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Brexit - Implications for therapeutic goods in Australia

25 February 2020

Brexit

The United Kingdom (UK) exited the European Union (EU) on 31 January 2020.

A transition period is in effect until the end of 2020 while the UK and EU negotiate additional arrangements. The current rules, including those for therapeutic goods, for the UK and EU will continue to apply during the transition period.

The exit agreement included provision for an extension of the transition timeframe or one or two years, should this be required.

The advice below covers the implications for Australia during the transition period, and anticipated action at the end of the transition period.

Transitional arrangements

The Medicines & Healthcare products Regulatory Agency (MHRA) is the UK regulator for medicines and medical devices.

Medical devices

Under the Brexit agreement, UK notified bodies continue to be recognised for the transition period through to 31 December 2020, so there is no immediate impact on manufacturers certified by these notified bodies. Sponsors of these devices can continue providing these certificates as conformity assessment documents for their medical devices in Australia. Similarly, if the transition timeframe is extended, current arrangements will continue until the transition ends.

Medicines

There will be no impact on the supply of medicines to Australia from the UK during the transition period. The UK remains in the EU single market and is subject to EU rules and regulations. The existing EU-Australia MRA remains in force for the UK until the transition period ends.

End of transitional arrangements

Medical devices

The TGA will implement changes to provide for minimal interruption in the supply of medical devices in Australia at the end of the UK's transitional arrangements. Based on arrangements put in place to provide for a 'no deal' Brexit, the MHRA enacted regulations to continue mirroring EU regulations. Assuming this a similar approach at the end of the transitional period, the TGA will continue accepting conformity assessment documents issued by UK notified bodies for existing products while these remain current for the purposes of UK market authorisation. This will apply to both existing Australian Register of Therapeutic Goods (ARTG) entries and applications for new inclusions of medical devices in ARTG:

  • Medical devices currently included in ARTG may continue to be imported and/or supplied in Australia with the current certification issued by UK notified bodies, which are subject to continuing MHRA oversight.
  • Two instruments will be amended to allow new applications for ARTG inclusion to proceed with conformity assessment documents issued by UK notified bodies:
    • The Therapeutic Goods (Overseas Regulators) Determination 2018 will be amended to include recognition of notified bodies granted ongoing legal status by the MHRA.
    • The Therapeutic Goods (Medical Devices - Information that Must Accompany Application for Inclusion) Determination 2018 will be amended to specify the conformity assessment documents issued by UK notified bodies that may accompany an application for inclusion in the ARTG.

This will be reviewed as details of UK arrangements for the end of the transition are released.

Medicines

Australia and the UK have signed a Mutual Recognition Agreement (MRA) on Conformity Assessment and Certifications guaranteeing continuity of the existing mutual recognition arrangements when the transition period ends. This will ensure continued collaborative and mutual recognition arrangements for medicines.

Mutual Recognition Agreement (MRA)

The MRA treaty is managed by the Department of Industry, Innovation and Science, who have issued the following statements:

Updating Manufacturer Evidence relating to medical devices

Some notified bodies have arranged or are arranging to transfer EU certificates from UK notified bodies to EU notified bodies (for example, BSI UK to the recently accredited BSI Netherlands).

In such cases where manufacturers now have EU certificates issued by a notified body accredited in one of the EU member states, sponsors may apply to the TGA requesting change of the current certificate.

A standard process for variation of the Manufacturer Evidence (submitting a Manufacturer Evidence application to the TGA) will apply. If replacement of the certificates result in the need to correct information entered on the ARTG, a Device Change Request will also be required.

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.

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 notified bodies are designated in the UK, and some have issued statements on Brexit arrangements:

BSI Group

SGS United Kingdom Limited

UL International (UK) Ltd

UL International has ceased providing notified body services relating to the Medical Devices Directive (93/42/EEC) (MDD) from 1 September 2019:

Lloyd's Register Quality Assurance Ltd

Lloyds has ceased providing notified body services relating to the Medical Devices Directive (93/42/EEC) (MDD) and the In-Vitro Diagnostic Devices Directive (98/79/EC) (IVDD):