MHRA Issues Consultation on Implementing FMD Safety Features

17th January 2018 - Source: Charles Gladwin

The medicines regulator has opened a consultation on implementing the safety features that will be required for dispensed medicines under the European Falsified Medicines Directive.

The DDA will be responding to the long-awaited consultation and would like to ensure members’ views are heard. Members are being encouraged to give their views as part of the consultation process. A response form is included on the Medicines and Healthcare products Regulatory Agency announcement.

Evidence on aspects such as anticipated expenditure, IT upgrades, impact on staff time and training, and views about funding would be particularly welcome.

The FMD comes into effect on February 9 2019 “to ensure that medicines in the EU are safe and that trade in medicines is properly controlled.” As part of the process, medicines will need to have:

  • a unique identifier (a 2D data matrix code and human readable information) that must be scanned at fixed points along the supply chain
  • an anti-tampering device allowing verification of whether the packaging of a medicinal product has been tampered with

Under the proposals, the default position will be that the person supplying the medicine to the patient will have to scan the pack so that the product can be verified as a legitimate item and be decommissioned (ie noted on a Europe-wide list as having been dispensed/supplied, making the code number no longer viable).

The Medicines and Healthcare products Regulatory Agency is now seeking views on how these safety features should be implemented, and has produced a consultation impact assessmentlooking at the implications for all parties involved – manufacturers, distributors and dispensers.

It also looks at how certain categories of people supplying medicines might be exempted from the obligation to scan at the point of supply. The current proposal is not to exempt “healthcare institutions” or pharmacies.

“Article 3 of the Delegated Regulation lists a number of definitions including a ‘healthcare institution’ as meaning ‘a hospital, in-or outpatient clinic or health centre’,” says the consultation. “The UK has classed General Practitioners (GPs) and Dispensing Doctors as health centres and therefore healthcare institutions. However, to remain equitable to what pharmacies have to do, we would expect Dispensing Doctors to decommission as pharmacies.”

There are seven core questions in the consultation including: “Can you provide any additional evidence or comment on the existing impact analysis to develop the cost benefit analysis in the impact assessment?”

It also asks about allowing wholesalers to verify and decommission medicinal products on behalf of those categories of people and circumstances where the exemption is permitted. Another question is whether information in addition to the unique identifier should be allowed in the 2D data matrix code.

The DDA has already identified the FMD as a challenge to dispensing practice and last year highlighted a number of specific aspects that needed to be addressed.

In February, the UK FMD Working Group for Community Pharmacy issued a report covering “key assumptions about FMD, high level processes for incorporating authentication in to existing dispensing workflows, handling stock transition, what IT systems will need to deliver and implications for patient safety.”