EU Falsified Medicines Directive Consultation
We need your views on how this Directive should be implemented.
Have your say by Completing a consultation form
What is the EU Falsified Medicines Directive
The NPA has worked hard to influence this European Directive, seeking to minimise the burden of regulation on members, whilst recognising the goal of improving patient safety. With the three year clock to implementation likely to start in early 2015, we really need to get down to practicalities.
We will work with Government, regulators, Pharmacy Voice and other pharmacy bodies and PMR suppliers to ensure the optimum implementation for our members.
Requirements of the Directive
The final requirements of this Directive will not become clear until the European Commission has published detailed “Delegated Acts”. This is likely to take place in early 2015. From the information we have to date, the following appears likely:
- The vast majority, if not all, prescription only medicines will display a 2D barcode.
- Some higher-risk over the counter medicines will also carry the barcode.
- This barcode will contain a unique serial number, a product code, a batch number and expiry date.
- There will be a requirement to scan the barcode at some point before the product reaches the patient, in order to authenticate it with the database
- Medicines will also carry a tamper evident seal
- The cost of running the databases will be met by the manufacturers
- The source of the funding for pharmacy costs (for example, a scanner, software upgrade and staff costs) has not been confirmed. It is our view that Government should cover this cost as it is imposing this additional regulatory burden
- The databases will contain a considerable volume of pharmacy data
- The database will probably be overseen by supply chain stakeholders (ie, representatives of wholesalers, manufacturers and pharmacy)
- Parallel traders will have to operate within the system
From discussions with members to date, we have heard many that are enthusiastic about the potential opportunities to make the most of the barcode. For example, it may be possible to use the scan as an additional accuracy check in the dispensing process. The system could also provide an alert to prevent an expired or recalled medicine from being dispensed. Many see the pressure that will be created by this system to adopt Original Pack Dispensing as another important opportunity for pharmacy.
Yet we know that many members are more concerned about the potential burden of this new system. The volume of regulatory and administrative requirements has been increasing year on year – despite the Government’s promise of a one-in-one-out policy. There is without a doubt a risk that this will increase workload in pharmacy.