Medicines Advisory Statements Specification updates

Including amended RASML No. 3 with effect 1 July 2017

30 June 2017

An updated edition of the Medicines Advisory Statements Specification (the '2017 Specification') has been registered on the Federal Register of Legislation (FRL).

The 2017 Specification includes an amended version of the Required Advisory Statements for Medicine Labels (RASML) document, RASML No. 3, in which:

  • all requirements that apply solely to listed medicines have been removed
  • the requirements for codeine have reverted to the lesser requirements that were in force in RASML No. 2.

The 2017 Specification also includes a fully updated version of the RASML ('RASML No.4').

As usual, the 2017 Specification allows for an 18-month transition period for adoption of the advisory statements in RASML No. 4 (new and amended) onto medicine labels. During this transition period, from 1 July 2017 to 1 January 2019, affected medicine labels may comply with either RASML No. 3 (as amended) or with RASML No. 4.

From 1 January 2019, affected medicine labels will be required to comply with RASML No. 4.

Removal of requirements that apply solely to listed medicines

All requirements that only apply to listed medicines have been removed from the RASML, as the relevant requirements are now included in the Therapeutic Goods (Permissible Ingredients) Determination ('the S26BB Determination'), and the Specification does not apply to listed medicines that are compliant with the S26BB Determination.

Removal of these entries from the RASML is consistent with the intent of the S26BB Determination in regards to labelling requirements for listed medicines, and avoids duplication.

Change to entries for codeine

The entries for codeine in the RASML No. 3 (and the RASML No. 4) have been amended by deleting the requirement for the statement 'If [coughing / symptoms] persist(s), consult your doctor or pharmacist'.

This statement was to be a new requirement for OTC codeine cough-and-cold medicines in RASML No. 3, from 1 July 2017. However, medicines containing codeine will all be re-scheduled to Schedule 4 of the SUSMP (Prescription Only Medicines) from 1 February 2018. After 1 February 2018, codeine-containing medicines will no longer be subject to the Specification, as it does not apply to Prescription Only Medicines.

The removal of the above new codeine-related statement means that the requirements for codeine in RASML No. 3 and RASML No. 4 will be identical to those that were in force in RASML No. 2.

This should facilitate the process for labelling changes necessary for the re-scheduling to Prescription Only.

Other changes

  • RASML No. 4 will include the new and amended statements that were the subject of public consultation between January 2016 and February 2017, as follows:
    • Consultation: Non-steroidal anti-inflammatory drugs: proposed additional advisory statement 11 October 2016 (Submissions received and TGA response 13 February 2017):
      • Outcome: current advisory statement regarding use in pregnancy expanded to

        Do not use if trying to become pregnant, or during the first 6 months of pregnancy, except on doctor's advice. Do not use at all during the last 3 months of pregnancy.

    • Consultation: Paracetamol and ibuprofen: advisory statements for medicines 11 October 2016 (Submissions received and TGA response 13 February 2017):
      • Outcome: oral medicines containing a combination of paracetamol and ibuprofen will require the following statements:

        Do not give to children under 12 years of age.

        Adults: Keep to the recommended dose. Do not take this medicine for longer than a few days at a time unless advised to by a doctor.

        Children and adolescents: Keep to the recommended dose. Do not give this medicine for longer than 48 hours at a time unless advised to by a doctor.

        Excessive use can be harmful and increase the risk of heart attack, stroke or liver damage.

        Do not use if pregnant or trying to become pregnant.

        Do not use if you have a stomach ulcer.

        Do not use if you have impaired kidney function.

        Do not use if you have heart failure.

        Do not use if you are allergic to ibuprofen or other anti-inflammatory medicines.

        If you get an allergic reaction, stop taking and see your doctor immediately.

        Unless a doctor has told you to, do not use if you have asthma.

        Unless a doctor has told you to, do not use if you are aged 65 years or over.

        Do not take with other products containing paracetamol, ibuprofen, aspirin or other anti-inflammatory medicines or with medicines that you are taking regularly, unless advised to do so by a doctor or pharmacist.

        If an overdose is taken or suspected, ring the Poisons Information Centre (Australia 13 11 26, New Zealand 0800 764 766) or go to hospital straight away even if you feel well because of the risk of delayed, serious liver damage.

  • The current 7 entries for Aspirin will be consolidated into 3 entries:
    • New 'Entry 1 of 3', with the Conditions 'When NOT in combination with other therapeutically active substances (other than effervescent agents), and NOT indicated for the prevention of cardiovascular disease or for the inhibition of platelet aggregation' – requirements as for the current 'Entry 1' and 'Entry 7'
    • New 'Entry 2 of 3', with the Conditions 'When indicated for the prevention of cardiovascular disease or for the inhibition of platelet aggregation' – requirements as for the current 'Entry 3' and 'Entry 4'
    • New 'Entry 3 of 3', with the Conditions 'When in combination with other therapeutically active substances (other than effervescent agents)' – requirements as for the current 'Entry 6'.
    The requirements of the current Entries 1 and 7 (unscheduled versus scheduled single-ingredient medicines for pain relief indications) are identical, as are those of the current Entries 3 and 4 (unscheduled versus scheduled medicines for the antiplatelet indications); and there are no currently registered aspirin products that are subject to the entries proposed for deletion. The TGA considers that there is no logical reason to retain the current Entries 2, 3, 5 or 7 in the RASML.
  • Substance names will be updated where these are affected by the TGA's recent changes to ingredient names (amethocaine/tetracaine and lignocaine/lidocaine).
  • A number of entries for Schedule 5/Schedule 6/Schedule 7 chemicals will be removed. No products will be affected by the deletion of these entries, as there are no approved medicines currently supplied in Australia that actually contain any of these substances, at the relevant concentrations/pH. If a medicine containing any of these ingredients as an active ingredient was ever proposed for registration and/or supply in the future, it would require full evaluation in the context of contemporary standards in regards to safety, including evaluation of appropriate label warnings. The list of entries to be removed is as follows:
    • Acetone (In concentrations greater than 75 per cent);
    • Chromates including dichromates of alkali metals or ammonia (When included in a schedule to the SUSMP);
    • Hydrofluoric acid including mixtures that generate hydrofluoric acid (In Schedule 5 to the SUSMP);
    • Hydrofluoric acid including mixtures that generate hydrofluoric acid (In Schedule 6 or Schedule 7 to the SUSMP);
    • Potassium hydroxide (When included in a schedule to the SUSMP, in liquid preparations containing 0.5 per cent or less of potassium hydroxide);
    • Potassium hydroxide (When included in a schedule to the SUSMP, in solid preparations containing MORE THAN 0.5 per cent of potassium hydroxide);
    • Potassium hydroxide (When included in a schedule to the SUSMP, in liquid preparations containing MORE THAN 0.5 per cent of potassium hydroxide);
    • Sodium hydroxide (When included in a schedule to the SUSMP, in liquid preparations containing 0.5 per cent or less of potassium hydroxide);
    • Sodium hydroxide (When included in a schedule to the SUSMP, in solid preparations containing MORE THAN 0.5 per cent of potassium hydroxide);
    • Sodium hydroxide (When included in a schedule to the SUSMP, in liquid preparations containing MORE THAN 0.5 per cent of potassium hydroxide);
    • Zinc chloride (In a schedule to the SUSMP);
    • Zinc sulfate (In Schedule 6 to the SUSMP).