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EXCLUSIVE: ‘No intention at this time’ to assess FMD impact on community pharmacy, says MHRA

By Léa Legraien

20 Jul 2018

The UK’s medicines watchdog has said it has ‘no intention at this time’ to publish an impact assessment on how the Falsified Medicines Directive (FMD) will affect community pharmacies.

The FMD is a series of anti-counterfeiting measures that will see pharmacists scan packs of medication before they are dispensed to verify their authenticity. It will come into force on 9 February in the UK.

The comments come after the Medicines and Healthcare products Regulatory Agency (MHRA) published an FMD impact assessment consultation for what are known as Article 23 providers on Monday (16 July).

The document looked at who should scan the products as well as the costs the different options for this could result in. However, community pharmacy was not mentioned in the document.


‘No legal flexibility’


An MHRA spokesperson told The Pharmacist on Wednesday (18 July) that it ‘has not published a UK-specific full impact assessment, and does not intend to publish one at this point in time’.

They added: ‘We are doing a focused impact assessment [on Article 23 providers] as we are only consulting on those areas where the UK has legal flexibility to make policy decisions.

‘Under the delegated regulation, pharmacies are required to decommission medicines and there is no legal flexibility available to the UK to make changes.’

Article 23 providers include:


  • People authorised or entitled to supply medicinal products to the public who do not operate within a healthcare institution or within a pharmacy
  • Veterinarians and retailers of veterinary medicinal products
  • Dental practitioners
  • Optometrists and opticians
  • Paramedics and emergency medical practitioners
  • Armed forces, police and other governmental institutions maintaining stocks of medicinal products for the purposes of civil protection and disaster control
  • Universities and other higher education establishments using medicinal products for the purposes of research and education, with the exception of healthcare institutions
  • Prisons
  • Schools
  • Hospices
  • Nursing homes


Community pharmacy costs still unknown


According to the UK’s FMD working group, community pharmacists will have to bear the costs of the barcode scanners, although it has not been able to confirm how much these might be.

In April, Sigma Pharmaceuticals Plc director Bharat Shah predicted that pharmacists could be forced to pay up to £3,000 for the scanners, hardware and software alone.

A National Pharmacy Association (NPA) spokesperson told The Pharmacist: ‘We are very concerned about the costs that may fall on community pharmacy as a result of FMD.

‘We and other pharmacy bodies have been raising this issue with government for a long time.’

For more information on FMD, click here.

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