Published: 4 June 2013

Consultations

Common Regulatory Framework Harmonisation Proposal:
International Harmonisation of Ingredient Names

4 June 2013

Dear Stakeholders

Medsafe wishes to draw your attention to a recent consultation document on proposed terminology for medicines ingredients issued by the Australian Therapeutic Goods Administration (TGA) and invite you to make a submission on the proposals by 10 July 2013.

Please send your submissions to Medsafe by email with 'International Harmonisation of Ingredient Names' in the subject line.

Submissions should be emailed to askmedsafe@health.govt.nz.

More information and the consultation document are available on the TGA website.

Background

In preparation for the establishment of the Australia New Zealand Therapeutic Products Authority (ANZTPA) in July 2016, Medsafe and the TGA are working together on a programme of regulatory harmonisation activities. The TGA is also responsible for the carriage of a large domestic “Blueprint” reform programme in Australia. Where the outcomes of those reforms have the potential to flow into the ANZTPA scheme arrangements, Medsafe is working alongside the TGA to ensure New Zealand stakeholders have the opportunity to provide input on those change proposals.

Medsafe considers that the work being undertaken by the TGA on ingredient names will further support international harmonisation and therefore the outcome of these reforms in Australia has the potential to be adopted under ANZTPA (and by Medsafe before then if feasible) . 

In order to manage and spread the workload, Medsafe will analyse the submissions from New Zealand stakeholders and provide that analysis to the TGA. The two regulators will then consider the feedback from submitters in both countries before developing final recommendations on change proposals.