Gazette notice - required advisory statements for medicine labels (RASML)

Published in the Commonwealth of Australia Gazette No. GN 25, 23 June 2004

I, Pio Cesarin, Director, Non-Prescription Medicines Branch, Therapeutic Goods Administration, give notice that:

Warning and advisory statements required on certain medicine labels applicable to therapeutic goods will be consolidated into a single document entitled Required Advisory Statements for Medicine Labels (RASML). The RASML is intended have effect on and from 1 July 2004.

Currently the Principal Regulations and various other ancillary documents, including Therapeutic Goods Order 69 General Requirements for labels for medicines, require warning statements to be included on the labels of certain medicines.

The Therapeutic Goods Amendment Regulations 2004 (No.2) [2004 Statutory Rule No. 127], commencing operation on 1 July 2004, will remove specific requirements in relation to warning statements from the Therapeutic Goods Regulations 1990 and replace them with references to the RASML.

The requirements of the RASML will generally apply in relation to applications for new products from the date of Gazettal of the specific requirement. For existing products, the requirements under the Therapeutic Goods Regulations 1990 continue to apply for a period of 12 months after the commencement of the Regulations. Any subsequent changes to the RASML would be published in the Gazette.

The other ancillary documents are intended to be amended to enable the consolidation of all warning statements in the RASML.

The RASML will be published on the Therapeutic Goods Administration website and can be accessed through: http://www.tga.gov.au/index.htm

Hard copies of the document can be obtained from the Publications unit, telephone 1800 020 653.

Dated 17 June 2004

Pio Cesarin
Director, Non-Prescription Medicines Branch