Pursuant to section 23(1) of the Medicines Act 1981, the Minister of Health hereby consents to the distribution in New Zealand of the following 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: Thalidomide Pharmion
Active Ingredient: Thalidomide 50mg
Dosage Form: Capsule
New Zealand Sponsor: Douglas Pharmaceuticals Limited
Manufacturer: Penn Pharmaceutical Services Limited, Tredegar, Gwent, United Kingdom
Note: This consent is given subject to the following conditions:
? Only members of the Royal Australasian College of Physicians may prescribe Thalidomide.
? Douglas Pharmaceuticals Limited shall manage the risk management programme relating to the distribution and use of thalidomide.
Dated this 2nd day of June 2009.
MARK RICHARDS, Acting Deputy Director-General, Sector Accountability and Funding Directorate, Ministry of Health (pursuant to delegation given by the Minister of Health on 6 July 2001).