What will be the cost of obtaining and maintaining a transitional approval?
All interim (manufacturing and product) licences will attract a fee. These licences will be issued at commencement of the Agency to all current New Zealand and Australian licensed manufacturers, to all sponsors of OTC medicines listed or registered on the ARTG and medicines with Ministerial consent in New Zealand. The fee incurred for holding an interim licence will be considered as the first annual fee for maintaining an Agency licence. Manufacture, supply, import or export of therapeutic products in Australia and/or New Zealand will be illegal unless covered by a valid interim (or full Agency) licence and will be liable to prosecution under the new therapeutic products legislation in each country.
