2192 NEW ZEALAND GAZETTE, No. 97 2 JULY 2009

DAA. The Ministry may or may not notify the DAA of any audit or review.

5. The DAA must immediately notify the Ministry in writing of any significant change to the DAA, including but not restricted to:

• any change in ownership and/or control of the legal entity;
• any change in management personnel;
• any change to the Auditor Register (refer to condition 7); and
• any change in the status of any third party accreditation the DAA may hold including evidence of such accreditation and copies of any Third Party Accreditation Audit Reports or notifications in respect of their accreditation.

6. The DAA must conduct as a minimum at least one annual:

• internal audit that focuses on the DAA’s auditing activities undertaken pursuant to the Act, together with a compliance audit against the requirements of the DAA as set out in the Act; and

• management review in respect of the DAA’s programmes operated pursuant to the Act.

7. The DAA shall at all times operate an internal appeals system which is documented and conveyed in writing to all clients. Auditable records of the facts and outcomes of all client appeals shall be maintained by the DAA. The DAA must provide these records to the Ministry when requested in writing by the Ministry.

8. The DAA must provide in a timely manner when requested by the Ministry in writing the details of the name, auditing qualifications and experience, and if relevant, the area of clinical or service competency of each auditor or technical expert approved by the DAA to undertake audits pursuant to the Act.

9. The DAA must provide all documentation to the Ministry in the form prescribed by the Ministry.

This designation expires on 2 July 2012.

Dated at Wellington this 2nd day of July 2009.

ANTHONY HILL, Deputy Director-General, Sector Accountability & Funding, Ministry of Health.

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Medicines Act 1981

Renewal of Provisional Consent to the Distribution of a 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:

Schedule

Product: Tykerb
Active Ingredient: Lapatinib ditosilate 405mg equivalent to Lapatinib 250mg
Dosage Form: Tablet
New Zealand Sponsor: GlaxoSmithKline New Zealand Limited
Manufacturer: Glaxo Operations UK Limited (t/a Glaxo Wellcome Operations), Ware, Hertfordshire, United Kingdom

Note: This renewal consent is valid for two years from 23 August 2009.

Dated this 29th day of June 2009.

ANTHONY HILL, Deputy Director-General, Sector Accountability and Funding Directorate, Ministry of Health (pursuant to delegation given by the Minister of Health on 6 July 2001).

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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: Anticol Max
Active Ingredient: Hexylresorcinol 2.721mg/dose
Dosage Form: Lozenge
New Zealand Sponsor: Nestle New Zealand Limited
Manufacturer: Nestle Australia Limited, Blacktown, New South Wales, Australia

Product: Intelence
Active Ingredient: Etravirine 100mg
Dosage Form: Tablet
New Zealand Sponsor: Janssen-Cilag New Zealand Limited
Manufacturer: Janssen-Cilag SpA, Via C. Janssen, Borgo San Michele, Latina, Italy

Product: Razene Allergy & Hayfever
Active Ingredient: Cetirizine hydrochloride 10mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Mylan New Zealand Limited
Manufacturer: Adcock Ingram Limited - A Medreich Group Company, Anekal Taluk, Bommasandra, Bangalore, India