18 de março de 2019

Brexit - Implications for therapeutic goods in Australia

From: www.tga.gov.au

Brexit 'no deal'

The Medicines & Healthcare products Regulatory Agency (MHRA) is the UK regulator for medicines and medical devices. They have released details of contingency legislation on their website, to ensure continued regulatory oversight and uninterrupted supply of medicines and medical devices in the event of a 'no deal' scenario.
Medical devices

In the event of a 'no deal' exit of the United Kingdom (UK) from the European Union (EU), the TGA will implement transitional arrangements to provide for minimal interruption in the supply of medical devices in Australia.

If there is a 'no deal' Brexit, 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 2018will be amended to specify the conformity assessment documents issued by UK notified bodies that may accompany an application for inclusion in the ARTG.

In the event of a Brexit 'no deal', there will be no impact on the supply of medicines to Australia from the UK. Under the UK-Australia MRA on Conformity Assessment, existing arrangements will continue whereby, TGA will accept batch certification on MHRA Certificates for supply of medicines from the UK to the Australian Market.
Brexit 'deal' or exit extension
Medical devices

Under the proposed Brexit 'deal', UK notified bodies would continue to be recognised for a transition period through to 31 December 2020, so there will be 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 timeframe for the exit of the UK from the EU is extended, current arrangements will continue until an exit occurs.

Under the proposed Brexit 'deal', there will be no immediate impact on the supply of medicines to Australia from the UK. The existing arrangements will continue under the UK-Australia MRA as under the EU-Australia MRA. Similarly, if the timeframe for the exit of the UK from the EU is extended, current arrangements will continue, under the EU-Australia MRA, until an exit occurs.
Mutual Recognition Agreement (MRA)

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

Separate arrangements under the Mutual Recognition Agreement (MRA) with the EU also provide for recognition of certification issued under that agreement to be recognised in Australia and Europe, and this supports a small number of medical device approvals in Australia, and provides for some Australian medical devices to be supplied in Europe.

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


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.
Further information

The Department of Foreign Affairs and Trade have released the following statement:

The MHRA has released several statements on its website on the implications of Brexit for medicines and medical devices:

The following notified bodies are designated in the UK, and some have issued statements on Brexit arrangements:
BSI Group
Lloyd's Register Quality Assurance Ltd
SGS United Kingdom Limited
UL International (UK) Ltd