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 medicine 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 and is valid to 18 December 2011:
? 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.
Dated this 25th day of September 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).