EU member states have until 9 February to implement the final part of the Falsified Medicines Directive (FMD), though the British Medical Association says that only 15% of products are expected to be compliant.
The prospect of a hard Brexit is also raising questions about whether the UK will have access to the EU repository of centralized data, which would create difficulties for UK stakeholders in verifying the unique identifier (UI) on each medicine’s package.
The UK’s Medicines and Healthcare products Regulatory Agency noted last month
that if such a hard Brexit were to occur, the legal obligation to follow the FMD would not apply to products within the UK, though the agency says it would still allow products with FMD safety features so long as they are also in compliance with UK packaging requirements.
Most recently, however, the MHRA has published guidance
for wholesalers, parallel import license holders and a link to guidance related to Medicines Homecare.
Similar to the US track and trace system, under the Directive, which was adopted in 2011, all new packs of prescription medicines placed on the European market will have to bear a UI in the form of a 2D data matrix (barcode) and an anti-tamper device (ATD).
The UI comprises: a product code to identify at least the name of the medicine, the common name, the pharmaceutical form, the strength, the pack size, and the pack type; a serial number; a batch number; and an expiration date and the national reimbursement number (which is not applicable in the UK). The UI also must be printed on the pack in a 2D data-matrix code and be printed in a way in which the information can be read by a human.
“Manufacturers will place the safety features on the packaging of prescription only medicines and upload the data into the European repository system prior to placing the product on the market. The 2D barcode will need to be scanned at various points in the supply chain to verify that it is an ‘authentic’ medicine,” the MHRA said.
And when a medicine is supplied to a patient, the unique identifier must be scanned from the FMD system, to prevent any duplication of a legitimate identifier for use on a falsified medicine, which will be checked against data in the national repository.
Also, beginning Friday, a new reporting form
is available on EMA’s website to be used by pharmaceutical companies when notifying EMA of any suspected falsification
of their centrally authorised medicines.
"The new form is specifically for notifications related to suspected and confirmed falsified medicines and suspicious offers, and is
an important step in streamlining processes for reporting and investigating falsifications of centrally authorised medicines," EMA said.
The British Medical Association explained to its members in December that only 15% of products are expected to be compliant from February and if a no-deal Brexit scenario were to occur, “it is unlikely that the Directive would come into effect in its current form.”
The Dispensing Doctors’ Association (DDA) also warned its members recently that, “All practices are reminded that the transition to FMD-compliant packaging will be gradual, and that only a small proportion of packs in the supply chain will be FMD compliant in the immediate aftermath of the Directive coming into force.”
The DDA also explained how the MHRA, which is responsible for taking action against noncompliance, “has made it clear to the DDA that it will take a pragmatic approach, given that it is now impossible that all GPs (and many other contractors in the NHS) will be compliant by 9 February. This is also the case in many other EU countries.”
How other countries respond to noncompliance remains to be seen. The European Commission noted in a letter to stakeholders in October 2018 that noncompliance “constitutes a violation of EU law,” although penalties are levied according to member state legislation.
MHRA: Implementing the Falsified Medicines Directive: Safety Features
FMD update – letter from the DDA CEO
Updated on 2/8/19 with information from EMA published Friday.