56 NEW ZEALAND GAZETTE No. 1

Product:
Velosulin HM(ge)

Active Ingredient(s):
Insulin, human (recombinant DNA origin) 100IU/mL

Dosage Form:
Solution for injection

New Zealand Sponsor:
Novo Nordisk Pharmaceuticals Limited

Manufacturer(s):
Novo Nordisk A/S, Kalundborg, Denmark
Novo Nordisk A/S, Bagsvaerd, Copenhagen, Denmark

Dated this 5th day of January 2001.

G. R. BOYD, Chief Advisor, Safety and Regulation (pursuant to delegation given by the Minister of Health on the 20th day of February 1997).

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Misuse of Drugs Act 1975

Medical Practitioners Who May Prescribe, Administer, or Supply Controlled Drugs for the Purpose of Treating People With Drug Dependence

Pursuant to section 24 (5) (a) of the Misuse of Drugs Act 1975, I, Anthony John Duncan, acting under delegated authority from the Minister of Health, specify

Dr Janet Blackman of Waltham Medical Centre,
83 Waltham Road, Beckenham, Christchurch

as a medical practitioner who may prescribe, administer, or supply controlled drugs for the purposes of that section.

Dated at Wellington this 19th day of December 2000.

ANTHONY DUNCAN, Deputy Director of Mental Health.

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New Zealand Public Health and Disability Act 2000

Authorisation of the New Zealand Blood Service to Perform Certain Functions

Under section 55 (1) (c) of the New Zealand Public Health and Disability Act 2000, I authorise the New Zealand Blood Service to perform the functions specified in the First Schedule to this authorisation.

This authorisation is subject to the terms and conditions specified in the Second Schedule to this authorisation and is effective from 1 January 2001.

First Schedule

The New Zealand Blood Service is authorised to perform the following functions:

(a) To collect, process, accredit, store, and distribute bone and skin.

(b) To receive, process, accredit, and store sperm from identified consumers whose treatment poses fertility risks and to return the identified consumer’s sperm to the identified consumer upon their request subject to clause (a) of the Second Schedule to this authorisation.

(c) To carry out therapeutic procedures relating to a consumer’s blood including collecting, processing, testing, and disposing of such blood.

(d) To collect, process, accredit, store, return for use, and dispose of autologous blood or autologous controlled human substances.

(e) To collect, process, accredit, store, distribute, and dispose of directed blood or directed controlled human substances. For the purposes of this clause, “directed blood” or “directed controlled human substances” means blood or controlled human substances collected from individuals (e.g. family members) who have been solicited by the intended recipient or by someone else (e.g. a mother requesting that her blood be used for her baby’s transfusion treatment).

Nothing in this authorisation prevents the New Zealand Blood Service from charging reasonable fees for services provided in relation to the above functions. It should be noted that the core blood supply system, as part of its functions under section 55 (1) (a) and (b) of the New Zealand Public Health and Disability Act 2000, is fully subsidised.

Second Schedule

Terms and conditions of this authorisation:

(a) The functions specified in clause (b) of the First Schedule to this authorisation are temporary functions that will be devolved to a third party or parties on or before 1 July 2001 at which time the New Zealand Blood Service shall inform the Minister of Health in writing of the third party or parties to whom these functions have been devolved.

(b) While carrying out the functions as specified in the First Schedule of this authorisation, the New Zealand Blood Service shall ensure those functions are carried out safely and to a level of high quality, and shall take all reasonable precautions with a view to ensuring that the blood, controlled human substances, bone, skin, and sperm are safe for use.

(c) The New Zealand Blood Service shall ensure that its authorised agents, its employees, and the employees of its agents, have appropriate skills and expertise, and use those skills and that expertise when carrying out the functions under this authorisation.

(d) The New Zealand Blood Service shall ensure that high quality systems are in place to efficiently monitor and trace the blood, controlled human substances, bone, skin, and sperm.

(e) The New Zealand Blood Service shall strive for efficiency in carrying out the functions for which it is responsible under this appointment, without compromising quality or safety.

(f) The New Zealand Blood Service shall consult with the Ministry of Health on issues having, or likely to have, substantial effects on consumers, or on the ability of the New Zealand Blood Service to carry out its functions under this authorisation or to comply with these terms and conditions. Where the likelihood of such issues is not foreseen by the New Zealand Blood Service, or where the issues come to the attention of the New Zealand Blood Service after the event, the consultation shall be as soon as reasonably practicable afterwards.

(g) The New Zealand Blood Service shall continue to develop relationships with interested parties and consumer groups to facilitate communication, co-operation, and community appreciation of the