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Required Advisory Statements for Medicine Labels (RASML) and the Labelling Order (TGO 69)

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Information for consumers, health professionals and industry

11 March 2016

The labels of over-the-counter and complementary medicines are often required to contain particular advisory statements about specific risks related to use of the medicines. These advisory statements are compiled into the Required Advisory Statements for Medicine Labels (RASML).

The newly revised RASML and the amendment to the Labelling Order (Therapeutic Goods Order No. 69D) has commenced on 12 June 2014.

The RASML is now registered as a Specification titled Medicines Advisory Statements Specification 2014 on the Federal Register of Legislation (FRL). The Specification is a legislative instrument under section 3(5A) of the Therapeutic Goods Act 1989 ('the Act').

The Labelling Order (Therapeutic Goods Order No. 69) has been amended by TGO 69D to make it mandatory for medicine labels to include any requirements as specified in the Medicines Advisory Statements Specification, as in force from time to time, that are relevant to the medicine. TGO 69 is an Order under section 10 of the Act.

The intention of this new Specification is to streamline the process of annual updates to the RASML as a Specification on FRL without issuing an entirely new Labelling Order each time the RASML is updated.

For further details, refer to the following documents:

In order to allow for a transition period for sponsors to comply with the updated requirements, the Specification includes two versions of the RASML, 'RASML No. 1' and 'RASML No. 2' as Schedule 1 and Schedule 2 to the Specification, respectively.

RASML No. 1

The current edition, from 12 June 2014 to 11 December 2015 is RASML No. 1.

No new label requirements have been introduced by RASML No. 1.

RASML No. 1 differs from the previous version (RASML Edition 1 including update 4, September 2008) as follows:

  • Some amended statements that will be required by RASML No. 2 have been included as alternative statements in RASML No. 1, in order to allow sponsors to prepare for compliance with RASML No. 2 without becoming non-compliant with RASML No. 1.
  • Requirements relate to prescription medicines have been removed because RASML does not apply to prescription medicines.
  • The layout and structure of RASML No. 1 is different, with the advisory statements no longer being numbered. Instead, the statements are shown in a table.

RASML No. 2

RASML No. 2 will come into effect on 12 December 2015.

RASML No. 2 includes all of the changes consulted about since September 2008.

Transition period

We recommend that sponsors take steps to amend their affected labels as soon as possible in order ensure that they will be compliant by 12 December 2015. This is the purpose of the 18 month transition period in which both RASML No.1 and No. 2 are published.

Using the RASML

Updating the RASML

The RASML will be periodically updated to include new and amended advisory statements.