Falsified Medicines Directive Deadline Looms

Peter Russell

February 05, 2019

The Dispensing Doctors' Association (DDA) advised members not to worry about the 9th February deadline for implementing the Falsified Medicines Directive (FMD), amid reports that less than half of UK pharmacies would be compliant in time.

Community pharmacies are required to implement the FMD regardless of Brexit.

With just days to go, SecurMed, the UK Medicines Verification Organisation, said it was currently experiencing a high volume of requests which were being dealt with on a first come first served basis. Credentials would be issued in 10 to 15 working days, it said.

SecurMed declined to update Medscape News UK on the latest registration figures but its general manager Jerome Bertin told the Pharmaceutical Journal last week that "less than half" of UK pharmacies would have registered, and had their credentials issued, by the time the legislation comes into force.

The FMD will introduce harmonised measures across the EU to fight medicine falsifications and ensure that medicines are safe. Measures include:

  • Obligatory safety features – a unique identifier and an anti-tampering device – on the outer packaging of medicines

  • A common, EU-wide logo to identify legal online pharmacies

  • Tougher rules on the import of active pharmaceutical ingredients

  • Strengthened record-keeping requirements for wholesale distributors

Prosecutions for Non-Compliance 'a Last Resort'

The Medicines and Healthcare products Regulatory Agency (MHRA) will be responsible for enforcing FMD compliance. Serious and persistent breaches could lead to criminal prosecution.

In its response to a consultation on FMD implementation published in December last year, the MHRA indicated that the Government would introduce statutory 'enforcement notices' for breaches of the requirements which would be issued before any prosecutions were considered. It said that should give "further reassurance that criminal prosecution would only be considered as a last resort".

In a letter addressing members' concerns, Matthew Isom, chief executive of the DDA, wrote: "The MHRA has the responsibility for taking the decision whether to take action against a contractor for non-compliance.

"The MHRA 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 9th February."

The government response to the FMD consultation also acknowledged that if the UK left the EU with no deal in place, the UK would disengage from the EU central data hub and it would probably mean that FMD compliance was no longer possible.

In that event, the MHRA said: "In the interests of public safety, we will evaluate the options around a future national falsified medicines framework."

If a Brexit transition deal was ratified by the UK, the FMD would also apply during the transition period from 29th March 2019 to 31st December 2020. The UK and the EU would also be committed to exploring how it could continue after that.

EMA Relocation

In other Brexit-related news, The European Medicines Agency (EMA) announced it would move from London to the Netherlands in early March.

Preparations for the move have been taking place from temporary premises in Amsterdam.

The EMA said the physical move from Churchill Place, London, was scheduled for 1st March, with staff operating by extended teleworking ahead of their migration to the Spark building in Amsterdam Sloterdijk between 11th and 15th March.

The EMA's permanent location will be in Amsterdam Zuidas.

A focus on core activities during relocation "should allow the Agency to cope with the anticipated staff loss of 25% of its total workforce", the EMA said.

Healthcare in the EU After Brexit

The Department of Health and Social Care (DHSC) updated healthcare advice for UK residents visiting the EU, the European Economic Area (EEA), and Switzerland in the event of a 'no-deal' Brexit.

It said the European Health Insurance Card (EHIC) issued by the UK would remain valid until 29th March but, depending on decisions made by individual countries, might not be valid after that date.

The DHSC said UK citizens should ensure that their foreign travel health insurance had the necessary healthcare coverage to ensure they could get any treatment they might need. They should declare any pre-existing conditions on their application form and ask their GP for advice about how to manage their condition when abroad.

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