Revised: 8 December 2025
Compliance
Supplying Unapproved Medicines
See also: Unapproved Medicines and Unapproved Use of Approved Medicines for an Unapproved Purpose
Sections 29, 29A and 29B of the Medicines Act deal with the supply of unapproved medicines.
Section 29 permits the supply of unapproved medicines to medical practitioners, nurse practitioners and pharmacist prescribers for the treatment of a named patient under their care.
Section 29A allows any authorised prescriber to access an unapproved medicine where it is funded by Pharmac as an alternative to an approved funded medicine that is in short supply, for the treatment of a named patient in their care.
The legislation places an obligation on the supplier of the medicine to collect information about the supply and report some of this to the Director-General of Health (delegated to Medsafe).
To fulfil this obligation, suppliers of unapproved medicines must notify Medsafe, as soon as practicable after the end of every month in which the medicine has been supplied, of the following:
- The trade name and generic name of the medicine supplied
- The dose form
- The strength
- The pack size
- The month and year of supply
- The quantity sold or supplied.
Download the Sections 29,29A, 29B Declaration/Notification Form (Microsoft Word document 26 KB, 1 page) which includes a declaration that the supplier will maintain the following records:
- the name(s) of the prescriber(s) who requested the supply of the medicine (need not be supplied to Medsafe)
- the name(s) of the patient(s) the medicine was required for (need not be supplied to Medsafe)
- the dose form(s), pack size(s) and strength(s) of the medicine
- the quantity supplied
- the month and year the medicine was supplied
- the name(s) of the place(s) the medicine was supplied (need not be supplied to Medsafe)
These records may be called in or audited by Medsafe.
The completed form should be sent, preferably by email, to:
or by post to
Compliance Management Branch
Medsafe
PO Box 5013
WELLINGTON
