1040 NEW ZEALAND GAZETTE, No. 40 4 MAY 2006

This designation is subject to the following conditions:

1. The auditing agency must ensure that where it audits the
   provision of health care services for people with physical
   or sensory disabilities, intellectual disabilities, psychiatric
   disabilities or mental illnesses, the auditing agency
   observes the following:

   • For audits involving services for people with physical
     or sensory disabilities, a person with a pronounced
     physical or sensory disability must fully participate
     in all aspects of the audit;
   • for audits involving services for people with
     intellectual disabilities, a person with an intellectual
     disability (accompanied by a support person where
     necessary), or a close family or whanau member of
     a person with an intellectual disability, must participate
     in all aspects of the audit; and
   • for people with psychiatric disabilities or mental
     illnesses, a past or present consumer of mental health
     services must fully participate in all aspects of the
     audit.

2. The auditing agency must inform the Ministry of Health
   immediately by way of written notice if there is any
   change to their accreditation status with JAS-ANZ.

3. The auditing agency must complete the accreditation
   process for JAS-ANZ Procedure 32 and provide the
   Director-General of Health with a copy of the JAS-ANZ
   Accreditation Schedule showing accreditation to
   Procedure 32 by 18 October 2006 (or, if not by
   18 October 2006, by any later date, as advised in writing
   by the Director-General of Health).

This notice, which expires on 18 October 2008, revokes and
replaces in its entirety the notice that designated Bureau
Veritas Quality International, published in the New Zealand
Gazette, 27 October 2005, No. 180, page 4556.

Dated at Wellington this 21st day of April 2006.

K. O. POUTASI (Dr), Director-General of Health.

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Medicines Act 1981

Consent to the Distribution of New Medicines

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

Schedule

Product:
Brevoxyl Creamy Wash

Active Ingredient:
Benzoyl peroxide 4%w/w

Dosage Form:
Topical cream

New Zealand Sponsor:
David Sparks Limited

Manufacturer:
Stiefel Laboratories Pte Limited, Jurong, Singapore

Product:
Celebrex

Active Ingredient:
Celecoxib 400mg

Dosage Form:
Capsule - powder filled

New Zealand Sponsor:
Pfizer New Zealand Limited

Manufacturer:
Pfizer Pharmaceuticals LLC, Caguas, Puerto Rico

Product:
Norditropin Nordiflex 10mg/1.5mL

Active Ingredient:
Somatropin 6.7mg/mL

Dosage Form:
Solution for injection

New Zealand Sponsor:
Novo Nordisk Pharmaceuticals Limited

Manufacturer:
Novo Nordisk A/S, Building HAC, Gentofte, Denmark

Product:
Norditropin Nordiflex 15mg/1.5mL

Active Ingredient:
Somatropin 10mg/mL

Dosage Form:
Solution for injection

New Zealand Sponsor:
Novo Nordisk Pharmaceuticals Limited

Manufacturer:
Novo Nordisk A/S, Building HAC, Gentofte, Denmark

Product:
Norditropin Nordiflex 5mg/1.5mL

Active Ingredient:
Somatropin 3.3mg/mL

Dosage Form:
Solution for injection

New Zealand Sponsor:
Novo Nordisk Pharmaceuticals Limited

Manufacturer:
Novo Nordisk A/S, Building HAC, Gentofte, Denmark