Australia, New Zealand Solicit Input on OTC Regulatory Harmonization

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.