shift to the immense technical challenge that delivering a workable supply chain solution entails. Due to its importance to distributors and wholesalers, the HDA will be debating the topic with its members at a number of forthcoming events, including its Annual Conference on Thursday 16th June in London and Business Day on Thursday 17th November in Chester. 

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