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Unapproved Medicines Supplied by NZBS under Section 29 - Quick Guide

What is Section 29?
  • Section 29 is a provision in the Medicines Act 1981 whereby a medical practitioner can prescribe a medicine that is not registered with Medsafe.
  • The medicines listed below do not have full New Zealand registration and so consultation with a NZBS Transfusion Medicine Specialist/medical Officer is required prior to release of the products.
  • The prescriber is responsible for informing the recipient that the medicine is unregistered.
  • NZBS notifies Medsafe of each prescription in accordance with the Act.

Why aren't these medicines registered?
  • In most cases this is because so little of the particular medicine is used in New Zealand that it is not financially worthwhile for the supplying company to register the medicine with Medsafe.
  • NZBS ensures that all of these medicines have been registered with at least one reputable regulatory authority e.g. FDA (USA).

List of Section 29 medicines supplied by NZBS

Provisionally Approved Medicines Supplied by NZBS under Section 23 - Quick Guide

What is Section 23?
  • Section 23 is a provision in the Medicines Act 1981 that provides for a conditional new medicine registration.
  

List of Section 23 medicines supplied by NZBS

Using Section 23 and 29 Medicines - Quick Guide

Storage and Infusion
  • Please read the manufacturer's instructions carefully before using. Please see the relevant datasheet.
  • Inject promptly.
  • If any delay store at 2-8°C in an appropriately monitored refrigerator.

Precautions
  • Stock of some of these products is very limited. Please give NZBS as much notice as possible for any requests of Section 23 or 29 products.
  • Ensure your patient is aware of the Section 29 nature of the medicine being prescribed/administered.
  • Read manufacturer's instructions carefully
  • Always observe for turbidity, floating material and sediment
  • Specific information about the administration of each product is given in the manufacturer's product information

DO NOT
  • DO NOT add medications to blood products.

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