About Medsafe

COVID-19 Archive

Approval Process for Medicines

New medicines
New uses for already approved medicines
Checking if a medicine is approved for COVID-19
Use of unapproved medicines
More information

New medicines

Companies who wish to sell a new medicine in New Zealand make an application to Medsafe (called a New Medicine Application or NMA). Medsafe evaluates the NMA to ensure that it complies with international standards and local requirements for quality, safety and efficacy. Only if the new medicine meets these standards will Medsafe recommend approval for use in New Zealand

This approval process will also apply for companies seeking approval for new medicines developed to treat COVID-19.

New uses for already approved medicines

Companies may have studied new uses (indications) for a medicine already approved in New Zealand. These new uses may include treatment of COVID-19. In these cases, the companies submit notifications to Medsafe (called a Changed Medicine Notification or CMN). Medsafe evaluates the CMN to ensure that the new uses comply with international standards and local requirements for safety and efficacy

This approval process will also apply for companies with approved medicines seeking new indications to treat COVID-19.

Checking if a medicine is approved for COVID-19

The approved indications for a medicine are included in the data sheet. You can find the data sheet for a particular medicine by searching on this page.

Dexmethsone (dexamethasone) 0.5 mg tablets (Aspen Pharmacare Australia Pty Ltd) are approved for the treatment of COVID-19 in adult and adolescent patients (aged 12 years and older with body weight at least 40 kg) who require supplemental oxygen therapy.

Use of unapproved medicines

Section 25 of the Medicines Act 1981 permits medical practitioners to procure any medicine for a particular patient in their care. Unapproved medicines have not been evaluated by Medsafe for safety and efficacy. It is the prescriber's responsibility to ensure that they are aware of any safety issues for any unapproved medicines they may be prescribing and communicate the risks and benefits to their patients.

More information

Please see the following pages on our website for more information.

MEDSAFE

New Zealand Medicines and Medical Devices Safety Authority