Revised: 6 May 2013

Compliance

Supplying Unapproved Medicines

See also: Unapproved Medicines and Unapproved Use of Medicines

Section 29 of the Medicine Act deals with the supply of unapproved medicines to medical practitioners for the treatment of a named patient under their care. The legislation places an obligation on the supplier of the medicine to report details of the supply to the Director-General of Health.

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:

• International non-proprietary name (INN) and trade name of the medicine supplied
• Dose form
• Month and year of supply
• Name and address of supplier.

Download the Section 29 Declaration/Notification Form (Microsoft Word document 26 KB, 1 page) which includes a declaration that the supplier will also maintain the following records:

• the name(s) of the medical practitioner(s) who requested the supply of the medicine
• the name(s) of the patient(s) the medicine was required for
• the dose form(s) and strength(s) of the medicine
• the date(s) of the month the medicine was supplied
• the name(s) of the place(s) the medicine was supplied to.

These records will be audited by Medsafe.

The completed form should be sent to:

Team Leader, Compliance
Medsafe
PO Box 5013
WELLINGTON