2260 NEW ZEALAND GAZETTE, No. 82 31 JULY 2014

Dated this 24th day of July 2014.

STEWART JESSAMINE, Group Manager, Medsafe, Ministry of Health (pursuant to delegation given by the Minister of Health on 11 September 2013).

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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: Lioresal Intrathecal
Active Ingredient: Baclofen 0.05mg/mL
Dosage Form: Solution for injection
New Zealand Sponsor: Novartis New Zealand Limited
Manufacturer: Novartis Pharma Stein AG, Stein, Switzerland

Note: This renewed consent is valid for two years from 26 November 2014.

Product: Lioresal Intrathecal
Active Ingredient: Baclofen 2mg/mL
Dosage Form: Solution for injection
New Zealand Sponsor: Novartis New Zealand Limited
Manufacturer: Novartis Pharma Stein AG, Stein, Switzerland

Note: This renewed consent is valid for two years from 26 November 2014.

Dated this 24th day of July 2014.

STEWART JESSAMINE, Group Manager, Medsafe, Ministry of Health (pursuant to delegation given by the Minister of Health on 11 September 2013).

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Provisional Consent to the Distribution of a New Medicine

Pursuant to section 23(1) of the Medicines Act 1981, the Minister of Health hereby provisionally consents to the sale, supply or use in New Zealand of the new medicine set out in the Schedule hereto:

Schedule

Product: Pandemrix
Active Ingredient: Influenza virus Haemagglutinin A/Vietnam/1194/2004 NIBRG-14 (H5N1) 3.75mcg
Dosage Form: Suspension for injection
New Zealand Sponsor: GlaxoSmithKline (NZ) Limited
Manufacturers: GlaxoSmithKline Biologicals SA, Rixensart, Belgium
GlaxoSmithKline Biologicals (Dresden), Dresden, Germany

Note: This consent is given subject to the following conditions:

1. The vaccine may only be marketed or distributed in accordance with the directives contained in the current version of the New Zealand Influenza Pandemic Action Plan.
2. In an officially declared influenza pandemic situation, GSK is to provide updated evidence of the surrogate markers used to estimate efficacy of the pandemic vaccine formulation and is committed to provide a Risk Management Plan for, or including, New Zealand.

Note: This consent is valid for two years from the date of publication of this notice.

Dated this 24th day of July 2014.

STEWART JESSAMINE, Group Manager, Medsafe, Ministry of Health (pursuant to delegation given by the Minister of Health on 11 September 2013).

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Police Organisations

Terrorism Suppression Act 2002

Renewed Designations of Terrorist Entities

On 20 July 2014, pursuant to section 35 of the Terrorism Suppression Act 2002, the terrorist designations of the entities listed below were renewed.

Any person who deals with the property of the entities listed below may be liable to prosecution for an offence under section 9 of the Terrorism Suppression Act 2002.

Shining Path (also known as Sendero Luminoso; the Peruvian Communist Party, PCP-SL and SL);

Devrimci Halk Kurtuluş Partisi-Cephesi (also known as Revolutionary People’s Liberation Party Front, Dev Sol, Devrimci Sol and DHKP/C); and

Jundallah (also known as People’s Resistance Movement of Iran (PRMI), Jonbesh-I Moqavemat-i-Mardom-I Iran, Popular Resistance Movement of God, Fedayeen-eIslam, Former Jundallah of Iran, Jundullah, Jondullah, Jondollah, Army of God (God’s Army), Baloch Peoples’ Resistance Movement (BPRM), Jaish al-Adl (JAA) and Army of Justice).