Could a company apply for the ANZTPA product licence in either Australia or New Zealand?
All applications will be processed through the Authority, whether the product licence is applied for in New Zealand or Australia. If a medicine has been approved for use in say New Zealand or rejected for use in Australia – would it still be able to get a product licence under the new scheme? And would a sponsor be required to submit new data about the medicine? These cases would be assessed on a case by case basis and may require the Authority to look at quality, safety and / or efficacy data. How would the new regulatory scheme affect the regulation of sunscreens? The claimed SPF will determine whether or not a sunscreen is treated as a cosmetic or a therapeutic product. It is proposed that all sunscreens over SPF 4 will be regulated by the Authority as Class 1 medicines. Will there be a central system for clinical trials? There will be clinical trial requirements for both countries under the new scheme. Certain trials will require assessment by the Authority prior to commencement; t
