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This section provides an overview of medicines approved for administration and/or supply by authorised vaccinators under Medicines Regulations 1984, Regulation 44A, for the purposes of approved immunisation programmes.
A9.1. Regulations and pathways that enable administration and/or supply of medicines
A9.1.1. Medicines Regulations
A9.1.1. Medicines Regulations
The Medicines (Administration and Supply of Medicines in Approved Immunisation Programmes) Amendment Regulations 2025 came into force on 19 December 2025 to amend Regulation 44A.
Regulation 44A now specifies requirements that allow authorised vaccinators to administer vaccines and administer and/or supply medicines without a prescription for the purposes of an approved immunisation programme.
A9.1.2. Authority for the addition of medicines to approved immunisation programmes
A9.1.2. Authority for the addition of medicines to approved immunisation programmes
New medicines may be authorised under Regulation 44A of the Medicines Regulations 1984 by the Director-General of Health or a Medical Officer of Health for the purposes of an approved immunisation programme. However, Health New Zealand has established an approval pathway for medicines to be approved for use in immunisation programmes by the Director of Public Health or the Director-General of Health.
A9.2. Medicines Classification and Terminology
Prescription medicines
- May be supplied only on the prescription of an authorised prescriber.
Restricted medicines
- This is also known as Pharmacist-Only Medicines.
- May be supplied without a prescription, but the transaction must be made by a registered pharmacist in a pharmacy, and the details of the sale must be recorded.
Pharmacy medicines
- May only be supplied in a community or hospital pharmacy by any pharmacy personnel.
General sales medicines
- Medicines not listed in Schedule 1 of the Medicines Regulations 1984 are deemed to be unclassified and are referred to as general sales medicines and may be supplied from any outlet.
A9.3. Approved medicines for immunisation programmes
Table A9.1: Summary of medicines approved for approved immunisation programmes
A9.3.1. Adrenaline 1:1000 ampoule
A9.3.1. Adrenaline 1:1000 ampoule
Adrenaline 1:1000 ampoule is a restricted (pharmacist-only) medicine, and it is used to treat anaphylaxis, a rare but serious adverse event following vaccination. Adrenaline 1:1000 ampoule is approved for use in all approved immunisation programmes for the treatment of post-vaccination anaphylaxis.
Table A9.2: Adrenaline dosing regimen
|
Available formulation |
Route of administration |
Dosing regimen |
|||||||||||||||
|
Adrenaline 1:1000 (1mg/ml) ampoule for injection |
Intramuscular, preferably into the anterolateral outer thigh muscle
|
|
Note:
a. Auto-injectors for self-administration of adrenaline are not recommended to be used as a substitute for adrenaline ampoules. However, if an adrenaline auto-injector is the only available adrenaline preparation when treating anaphylaxis, then health care providers should use it.
A9.3.2. Paracetamol liquid formulation
A9.3.2. Paracetamol liquid formulation
Paracetamol suspension is a pharmacy-only medicine, and it is approved for use in the National Immunisation Programme (The National Immunisation Schedule).
Clinical guidance recommends paracetamol for children under two years receiving the Bexsero (meningococcal B) vaccine. Bexsero is scheduled as part of the National Immunisation Schedule at ages 3-months, 5-months and 12-months.
A prophylactic weight-based dose (15mg/kg) of paracetamol is recommended to reduce risk of fever. This is administered at the time of, or up to 30 minutes before, or immediately after Bexsero vaccination, followed by two further doses spaced 4 to 6 hours apart.
Authorised vaccinators are able to administer the first prophylactic dose of paracetamol and supply additional doses for the parent/caregiver to take home. Authorised vaccinators must advise the parent/caregiver on the recommended dose volume in millilitres for the strength of liquid paracetamol supplied, and the dosing intervals and times these should be administered. A maximum of 4 doses of paracetamol can be given in a 24-hour period.
Table A9.3: Paracetamol dosing regimen
|
Available formulation |
Route of administration |
Dosing regimen for administration when receiving Bexsero vaccine from age 2 months to 24 months. |
|
Paracetamol oral liquid 120mg/5ml |
Oral
|
Confirm the strength of paracetamol being administered and supplied.
Dose is 15 mg/kg per dose every 4 to 6 hours; up to a maximum of 4 doses in 24 hours.
|
|
Paracetamol oral liquid 250mg/5ml |