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Published: 30 October 2025

Committees

Minutes for the 74^th meeting of the Medicines Classification Committee held at 133 Molesworth Street, Wellington on 23 July 2025

Welcome
Apologies
Confirmation of the minutes of the 73^rd meeting held on 26 February 2025
Declaration of conflicts of interest
Submissions for reclassification
New Chemical Entities
Harmonisation of New Zealand and Australian schedule
- 7.1 New chemical entities which are not yet classified in New Zealand
- 7.2 Decisions by the Secretary to Department of Health and Aged Care Australia (or the Secretary’s Delegate).
Agenda items for the next meeting

8.1 Objections to recommendations made at the 73rd meeting
8.2 Brimonidine
8.3 Sedating antihistamines
8.4 Cetirizine

Agenda items for the next meeting
General business
Date of the next meeting

Present

Alison Cossar (Chair)
Dr Tim Hanlon
Dr Ben Hudson
Dr Marcia Walker
Megan Peters
Bronwen Shepherd
Holly Wilson (Secretariat)

In attendance from Medsafe

Matthew Spencer (Manager, Product Regulation)

Observing

Derek Fitzgerald (Manager, Compliance)
Leah Russell (Team Leader Medicines Assessment, Product Regulation)
Karin Van Bart (Senior Medical Advisor, Clinical Risk)
Karen Fu (Advisor - Science, Product Regulation)
Billy Allan (Clinical Chief Advisor, Medicines) accompanied by two pharmacy students from the University of Auckland

1. Welcome

The Chair opened the 74^th Medicines Classification Committee (MCC) meeting at 9:33am and welcomed members and guests.

2. Apologies

No apologies were received for this meeting.

3. Confirmation of the minutes of the 73^rd meeting held on 26 February 2025

The minutes of the 73^rd meeting were accepted as a true and accurate record. The minutes had been signed digitally prior to this meeting.

4. Declaration of conflicts of interest

There were no new conflicts of interest declared from members of the 74^th meeting which would preclude their participation.

5. Submissions for reclassification

5.1 Tenofovir disoproxil and emtricitabine (Burnett Foundation)

Purpose

Tenofovir disoproxil and emtricitabine are used for the treatment of HIV, and in pre-exposure prophylaxis (PrEP), with other safe sex practices to reduce the risk of sexually acquired HIV.

Tenofovir disoproxil and emtricitabine were recently discussed at the 73^rd MCC meeting held on 26 February 2025. The original submission (PDF, 11.91MB, 324 pages) proposed that tenofovir disoproxil and emtricitabine be reclassified to:

Prescription: except when supplied for HIV prophylaxis to people who are over 18, are HIV negative, and meet the clinical and eligibility criteria of an approved training programme, when provided by a pharmacist who meets the requirements of the Pharmacy Council.

At that time, the MCC recommended to defer a decision on tenofovir disoproxil and emtricitabine, pending further information from the submitter. This resubmission (PDF, 1.11MB, 26 pages) was considered at the 74^th MCC meeting.

Background

The MCC acknowledged the resubmission received from the Burnett Foundation, which primarily addressed the roles and responsibilities of key stakeholders involved in laboratory testing.

The MCC noted that extensive consultation had been undertaken by the Burnett Foundation with several groups, including Awanui Labs and the Pharmaceutical Society of New Zealand (PSNZ).

The MCC noted that, following this consultation, changes have been made to the proposed community-led initiation model of supply of HIV PrEP to promote a collaborative care model. The MCC noted that pharmacists would be able supply HIV PrEP provided the patient meets pre-defined criteria. The MCC noted that pharmacists could facilitate self-requested testing via community laboratories if consultation with an authorised prescriber was not possible. The MCC acknowledged that the pharmacist would not be responsible for ordering or managing laboratory results.

Comments

The MCC acknowledged that four comments were received regarding HIV PrEP, all of which expressed support for the submission.

The MCC acknowledged one comment received from Awanui Labs, which provided a summary of their clinical and technical ability to support this initiative, and their plans to strengthen the self-request pathway.

Discussion

The MCC reviewed and considered all the information provided in the submission and the comments received.

The MCC acknowledged the role for self-requested laboratory testing in the context of HIV PrEP and other health initiatives, and noted that self-requested laboratory testing is becoming more common. The MCC discussed costs associated with self-requested laboratory testing and acknowledged that the Burnett Foundation is working with laboratories to establish low-cost and publicly funded pathways. The MCC noted that Awanui laboratories is privately run and that there may in the future be other laboratories wishing to undertake this testing.

The MCC noted that the key point of concern raised following the original submission related to patients not enrolled with a GP. The MCC acknowledged the detail provided by the Burnett Foundation regarding how such patients are managed, and agreed that these issues have been addressed. The MCC acknowledged the standardised pharmacist checklists received from the Burnett Foundation, and agreed that these were comprehensive and clear.

The MCC discussed the role of patient management systems in this initiative. The MCC acknowledged that whilst recording of patient information is not compulsory, a pharmacist cannot supply HIV PrEP without sighting the patient's blood test results. The MCC acknowledged that patients can receive results via email, which will include wording about the need to seek care, how to do so, and appropriate referral pathways.

The MCC discussed the wording of the proposed reclassification outlined in the original submission. The MCC queried the inclusion of the Pharmacy Council in the classification statement, and noted that the PSNZ are typically responsible for the design and provision of training programmes. The MCC agreed that clarity was needed in this regard.

Overall, the MCC agreed that issues raised from the original submission have been addressed.

Recommendation

The MCC agreed that the classification of tenofovir disoproxil and emtricitabine should be amended to:

Prescription: except when supplied for HIV prophylaxis to people who are aged 18 years and older, are HIV negative, and meet the clinical and eligibility criteria of a Pharmaceutical Society of New Zealand approved training programme, when provided by a registered pharmacist who meets the requirements of the Pharmacy Council and who has successfully completed the approved training programme.

5.2 Respiratory Syncytial Virus (RSV) vaccine, adjuvanted (GSK New Zealand)

Purpose

This submission (PDF, 928KB, 26 pages) is a proposal for the classification of the Respiratory Syncytial Virus (RSV) vaccine to be expanded to include persons aged 50-59 who are at increased risk of RSV disease. The proposed reclassification is:

Prescription: except when administered for the prevention of lower respiratory tract disease caused by respiratory syncytial virus RSV-A and RSV-B subtypes to a person 60 years of age and older, or persons 50 through 59 years of age who are at increased risk for RSV disease, by registered pharmacists and/or authorised vaccinator, who have successfully completed the Vaccinator Foundation Course (or any equivalent training course approved by Te Whatu Ora) and who complies with the immunisation standards of Health NZ/Te Whatu Ora.

The classification of the RSV vaccine was recently considered at the 72^nd MCC meeting held on 12 June 2024, where expansion to enable administration of the vaccine by specified vaccinators, without prescription, to those 60 years of age and over was proposed. At that time, the MCC recommended not to reclassify the RSV vaccine based on the information submitted.

However, as discussed at the 73^rd MCC meeting, following the receipt of additional information that was unavailable at the 72^nd MCC meeting, the Group Manager of Medsafe, Ministry of Health, acting under delegated authority, changed the classification of the RSV vaccine by gazette on 18 December 2024.

The current submission seeks to further expand administration of the vaccine by specified vaccinators, without a prescription, to those aged 50 years and older. This follows approval of an extension to the approved indication to include this age group.

Background

The MCC acknowledged the submission from GlaxoSmithKline New Zealand (GSK) and noted that the purpose of the submission is to expand the classification of the RSV vaccine to enable administration by authorised vaccinators to people aged 50-59 years who are at increased risk for RSV disease. The MCC noted that the current classification enables registered pharmacists to administer the vaccine to individuals aged 60 years and older.

The MCC noted the discussions surrounding the RSV vaccine at the 72^nd and 73^rd meetings, acknowledging that the Group Manager of Medsafe, Ministry of Health, acting under delegated authority, changed the classification of the RSV vaccine following the receipt additional information provided by GSK.

Comments

The MCC acknowledged that three comments were received regarding this submission, all of which expressed support for the proposed classification change.

Discussion

The MCC discussed the minutes from the 72^nd MCC meeting, noting that the novelty of the vaccine was one factor that influenced their recommendation not to reclassify the RSV vaccine at that time. The MCC discussed whether the vaccine is still considered novel, and noted vaccination rates overseas. The MCC noted that the RSV vaccine has been approved in New Zealand for around one year.

The MCC acknowledged that the indication extension to include those aged 50 to 59 at increased risk of RSV disease was approved by Medsafe in May 2025, and that this indication has also recently been approved in other jurisdictions.

Medsafe provided a description of what clinical data is assessed when approving new indications which extend the age ranges for approved vaccines in New Zealand. This assessment is typically based on immunogenicity bridging studies and safety studies, which if positive, is supportive and is sufficient to demonstrate efficacy for approval.

The MCC acknowledged Medsafe's advice that immunogenicity studies are sufficient to support efficacy and approval of this indication.

The MCC discussed the proposed reclassification, noting that 'persons at increased risk for RSV disease' could be interpreted as covering a wide range of people. The MCC queried the inclusion of all authorised vaccinators in the proposed reclassification, noting that clinical judgement would be required to determine when administration of the vaccine is appropriate. The MCC agreed that, whilst pharmacists would be well-placed to do this, it is not clear if all authorised vaccinators would be.

The MCC noted that, should the RSV vaccine be able to be administered by all authorised vaccinators, it would be important that individual patient uptake of the RSV vaccine is recorded in the Aotearoa Immunisation Register (AIR). The MCC noted that a training plan and protocol for implementation were not included in the submission, and it is therefore unclear how all authorised vaccinators would identify whether administration of the vaccine is appropriate and ensure appropriate records of administration are kept. The MCC noted that the current classification of the RSV vaccine enables pharmacist administration of the vaccine to those aged 60 years and over. The MCC considered whether increasing accessibility by enabling all authorised vaccinators to administer the vaccine to individuals aged 50 to 59 years of age at increased risk of RSV disease would result in improved public health for this higher risk population.

The MCC agreed that, whilst there are potential benefits to enabling pharmacist administration of the vaccine to this higher risk population, there are outstanding concerns around this being extended to all authorised vaccinators. As such, the MCC agreed to recommend that the RSV vaccine be reclassified to enable administration to individuals aged 50 to 59 years of age at increased risk of RSV disease by pharmacists only.

Recommendation

Prescription: except when administered for the prevention of lower respiratory tract disease caused by respiratory syncytial virus RSV-A and RSV-B subtypes to a person 60 years of age and older, or persons 50 through 59 years of age who are at increased risk for RSV disease, by a registered pharmacist who has successfully completed the Vaccinator Foundation Course (or any equivalent training course approved by Te Whatu Ora) and who complies with the immunisation standards of Health NZ/Te Whatu Ora.

5.3 Bilastine (Menarini New Zealand Pty Limited)

Purpose

Bilastine is a non-sedating antihistamine used for the symptomatic treatment of seasonal and perennial allergic-rhinoconjunctivitis and urticaria. The current classification of bilastine in New Zealand is:

Prescription: except when specified elsewhere in this schedule

Pharmacy-only: for oral use

This submission (PDF, 211KB, 15 pages) proposes to change the classification of bilastine to:

Prescription: except when specified elsewhere in this schedule

Pharmacy-only: for oral use; for ophthalmic use in adults except when sold in practice by an optometrist registered with the Optometrists and Dispensing Opticians Board.

Background

The MCC acknowledged the submission from Menarini New Zealand Pty Limited (Menarini) and noted that the purpose of the submission is to reclassify bilastine for ophthalmic use to pharmacy-only.

The MCC noted that this submission is focussed on bilastine eye drops, which are indicated for the treatment of ocular signs and symptoms of seasonal and perennial allergic conjunctivitis.

The MCC acknowledged that bilastine eye drops are not currently approved in New Zealand, but that there are other antihistamine eye drops that are approved (including lodoxamide and levocabastine). The MCC noted that products containing bilastine for oral use have been approved in New Zealand since 2018.

Comments

The MCC acknowledged that one comment was received regarding this submission, which expressed support for the proposal.

Discussion

The MCC considered the approval of bilastine eye drop products overseas, and noted that they are not registered in Australia, Canada, Japan, the UK, or the US. The MCC acknowledged that this product is registered in 22 European countries.

Medsafe advised that such a product would be considered a low-risk level 3 medicine, as per the Guideline on the Regulation of Therapeutic Products in New Zealand - New Medicine Applications document. Medsafe advised that an application for this product would require an assessment of clinical safety and efficacy.

The MCC discussed the risks associated with the submission, and agreed these were minimal. The MCC considered that a key risk associated with eye drop products is infection due to poor hygiene practices, in particular not cleaning the nozzle of the bottle before and after use. This could present a clinical risk, and may be resolved through a combination of patient education, labelling, or warning statements.

The MCC considered the proposed warning statements. The MCC discussed the stated maximum duration for use of 8 weeks, and noted this was a long period compared to other medications. However, the MCC agreed that this length of time was reasonable for the treatment of hay fever, and has been approved previously in the case of levocabastine eye drops. The MCC agreed that the proposed warning statements were appropriate, and should be included on any future products approved in New Zealand.

The MCC discussed the wording of the proposed classification, and queried whether an age limit should be stated. The MCC noted that the proposed warning statements include the statement 'do not use if you are under 18 years of age'. The MCC agreed that this is acceptable, noting that other antihistamines for ophthalmic use do not have age limits in the classification statement.

The MCC agreed that the submission from Menarini was comprehensive, and that clinical data was of good quality. The MCC agreed that the overall balance of risks and benefits for the proposed reclassification is favourable. The MCC therefore recommended to reclassify bilastine for ophthalmic use to pharmacy-only.

Recommendation

The MCC recommended that the classification of bilastine should be amended to:

Prescription: except when specified elsewhere in this schedule

Pharmacy-only: for oral use; for ophthalmic use in adults except when sold in practice by an optometrist registered with the Optometrists and Dispensing Opticians Board.

5.4 Lithium (Prof Julia Rucklidge)

Purpose

This submission (PDF, 219KB, 16 pages) proposes changes to the classification of lithium to introduce a recommended daily dose of 3 mg:

Prescription: except when specified elsewhere in this schedule

Pharmacy-only: for dermal use in medicines containing 1% or less but more than 0.01%; except when present as an excipient in dermal medicines containing 0.25% or less; except when present in products for internal use containing no more than 3 mg of lithium as the recommended daily dose

General sale: for dermal use in medicines containing 0.01% or less; when present as an excipient in medicines for dermal use containing 0.25% or less; when present in products for internal use containing no more than 3 mg of lithium as the recommended daily dose

Background

The MCC acknowledged the submission from Prof Julia Rucklidge, and noted that the purpose of the submission is to enable lithium to be sold at general sales for internal use at a maximum recommended daily dose of 3 mg.

The MCC discussed the regulation of lithium overseas, noting that there does not appear to be a consistent approach to the regulation of lithium globally. The MCC acknowledged that the New Zealand classification of lithium is currently harmonised to that in Australia.

The MCC noted that the submission highlights several observational and animal studies that describe a range of health benefits linked to lithium supplementation. The MCC also noted that some sections of the submission were not completed, including an integrated benefit-risk assessment.

Comments

The MCC acknowledged that one comment was received regarding this submission, which did not support the proposal.

Discussion

Medsafe provided additional context to the MCC regarding the Medicines Act 1981 and the Dietary Supplements Regulations 1985. Medsafe explained that if a product is for a therapeutic purpose, then it is a medicine, as defined in the Medicines Act. Medsafe explained that where substances are not for a therapeutic purpose and they meet the requirements of the Dietary Supplement Regulations, they do not require approval under the Medicines Act and may be sold as dietary supplements.

The MCC acknowledged that the interface between the Medicines Act 1981 and the Dietary Supplements Regulations 1985 can be difficult to navigate. The MCC emphasised that any product that makes therapeutic claims is a medicine, which requires approval by Medsafe.

The MCC acknowledged the current classification of lithium, noting that lithium is a prescription medicine, except for dermal use under certain stipulations:

Prescription: except when specified elsewhere in this schedule; except when present as an excipient in dermal medicines containing 0.25% or less

Pharmacy-only: for dermal use in medicines containing 1% or less but more than 0.01%; except when present as an excipient in dermal medicines containing 0.25% or less

General sale: for dermal use in medicines containing 0.01% or less; when present as an excipient in medicines for dermal use containing 0.25% or less

The MCC queried why lithium may be present in higher amounts in medicines for dermal use if it is declared as an excipient rather than an active ingredient. Medsafe agreed to investigate this statement following the meeting (see secretariat note below).

The MCC noted that lithium was included on the MCC agenda at the 56^th meeting in 2017 in anticipation of implementation of the Natural Health Products Bill at the time, which was cancelled in November 2017. The MCC discussed the submission for lithium from the 56^th meeting, and noted that much of the content in the present submission is duplicated from the MCC56 submission. The MCC queried whether the information provided in the present submission is up to date.

The MCC discussed the risk of adverse reactions and interactions with other medicines associated with lithium. The MCC opinion was that the submission did not include sufficient information in this regard.

The MCC agreed that the present submission did not include sufficient information on the risks associated with lithium, and queried the quality of the studies cited throughout the submission. The MCC noted that lithium supplementation is often considered to promote mental health. Any lithium product, regardless of concentration, is a medicine if intended to be used for a therapeutic purpose.

The MCC considered whether the proposed reclassification could disproportionately increase the risk of harm to mental health patients. The MCC agreed that there are outstanding concerns associated with the proposed changes, and that reclassification could not be recommended based on the information available.

Secretariat’s Note:

Medsafe has reviewed the classification statement for lithium regarding its use as an excipient. This statement was introduced in 2007. It appears that the purpose of this statement is to make it clear that certain dermal cosmetics that contain lithium as an excipient, when not used for a therapeutic purpose, are not medicines. There are no approved medicines in New Zealand that are impacted by this statement (i.e. no dermal medicines that contain lithium as an excipient). The statement is therefore not relevant for the purpose of this submission.

Recommendation

The MCC agreed that the classification of lithium should remain unchanged.

5.5 Vitamin D (Prof Julia Rucklidge)

Purpose

This submission (PDF, 221KB, 15 pages) proposes changes to the classification of Vitamin D (including cholecalciferol and ergocalciferol) to increase the recommended daily dose limit from 25 micrograms to 75 micrograms:

Prescription: for internal use in medicines containing more than 75 micrograms per recommended daily dose except in parenteral nutrition replacement preparations

General sale: when in products for internal use containing 75 micrograms or less per recommended daily dose; when in parenteral nutrition replacement preparations; when in products for external use

Background

The MCC acknowledged the submission from Prof Julia Rucklidge, and noted that the purpose of the submission is to increase the recommended daily dose of vitamin D for internal use at general sales from 25 micrograms to 75 micrograms.

The MCC acknowledged the presence of vitamin D deficiency in New Zealand, and noted that vitamin D supplementation is usually only needed for individuals at increased risk of deficiency. The MCC noted that vitamin D is not routinely screened in the New Zealand population. The MCC agreed that testing vitamin D levels in individuals with risk factors or symptoms suggestive of vitamin D deficiency is appropriate.

The MCC acknowledged the varying approaches to vitamin D classification overseas, and noted that the current New Zealand classification is similar to that in both Australia and Canada.

The MCC noted that several components of the submission did not include sufficient information, including sections describing important considerations relating to New Zealand, indications and dose, overdose, and the potential for medication errors, misuse, or abuse.

Comments

The MCC acknowledged that one comment was received regarding this submission, which did not support the proposal.

Discussion

However, when used to supplement the diet (rather than for a therapeutic purpose) vitamin D is a dietary supplement, provided it meets if requirements of Dietary Supplement Regulations. The regulations limit the maximum daily dose of vitamin D to 25 micrograms. This means that products containing more than 25 micrograms of vitamin D per recommended daily dose OR products that make therapeutic claims are medicines.

The MCC acknowledged that the interface between the Medicines Act 1981 and the Dietary Supplements Regulations 1985 can be difficult to navigate. Medsafe reiterated that any product that makes therapeutic claims is a medicine, which requires approval by Medsafe.

The MCC noted that, should the proposed reclassification of vitamin D be implemented, products containing less than 75 micrograms and more than 25 micrograms of vitamin D would likely still be for a therapeutic purpose (to treat vitamin D deficiency), and therefore would be considered a general sale medicine rather than a dietary supplement (which would still only permit a maximum daily dose of 25 micrograms). The impact of a classification change would increase the amount of vitamin D permitted in a general sale medicine from 25 micrograms to 75 micrograms. As medicines, they would require approval by Medsafe.

The MCC noted that vitamin D was included on the MCC agenda at the 56^th meeting in 2017 in anticipation of implementation of the Natural Health Products Bill at the time, which was cancelled in November 2017. The MCC discussed the submission for vitamin D from the 56^th meeting, and noted that much of the content in the present submission is duplicated from the MCC56 submission. The MCC queried whether the information provided in the present submission is up to date.

The MCC noted that the New Zealand Formulary defines a daily dose of 10 micrograms of vitamin D sufficient for nutritional or physiological supplementation in high-risk adults, to treat vitamin D deficiency.

The MCC considered the benefits of the proposed changes outlined in the submission. The MCC opinion was that the benefits were not clear, particularly with regards to improving clinical and public health outcomes.

The MCC discussed the risks associated with vitamin D supplementation and multi-supplementation. The MCC noted that many supplements do not clearly state their ingredients, and agreed that the risk of excessive vitamin D intake due to misuse or multi-supplementation is of concern.

The MCC noted that there are a range underlying medical causes of vitamin D deficiency, including liver disease, kidney disease, and malabsorption issues. The MCC agreed that vitamin D deficiency needs to be diagnosed and the underlying causes investigated to ensure appropriate treatment is initiated in these patients.

The MCC agreed that the above considerations would only be exacerbated by increasing the general sales limit of vitamin D from 25 to 75 micrograms.

The MCC considered the role of vitamin D supplementation in resolving vitamin D deficiencies at a population level. The MCC noted that there was a lack of evidence outlined in the submission in this regard.

Overall, the MCC agreed that there are outstanding concerns associated with the proposed changes, and that reclassification could not be recommended based on the information available.

Recommendation

The MCC agreed that the classification of vitamin D should remain unchanged.

5.6 Liquid Paracetamol - proposal to allow provision by vaccinators (Te Whatu Ora)

Purpose

This submission (PDF, 109KB, 2 pages) proposes to amend the classification of paracetamol to include a statement that permits authorised vaccinators to administer liquid paracetamol to children under the age of 2 years concurrently with the Bexsero vaccine to prevent and treat fever:

Pharmacy-only; except when administered by vaccinators, registered pharmacists, or registered intern pharmacists who have successfully completed the Vaccinator Foundation Course (or any equivalent training course approved by the Ministry of Health) and who comply with the immunisation standards of the Immunisation Handbook, to a child under the age of two with the administration of Bexsero vaccine to prevent and treat fever.

Background

The MCC acknowledged the submission from Te Whatu Ora - Health New Zealand and noted that the purpose of the submission is to enable authorised vaccinators to administer liquid paracetamol to children being administered the Bexsero vaccine.

The MCC noted that fever and pain are common side effects of the Bexsero vaccine, and acknowledged the clinical need for liquid paracetamol in this regard.

The MCC acknowledged that the proposed change in classification for liquid paracetamol is complex. The MCC noted that Section 44D of the Medicines Regulations 1984 enables the supply of restricted and pharmacy-only medicines by an individual only if they are authorised to supply the medicine in accordance with a standing order, and supplies that medicine in accordance with that standing order.

Comments

The MCC acknowledged the seven comments that were received regarding this submission, all of which expressed support for the proposed classification change. The MCC acknowledged several points that were raised, including the prophylactic use of ibuprofen to treat immunisation-related pain and fever, and the broadening of the proposed classification to all Meningococcal B vaccines, rather than only Bexsero.

Discussion

The MCC considered comments that suggested the proposed classification be expanded to include all Meningococcal B vaccines, rather than Bexsero alone. The MCC noted that fever and pain are more common with the Bexsero vaccine compared with other Meningococcal B vaccines. The MCC agreed that it was appropriate for the proposed classification to include only the Bexsero vaccine at this time.

The MCC acknowledged the comments noting that ibuprofen is also recommended for the treatment of fever and pain following immunisation with Bexsero. The MCC considered the need for a similar change for ibuprofen in this context. The MCC agreed that the classification of ibuprofen fell beyond the scope of the submission, and would not be discussed at this time.

The MCC noted that the submission did not include information regarding the mechanisms and safety procedures associated with the proposed classification change. The MCC agreed that this information would be required to ensure a thorough risk-benefit assessment of the proposed reclassification is undertaken.

The MCC discussed the labelling of liquid paracetamol, noting that labels and dosing instructions for these products are often complex and are not always clear for parents administering medication to their children.

The MCC agreed that there is a clinical need for liquid paracetamol in the context of Bexsero and other Meningococcal B vaccines. The MCC considered whether the proposal was limited by the Medicines Regulations 1984 (the Regulations). The MCC noted that a consequence of Section 44D of the Regulations is that even if liquid paracetamol was down-scheduled, vaccinators, registered pharmacists, or registered intern pharmacists would be unable to supply liquid paracetamol without a standing order.

The MCC concluded that, whilst they were in agreement with the proposed outcome of the submission, this issue could not be solved by reclassification of liquid paracetamol.

The MCC will provide individual feedback to Te Whatu Ora - Health New Zealand. Standing orders remains a legislative option to enable supply.

Recommendation

The MCC agreed that the classification of liquid paracetamol should remain unchanged.

5.7 Peptide Groups (Medsafe)

Purpose

This submission (PDF, 509KB, 16 pages) from Medsafe proposes to introduce ten group entries for unscheduled peptides that have been intercepted at the border, to classify them as prescription medicines. Many of these peptides are being imported by private individuals who intend to administer them for a therapeutic purpose, posing a risk to health as the product quality, efficacy, and interactions with other medicines are unknown. The proposed group entries are:

Thymic peptide hormones and their analogues
Body Protective Compound (BPC)-157 and its analogues
Adrenocorticotropic hormone analogues
Pineal gland peptides and their analogues
Anti-microbial peptides and their precursors
Myostatin modulator peptides
Mitochondria-derived peptides and their analogues
Erythropoietin and its analogues
Tuftsin and its analogues
Kisspeptins

This submission also proposes the classification of six individual peptides as prescription medicines, to avoid doubt that these are prescription medicines: larazotide, PTD-DBM, AICAR, B7-33, PNC-27, and SS-31.

Background

The MCC acknowledged the submission received from Medsafe to introduce several group classifications for a range of unscheduled peptides. The MCC considered the reported activities of the unscheduled peptides included in the submission. The MCC noted that these products are reportedly purchased for a range of uses, including immune system modulation, tissue repair, anti-aging, anti-cancer, performance & image enhancing, and puberty & fertility regulation.

Comments

The MCC acknowledged that one comment was received regarding this submission, which supported for the proposal.

Discussion

The MCC noted that many of the products within these groups are being imported for personal use to treat serious conditions such as cancer, HIV, sepsis, and heart failure. The MCC expressed concern that use of these unapproved products without the input of a medical practitioner poses a risk of harm to New Zealanders. The MCC agreed that classification of the unscheduled peptides listed in the submission as prescription medicines would help to reduce this risk of harm.

The MCC noted that, should these peptides be classified, if there is legitimate use for any of these products patients can continue to access them, provided they obtain a prescription from a health professional.

The MCC considered whether any of the proposed peptides would have legitimate uses in other contexts such as in the cosmetics industry, and whether a classification could have unintended consequences. The MCC acknowledged that this would be difficult to determine, but agreed that more information regarding the potential impact of this classification on external parties would be needed before a recommendation to classify these substances as prescription medicines could be made.

Recommendation

The MCC is deferring the decision pending additional information.

Secretariat’s Note:

Medsafe consulted with professional bodies in the cosmetics industry regarding this agenda item. No issues were raised regarding the proposal to classify these unscheduled peptides as prescription medicines. Medsafe therefore recommends the peptides outlined in this proposal are classified as prescription medicines.

6. New medicines for classification

The following new chemical entities are submitted to the Committee for classification.

6.1 Anifrolumab

Anifrolumab is a human immunoglobulin G1 kappa (IgG1k) monoclonal antibody indicated in adult patients with moderate to severe active systemic lupus erythematosus (SLE), despite standard therapy.

Recommendation

The MCC recommended that anifrolumab be added to the New Zealand Medicines Schedule as a prescription medicine.

6.2 Deutivacaftor

Deutivacaftor is a cystic fibrosis transmembrane conductance regulator (CFTCR) potentiator included in a triple combination therapy (vanzacaftor/tezacaftor/deutivacaftor) indicated for the treatment of cystic fibrosis in people aged 6 years and older who have at least one F508del mutation or another responsive mutation in the cystic fibrosis transmembrane conductance regulator gene.

Recommendation

The MCC recommended that deutivacaftor be added to the New Zealand Medicines Schedule as a prescription medicine.

6.3 Mirvetuximab soravtansine

Mirvetuximab soravtansine is a folate receptor alpha (FRa)-directed antibody-drug conjugate indicated in the treatment of adult patients with FRa-positive, platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer, who have received one to three prior systemic treatment regimens.

Recommendation

The MCC recommended that mirvetuximab soravtansine be added to the New Zealand Medicines Schedule as a prescription medicine.

6.4 Vanzacaftor

Vanzacaftor is a cystic fibrosis transmembrane conductance regulator (CFTCR) modulator included in a triple combination therapy (vanzacaftor/tezacaftor/deutivacaftor) indicated for the treatment of cystic fibrosis in people aged 6 years and older who have at least one F508del mutation or another responsive mutation in the cystic fibrosis transmembrane conductance regulator gene.

Recommendation

The MCC recommended that vanzacaftor be added to the New Zealand Medicines Schedule as a prescription medicine.

7. Harmonisation of the New Zealand and Australian schedules

Recent scheduling changes made to the Poisons Standard in Australia are to be considered by the Medicines Classification Committee for their implementation in New Zealand.

Public consultation is an important part of the Medicines Classification Committee process, stakeholders are welcome to provide comments on all agenda items including those being considered for harmonisation.

The Medsafe Medicines Classification Committee - Public Consultation on Agenda Items webpage provides information on how to comment on agenda items.

7.1 New chemical entities which are not yet classified in New Zealand

27 September 2024 Scheduling Final Decisions Public Notice

7.1a Vutrisiran

Vutrisiran is a medicine indicated in the treatment of hereditary transthyretin-mediated amyloidosis (hATTR amyloidosis) in adult patients with stage 1 or stage 2 polyneuropathy.

From 1 October 2024 vutrisiran was classified as a Schedule 4 (prescription) medicine in Australia.

Recommendation

The MCC recommended that vutrisiran be added to the New Zealand Medicines Schedule as a prescription medicine.

7.1b Ritlecitinib

Ritlecitinib is a Janus-associated kinase (JAK) inhibitor indicated in the treatment of severe alopecia areata in adults and adolescents 12 years of age and older.

From 1 October 2024 ritlecitinib was classified as a Schedule 4 (prescription) medicine in Australia.

Recommendation

The MCC recommended that ritlecitinib be added to the New Zealand Medicines Schedule as a prescription medicine.

7.1c Odevixibat

Odevixibat is a selective inhibitor of the ileal bile acid transporter (IBAT) indicated in the treatment of progressive familial intrahepatic cholestasis.

From 1 October 2024 odevixibat was classified as a Schedule 4 (prescription) medicine in Australia.

Recommendation

The MCC recommended that odevixibat be added to the New Zealand Medicines Schedule as a prescription medicine.

7.1d Pinaverium bromide

Pinaverium bromide is a calcium channel blocker indicated in the treatment of functional gastrointestinal disorders, including irritable bowel syndrome (IBS).

From 1 October 2024 pinaverium bromide was classified as a Schedule 4 (prescription) medicine in Australia.

Recommendation

The MCC recommended that pinaverium bromide be added to the New Zealand Medicines Schedule as a prescription medicine.

7.1e Lumasiran

Lumasiran is a medicine indicated in the treatment of primary hyperoxaluria type 1 (PH1) in all age groups.

From 1 October 2024 lumasiran was classified as a Schedule 4 (prescription) medicine in Australia.

Recommendation

The MCC recommended that lumasiran be added to the New Zealand Medicines Schedule as a prescription medicine.

7.1f Capivasertib

Capivasertib is an anti-cancer drug (used in combination with fulvestrant) that is indicated in the treatment of adult patients with hormone receptor (HR) positive, human epidermal growth factor receptor 2 (HER2) negative locally advanced or metastatic breast cancer, following recurrence or progression on or after an endocrine-based regimen.

From 1 October 2024 capivasertib was classified as a Schedule 4 (prescription) medicine in Australia.

Recommendation

The MCC recommended that capivasertib be added to the New Zealand Medicines Schedule as a prescription medicine.

7.1g Vorasidenib

Vorasidenib is an inhibitor of mutated isocitrate dehydrogenase (IDH) 1 and 2 enzymes. It is indicated in the treatment of Grade 2 astrocytoma or oligodendroglioma brain tumours with a susceptible IDH1 or IDH2 mutation in adults and children aged 12 years and older, who do not require immediate chemotherapy or radiotherapy following surgical intervention.

From 1 October 2024 vorasidenib was classified as a Schedule 4 (prescription) medicine in Australia.

Recommendation

The MCC recommended that vorasidenib be added to the New Zealand Medicines Schedule as a prescription medicine.

7.1h Iptacopan

Iptacopan is a complement system inhibitor indicated in the treatment of adults with paroxysmal nocturnal haemoglobinuria.

From 1 October 2024 iptacopan was classified as a Schedule 4 (prescription) medicine in Australia.

Recommendation

The MCC recommended that iptacopan be added to the New Zealand Medicines Schedule as a prescription medicine.

7.1i Danicopan

Danicopan is a complement system inhibitor indicated in the treatment of adults with paroxysmal nocturnal haemoglobinuria.

From 1 October 2024 danicopan was classified as a Schedule 4 (prescription) medicine in Australia.

Recommendation

The MCC recommended that danicopan be added to the New Zealand Medicines Schedule as a prescription medicine.

7.1j Sotatercept

Sotatercept is an activin signalling inhibitor indicated in the treatment of pulmonary arterial hypertension.

From 1 October 2024 sotatercept was classified as a Schedule 4 (prescription) medicine in Australia.

Recommendation

The MCC recommended that sotatercept be added to the New Zealand Medicines Schedule as a prescription medicine.

16 December 2024 Scheduling Final Decisions Public Notice

7.1k Fedratinib

Fedratinib is an anti-cancer medication indicated in the treatment of disease-related splenomegaly or symptoms in adult patients with primary myelofibrosis, post polycythaemia vera myelofibrosis or post essential thrombycythaemia who are Janus-associated kinase (JAK) naïve or have been treated with ruxolitinib.

From 1 February 2025 fedratinib was classified as a Schedule 4 (prescription) medicine in Australia.

Recommendation

The MCC recommended that fedratinib be added to the New Zealand Medicines Schedule as a prescription medicine.

7.1l Abaloparatide

Abaloparatide is a medicine indicated in the treatment of osteoporosis in post-menopausal women at increased risk of fracture.

From 1 February 2025 abaloparatide was classified as a Schedule 4 (prescription) medicine in Australia.

Recommendation

The MCC recommended that abaloparatide be added to the New Zealand Medicines Schedule as a prescription medicine.

7.1m Efgartigimod alfa

Efgartigimod alfa is a medicine indicated as an add-on to standard therapy for the treatment of adult patients with generalised myasthenia gravis (gMG) who are anti-acetylcholine receptor (AChR) antibody positive.

From 1 February 2025 efgartigimod alfa was classified as a Schedule 4 (prescription) medicine in Australia.

Recommendation

The MCC recommended that efgartigimod alfa be added to the New Zealand Medicines Schedule as a prescription medicine.

7.1n Dexrazoxane

Dexrazoxane is a medicine indicated for use in the prevention of cardiotoxicity caused by anthracycline use.

From 1 February 2025 dexrazoxane was classified as a Schedule 4 (prescription) medicine in Australia.

Recommendation

The MCC recommended that dexrazoxane be added to the New Zealand Medicines Schedule as a prescription medicine.

7.1o Zolbetuximab

Zolbetuximab is a monoclonal antibody indicated for patients with human epidermal growth factor receptor 2 (HER2)-negative gastric or gastroesophageal junction (GEJ) adenocarcinoma whose tumours are Claudin (CLDN) 18.2 positive.

From 1 February 2025 zolbetuximab was classified as a Schedule 4 (prescription) medicine in Australia.

Recommendation

The MCC recommended that zolbetuximab be added to the New Zealand Medicines Schedule as a prescription medicine.

7.1p Marstacimab

Marstacimab is a monoclonal antibody indicated for routine prophylaxis of bleeding episodes in patients 12 years of age and older with either severe haemophilia A without factor VIII inhibitors or severe haemophilia B without factor IX inhibitors.

From 1 February 2025 marstacimab was classified as a Schedule 4 (prescription) medicine in Australia.

Recommendation

The MCC recommended that marstacimab be added to the New Zealand Medicines Schedule as a prescription medicine.

7.1q Rozanolixizumab

Rozanolixizumab is a monoclonal antibody indicated as an add-on to standard therapy for the treatment of generalised myasthenia gravis (gMG) in adult patients who are anti-acetylcholine receptor (AchR) or anti-muscle-specific tyrosine kinase (MuSK) antibody positive.

From 1 February 2025 rozanolixizumab was classified as a Schedule 4 (prescription) medicine in Australia.

Recommendation

The MCC recommended that rozanolixizumab be added to the New Zealand Medicines Schedule as a prescription medicine.

7.1r Elacestrant dihydrochloride

Elacestrant dihydrochloride is a selective oestrogen receptor degrader indicated in the treatment of oestrogen receptor (ER) positive and human epidermal growth factor receptor 2 (HER2) negative, oestrogen receptor (ESR) 1 mutated, advanced or metastatic breast cancer.

From 1 February 2025 elacestrant dihydrochloride was classified as a Schedule 4 (prescription) medicine in Australia.

Recommendation

The MCC recommended that elacestrant dihydrochloride be added to the New Zealand Medicines Schedule as a prescription medicine.

7.1s Cipaglucosidase alfa

Cipaglucosidase alfa is a long-term enzyme replacement therapy used in combination with the enzyme stabilise miglustat for the treatment of adults with late onset Pompe disease (acid alpha-glucosidase deficiency).

From 1 February 2025 cipaglucosidase alfa was classified as a Schedule 4 (prescription) medicine in Australia.

Recommendation

The MCC recommended that cipaglucosidase alfa be added to the New Zealand Medicines Schedule as a prescription medicine.

7.1t Inebilizumab

Inebilizumab is a monoclonal antibody indicated in the treatment of adult patients with neuromyelitis optica spectrum disorders (NMOSD) who are anti-aquaporin-4 immunoglobulin G (AQP4-IgG) seropositive.

From 1 February 2025 inebilizumab was classified as a Schedule 4 (prescription) medicine in Australia.

Recommendation

The MCC recommended that inebilizumab be added to the New Zealand Medicines Schedule as a prescription medicine.

7.1u Palopegteriparatide

Palopegteriparatide is a parathyroid hormone (PTH) analogue indicated for the replacement of endogenous PTH in adult patients with hypoparathyroidism.

From 1 February 2025 palopegteriparatide was classified as a Schedule 4 (prescription) medicine in Australia.

Recommendation

The MCC recommended that palopegteriparatide be added to the New Zealand Medicines Schedule as a prescription medicine.

7.1v Garadacimab

Garadacimab is a monoclonal antibody against the activated coagulation factor XIIa. It is indicated for routine prevention of recurrent hereditary angioedema (HAE) attacks in patients aged 12 years and older with C1-esterase inhibitor deficiency/dysfunction HAE.

From 1 February 2025 garadacimab was classified as a Schedule 4 (prescription) medicine in Australia.

Recommendation

The MCC recommended that garadacimab be added to the New Zealand Medicines Schedule as a prescription medicine.

7.1w Sodium citrate dihydrate

Sodium citrate dihydrate is a biological buffer and anticoagulant for therapeutic use in dialysis, diafiltration, or total plasma exchange.

From 1 February 2025 sodium citrate dihydrate was classified as a Schedule 4 (prescription) medicine in Australia.

Recommendation

The MCC recommended that sodium citrate dihydrate be added to the New Zealand Medicines Schedule as a prescription medicine.

19 May 2025 Scheduling Final Decisions Public Notice

7.1x Datopotamab deruxtecan

Datopotamab deruxtecan is an anti-cancer medication indicated for the treatment of adult patients with locally advanced or metastatic non-squamous non-small cell lung cancer who have received prior systemic therapy.

From 1 June 2025 datopotamab deruxtecan was classified as a Schedule 4 (prescription) medicine in Australia.

Recommendation

The MCC recommended that datopotamab deruxtecan be added to the New Zealand Medicines Schedule as a prescription medicine.

7.1y Elafibranor

Elafibranor is indicated for the treatment of primary biliary cholangitis in combination with ursodeoxycholic acid (UDCA) in adults with an inadequate response to UDCA, or as a monotherapy in adults unable to tolerate UDCA.

From 1 June 2025 elafibranor was classified as a Schedule 4 (prescription) medicine in Australia.

Recommendation

The MCC recommended that elafibranor be added to the New Zealand Medicines Schedule as a prescription medicine.

7.1z Futibatinib

Futibatinib is a kinase inhibitor used in the treatment of metastatic cholangiocarcinoma (bile duct cancer).

From 1 June 2025 futibatinib was classified as a Schedule 4 (prescription) medicine in Australia.

Recommendation

The MCC recommended that futibatinib be added to the New Zealand Medicines Schedule as a prescription medicine.

7.1aa Inavolisib

Inavolisib is an anti-cancer medication indicated for the treatment of adult patients with PIK3CA-mutateed, hormone receptor positive, human epidermal growth factor receptor 2 (HER2)-negative, locally advanced or metastatic breast cancer.

From 1 June 2025 inavolisib was classified as a Schedule 4 (prescription) medicine in Australia.

Recommendation

The MCC recommended that inavolisib be added to the New Zealand Medicines Schedule as a prescription medicine.

7.1ab Landiolol

Landiolol is a beta-blocker used for the acute treatment of elevated heart rate and irregular heartbeat (arrhythmia).

From 1 June 2025 landiolol was classified as a Schedule 4 (prescription) medicine in Australia.

Recommendation

The MCC recommended that landiolol be added to the New Zealand Medicines Schedule as a prescription medicine.

7.1ac Lazertinib

Lazertinib is a kinase inhibitor is a first-line treatment for adults with locally advanced or metastatic non-small cell lung cancer, in combination with amivantamab.

From 1 June 2025 lazertinib was classified as a Schedule 4 (prescription) medicine in Australia.

Recommendation

The MCC recommended that lazertinib be added to the New Zealand Medicines Schedule as a prescription medicine.

7.1ad Pegunigalsidase alfa

Pegunigalsidase alfa is a recombinant enzyme replacement therapy used in the treatment of Fabry disease, a genetic disorder causing a deficiency of the enzyme alpha-galactosidase A.

From 1 June 2025 pegunigalsidase alfa was classified as a Schedule 4 (prescription) medicine in Australia.

Recommendation

The MCC recommended that pegunigalsidase alfa be added to the New Zealand Medicines Schedule as a prescription medicine.

7.1ae Repotrectinib

Repotrectinib is an anti-cancer medication indicated for the treatment of adult patients with ROS1-positive locally advanced or metastatic non-small cell lung cancer.

From 1 June 2025 repotrectinib was classified as a Schedule 4 (prescription) medicine in Australia.

Recommendation

The MCC recommended that repotrectinib be added to the New Zealand Medicines Schedule as a prescription medicine.

7.1af Sepiapterin

Sepiapterin is an oral therapy for the treatment of individuals with hyperphenylalaninaemia.

From 1 June 2025 sepiapterin was classified as a Schedule 4 (prescription) medicine in Australia.

Recommendation

The MCC recommended that sepiapterin be added to the New Zealand Medicines Schedule as a prescription medicine.

7.1ag Teprotumumab

Teprotumumab is a monoclonal antibody indicated for the treatment of Thyroid Eye Disease (Graves' ophthalmopathy).

From 1 June 2025 teprotumumab was classified as a Schedule 4 (prescription) medicine in Australia.

Recommendation

The MCC recommended that teprotumumab be added to the New Zealand Medicines Schedule as a prescription medicine.

7.1ah Velmanase alfa

Velmanase alfa is a recombinant human lysosomal alpha-mannosidase used to treat alpha-mannosidosis.

From 1 June 2025 velmanase alfa was classified as a Schedule 4 (prescription) medicine in Australia.

Recommendation

The MCC recommended that velmanase alfa be added to the New Zealand Medicines Schedule as a prescription medicine.

7.2 Decisions by the Secretary to Department of Health and Aged Care Australia (or the Secretary's Delegate)

7.2a Desloratadine

Purpose

Desloratadine is a second-generation antihistamine used to treat seasonal allergic rhinitis.

The TGA recently made the final decision to reschedule desloratadine to permit general sales supply. The new classification in Australia is:

Schedule 4 (Prescription)

except when included in Schedule 2; or in divided preparations for oral use for the treatment of seasonal allergic rhinitis in adults and children 6 years and over, when:

in a primary pack containing 10 dosage units or less; and
labelled with a recommended daily dose not exceeding 5 mg of desloratadine.

Schedule 2 (Pharmacy-only)

in preparations for oral use except in divided preparations for the treatment of seasonal allergic rhinitis when:

in a primary pack containing 10 dosage units or less when labelled for adults and children 6 years and over; and
labelled with a recommended daily dose not exceeding 5 mg of desloratadine.

This scheduling change was implemented on 1 February 2025.

In New Zealand, desloratadine is currently scheduled as:

Prescription; except for oral use

Pharmacy-only; for oral use

At the 74^th meeting, the MCC considered whether it would be appropriate to reclassify desloratadine in New Zealand to harmonise with Australia.

Comments

The MCC acknowledged that one comment was received regarding this submission, which did not support the proposal.

Discussion

The MCC noted that there is one approved solid-form desloratadine product in New Zealand, which is currently classified as pharmacy-only.

The MCC acknowledged that the Australian reclassification of desloratadine was undertaken to align the classifications of loratadine and desloratadine.

The MCC noted the current classification of loratadine in New Zealand:

Prescription: except when specified elsewhere in this schedule

Pharmacy-only: for oral use; except in divided solid dosage forms for oral use containing 10 milligrams or less per dose form for the treatment of seasonal allergic rhinitis when sold in the manufacturer's original pack containing not more than 10 days' supply

General sale: in divided solid dosage forms for oral use containing 10 milligrams or less per dose form for the treatment of seasonal allergic rhinitis when sold in the manufacturer's original pack containing not more than 10 days' supply

The MCC acknowledged that the current classification of loratadine is similar to the proposed reclassification. The MCC agreed that the classifications of loratadine and desloratadine should be consistent.

The MCC considered the safety profile of desloratadine, noting that its safety has been well established. The MCC noted that desloratadine has a higher potency than loratadine, hence the 5 milligram dose in the Australian classification statement, compared with 10 milligrams for loratadine.

The MCC agreed that reclassification of desloratadine to align with that of loratadine is appropriate.

Recommendation

The MCC recommended that the classification of desloratadine should be amended to:

Prescription: except when specified elsewhere in this schedule

Pharmacy-only: for oral use; except in divided solid dosage forms for oral use containing 5 milligrams or less per dose form for the treatment of seasonal allergic rhinitis when sold in the manufacturer's original pack containing not more than 10 days' supply

General sale: in divided solid dosage forms for oral use containing 5 milligrams or less per dose form for the treatment of seasonal allergic rhinitis when sold in the manufacturer's original pack containing not more than 10 days' supply

Secretariat’s Note:

The MCC has recommended that the classification of desloratadine is aligned with that of loratadine. Medsafe intends that label statements of desloratadine will also be aligned to those of loratadine, should this reclassification be implemented. The MCC are in agreement with this approach.

7.2b Atropa belladonna

Purpose

Atropa belladonna (commonly known as deadly nightshade or belladonna) is a herbaceous plant used in some herbal/alternative medicines.

The TGA recently made the final decision to reschedule Atropa belladonna to introduce an age limit for pharmacy-only supply to reduce toxicity in children. The new classification of Atropa belladonna in Australia is:

Schedule 4 (Prescription)

except when included in Schedule 2

Schedule 2 (Pharmacy-only)

for external use in preparations containing 0.03% or less of total solanaceous alkaloids; or

for oral use in adults and children 6 years of age and over:

in undivided preparations containing 0.03% or less of total solanaceous alkaloids when labelled with a dose of 0.3 mg or less of total solanaceous alkaloids and a recommended daily dose of 1.2 mg or less of total solanaceous alkaloids; or
in divided preparations containing 0.3 mg or less of total solanaceous alkaloids per dosage unit, when labelled with a recommended daily dose of 1.2 mg or less of total solanaceous alkaloids

This scheduling change was implemented on 1 June 2025.

The classification of Atropa belladonna in New Zealand is:

Prescription: except when specified elsewhere in this schedule; except in medicines containing 300 micrograms or less of total solanaceous alkaloids per litre or per kilogram

Pharmacy-only; for external use in medicines containing 0.03% or less of the alkaloids of belladonna; for oral use in liquid form in medicines containing 0.03% or less and 0.3 milligrams or less per dose and not more than 1.2 milligrams per recommended daily dose of the alkaloids of belladonna or in solid dose form in medicines containing 0.3 milligrams or less per dose form and not more than 1.2 milligrams per recommended daily dose of the alkaloids of belladonna

There are no products containing Atropa belladonna with current approval in New Zealand.

At the 74^th meeting, the MCC considered whether it would be appropriate to reclassify Atropa belladonna in New Zealand to introduce an age limit, as in Australia.

Comments

The MCC acknowledged that one comment was received regarding this submission, which supported the proposal.

Discussion

The MCC discussed the reasoning behind the change implemented in Australia, noting that products to treat colic and teething symptoms were of the greatest concern. The MCC noted that adverse events associated with Atropa belladonna use in children include dry mouth, mydriasis, tachycardia, urinary retention, gastrointestinal ileus, fever, agitation, drowsiness, floppiness, poor feeding, and occasionally seizures.

The MCC noted that, whilst there are currently no approved products in New Zealand, the current classification would enable pharmacy-only products indicated for children to be approved. The MCC agreed that, given the risk of toxicity associated with Atropa belladonna, this is not appropriate. The MCC agreed that, in the interest of harm minimisation, the classification of Atropa belladonna should be aligned to that in Australia to introduce an age limit.

Recommendation

The MCC recommended that the classification of Atropa belladonna should be amended to:

Prescription: except when specified elsewhere in this schedule; except in medicines containing 300 micrograms or less of total solanaceous alkaloids per litre or per kilogram

Pharmacy-only; for external use in medicines containing 0.03% or less of the alkaloids of belladonna; for oral use in adults and children 6 years of age and over in liquid form in medicines containing 0.03% or less and 0.3 milligrams or less per dose and not more than 1.2 milligrams per recommended daily dose of the alkaloids of belladonna or in solid dose form in medicines containing 0.3 milligrams or less per dose form and not more than 1.2 milligrams per recommended daily dose of the alkaloids of belladonna

8. Matters arising

8.1 Objections to recommendations made at the 73^rd meeting

The deadline for intentions to object to a recommendation made at the 73^rd MCC meeting, together with a statement of the grounds on which the objection would be made, was 16 May 2025. No valid objections were received.

8.2 Brimonidine

Background

Brimonidine is a medicine which may be used to lower intraocular pressure in patients under certain conditions, or may be used to relieve redness of the eye due to minor eye irritations. From 1 June 2023 the TGA re-scheduled brimonidine to:

Schedule 4 (prescription): except when included in schedule 2,
Schedule 2 (pharmacy-only): in ophthalmic preparations for adult use containing not more than 0.025% brimonidine.

In New Zealand brimonidine is currently classified as a prescription medicine.

Brimonidine was an agenda item at the 71^st MCC meeting held on 14 November 2023. Two comments were received that supported the proposed alignment with Australia.

The MCC discussed the risks and benefits of reclassification, and noted that submissions from ophthalmologist and optometrist professional bodies would be beneficial. The MCC recommended that the classification of brimonidine should align with Australia, and therefore be amended to:

Prescription: except when specified elsewhere in this schedule.
Pharmacy-only: in ophthalmic preparations containing not more than 0.025% brimonidine.

Following the meeting, Medsafe invited several optometrist and ophthalmologist professional bodies to comment on this recommendation. Two valid objections were received, on the grounds that the MCC did not consider all safety information, as some information that would be useful to inform a recommendation was not provided to them:

Some topical decongestants have a history of inappropriate use and/or overuse.
The risk of allergic reaction and whether this risk would be reduced for products with strengths lower than 0.025% should be further investigated.

The Minister's delegate therefore decided to refer brimonidine to a future MCC meeting for further consideration.

Comments

The MCC acknowledged the three comments received regarding this agenda item. The MCC noted that two comments were in support of the proposed reclassification of brimonidine, and one comment was opposed.

Discussion

The MCC acknowledged the objections received from ophthalmologist and optometrist professional bodies following the recommendations made at the 71^st MCC meeting.

The MCC discussed the risks associated with brimonidine, noting that brimonidine is associated with a lower risk profile compared with other ocular decongestants on the market (such as naphazoline and tetrahydrozoline). The MCC noted that pharmacists are trained to manage the sale of these ocular decongestants.

The MCC discussed the risks associated with ocular decongestant use, noting the potential for these products to mask serious eye disease. The MCC noted that many of these products are used to treat red eye, which may not address any underlying causes of this symptom. The MCC acknowledged that this poses a clinical risk for pharmacy-only supply of these medicines. The MCC considered whether the risks of ocular decongestants as a group of medicines should be reviewed. The MCC agreed that it would be beneficial for Medsafe to provide a review of the clinical risks associated with all ocular decongestants to inform any future discussion surrounding their classification.

The MCC acknowledged that warning statements for ocular decongestants were recently considered by the Medicines Adverse Reaction Committee (MARC), which resulted in the introduction of a mandatory warning statement 'do not use in children under 12 years of age' for these products. The MCC agreed with this warning statement.

The MCC agreed that, at the present time, the classification of brimonidine should be aligned to that of other ocular decongestants. The MCC noted that the mandatory warning statement for ocular decongestants restricting use in children would also apply to brimonidine.

Recommendation

The MCC recommended that the classification of brimonidine should be amended to:

Prescription: except when specified elsewhere in this schedule.

Pharmacy-only: in ophthalmic preparations containing not more than 0.025% brimonidine.

The MCC also recommended that Medsafe review the clinical risks associated with all ocular decongestants to inform a future discussion on their classification.

8.3 Sedating antihistamines

Background

Sedating antihistamines were discussed at the 72^nd MCC meeting held on 12 June 2024. The MCC decided to recommend reclassification of sedating antihistamines to remove the indication for sedation in children aged under 12 years, which was consistent with the Medsafe submission for reclassification. These changes were implemented on 17 April 2025 via gazette notice.

The MCC also recommended that all oral sedating antihistamines available over-the-counter are restricted to use in those aged 6 years and older. There were two valid objections received regarding this recommendation to change the restricted classification for sedating antihistamines from children over 2 years of age, to children over 6 years of age. These objections were accepted as valid on the basis that the MCC made recommendations of a broader scope than the submission provided to them.

To further consider the MCC recommendation, the Minister's delegate decided to refer sedating antihistamines to a future MCC meeting to discuss the restricted classification age limit of sedating antihistamines.

Comments

The MCC acknowledged that two comments were received regarding this agenda item, both of which expressed support for the proposal.

Discussion

The MCC considered the previous recommendation made at the 72^nd meeting regarding sedating antihistamines. The MCC noted that the indication for sedation in children aged under 12 years has since been removed from these products. The MCC noted that the recommendation to restrict oral sedating antihistamines available over-the-counter to those aged 6 years and older was beyond the scope of the submission at the time.

The MCC considered their previous reasoning, and agreed that amending the restricted classification for sedating antihistamines from children over 2 years of age to children over 6 years of age was appropriate.