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Medicines Advisory Statements Specification updates

1 March 2019

An updated edition of the Therapeutic Goods (Medicines Advisory Statements) Specification (the '2019 Specification') has been registered on the Federal Register of Legislation (FRL).

The 2019 Specification includes an updated version of the Required Advisory Statements for Medicine Labels (RASML) document ('RASML No. 5') with updated advisory statement requirements that were the subject of public consultation between May and October 2018.

As usual, the 2019 Specification will allow for an 18-month transition period for adoption of the new and amended advisory statements in RASML No. 5 onto medicine labels. During this transition period, from 1 March 2019 to 31 August 2020, affected medicine labels may comply with either RASML No. 4 or with RASML No. 5

Unlike previous Specifications, the 2019 Specification includes only the updated RASML (RASML No. 5). However, RASML No. 4, contained in Schedule 2 to the previous Medicines Advisory Statements Specification 2017 continues to apply for the duration of the transition period despite repeal of the 2017 Specification.

From 1 September 2020, affected medicine labels will be required to comply with RASML No. 5. This date coincides with the date by which labelling must also comply with Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines (TGO 92).

Changes in RASML 5

  • RASML No. 5 will include the new and amended statements that were the subject of public consultation between May and October 2018, as follows:
    • Consultation: Sedating antihistamines: proposed additional advisory statements for medicines 24 May 2018 (Submissions received and TGA response 25 September 2018):
      • Outcomes: current advisory statements for sedating antihistamines are updated as follows:

        Inclusion of the statement "Do not give to children under 2 years [or higher] of age" for all oral medicines (currently only required for those labelled for use in cough, cold or flu).

        Inclusion of the statement "Do not give to children aged between 2 and 11 years of age, except on the advice of a doctor, pharmacist or nurse practitioner" for all oral medicines, in line with current requirements for those labelled for use in cough, cold or flu in children aged 6-11 years.

        Inclusion of the statement "This medication may cause drowsiness" for oral medicines labelled exclusively for use in children for cough, cold or flu (as required for all other sedating antihistamine-containing oral medicines).

        Changes to the pregnancy warning statements for oral medicines for short term use in insomnia, for consistency with TGO 92 requirements.

        Addition of a specific entry for Alimemazine (trimeprazine), which is currently covered only by the general entry for "Antihistamines"

        Changes to the presentation of advisory statement requirements to more clearly specify the requirements.

    • Consultation: Benzocaine: proposed advisory statements for medicines 18 September 2018 (Submissions received and TGA response 14 January 2019):
      • Outcome: preparations for topical oral use except lozenges will require the following statement:

        "Do not give to children under 2 years of age".

    • Consultation: Miconazole and fluconazole: proposed advisory statements for medicines 24 May 2018 (Submissions received and TGA response 14 September 2018):
      • Outcome: current advisory statements for miconazole for topical oral and for vaginal use and fluconazole for oral use are updated as follows:

        Inclusion of the statement "Ask your doctor or pharmacist before use if you are taking warfarin"

        Update of the pregnancy warning statement for fluconazole for consistency with TGO 92.

  • RASML No. 5 will include a new entry for fennel oil with the advisory statement "Keep out of reach of children", required for exclusion from Schedule 6 of the Poisons Standard. This advisory statement is included in RASML 5 in accordance with the entry for fennel oil included in Schedule 6 of the Poisons Standard on 1 June 2017 following public consultation.