The MHRA has published a consultation on several areas of the EU Falsified Medicines Directive (FMD). The consultation focuses on the safety features where the UK has flexibility within the Delegated Act on how to implement and the options available.
The UK medicines supply chain is complex and this consultation is looking primarily at how to accommodate the Directive where medicines are supplied to the public from places other than directly from pharmacies e.g. hospices, schools, prisons, dentists and vets. The consultation also looks at options for sanctions and enforcement and explains the implications of Brexit.
Aileen Bryson MRPharmS RPS Deputy Director for Scotland and Practice and Policy Lead commented:
“This consultation focuses on some of the detail where the MHRA has scope to change or amend the Delegated Act for implementation in the UK. Much of the FMD is already embedded in legislation with no “wriggle room“ and the work to try to get the Directive to a place suitable for the UK supply chain has been done already.
“The UK supply chain is complex. The Directive states that the new barcodes are scanned for authentication “as close to the patient as possible“ so the questions this time around are concerning where this should occur for places not defined as healthcare institutions such as paramedics, nursing homes, hospices and many more. The proposal that this is done at wholesaler level for all the organisations listed in Article 23 of the Delegated Act.
“The consultation also includes an impact assessment for businesses because no matter which option is decided on there will be costs involved. It also looks at the sanctions and how they should approach enforcement.”
RPS will be responding and would welcome any comments or answer any questions you can contact Aileen here.