THE Therapeutic Goods Administration (TGA) has announced details of transitional arrangements in the event of a "no deal" exit of the United Kingdom from the European Union.
The TGA noted that 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 (Mutual Recognition Agreement) 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".
In terms of medical devices, if no Brexit deal is reached, the TGA says it will continue accepting conformity assessment documents issued by UK notified bodies for existing products while they remain current for the purpose of UK market authorisation.
If Great Britain comes to an agreement with the European Union, either in terms of a Brexit deal or an extension of its exit date, there would be no immediate impact on the supply of medicines or devices to Australia from the UK.
The TGA noted that some bodies are arranging to transfer EU certifices from UK notified bodies to EU notified bodies, and sponsors may apply to the TGA requesting changes of their current certificates.
Australian medicine sponsors should 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.
More info at tga.gov.au.
The above article was sent to subscribers in Pharmacy Daily's issue from 19 Mar 19
To see the full newsletter, see the embedded issue below or CLICK HERE to download Pharmacy Daily from 19 Mar 19
