The Researched Medicines Industry Association (RMI) has an important role to play in representing its members’ views on Government policy, legislation and other matters open to public consultation. For copies of previous submissions click here
Improving New Zealand’s environment to support innovation through clinical trials - April 2010 Public Health Bill - March 08
Draft revised National Application Form for Ethical Approval of a Research Project and Guidelines - Feb 08.
Final submission to the High Cost Medicines Panel - February 2010. Copy of Annex 2 referred to in the submission.
Initial submission to the High Cost Medicines Panel - October 2009
Acceptance of the Protocol Amending the TRIPS Agreement to Implement the Doha Delcaration on TRIPS and Public Health : Discussion Document - Dec 07
Bioprospecting : Harnessing Benefits for New Zealanders - Oct 07
NZ Public Health and Disability Amendment Bill 2010 - Jun 10
Proposed Clinical Trials Guidelines - Nov 09
Proposed Changes to Fees Payable Under the Medicines Regulations 1984 - May 09
Ethics of Intervention Studies - Discussion Document and Draft Ethical Guidelines for Intervention Studies - Jun 08
Review of the Appointment Protocol for the Pharmacological and Therapeutics Advisory Committee - Apr 07
Towards a New Zealand Medicines Strategy Consultation Document - Mar 07
Medsafe's Proposal to Increase Fees Payable under the Medicines Act 1981 and Misuse of Drugs Act 1975. March 2006.
Consumer Participation Discussion Document - Dec 09
Proposal to change the format of Section H - Oct 09
2009/10 Multi-product Tender - Oct 09
Input into Consultation on Revised Funding Application Guidelines - July 2009
Input into the Consumer Advisory Committee Terms of Reference Review - July 2009
Consultation on proposal to re-invest a portion of savings back into pharmacy sector - Jan 09
Consultation on the Draft Voluntary Checklist for Health Consumer Organisations Entering into Health Industry Sponsorship - Oct 08
Review of Guidelines for the Pharmacology and Therapeutics Advisory Committee (PTAC) and its Subcommittees - Jun 08 Response to Proposal for levetiracetam - Jun 08 Alternative Brand Access Proposal - Oct 07 High Cost Medicines Review - Mar 07 Draft Guidelines for Pharmacoeconomic Analysis - Oct 06
Proposed clinical trial regulatory arrangements under the Australia New Zealand Therapeutics Products Authority
Draft Order Packaging Requirements for Therapeutic Products
Improving Access to Consumer Medicines Information (CMI) and Product Information (PI)
Australia New Zealand Therapeutic Products Regulatory Scheme (Advertising) Rule 2006
Therapeutic Products and Medicines Bill - Submission to Government Administration Select Committee
Consultation paper on Product Vigilance in the Australia New Zealand Therapeutics Products Authority
Australia New Zealand Therapeutics Products Regulatory Scheme (Administration and Interpreation) Rule 2006. Extracts relating to the scheduling of therapeutic products.
Consultation on Microbiological Standards for Medicines in the Australia New Zealand Therapeutic Products Authority (ANZTPA).
ANZTPA Regulatory Scheme (Admininistration and Interpretation) Rule 2006
Proposed Grouping Order
Draft General Requirements for the Labelling of Medicines Australia New Zealand Therapeutic Products
ANZTPA Regulatory Scheme (Medicines) Rule 2006
Guidelines for Transition to the Joint Regulatory Scheme for Class 2 Medicines
Child Resistant Packaging of Therapeutic Products
Discussion Paper : Workflow Practices within Drug Safety and Evaluation Branch (DSEB) of the TGA . January 2006.