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AHMAC - Scheduling policy framework for medicines and chemicals, 2015
Chapter 4: Guidelines for applications and information requirements
1. Scheduling and rescheduling
Application and information requirements for scheduling of new substances and rescheduling of existing substances are to be included in those already in place for the evaluation of the relevant medicine or poison, where a regulatory framework exists.
2. Scheduling and rescheduling human medicines
For a human medicine, it is generally expected that an application for rescheduling to a lower schedule or for an exemption from the requirements of the SUSMP would be supported by at least two years of local clinical use or post-marketing experience with the human medicine. Other suitable evidence such as an appropriate period of distribution and use in comparable markets overseas (this being a country with a well-developed pharmacovigilance system) will be considered in lieu of local post-market experience. This requirement will be assessed on a case-by-case basis.
Suitable evidence includes:
- evidence from comparable overseas countries (such as Canada, Sweden, Netherlands, United States, United Kingdom and Europe generally); or
- relevant public "exposure" information in comparable countries with a greater population base than Australia; or
- any available information from post-marketing surveillance (spontaneous and any post marketing surveillance studies, local or overseas); or
- any relevant previous Australian consideration of scheduling of the medicinal substance (e.g. different route of administration).
- any relevant Australian experience with the medicine including a different route of administration.
The rescheduling process takes into consideration relevant market experience and distribution of use of the substance in Australia or overseas.
For further information on application requirements for human medicines refer to:
|Type of Human Medicine||TGA Guideline|
|Prescription Medicines||Australian Regulatory Guidelines for Prescription Medicines (ARGPM)|
|Over the Counter (OTC) Medicines||Australian Regulatory Guidelines for OTC Medicines (ARGOM)|
|Complementary Medicines||Australian Regulatory Guidelines for Complementary Medicines (ARGCM)|
3. Scheduling agricultural and veterinary chemicals
Applications for the scheduling of new agricultural and veterinary chemicals are made directly to the APVMA as part of an application for registration of a new agricultural or veterinary product. The scheduling aspect of the application is referred to the Department by the APVMA as part of the health risk assessment process for registration.
Application and information requirements for agricultural and veterinary chemicals are available on-line at the Australian Pesticides and Veterinary Medicines Authority.
4. Rescheduling agricultural and veterinary chemicals
Applications for rescheduling an existing agricultural and veterinary chemical can be made directly to the APVMA (and referred to the Department). The ACCS will make a recommendation to the Secretary on the rescheduling application based on the assessment of the submitted information provided and any stakeholder submissions received as part of the consultation process.
Application and information requirements for rescheduling existing agricultural and veterinary chemicals are available on-line at Australian Pesticides and Veterinary Medicines Authority.
5. Scheduling and rescheduling domestic and other chemicals
Applications for scheduling and rescheduling domestic and other chemicals are made directly to the Department. A request for advice regarding scheduling of a domestic or an industrial chemical with domestic use may also be made by NICNAS as a result of the assessment process for these substances. Applications may also be referred to NICNAS for technical advice by the Department as required. The format for NICNAS applications is available on-line at National Industrial Chemicals Notification and Assessment Scheme.
Note: Application guidelines and information requirements for domestic and other chemicals are set out in the electronic application template available at the Scheduling website.