Safety Information

Revised: 2 July 2013

MHRA Independent Eltroxin Review

Due to the level of public concern expressed after the change in Eltroxin formulation, the Ministry of Health commissioned an independent review of the circumstances surrounding the supply of Eltroxin in New Zealand.

The United Kingdom Medicines and Healthcare products Regulatory Agency (MHRA) agreed to provide an independent expert opinion on whether Medsafe applied appropriate regulatory standards when handling the application seeking approval for the new formulation of Eltroxin. The MHRA also agreed to review whether Medsafe reacted appropriately to the large volume of adverse events relating to the reformulated product.

Medsafe welcomes the MHRA report and supports its conclusion that Medsafe acted appropriately and in accordance with international regulatory guidelines in effect at the time.

The MHRA has made some suggestions for enhancing Medsafe's procedures. Medsafe is currently reviewing these recommendations.

Please note that to comply with the Official Information Act 1982 only commercially sensitive information has been blacked out. In the interests of transparency the redaction of information has been kept to a minimum.

Follow the link below for a copy of the MHRA's report.