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FMD rules exemption advice published

Flexibility introduced for certain healthcare institutions

January 4th 2019

Tagged: Dispensary guidance news FMD

By Ailsa Colquhoun

The Government has clarified the circumstances in which a healthcare institution is exempt from its obligations to verify and decommission medicines under the Falsified Medicines Directive.

Guidance makes clear that dispensing GPs are considered a healthcare institution under the FMD.

The clarification, contained within the response to an FMD consultation, includes the following exemption, as long as all following conditions are met:

a) the person authorised or entitled to supply medicinal products to the public obtains the medicinal product through a wholesaler belonging to the same legal entity as the healthcare institution

b) the verification and decommissioning of the unique identifier is performed by the wholesaler that supplies the product to the healthcare institution

c) no sale of the medicinal product takes place between the wholesaler supplying the product and that healthcare institution

d) the medicinal product is supplied to the public within that healthcare institution.

Further details on proposed sanctions for non-compliance with the FMD are also given in the consultation response, published by the Government.

These include the introduction of statutory ‘enforcement notices’ for breaches of the requirements around supplying medicines to the public. These must be issued before criminal proceedings can be considered.

DDA advice remains that dispensaries should not purchase FMD compliant systems until DDA/BMA negotiations on IT funding have concluded.

The consultation response also provides guidance for dispensaries handling medicines that will pass through the system in the initial period following implementation which may be in scope of the new requirements but may not yet exhibit the new packaging, and it will not be immediately obvious to those asked to scan these products whether they should be scanned or not (ie, they were placed on the market before or after 9 February 2019).

This sets out the need for organisations such as dispensaries to:

  • prevent unnecessary disruption to the supply of medicine
  • have clear operating procedures in place
  • empower individuals to make judgment calls that they would feel able to justify.

Other aspects covered by the consultation response include:

  • Extending the scope of the unique identifier or tamper-evident packaging
  • Addition of a national reimbursement number
  • Allowing additional information to be added to the 2D barcode.