RAPS recognizes that the current situation in Ukraine impacts our members and customers on many levels. If you are directly impacted by the current situation in the region and are challenged to meet your deadlines or obligations to RAPS, please reach out to raps@raps.org so that we can defer those challenges. Your health and safety are paramount to us.

Regulatory Focus™ > News Articles > Australia, New Zealand Solicit Input on OTC Regulatory Harmonization

Australia, New Zealand Solicit Input on OTC Regulatory Harmonization

Posted 18 September 2012 | By Louise Zornoza

Australia's Therapeutic Goods Administration (TGA) has opened a consultation on a proposed harmonized approach to the regulation of over-the-counter (OTC) medicines in New Zealand and Australia, in anticipation of the 2016 merger between TGA and New Zealand's Medsafe.  

Full implementation of the proposed harmonized approach will require amending legislation in each of the two countries. Consequently, implementation of some aspects of the proposal is not expected to occur until the merged new agency, the Australian and New Zealand Therapeutic Products Agency (ANZTPA), comes into force.  Pending the actual merger, Medsafe and the TGA will phase in the harmonized OTC regulatory framework locally.  Comments on the proposal must be submitted by 7 November 2012.

The decision to merge Medsafe and the TGA into a new joint agency, ANZTPA, over a 5-year transitional period was announced on 20 June 2011 at the signing of a statement of intent by the Prime Ministers of both governments.  


© 2022 Regulatory Affairs Professionals Society.

Regulatory Focus newsletters

All the biggest regulatory news and happenings.