23 MAY 2013 NEW ZEALAND GAZETTE, No. 64 1777

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 8); 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 in writing to the Ministry when requested by the Ministry.

8. 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.

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

10. The DAA must hold third party accreditation with a Ministry approved third party accreditation body.

11. The DAA must notify the Ministry of any intent to audit Hospital care services (as defined in section 4(1) of the Act, that are:

• children’s health services,
• geriatric services,
• maternity services,
• medical services,
• mental health services,
• surgical services;

and satisfy the Ministry, as per section 33(b) of the Act, that it has:

(i) the technical expertise to audit the provision of services of that kind; and

(ii) has in place effective systems for auditing the provision of services of that kind.

Dated at Wellington this 23rd day of May 2013.

DR DON MACKIE, Chief Medical Officer.

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: Arrow - Penicillin V
Active Ingredient: Phenoxymethylpenicillin potassium 27.72mg/mL equivalent to phenoxymethylpenicillin 25mg/mL
Dosage Form: Powder for oral solution
New Zealand Sponsor: Arrow Pharmaceuticals (NZ) Limited
Manufacturer: Micro Labs Limited, Bangalore, India

Product: Arrow - Penicillin V
Active Ingredient: Phenoxymethylpenicillin potassium 55.44mg/mL equivalent to phenoxymethylpenicillin 50mg/mL
Dosage Form: Powder for oral solution
New Zealand Sponsor: Arrow Pharmaceuticals (NZ) Limited
Manufacturer: Micro Labs Limited, Bangalore, India

Product: Max Optifresh
Active Ingredient: Polihexanide 0.001mg/mL
Dosage Form: Contact lens solution
New Zealand Sponsor: Solanki Ventures Limited
Manufacturer: Stericon Pharma Pvt Limited, Bangladore, India

Product: Strepsils Blood Orange
Active Ingredients: Amylmetacresol 0.6mg
Dichlorobenzyl alcohol 1.2mg
Dosage Form: Lozenge
New Zealand Sponsor: Reckitt Benckiser (New Zealand) Limited
Manufacturer: Reckitt Benckiser Healthcare International Limited, Nottinghamshire, United Kingdom

Dated this 17th day of May 2013.

DR DON MACKIE, Chief Medical Officer, Clinical Leadership, Protection and Regulation Business Unit, Ministry of Health
(pursuant to delegation given by the Minister of Health on 6 July 2001).