Your Variation Identification Agent for Post Approval Change Management Watch Via in Action
May 2026Australia has updated its regulatory framework for therapeutic goods, medicines, and medical devices following Brexit, introducing a new Mutual Recognition Agreement (MRA) with the United Kingdom effective from 01 January 2021.
The agreement supports continued certification and supply of medicines and medical devices between Australia and the UK while requiring compliance with updated regulatory processes.
For medical devices, UK Conformity Assessment (UKCA) certification is recognized for certain Australian manufacturers. From 01 December 2025, the UK is also recognized under Australia’s comparable overseas regulator arrangements.
The guidance highlights that UK Notified Body certificates are no longer valid in the EU, meaning manufacturers may need to update regulatory documentation and transfer certifications to EU-recognized bodies.
For medicines, changes to manufacturing sites now require updates to ARTG entries and GMP clearances to maintain compliance.
Australian sponsors are encouraged to review manufacturer evidence, submit extension applications where needed, and ensure uninterrupted market access for therapeutic goods post-Brexit.
Region: Australia
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