Pursuant to section 23 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:
Product: Thalidomide Pharmion
Active Ingredient: Thalidomide 50mg
Dosage Form: Capsule
New Zealand Sponsor: Douglas Pharmaceuticals Limited
Manufacturer: Penn Pharmaceuticals Limited, Tafarnaubach Industrial Estate, Tredegar, Gwent, United Kingdom
Note: This consent is given subject to the following conditions:
? Thalidomide may only be prescribed by registered medical practitioners as defined in the Health Practitioners Competence Assurance Act 2003 and who are certified as competent by the Medical Council of New Zealand in the scope and practice of internal medicine.
? Douglas Pharmaceuticals Limited will manage the risk management programme relating to the distribution and use of Thalidomide.
Note: This consent is valid for two years from 18 December 2007.
Dated this 30th day of August 2007.
JOHN HAZELDINE, Acting Deputy Director-General, Sector Accountability and Funding Directorate (pursuant to delegation given by the Minister of Health on 6 July 2001).