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New Zealand Gazette – 2010 – No. 60

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✨ Health and Medicines Notices

1718 NEW ZEALAND GAZETTE, No. 60 27 MAY 2010

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.

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 in writing to the Ministry when requested by the Ministry.
The DAA must provide in writing, in a timely manner when requested by the Ministry, 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.
The DAA must provide all documentation to the Ministry in the form prescribed by the Ministry.
The DAA must publish information in relation to its pricing and fee structure and ensure that information is available across the sector to enable service providers to obtain and compare prices. A DAA must, at a minimum, publish the information on its website and/or in a brochure. The Ministry intends to publish the information on its website.
The DAA must hold third party accreditation with a Ministry approved third party accreditation body.

This designation expires on 18 May 2013.

Dated at Wellington this 18th day of May 2010.

MARK RICHARDS, Acting Deputy Director-General, Regulation & Governance Directorate, Ministry of Health.

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Medicines Act 1981

Consent to the Distribution of New Related Products

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

Schedule

Product: Head & Shoulders Anti-Dandruff Conditioner - Itchy Scalp Care
Active Ingredient: Pyrithione zinc 0.5%w/w
Dosage Form: Scalp lotion
New Zealand Sponsor: Procter & Gamble Distributing New Zealand Limited
Manufacturer: Procter & Gamble Manufacturing (Thailand) Limited, Bangkpakong, Thailand

Product: Head & Shoulders Anti-Dandruff Shampoo - Itchy Scalp Care
Active Ingredient: Pyrithione zinc 1%w/w
Dosage Form: Shampoo
New Zealand Sponsor: Procter & Gamble Distributing New Zealand Limited
Manufacturer: Procter & Gamble Manufacturing (Thailand) Limited, Bangkpakong, Thailand

Dated this 21st day of May 2010.

ANTHONY HILL, Deputy Director-General, Regulation and Governance 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: Apo-Amlodipine
Active Ingredient: Amlodipine besilate 3.5mg equivalent to 2.5mg amlodipine
Dosage Form: Tablet
New Zealand Sponsor: Apotex NZ Limited
Manufacturer: Apotex Inc, Etobicoke, Canada

Product: Codral Relief Head Cold
Active Ingredient: Phenylephrine hydrochloride 10mg/mL
Dosage Form: Tablet
New Zealand Sponsor: Johnson & Johnson (New Zealand) Limited
Manufacturer: Johnson & Johnson Pty Limited, Cape Town, South Africa

Product: Duro-Tuss Chesty Cough Lozenges Sugar Free Lime
Active Ingredients:

Bromhexine hydrochloride 8mg
Cetylpyridinium chloride monohydrate 1.33mg
Dosage Form: Lozenge
New Zealand Sponsor: iNova Pharmaceuticals (New Zealand) Limited
Manufacturers:
Nestle Australia Limited, Blacktown, Australia
iNova Pharmaceuticals (Australia) Pty Limited, Thornleigh, Australia

Gazette.govt.nz — NZ Gazette 2010, No 60

Parliament House (depicted) was completed in 1918 and remains the primary seat of Parliament.

✨ LLM interpretation of page content

🏥 Designation of Auditing Agency under Health and Disability Services (Safety) Act 2001 (continued from previous page)

Domain🏥 Health & Social Welfare
Dated18 May 2010
KeywordsHealth, Auditing Agency, DAA, Ministry of Health, Compliance Audit
👩‍💼 Officials

MARK RICHARDS, Acting Deputy Director-General, Regulation & Governance Directorate, Ministry of Health

🏥 Consent to the Distribution of New Related Products

Domain🏥 Health & Social Welfare
Dated21 May 2010
KeywordsMedicines, Distribution, Head & Shoulders, Pyrithione zinc, Procter & Gamble
👩‍💼 Officials

ANTHONY HILL, Deputy Director-General, Regulation and Governance Directorate, Ministry of Health

🏥 Consent to the Distribution of New Medicines

Domain🏥 Health & Social Welfare
Dated21 May 2010
KeywordsMedicines, Distribution, Amlodipine, Codral, Duro-Tuss, Apotex, Johnson & Johnson, iNova Pharmaceuticals
👩‍💼 Officials

ANTHONY HILL, Deputy Director-General, Regulation and Governance Directorate, Ministry of Health

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