100 days to FMD – NPA support
01 Nov 2018
Community pharmacies are being urged “not to delay preparations” as the deadline for the EU’s Falsified Medicines Directive (FMD) fast approaches with only 100 days to go from today.
The NPA is helping its members to prepare by providing detailed advice, which includes a webinar and arranging favourable prices for members, on FMD hardware and software.
The relevant NPA dispensing standard operating procedures (SOPs) will also be amended to support members to be FMD ready.
Gareth Jones, Head of Corporate Affairs at the NPA said: “Just because we don’t know everything doesn’t mean pharmacies can’t do anything to get ready. The NPA will be working hard in the weeks ahead to provide as much information on FMD as possible in a bid to help members get prepared. With only 100 days to go, we are advising members to start planning now and not to delay preparations. While Brexit creates uncertainty it won’t stop FMD coming live on 9 February. We do however advise caution around long term contracts due to the uncertainty.”
FMD, which comes into force on 9th February 2019, requires the packaging of medicines to have a 2D-barcode containing the pack’s unique identifier and an anti-tampering device, both of which must be checked at various points in the supply chain. For each pack, pharmacies will have to check the integrity of the anti-tampering device and scan the 2D barcode to mark the pack as decommissioned (e.g. dispensed) in the national database.
FMD requires you to have a system in place by this date. It makes sense to plan in advance how you will comply. We would advise our members to:
- Familiarise yourself with FMD regulations by reading The Way Forward, available at fmdsource.co.uk
- Ask your PMR supplier what solution they are offering, but look at standalone systems as well.
- Consider workflows, and where scanners can be sited.
- Procure a system. Look out for contract length and whether there are exit clauses.
- When you know which system you are going to be using, you will be able to register with SecurMed UK. This process, as of 31 October, has now gone live.
- Update your SOPs (NPA are updating templates) and train staff accordingly.
For more information go to www.npa.co.uk/fmd