Brexit
As of 1 January 2021, the UK is no longer in the European Union Single Market and Customs Union. Transitional arrangements, which had been in place since early 2020, have been superseded by a new Mutual Recognition Agreement (MRA).
The implications for therapeutic goods supplied in Australia are outlined below.
End of transitional arrangements
The UK regulator, the Medicines & Healthcare products Regulatory Agency (MHRA), released Guidance for industry and organisations to follow from 1 January 2021 includes information on importing and exporting medicines, devices and clinical trials that may be relevant to Australian sponsors.
Medical devices
On 24 December 2020, a post Brexit deal was agreed between the European Union (EU) and the United Kingdom (UK), but this did not include mutual recognition in respect of medical device certification. Consequently, certificates issued by UK Notified Bodies ceased to be recognised in the EU after 31 December 2020.
The MHRA issued advice on the new approach for medical device assessment and marking at Regulating medical devices in the UK, including transitional arrangements.
At this stage, the UK is not recognised under TGA's comparable overseas regulator arrangements for medical devices, with the UK currently considering longer term options for ongoing regulation of medical devices. This is not expected to cause any practical issues given the two UK conformity assessment bodies (formerly notified bodies) - BSI UK and SGS UK - are also operating as notified bodies in the EU (BSI Netherlands, SGS Belgium and SGS Finland) and so in practice are likely issuing both CE and UKCA certificates for products. If manufacturers or sponsors do experience any issues please contact the TGA.
This will be reviewed as details of UK plans for ongoing regulatory arrangements are released.
Mutual Recognition Agreement (MRA)
A new Mutual Recognition Agreement (MRA) for Conformity Assessment, Certificates and Markings between Australia and the UK came into force on 1 January 2021.
Devices
Under the MRA, the TGA can issue UK Conformity Assessment (CA) certification to Australian medical device manufacturers for use in the UK (subject to a range of requirements). Please contact TGA if you would like further information on medical device MRA certification.
Medicines
The new MRA provides continuity of the mutual recognition arrangements for medicines that applied prior to the final exit of the UK from the EU.
If any changes are made to the location of a manufacturing site registered to conduct Release for Supply to the Australian market, sponsors will need to:
- amend the relevant ARTG entry and any associated GMP clearances.
- consider any impact on medicine supply and ensure they fulfill their responsibilities for medicine shortages reporting.
Further information on the MRA
The MRA treaty outlined above is managed by the Department of Industry, Innovation and Science. Further information is available at Australia and UK sign Mutual Recognition Agreement and a copy of the treaty is available on the Australian treaties website.
Updating Manufacturer Evidence relating to medical devices
As an alternative to MRA certificates, many ARTG entries are supported by certification from comparable overseas regulators, such as European notified bodies.
Following Brexit, notified bodies previously operating in the UK (now UK CA bodies) are no longer recognised under European arrangements. Some notified bodies have arranged or are arranging to transfer certificates issued under European regulations from UK notified bodies to EU notified bodies (for example, BSI UK to the BSI Netherlands). In some cases, the manufacturer evidence held by TGA may need to be updated. See TGA's guidance on Manufacturer evidence for medical devices and IVD medical devices for details on when this will be necessary and how to proceed.
IMPORTANT
Sponsors must ensure that, at all times while they supply a medical device in Australia, the manufacturer of their medical device holds a valid conformity assessment document that demonstrates that the conformity assessment procedures or requirements comparable to those procedures have been applied to the kind of medical device.
Note: UK CA certification is not accepted under current TGA Comparable Overseas Regulator arrangements.
Release for Supply relating to Medicines
Australian sponsors need to be aware that if any changes are made to the location of a manufacturing site registered to conduct Release for Supply to the Australian Market, the relevant ARTG entry and any associated GMP clearances will also need to be amended appropriately. If such arrangements are required, sponsors may need to consider any impact on medicine supply and ensure they fulfill their responsibilities for medicine shortages reporting.
GMP Clearances using MHRA desk-top assessments
We would encourage Australian Sponsors to submit extension applications for UK manufacturers that have been subject to desk-top assessments and provide the updated GMP Certificate as evidence via email to GMPclearance@health.gov.au.
Further information
The Department of Foreign Affairs and Trade have released the following statement:
The following UK CA bodies, previously designated under European regulations, have issued statements on Brexit arrangements: