ARTG 337122: Softmed 3PLY earloop disposable face mask (M House Pty Ltd)
On 4 August 2022, a delegate of the Secretary, Department of Health and Aged Care made a decision under s 61(5C) of the Therapeutic Goods Act 1989 to release certain information about batches N/B-BTWT260031 and LX202010 of ARTG 337122 on the TGA’s website.
M House Pty Ltd, the sponsor of ARTG 337122, applied to the Federal Court for judicial review of the delegate’s decision on the basis that the release of information was not authorised by s 61(5C).
The Federal Court has determined that the release of information was not authorised by s 61(5C). The Court found that:
- for s 61(5C) to authorise the release of information, the information must be of a kind specified in a relevant legislative instrument;
- the Therapeutic Goods Information (Laboratory Testing) Specification 2017, being the relevant legislative instrument, does not specify information about sampling and testing not conducted under Part 5 of the Therapeutic Goods Regulations 1990;
- the released information was about sampling and testing not conducted under Part 5 of the Therapeutic Goods Regulations 1990;
- the released information was therefore not of a kind specified in the Therapeutic Goods Information (Laboratory Testing) Specification 2017.
On 7 July 2023, the Federal Court gave its reasons for judgment. Later that day, the TGA removed the information from its website.
By order of the Federal Court (dated 24 July 2023):
- the delegate’s decision was quashed from the date it was made, pursuant to s 16(1)(a) of the Administrative Decisions (Judicial Review) Act 1977; and
- the Secretary, Department of Health and Aged Care must publish this statement on its website and social media channels, pursuant to s 16(1)(d) of the Administrative Decisions (Judicial Review) Act 1977.
The full text of the decision is at www.judgments.fedcourt.gov.au/judgments/Judgments/fca/single/2023/2023fca0768.
The Federal Court Rules 2011 provide that the Secretary may appeal the Court’s order within 28 days after the Court’s order was made.
