Revised: 27 May 2013
Consultations
Over-the-Counter (OTC) Medicines Business Process Reform Consultation Paper
Link to consultation document " Over-the-Counter (OTC) Medicines Business Process Reform in PDF (PDF document 1411 KB)
Invitation to comment
Medsafe and the TGA are seeking comments from interested parties on proposed reforms to the business processes for the evaluation of over-the-counter (OTC) medicines.
Timetable
Document released for consultation on Thursday 13th September 2012
Interested parties should respond by close of business Wednesday 7th November 2012
Feedback will be released following consideration of submissions.
Background
The Australian Therapeutic Goods Administration (TGA) and the New Zealand Medicines and Medical Devices Safety Authority (Medsafe) have been working on a review of the business processes for the evaluation of OTC medicines. The objectives of the reforms are to:
- deliver more efficient and cost-effective processes
- provide sponsors of OTC medicines with greater clarity, transparency and predictability
- harmonise the OTC medicines evaluation processes in Australia and New Zealand
- improve the quality of OTC medicine applications
- ensure an appropriate benefit/risk model is applied to approvals of OTC medicines
About the consultation
This consultation paper outlines the key elements of the proposed business process reforms. The purpose is to seek feedback on the proposed reforms before proceeding with a detailed design of the new business processes, and development of associated documentation, such as regulatory guidelines.
Information on how to make a submission
Detailed information on how to make a submission, and who to contact for further information about the proposed reforms, is detailed within the body of the consultation paper.
Your submission should include:
- your name and full contact details including: address, telephone number, email and if applicable facsimile
- the particular issue being addressed
- relevant evidence and/or examples to support the views expressed
- in the case of organisations, the level at which the submission was authorised.
Please note: Submissions should be confined to the specific subject matter of this consultation paper. Any submissions received that do not directly relate to the subject area, or that reference other consultation papers, will not be considered.
Confidentiality of submissions
If you wish any information contained in your submission to be treated as confidential, please clearly identify that information and outline the reasons why you consider it to be confidential. Note that general disclaimers in covering emails will not be taken to be sufficient reason for submissions to be treated confidentially.
Address for submissions
- Electronic submissions should be e-mailed to:
Medsafe: medsafeapplications@health.govt.nz
TGA: OTCBPRconsultationpaper@tga.gov.au
with OTC BPR in the subject heading. - Hardcopy submissions should be mailed to one of the following addresses
:
Manager Product Regulation
Medsafe, Ministry of Health
PO Box 5013
WELLINGTON 6011
NEW ZEALANDOTC Medicines Regulatory Process Review
Therapeutic Goods Administration
PO Box 100
WODEN ACT 2606
AUSTRALIA
Questions relating to submissions
In Australia:
Any questions relating to submissions should be directed to the
OTC Medicines Business Process Reform, via email to
OTCBPRconsultationpaper@tga.gov.au
In New Zealand:
Any questions relating to submissions should be directed to the
Manager Product Regulation, via email to
medsafeapplications@health.govt.nz
Deadline for submissions
The deadline for receipt of submissions is: 7th November 2012
Next steps
The period for consultation on the proposed reforms to the business processes for OTC medicines has now closed. Analysis of submissions is currently being undertaken and the outcome of this will be advised on the Medsafe website and the Therapeutic Goods Administration website at www.tga.gov.au as soon as possible. Implementation of the changes is expected to commence in both countries by the end of April 2013.
