18 DECEMBER

NEW ZEALAND GAZETTE

4771

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 set out in the Schedule hereto:

Schedule

Product: Bisacodyl

Active Ingredient: Bisacodyl 5mg

Dosage Form: Enteric coated tablet

New Zealand Sponsor: AFT Pharmaceuticals Limited

Manufacturer: Remedica, Limassol, Cyprus

Dated this 12th day of December 2003.

DON MATHESON, Deputy Director-General, Public Health (pursuant to delegation given by the Minister of Health on the 6th day of July 2001).

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Consent to the Distribution of a Changed Medicine

Pursuant to section 20 of the Medicines Act 1981, the Minister of Health hereby consents to the distribution in New Zealand of the changed 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: Vaxigrip vaccine

Active Ingredients: Influenza virus haemagglutin type A/Moscow/10/99 H3N2 – like strain 30µg/mL
Influenza virus haemagglutin type A/New Caledonia/20/99 H1N1 – like strain 30µg/mL
Influenza virus haemagglutin type B/Hong Kong/330/2001 – like strain 30µg/mL

Dosage Form: Solution for injection

New Zealand Sponsor: CSL New Zealand Limited

Manufacturers: Aventis Pasteur SA, Marcy L’Etoile, France
Aventis Pasteur SA, Val-De-Reuil Cedex, France

Dated this 12th day of December 2003.

DON MATHESON, Deputy Director-General, Public Health (pursuant to delegation given by the Minister of Health on the 6th day of July 2001).

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Medicines (Database of Medical Devices) Regulations 2003

Exemption Medical Devices (in vitro Diagnostic Devices) Notice (No. 1) 2003

I declare the following class of medical device to be an exempt class of medical device for the purposes of the Medicines (Database of Medical Devices) Regulations 2003:

Any diagnostic device that is commonly known as an in vitro diagnostic device.

For the purposes of this notice, an in vitro diagnostic device means:

“any device which is—

(a) a reagent, reagent product, calibrator, control material, kit, instrument, apparatus, equipment or system, whether used alone or in combination with other diagnostic devices for in vitro use; and

(b) intended by the manufacturer to be used in vitro for the examination of specimens (including blood and tissue donations) derived from the human body:

(i) solely or principally for the purpose of giving information about a physiological or pathological state or a congenital abnormality; or

(ii) to determine safety and compatibility with a potential recipient.”

I make this declaration pursuant to paragraph (i) of Schedule 1 of the Medicines (Database of Medical Devices) Regulations 2003.

This declaration comes into effect on 1 January 2004.

Dated at Wellington this 12th day of December 2003.

DR KAREN O. POUTASI, Director-General of Health.

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Internal Affairs

Marriage Act 1955

Marriage (Approval of Organisation) Notice No. 27

Pursuant to the Marriage Act 1955, the Registrar-General of Marriages hereby gives notice as follows.

1. This notice may be cited as the Marriage (Approval of Organisation) Notice No. 27.

2. The organisation specified in the Schedule hereto is hereby declared to be an approved organisation for the purpose of the Marriage Act 1955.

Schedule

Central Lakes Church (formerly Cromwell Christian Fellowship).