ERMA New Zealand is commencing public consultation on Douglas Pharmaceuticals Limited’s proposal to issue a new group standard for pharmaceutical active ingredients that are intended for use in the manufacture of human pharmaceutical medicines. It is proposed that the scope of the group standard is restricted to active ingredients for use in medicines that have been approved by Medsafe when intended for the NZ market; or another equivalent governmental regulatory body (i.e. USA, European Union, Japan, and Australia) when manufactured solely for the export market.
This public consultation is in accordance with Part 6A of the Hazardous Substances and New Organisms Act 1996. Copies of the consultation document and the proposed group standard document are available from our website:
Consultation document: available here
Draft group standard document: available here
The closing date for submissions on the Group Standard proposal is 16 March 2010.
Submissions may be made in writing or by email ( submissions@ermanz.govt.nz ) or by using our submission form, which can be downloaded from our website http://www.ermanz.govt.nz.
If you have any queries on group standards, how they work and what they mean for you or your business or organisation, you can email us at: hsinfo@ermanz.govt.nz or call 0800 376 234