You are here

Scheduling delegate's interim decisions and invitation for further comment: ACMS, June 2015

Scheduling medicines and poisons

3 June 2015

Book pagination

Part A - Interim decisions on matters referred to an expert advisory committee: ACMS#14 (1.4-1.6)

1. Scheduling proposals referred to the March 2015 meeting of the Advisory Committee on Medicines Scheduling (ACMS #14)

1.4 Rantidine

Scheduling proposal

The medicines scheduling delegate (the delegate) has referred the following scheduling proposal for consideration by the Advisory Committee on Medicines Scheduling (ACMS):

  • To exempt ranitidine from Schedule 2 when in divided preparations for oral use containing 300 mg or less of ranitidine per dosage unit in the manufacturer's original pack containing not more than 7 dosage units.
  • The delegate referred the proposal to the Advisory Committee on Medicines Scheduling (ACMS) for advice.
Substance summary

Ranitidine is a member of the class of histamine H2-receptor antagonists with antacid activity. Ranitidine is a competitive and reversible inhibitor of the action of histamine, released by enterochromaffin-like (ECL) cells, at the histamine H2-receptors on parietal cells in the stomach, thereby inhibiting the normal and meal-stimulated secretion of stomach acids. It is used in the management of dyspepsia, gastric ulcer and reflux oesophagitis.

Scheduling status

RANITIDINE is currently listed in Schedules 4 and 2.

Schedule 4

RANITIDINE except:

  1. when included in Schedule 2; or
  2. in divided preparations for oral use containing 150 mg or less of ranitidine per dosage unit when supplied in the manufacturer's original pack containing not more than 14 dosage units.
Schedule 2

RANITIDINE in preparations supplied in the manufacturer's original pack containing not more than 14 days' supply except in divided preparations for oral use containing 150 mg or less of ranitidine per dosage unit in the manufacturer's original pack containing not more than 14 dosage units.

Scheduling history
Drugs and Poisons Schedule Standing Committee - November 1993

The Committee considered applications for rescheduling of small packs of H2-receptor antagonists (cimetidine, famotidine and ranitidine) from S4 to S3. The Committee supported this proposal.

National Drugs and Poisons Schedule Committee - August 1994

The Committee considered a submission from Glaxo Australia Pty Ltd to reschedule ranitidine 150 mg from Schedule 4 to Schedule 3 when indicated for the short term relief of heartburn and other symptoms of reflux oesophagitis, and supplied in packs containing 15 doses or less. The Committee decided to request:

  • The Secretary to advise applicants to approach TGA (if they have not already done so) to have any proposed minor indications for OTC preparations approved by TGA before further consideration by Committee; and
  • The Secretary to advise sponsors also of the preferred set of warning statements.

The Committee noted that the approved product indications for the use of ranitidine included "short-term symptomatic treatment of reflux oesophagitis unresponsive to conservative anti-reflux measures and simple drug therapies such as antacids". The Committee reaffirmed its original recommendation for the inclusion of ranitidine in Schedule 3 when in a pack containing not more than 14 days' supply and when labelled with certain warning statements.

National Drugs and Poisons Schedule Committee - February 1996

The Committee noted that Australian Drub Evaluation Committee had recommended that approval should be given to the registration of ranitidine in preparations containing 75 mg of ranitidine per tablet for the symptomatic relief of heartburn, dyspepsia and hyperacidity.

National Drugs and Poisons Schedule Committee - February 1997

The Committee considered comment received in the post-meeting consultation period concerning the decision made at the November 1996 meeting relating to the removal of the dosage size and formulation type from the Schedule 3 entries for cimetidine, famotidine, nizatidine and ranitidine. The Committee reaffirmed its decision.

National Drugs and Poisons Schedule Committee - August 1998

The Committee supported the inclusion of ranitidine in Appendix H.

National Drugs and Poisons Schedule Committee - May 1999

The Committee noted the recommendation from the Trans-Tasman Harmonisation Working Party that the SUSDP Schedule 4 and the Part 1 entries for the following drugs are harmonised: CIMETIDINE; FAMOTIDINE; NIZATIDINE; RANITIDINE.

National Drugs and Poisons Schedule Committee - November 1999

The committee noted that: The August 1999 Committee endorsed a recommendation from the Working Party that it remove the words 'as the only therapeutically active substance in preparations for oral use' from the S3 entries. With adoption of recommendations by the NZ MOH the S3 entries for these substances would be harmonised. The NDPSC supported the Working Party view that similar products should be available in both countries.

With regard to cimetidine, famotidine, nizatidine and ranitidine, the Committee accepted the findings of the AHMAC Committee in relation to matters mentioned in subsection 52E (1) of the Act, and decided that there should be no variation to the scheduling decision taken by AHMAC Committee.

National Drugs and Poisons Schedule Committee - February 2000

The Committee considered a request for advice from the OTC Medicines Evaluation Section in regard to the application of the NZ MOH Guidelines for OTC packs of the histamine-2 antagonists.

National Drugs and Poisons Schedule Committee - November 2000

The Committee supported a proposal to rescheduling of ranitidine from Schedule 3 to Schedule 2 with retention of the Appendix F warning statements, and consequential amendments to Schedule 3 and Appendix H.

National Drugs and Poisons Schedule Committee - February 2001

The Committee considered a proposal to include a Schedule 5 entry for ranitidine in the SUSDP, to accommodate the product. The Committee decided that as ranitidine was already included in Schedule 4 of the SUSDP, no further action was required.

National Drugs and Poisons Schedule Committee - June 2002

The Committee considered the proposal to exempt ranitidine from Warning Statements (WS) 68, 69 and 70. The Committee agreed to finalise the following foreshadowed amendments at the October 2002 meeting to: delete WS 35, 68 and 69 in Appendix F, Part 3 for cimetidine, famotidine, nizatidine and ranitidine and delete WS 70 in Appendix F, Part 3 for famotidine, nizatidine and ranitidine, but retain WS 70 for cimetidine. The Committee also decided to include a requirement for WS 96 in Appendix F, Part 3 for cimetidine, famotidine, nizatidine and ranitidine.

National Drugs and Poisons Schedule Committee - June 2002

The Committee considered the foreshadowed amendments to the Appendix F, Part 3 entries of the SUSDP for ranitidine, cimetidine, famotidine and nizatidine. The Committee agreed to amend the new WS 96 as proposed by MEC.

National Drugs and Poisons Schedule Committee - February 2005

The Committee noted advice from the Trans-Tasman Harmonisation Working Party that the scheduling for cimetidine, famotidine, nizatidine and ranitidine was almost "essentially harmonised". The Committee's foreshadowed decision was to be considered at the June 2005 meeting.

National Drugs and Poisons Schedule Committee - June 2005

The Committee considered amendments to the scheduling of cimetidine, ethyl chloride, famotidine, nizatidine, prilocaine, ranitidine and silver sulfadiazine to achieve harmonisation with New Zealand. The Committee agreed to the foreshadowed amendments to the scheduling of the H2 antagonists, (cimetidine, famotidine, nizatidine and ranitidine) and also the scheduling for prilocaine and ethyl chloride to harmonise with New Zealand.

National Drugs and Poisons Schedule Committee - February 2007

The Committee considered a proposal to reschedule ranitidine from Schedule 2 to exempt from scheduling for ranitidine 150 mg, with a maximum dose of 300 mg/day, for the effective long lasting relief of heartburn and acid indigestion in packs containing no more than 7 days' supply. The Committee agreed to amend the scheduling of ranitidine when sold in solid dosage forms in manufacturer's original pack containing not more than 7 day's supply with a maximum dose of 300 mg per day from Schedule 2 to exempt from scheduling. The Committee agreed to refer the matter to the Drafting Advisory Panel to fine tune the wording of the schedule entries.

National Drugs and Poisons Schedule Committee - June 2007

The Committee considered post-Meeting comment received in response to the February 2007 NDPSC Meeting decision on the scheduling of ranitidine. The Committee agreed to vary the February 2007 NDPSC decision to exempt from scheduling ranitidine when supplied as divided preparations for oral use containing 150 mg or less of ranitidine per dosage unit in the manufacturer's original pack, by removing the reference to 'days' supply' from the exemption and including reference to not more than 14 dosage units.

Pre-meeting public submissions

Three submissions were received. All opposed the proposal on the basis that there was a risk of inappropriate treatment masking underlying disease.

ACMS advice to the delegate

The ACMS recommended that ranitidine be exempted from Schedule 2 when in divided preparations for oral use containing 300 mg or less of ranitidine per dosage unit in the manufacturer's original pack containing not more than seven dosage units.

The ACMS recommended an implementation date of 1 October 2015.

The matters under subsection 52E (1) of the Therapeutic Goods Act 1989 considered relevant by the delegate included: a) the risks and benefits of the use of the substance; b) the purposes for which a substance is to be used and the extent of use of a substance; c) the toxicity of the substance; d) the dosage, formulation, labelling, packaging and presentation of a substance; and f) any other matters that the Secretary considers necessary to protect public health.

The reasons for the recommendation comprised the following:

  • Both the 300 mg and 150 mg ranitidine products are indicated for relief of symptoms of gastro-oesophageal reflux. The 7 x 300 mg tablet packs and 14 x 150 mg tablet packs each contain the same total quantity of ranitidine - both packs would provide seven days' supply at the maximum daily dose. Once daily dosing (with 300 mg tablets) could be seen as a benefit over the twice daily dosing which may be required for efficacy with the 150 mg tablets.
  • Consumers are more likely to seek medical aid due to perceived inefficacy of a product marketed as being stronger.
  • The 300 mg dosage unit provides an easier to access dosage form of a dose that is also possible with the currently unscheduled medication, albeit one that is not recommended (for all users) by the pack instructions.
Delegate's considerations

The delegate considered the following in regards to this proposal:

  • Scheduling proposal;
  • Public submissions received;
  • ACMS advice;
  • Section 52E of the Therapeutic Goods Act 1989;
  • Scheduling factors4
  • Other relevant information.
Delegate's interim decision

The delegate's interim decision is that ranitidine be exempted from Schedule 2 when in divided preparations for oral use containing 300 mg or less of ranitidine per dosage unit in the manufacturer's original pack containing not more than seven dosage units.

The proposed implementation date is 1 October 2015.

The matters under subsection 52E (1) of the Therapeutic Goods Act 1989 considered relevant by the delegate included: a) the risks and benefits of the use of the substance; b) the purposes for which a substance is to be used and the extent of use of a substance; c) the toxicity of the substance; d) the dosage, formulation, labelling, packaging and presentation of a substance; and f) any other matters that the Secretary considers necessary to protect public health.

The reasons for the recommendation comprised the following:

  • Both the 300 mg and 150 mg ranitidine products are indicated for relief of symptoms of gastro-oesophageal reflux. The 7 x 300 product has the same quantity of Ranitidine as the currently exempted 14 x 150mg packs- both packs would still only provide seven days' supply at the maximum daily dose. Once daily dosing (with 300 mg tablets) could be seen as a benefit over the twice daily dosing which may be required for efficacy with the 150 mg tablets.
  • Consumers are more likely to seek medical aid due to perceived inefficacy of a product marketed as being stronger.
  • The 300 mg dosage unit provides an easier to access dosage form of a dose that is also possible with the currently unscheduled medication, albeit one that is not recommended (for all users) by the pack instructions.
Schedule entry
Schedule 4 - Amendment

RANITIDINE except:

  1. when included in Schedule 2; or
  2. in divided preparations for oral use containing 150 mg or less of ranitidine per dosage unit in the manufacturer's original pack containing not more than 14 dosage units; or
  3. in divided preparations for oral use containing 300 mg or less of ranitidine per dosage unit in the manufacturer's original pack containing not more than 7 dosage units.
Schedule 2 - Amendment

RANITIDINE in preparations supplied in the manufacturer's original pack containing not more than 14 days' supply except:

  1. in divided preparations for oral use containing 150 mg or less of ranitidine per dosage unit in the manufacturer's original pack containing not more than 14 dosage units; or
  2. in divided preparations for oral use containing 300 mg or less of ranitidine per dosage unit in the manufacturer's original pack containing not more than 7 dosage units.

1.5 Esomeprazole

Scheduling proposal

The medicines scheduling delegate (the delegate) has referred the following scheduling proposal for consideration by the Advisory Committee on Medicines Scheduling (ACMS):

  • To create a new entry in Appendix H for esomeprazole in oral preparations containing 20 mg or less per dosage unit for the relief of heartburn and other symptoms of gastro-oesophageal reflux disease (GORD), in packs containing not more than 14 days' supply.

The delegate referred the proposal to the Advisory Committee on Medicines Scheduling (ACMS) for advice.

Substance summary

Esomeprazole magnesium trihydrate is a proton pump inhibitor used for the relief of heartburn and other symptom of gastro-oesophageal reflux disease.

Scheduling status

ESOMEPRAZOLE is currently listed in Schedules 4 and 3

Schedule 4

ESOMEPRAZOLE except when included in Schedule 3

Schedule 3

ESOMEPRAZOLE in oral preparations containing 20 mg or less per dosage unit for the relief of heartburn and other symptoms of gastro-oesophageal reflux disease, in packs containing not more than 14 days' supply.

Scheduling history
National Drugs and Poisons Schedule Committee: November 2000

New Zealand Ministry of Health requested the Committee to consider scheduling esomeprazole to harmonise with New Zealand's inclusion of the substance in Schedule 1, Part 1 (equivalent to Schedule 4 in the SUSMP). The Committee supported harmonisation and included esomeprazole in Schedule 4.

Omeprazole
National Drugs and Poisons Schedule Committee: May 1989

Omeprazole was considered by the Committee as the first in a new class of drug that was useful for the treatment of duodenal ulcers, reflux and Zollinger-Ellison syndrome. The committee recommended it be entered under Schedule 4. It was then reconsidered in November 2001 for veterinary use, which was captured by its Schedule 4 entry.

National Drugs and Poisons Schedule Committee: February 2010

Omeprazole and other Proton Pump Inhibitors (PPIs) (pantoprazole and lansoprazole) were considered by the Committee for a Schedule 3 entry. The committee decided to create a new Schedule 3 entry for omeprazole in oral preparations containing 20 mg or less per dosage unit of omeprazole for the relief of heartburn and other symptoms of gastro-oesophageal reflux disease, in packs containing not more than 14 days of supply.

Pre-meeting public submissions

Five public submissions were received.

All the submissions supported the proposal and two were of the opinion that, if this proposal was supported, then all commercially available PPIs available should be considered for Appendix H given that they have similar safety and efficacy profiles.

One submission, an independent report on the proposal (paid for by the applicant), supported the proposal on the basis that there is a public health and cost benefit, and that there is currently a low level of consumer awareness of the availability of non-prescription PPIs that offer safe and effective therapies.

ACMS advice to the delegate

The ACMS recommended that a new entry be created in Appendix H for esomeprazole in oral preparations containing 20 mg or less per dosage unit for the relief of heartburn and other symptoms of gastro-oesophageal reflux disease (GORD), in packs containing not more than 14 days' supply.

The ACMS recommended an implementation date of 1 October 2015.

The matters under subsection 52E (1) of the Therapeutic Goods Act 1989 considered relevant by the delegate included: a) the risks and benefits of the use of the substance; b) the purposes for which a substance is to be used and the extent of use of a substance; d) the dosage, formulation, labelling, packaging and presentation of a substance; and f) any other matters that the Secretary considers necessary to protect public health.

The reasons for the recommendation comprised the following:

  • Esomeprazole is a safe and effective first line treatment for consumers with frequent symptoms of gastro-oesophageal reflux disease.
  • Gastro-oesophageal reflux disease is a common condition. Increasing public awareness of the availability of a Schedule 3 Proton Pump Inhibitor in Pharmacy may have public health benefits through making consumers aware of more effective treatment options. Consumers may be more likely to seek advice from a pharmacist about the most appropriate treatment option.
  • The Schedule 3 pack size, 14 days' supply, minimises the risk of inappropriate use. The RASML (Required Advisory Statements for Medicine Labels) warning statements help ensure appropriate use of the product.
  • Other less effective treatments for the symptoms of gastro oesophageal reflux disease are advertised to consumers.

The ACMS also recommended that the delegate:

  • give consideration of other PPIs being listed in Appendix H, based on the quality of evidence included in this proposal; and
  • review the scheduling of PPIs.
Delegate's considerations

The delegate considered the following in regards to this proposal:

  • Scheduling proposal;
  • Public submissions received;
  • ACMS advice;
  • Section 52E of the Therapeutic Goods Act 1989;
  • Scheduling factors5;
  • Other relevant information.
Delegate's interim decision

The delegate's interim decision is that a new entry be created in Appendix H for esomeprazole.

The proposed implementation date is 1 October 2015.

The matters under subsection 52E (1) of the Therapeutic Goods Act 1989 considered relevant by the delegate included: a) the risks and benefits of the use of the substance; b) the purposes for which a substance is to be used and the extent of use of a substance; d) the dosage, formulation, labelling, packaging and presentation of a substance; and f) any other matters that the Secretary considers necessary to protect public health.

The reasons for the recommendation comprised the following:

  • Esomeprazole is a safe and effective first line treatment for consumers with frequent symptoms of gastro-oesophageal reflux disease.
  • Gastro-oesophageal reflux disease is a common condition. Increasing public awareness of the availability of a Schedule 3 Proton Pump Inhibitor in Pharmacy may have public health benefits through making consumers aware of more effective treatment options. Consumers may be more likely to seek advice from a pharmacist about the most appropriate treatment option.
  • The Schedule 3 pack size, 14 days' supply, minimises the risk of inappropriate use. The RASML (Required Advisory Statements for Medicine Labels) warning statements help ensure appropriate use of the product.
  • Other less effective treatments for the symptoms of gastro oesophageal reflux disease are advertised to consumers.
  • The quality of evidence provided by the applicant in support of the proposal.
Schedule entry
Appendix H - New entry

Esomeprazole.

1.6 Aciclovir

Scheduling proposal

A proposal to reschedule aciclovir in muco-adhesive tablets containing 50 mg in a pack of two tablets or less from Schedule 4 to Schedule 2 was published as a part of the Consultation: Invitation for public comments - ACMS meeting, March 2015 on 13 November 2014. The proposal and application has since been withdrawn and therefore there is no recommendation of the ACMS or delegate decision for this item.


  1. Scheduling Policy Framework for Medicines and Chemicals (SPF, 2015)
  2. Scheduling Policy Framework for Medicines and Chemicals (SPF, 2015)

Book pagination