Required Advisory Statements for Medicine Labels (RASML)

1 February 2016

About the RASML

The Therapeutic Goods Order No. 69 - General requirements for labels for medicines requires the labels of some over-the-counter and complementary medicines to contain particular warning statements ('advisory statements') about specific risks related to use of the medicines.

These advisory statements are set out in the Required Advisory Statements for Medicine Labels (RASML), which is registered on the Federal Register of Legislative Instruments as schedules to the Specification titled Medicines Advisory Statements Specification 2016.

The Medicines Advisory Statements Specification 2016 ('the Specification') came into effect on 1 January 2016.

The Specification includes two versions of the RASML, as Schedule 1 and Schedule 2 to the Specification, respectively. This is intended to allow for a transition period for sponsors to comply with new label requirements in Schedule 2 that will come into effect on 1 July 2017.

RASML No. 2 (Schedule 1)

The current edition, The current edition, RASML No. 2. , came into effect on 1 January 2016.

RASML No. 2 will remain in effect untill 1 July 2017.

RASML No. 3 (Schedule 2)

RASML No. 3 will come into effect on 1 July 2017.

Summary of new label requirements in RASML No. 3

RASML No. 3 will include the new and amended statements that were the subject of either public consultation, or a new Condition of Listing, between January 2014 and October 2015, as follows:

For further details, see also: Explanatory Statement on the Amendment Specification

Transition period

We recommend that sponsors take steps to amend any labels affected by the new requirements in RASML No. 3 immediately in order to ensure that they will be compliant by 1 July 2017. This is the purpose of the 18 month transition period in which both RASML No.2 and No.3 are published.

How to use RASML

Updating the RASML

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

Historical information