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
- Berinert (C1 Esterase Inhibitor) (intravenous; subcutaneous) Australian product datasheets
- Berirab P (Rabies Immunoglobulin) 300 IU (English datasheet supplied by CSL Behring)
- Fibrogammin (Factor XIII) 250 IU (UK datasheet)
- Kybernin (Anthithrombin III) 500 IU (CSL datasheet)
- Rhophylac (Intravenous Anti-D) 1500 IU (Australian product datasheet)
- TetagamP (Intramuscular Tetanus Immunoglobulin) 250 IU (CSL datasheet)