1486

NEW ZEALAND GAZETTE

No. 67

inquiry, or to develop and test new drugs or potential therapies:

(iii) A delay in applying to the Authority for approval to field test a genetically modified organism until after 31 August 2001 means that there is a substantial risk of New Zealand losing scientific inquiry knowledge, or that New Zealand would lose the potential health, environmental, or commercial benefits from the use of the organism; and

(iv) The level of investment in an ongoing line of inquiry is substantial and the delay in applying to the Environmental Risk Management Authority for approval to field test a genetically modified organism would prejudice the value of the earlier investment.

5. Controls necessary for exemption—(1) If the application is to field test a genetically modified plant, conditions will be placed on the test will ensure that:

(a) Once any reproductive structure above the ground reaches the stage where it is capable of releasing heritable material it shall be immediately removed, and transported in secure containment if required, and destroyed; and

(b) Any heritable material beneath the ground is retrieved, transported in secure containment if required, and destroyed once the test is complete;

unless the heritable material is required for research purposes in which case it shall be retained in conditions of high security.

(2) If the application is to field test a genetically modified animal, and that animal contains human genes, controls will be placed on that field test to ensure that all animals forming part of the test, including their offspring, are:

(a) Held in secure containment; and

(b) Clearly identified in case the animal escapes.

6. Effect of exemption—If the Minister for the Environment, in consultation with other relevant Ministers, agrees to exempt a proposed application from the voluntary moratorium, the person may lodge the application with the Environmental Risk Management Authority and receipt of that application by the Authority will not breach the voluntary moratorium.

7. Definition of terms—The terms “release”, “field test” and “genetically modified organism” have the meanings given to them in the Hazardous Substances and New Organisms Act 1996.

8. Effect of moratorium—(1) The voluntary moratorium is a voluntary commitment and has no legal status or binding effect.

(2) The establishment of the voluntary moratorium does not affect the Government’s ability to introduce legislation imposing a moratorium on applications to the Environmental Risk Management Authority if the voluntary moratorium is breached or for any other reason that the Government considers relevant. The contents and effect of any legislation may differ from the content and effects of the voluntary moratorium.

(3) No person is entitled to any remedy for a breach of the moratorium or for the introduction or enactment of any legislation imposing a moratorium on applications under the Hazardous Substances and New Organisms Act 1996.

(4) The provisions of the voluntary moratorium do not preclude any person, for the purpose of pre-application discussions or advice, from discussing a proposed field test of a genetically modified organism with the Environmental Risk Management Authority, or submitting material related to a proposed field test to the Authority, prior to lodging the application with the Authority.

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Health

Medicines Act 1981

Consent to the Distribution of a New Medicine

Pursuant to section 20 of the Medicines Act 1981, the Minister of Health hereby consents to the distribution in New Zealand of the new medicine set out in the schedule hereto:

Schedule

Product: Anzatax

Active Ingredient(s): Paclitaxel 6mg/mL

Dosage Form: Concentrate for injection

New Zealand Sponsor: Baxter Healthcare Limited

Manufacturer(s): David Bull Laboratories Limited, Mulgrave North, Victoria, Australia

Product: Begrivac

Active Ingredient(s): Influenza virus haemagglutinin type A/Beijing/262/95-like (H1N1) 15μg/dose
Influenza virus haemagglutinin type A/Sydney/5/97-like (H3N2) 15μg/dose
Influenza virus haemagglutinin type B/Beijing/184/93-like 15μg/dose

Dosage Form: Suspension for injection

New Zealand Sponsor: Multichem Laboratories Limited

Manufacturer(s): Chiron Behring GmbH & Co, Marburg, Germany

Product: Captohexal

Active Ingredient(s): Captopril 12.5mg

Dosage Form: Tablet

New Zealand Sponsor: Hexal New Zealand Limited

Manufacturer(s): Hexal-Pharma GmbH, Holzkirchen, Germany