Notice Type
Notice Title

Renewal of Provisional Consent to the Distribution of Medicine

Pursuant to section 23(4A) of the Medicines Act 1981, the Minister of Health hereby renews the provisional consent to the sale, supply or use in New Zealand of the medicine set out in the Schedule hereto:


Active Ingredient:
Dosage Form:
New Zealand Sponsor:

Influenza virus haemagglutinin type A/Vietnam/1194/2004 NIBRG-14 (H5N1) 3.75mcg
Suspension for injection
GlaxoSmithKline (NZ) Limited
GlaxoSmithKline Biologicals (Dresden), Dresden, Germany
GlaxoSmithKline Biologicals SA, Rixensart, Belgium

Note: This consent is given subject to the following conditions:

  1. The vaccine may only be marketed or distributed in accordance with the directives contained in the current version of the New Zealand Influenza Pandemic Action Plan.
  2. In an officially declared influenza pandemic situation, GSK is to provide updated evidence of the surrogate markers used to estimate efficacy of the pandemic vaccine formulation and is committed to provide a Risk Management Plan for, or including, New Zealand.

Note: This renewed consent is valid for two years from 31 July 2016.

Dated this 13th day of May 2016.

CHRIS JAMES, Acting Group Manager, Medsafe, Ministry of Health (pursuant to delegation given by the Minister of Health on 11 September 2013).