Consultation documents released
23 May 2006
Please note: This consultation closed on 15 August 2006.
Documents detailing the proposed joint regulatory scheme for the new Australia New Zealand Therapeutic Products Authority (ANZTPA) have been released for public consultation.
Submissions are being welcomed on the proposed regulatory scheme or "draft Rules" for medicines and medical devices; a description of the proposed Grouping Order for medicines; draft guidelines on transition provisions for product licensing; the key components of the draft Administration Rule; and the consultation document on the proposed fees and charges.
The closing date for submissions on the consultation documents is 15 August 2006.
The proposed regulatory scheme for prescription, over-the-counter (OTC) and complementary medicines and medical devices aims to protect the health and safety of Australians and New Zealanders through jointly regulating therapeutic products in accordance with international best practice.
It is proposed that the level of regulation will reflect the degree of risk associated with a product. For lower risk products such as most complementary medicines, the proposed regulatory scheme will be less stringent than for products such as prescription medicines which go through a strict evaluation and approval process before consumers can use them.
This is the first of three consultation phases on the proposed regulatory scheme.
Further information
The draft Medicines Rule
This draft Rule covers the proposed regulatory scheme for prescription and over-the-counter medicines and complementary medicines. It includes:
- The approval processes and authorisation requirements to licence a medicine.
- The licensing requirements for medicine manufacturers.
- Exemptions where no licence would be required.
- The requirements for medicine recalls.
Download a copy of the consultation document - draft Medicines Rule (pdf,489kb)
A description of the proposed Grouping Order for medicines
This consultation document describes how medicines with certain shared characteristics can be grouped together on one product licence. The draft Order, when finalised, would sit underneath the Medicines Rule.
A draft guideline on transition provisions for product licensing
The document describes how therapeutic products, that are lawfully being supplied in Australia or New Zealand, will be issued with an interim licence for 3-years enabling products to continue to be sold during the initial 3-year transition period. The draft transition guideline also describes the transition process for obtaining an ANZTPA product licence that would authorise therapeutic product supply in both Australia and New Zealand.
The draft guideline for transition to the joint regulatory scheme covers:
- Class 1 medicines (most complementary medicines)
- Class 2 medicines (prescription and over-the-counter (OTC) medicines)
- Medical Devices
The draft Medical Devices Rule
This draft Rule covers the proposed regulatory scheme for medical devices including:
- The essential principals and medical device standards.
- Conformity assessment for medical devices.
- The requirements for the manufacture of medical devices.
- Medical devices product approval and licensing.
- Products that are exempt from certain requirements.
- Product recalls.
Download a copy of the consultation document - draft Medical Devices Rule (pdf,754kb)
Also see: In-Vitro Diagnostic Devices (IVD) Revision Draft of the proposed Australia New Zealand Therapeutic Products Regulatory Scheme (Medical Devices) Rule 2007 (24 April 2007)
The draft administration Rule
Key components of the draft Administration Rule including:
- The proposed establishment and role of expert advisory committees which would provide advice to the ANZTPA.
- The inspection of premises where therapeutic products are manufactured or sold including factories or business premises.
- The proposed scheduling framework for medicines.
Please note that the remaining aspects of the draft Administration Rule will be released during future phases of consultation.
Download a copy of this consultation document - draft administration Rule (pdf,330kb)
The consultation document on the proposed fees and charges
This is a discussion paper which sets out the approach for proposed fees and charges including:
- The policy objectives for cost recovery.
- The cost base for the ANZTPA.
- Details of the fees and charges proposals and seeks views on fee options for potential impacts.
Accompanying resource documents
The Medicines Manufacturing Principles (pdf,45kb) provides information on aspects of manufacture such as quality management, personnel, premises and equipment, documentation, production and quality control, contract manufacture and analysis, complaints and product recalls and self inspection.
A Plain English Guide on the proposed regulatory scheme outlined in the draft Rules (pdf,417kb) is also available to provide context and assist readers' understanding of the key features of the regulatory proposals.
Note (14 June 2006): Attachment 1 to the Plain English Guide has been appended to include Explanatory Notes and a Glossary, in order to provide clarity around the use of terms relating to complementary medicines in the draft Medicines Rule. Those terms not currently included in the draft Medicines Rule may eventually be included in a Managing Director Order (MDO). As part of the development of any MDO, further consultation would be undertaken, and this would include an opportunity for stakeholders to comment further on those definitions which are not currently included in the draft Medicines Rule.
URL: http://www.anztpa.org/consult/consdocs1.htm
Links in this information:
Consultation phases - http://www.anztpa.org/consult/programme0607.htm
Draft Medicines Rule - http://www.anztpa.org/consult/dr-medrule.pdf
Proposed Grouping Order for medicines - http://www.anztpa.org/consult/dr-medgrouping.pdf
Draft guideline on transition provisions for product licensing - http://www.anztpa.org/consult/dr-translicensing.pdf
Draft Medical Devices Rule - http://www.anztpa.org/consult/dr-devrule.pdf
Draft Administration Rule - http://www.anztpa.org/consult/dr-adminrule.pdf
Proposed fees & charges - http://www.anztpa.org/consult/dr-fees.pdf
Medicines Manufacturing Principles - http://www.anztpa.org/consult/dr-mpmedicines.pdf
Plain English guide to proposed regulatory scheme - http://www.anztpa.org/about/regscheme.pdf