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Consultation: Over-the-counter (OTC) medicines business process reform
This consultation closed on 7 November 2012
Invitation to comment
Medsafe and the TGA sought comments from interested parties on proposed reforms to the business processes for the evaluation of over-the-counter (OTC) medicines.
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- Over-the-counter (OTC) medicines business process reform consultation paper (pdf,798kb)
- Over-the-counter (OTC) medicines business process reform consultation paper (Word,1.25Mb)
Document released for consultation on Thursday 13 September 2012.
Interested parties responded by close of business Wednesday 7 November 2012.
Feedback will be released following consideration of submissions.
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.
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.
Questions relating to submissions
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 firstname.lastname@example.org.
Deadline for submissions
The deadline for receipt of submissions was 7 November 2012.
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 ANZTPA.org website, the Medsafe website and the Therapeutic Goods Administration website as soon as possible. Implementation of the changes is expected to commence in both countries by the end of April 2013.
These are the submissions received by the TGA in response to the consultation paper.
- Consultation submission: Accord Australasia Limited (pdf,206kb)
- Consultation submission: Australian Self Medication Industry Inc. (pdf,200kb)
- Consultation submission: GMiA (pdf,23kb)
- Consultation submission: New Zealand Self Medication Industry Inc. (pdf,156kb)
- Consultation submission: Consumers Health Forum of Australia (pdf,116kb)
- Consultation submission: National Prescribing Service (pdf,34kb)
- Consultation submission: The Pharmacy Guild of Australia (pdf,78kb)
- Consultation submission: Apotex Australia & NZ (pdf,70kb)
- Consultation submission: Bayer Health Care (pdf,63kb)
- Consultation submission: Bausch & Lomb (pdf,147kb)
- Consultation submission: Ego Pharmaceuticals (pdf,91kb)
- Consultation submission: Fresenius Kabi (pdf,129kb)
- Consultation submission: GlaxoSmithKline (pdf287,kb)
- Consultation submission: Johnson & Johnson Pacific (pdf,162kb)
- Consultation submission: Pfizer Consumer Healthcare (pdf,63kb)
- Consultation submission: Proctor and Gamble (pdf,73kb)
- Consultation submission: Reckitt Benckiser Australia (pdf,46kb)
- Consultation submission: Reckitt Benckiser New Zealand (pdf,43kb)