The Northern Ireland Protocol came into effect from 1 st January 2021 and the Falsified Medicines Directive continues to apply in Northern Ireland.

The Protocol requires that all organisations in Northern Ireland that handle or dispense prescription medicine, remain compliant with the Falsified Medicines Directive.

Organisations that handle and dispense prescription medicines include, but are not limited to:

  • Parallel Distributors
  • Marketing Authorisation Holders (MAHs)
  • End Users
  • Community Pharmacies
  • Hospital Pharmacies
  • GP Practices and Health Centres
  • Dispensing Doctors
  • Inpatient/Outpatient Clinics
  • Wholesalers

MAHs manufacturer and distribute prescription medicines to these organisations and upload Product, Batch and Pack data to the UKNI MVS via the EMVS Hub.

Software Suppliers must be registered with SecurMed via our IT Partner Arvato Systems GmbH Supplier portal. Their software must be developed using a specified Software Development Kit (SDK) and must meet the required standards the SDK defines. Software Suppliers and their software must be approved by SecurMed before their software can be used by End Users..