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Permissible Ingredients Determination: Frequently asked questions
On 1 January 2016, a new legislative instrument under section 26BB of the Therapeutic Goods Act 1989 commenced. This instrument brings together all of the ingredients that are available for use in listed medicines and their associated requirements.
The Complementary and OTC Medicines Branch has prepared the following FAQs to inform sponsors about the new instrument. The FAQs will be updated in response to common inquiries from sponsors.
If you have a question regarding the 26BB Legislative Instrument which is not captured in the frequently asked questions below, please contact the Complementary and OTC Medicines Branch.
- email: firstname.lastname@example.org
- phone: 1800 020 653 (freecall within Australia) or +61 2 6232 8634
Frequently asked questions
26BB - What is the 26BB Legislative Instrument?
The 26BB 'permitted ingredients' Legislative Instrument is a Determination by the Minister under section 26BB of the Therapeutic Goods Act 1989 (the Act).The purpose of the proposed determination is to simplify the range of Legislative Instruments which currently contain ingredients permitted for use in listed medicines.
The 26BB Legislative Instrument (the 26BB list) will capture all of the ingredients available for use in listed medicines and their requirements. It is due to be implemented on 1 January 2016.
The 26BB list will capture all ingredients that are currently permitted for use in listed medicines and their requirements. This includes:
- All ingredients that are currently included in listing notices under section 9A(5) of the Act
- All ingredient that are currently available in Schedule 4 to the Therapeutic Goods Regulations (1990) (the Regulations)
- All previously grandfathered ingredients
After 1 January 2016, all new ingredients for use in listed medicines will also be included in the 26BB Legislative Instrument once an evaluation of the ingredient has occurred consistent with current practice.
The 26BB list will only include ingredients available for use in listed medicines. Components of ingredients will not be included in the 26BB list, as these are not ingredients in their own right.
Over-the-counter and prescription medicine ingredients will not be included in the 26BB Legislative Instrument.
No, the 26BB Legislative Instrument will capture and replace a number of legislative requirements for listed medicines ingredients. As a result,
- Schedule 4 to the Regulations will be simplified to remove all references to individual ingredients and their requirements.
- Regulation 3AA will be amended to remove listed medicines from the regulatory remit of the Medicines Advisory Statements Specification 2014.
- Listing notices for listed medicines ingredients will be repealed.
The process of bringing together all of the ingredients and their requirements was a manual one. As such, there is potential that the list contains some human error. Further, we took the opportunity to rectify mistakes in the ingredients currently included in the TGA listed medicines eBusiness Portal (ELF), including removing duplication and correcting names.
We have requested industry comment on the ingredients and their requirements to ensure that they are correct and the 26BB list will be fit-for-purpose.
The Parliament can delegate its power to make laws on particular matters to other persons and bodies. The term Legislative Instrument captures a range of subordinate rule making instruments, for example the Therapeutic Goods Regulations 1990 are a Legislative Instrument.
One of the reasons for using the 26BB Legislative Instrument is that it is more flexible and easier to change than the instruments which currently provide for permitted ingredients and their requirements. For example, changes to Schedule 4 to the Regulations are made by the Governor General and must be tabled in Parliament. This is a lengthy administrative process.
Changes to the 26BB Legislative Instrument will be made by a Delegate of the Minister. Currently, the Delegate for the purposes of 26BB is the First Assistant Secretary (or the Division Head) of the Medicines Regulation Division, which includes the Complementary and Over the Counter Medicines Branch. This level of delegation provides a significantly improved amount of flexibility.
Ingredients that are currently permitted for use in listed medicines, and their requirements, will remain the same. Medicines that are currently compliant will remain compliant.
Before new ingredients can be used in listed medicines, they must be included in the 26BB Legislative Instrument. For more information, see the 26BB evaluation process below.
26BB - Evaluation process
There are two ways in which a new ingredient can be added to the 26BB Legislative Instrument:
- Variation by the Minister, as per section 26BC of the Act or
- Variation by application by a person, as per section 26BD of the Act.
No, the evaluation process for listed medicines will remain the same and the same fees will continue to be charged. As a result, Schedule 9 of the Regulations will simultaneously be amended to reflect an evaluation fee under section 26BD of the Act.
The evaluation processes for ingredients, including timeframes, are currently being updated and improved in collaboration with industry in the Complementary Medicines Business Process Reform.
Once an ingredient has been approved for use in listed medicines, sponsors will be notified of this decision and the date in which the ingredient will be included in the 26BB Legislative Instrument.
An ingredient can be used by all sponsors once it is included in the 26BB Legislative Instrument.
No, currently the administrative process of making ingredients available for use in listed medicines via listing notices takes between two and four months. This can depend on consultation periods and both internal and external administrative processes. The 26BB Legislative Instrument gives us the opportunity to make multiple updates and changes at a single time.
The TGA has proposed regularly scheduled quarterly updating to improve the timeliness. This means that the longest time before an ingredient is made available would be three months, but could be much shorter depending on when in the cycle a new ingredient is approved.
Where we identify trends or groups of changes that offer deregulation benefits, we will endeavour to make those changes under section 26BC - variation of the list by the Minister's initiative.
26BB - Next steps
No, currently listed medicines will not be affected by these changes. Medicines that are currently compliant will continue to remain compliant.
We are working with industry to ensure that all ingredients and their requirements are accurately captured in the Legislative Instrument. Although we have taken every care to ensure that the list is correct, there may be minor issues. We will be pragmatic in the listing compliance approach and envisage that your comments will ensure that the list is as accurate as possible.
No, the 26BB Legislative Instrument will not result in any changes to the availability of listed ingredients and their requirements. It will not result in any changes to industry business processes.
No, TBS will continue to look and function in the same way. All permitted ingredients will continue to be available for inclusion in an application in the same way.