TGA issues summary of amendments to Therapeutic Goods Act 1989

A number of amendments to the Therapeutic Goods Act 1989 came into effect on 28 February 2014. The Therapeutic Goods Administration (TGA) has issued a summary of the 13 main sets of amendments.

The amendments were made by the Therapeutic Goods Amendment (2013 Measures No. 1) Act 2014.

The TGA says the amendments make a number of minor but important changes that streamline and improve the operation of the regulatory scheme for industry, consumers, health professionals and the TGA itself.

The 13 main sets of amendments are:

1. Excluding goods from the Therapeutic Goods Act
2. Removing products from the Australian Register of Therapeutic Goods (ARTG) that are not considered ‘therapeutic goods’
3. Giving false or misleading information to the TGA
4. New powers of cancellation in relation to the presentation of listed and registered therapeutic goods
5. Commencement of conditions
6. Publication of information about regulatory decisions
7. Notification of selection for audit of some applications for inclusion on the ARTG
8. Making consistent the revocation of sponsor-initiated cancellations
9. Definition of ‘kit’
10. Right of review in relation to conditions imposed on section 14 and 14A exemptions
11. Technical amendments to the Act in relation to evaluation and registration of therapeutic goods
12. Requesting information about registered goods
13. Advertising - references to the Therapeutic Goods Advertising Code

Full summaries of each of the 13 sets of amendments are available here