Federal Register of Legislation
Therapeutic Goods (Complementary Medicines—Information that Must Accompany Application for Section 26AE Listing) Determination August 2018
I, Jane Cook, Acting First Assistant Secretary, Medicines Regulation Division, Health Products Regulation Group, a delegate of the Secretary of the Department of Health for the purposes of section 23B of the Therapeutic Goods Act 1989, revoke the Therapeutic Goods (Complementary Medicines – Information that Must Accompany Application for Section 26AE Listing) Determination 2018, registered on 21 May 2018, and make the following Determination under subsections 23B(9) and (10) of that Act.
Dated 20th August 2018
(Signed by)
JANE COOK Delegate of the Secretary of the Department of Health
1 Name This instrument is the Therapeutic Goods (Complementary Medicines—Information that Must Accompany Application for Section 26AE Listing) Determination August 2018.
2 Commencement This instrument commences on the day after it is registered.
3 Definitions In this instrument: Act means the Therapeutic Goods Act 1989. complementary medicine means a medicine of the kind specified in paragraph 4(1)(b) of the Therapeutic Goods (Classes of Therapeutic Goods) Instrument 2018. TGA means the part of the Department of Health known as the Therapeutic Goods Administration.
4 Applications to which this instrument applies This instrument applies to an application to list a complementary medicine under section 26AE of the Act.
5 Kind of information For the purposes of subsection 23B(9) of the Act, the application must be accompanied by: (a) the information required by the document titled CTD Module 1: Administrative information for assessed listed medicines, version 1, published by the TGA in March 2018; and (b) the information required by the document titled Mandatory requirements for an assessed listed medicine application to pass preliminary assessment, version 1, published by the TGA in March 2018. Note: The documents mentioned in section 5 are available on the TGA website (www.tga.gov.au).
We try to embed the page this law was scraped from. If the site blocks framing, you still get the link and a local excerpt.
Last checked with source on —
Checking whether the official page can be embedded…
Plain-English simplify of this law: a short summary, key points, and both sides of the argument. Generated on first view via Replicate, then cached. Vote on what helps your study.
No study brief is cached for this law yet. Sign up to generate a plain-English brief.
Sign up to generate