3590 NEW ZEALAND GAZETTE, No. 127 18 AUGUST 2011

4. During the term of the DAA’s designation, the DAA will allow the Ministry to audit or to commission the undertaking of audits or reviews of the DAA. This could also include attending audits being undertaken by the 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 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 to the Ministry when requested in writing 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 ensure that the lead auditor for all audits of district health boards has access to advice from a technical expert, approved by the Ministry, with current experience of district health board clinical governance and patient safety systems.

Dated at Wellington this 15th day of August 2011.

DR DON MACKIE, Chief Medical Officer.

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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 which was referred to the Minister of Health under the provisions of section 24(5) of the Act and is set out in the Schedule hereto:

Schedule

Product: Medrol
Active Ingredient: Methylprednisolone 4mg
Dosage Form: Tablet
New Zealand Sponsor: Pfizer New Zealand Limited
Manufacturer: Pfizer Italia SrL, Ascoli Piceno, Italy

Dated this 10th day of August 2011.

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).

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Renewal of Provisional Consent to the Distribution of Medicines

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 medicines set out in the Schedule hereto:

Schedule

Product: Priligy
Active Ingredient: Dapoxetine hydrochloride 33.6mg equivalent to dapoxetine base 30mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Janssen-Cilag (New Zealand) Limited
Manufacturer: Janssen Ortho LLC, Gurabo, Puerto Rico
Note: This renewed consent is valid for two years from 12 November 2011.

Product: Priligy
Active Ingredient: Dapoxetine hydrochloride 67.2mg equivalent to dapoxetine base 60mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Janssen-Cilag (New Zealand) Limited
Manufacturer: Janssen Ortho LLC, Gurabo, Puerto Rico
Note: This renewed consent is valid for two years from 12 November 2011.