TGA use only

This form, whencompleted, willbeclassified as 'For official use only'.
For guidance on how your information willbetreated by the TGA see: Treatment of information provided to the TGA at <

Application form

Application for evaluation of a substance for use in listed complementary medicines

This form must be used for an application under section 26BE of the Therapeutic Goods Act 1989(the Act) to vary a determination made under section 26BB of the Act (the Therapeutic Goods (Permissible Ingredients) Determination). The application form is to be used by applicants in conjunction with the Guidance for completing the application for evaluation of a substance for use in listed complementary medicines.

Part 1 Applicant and agent details

1.1Applicant details

Applicant name
Company
eBS client ID
(if held by the company)
Postal address
Street address
Primary contact / Secondary contact
Contact person
Position
(e.g. regulatory affairs officer, agent)
Telephone number
Mobile number
(optional)
Fax number
Email address

1.2Agent details

Agent name
Company
eBS client ID
(for Australian agents only)
Postal address
Street address

Note:For agents not based in Australia attach a letter with the application form indicating that the company being represented provides permission for such representation.

Note:For agents that already have an eBS client ID, ensure that the relationship with the applicant is in the eBS client database.

1.3 Application category

Select one application category

IN1: Evaluation of safety and quality based on reports from comparable overseas regulators
IN2: Evaluation of safety based on reports from comparable overseas regulators and an independent evaluation of quality
IN3: Evaluation of quality based on reports from comparable overseas regulators or an accepted monograph and an independent evaluation of safety
IN4: A full independent evaluation of safety and quality

Is this a Comparable Overseas Regulatory (COR) report-based application(IN1, IN2 and IN3)?

Yes No

If yes, provide the completed COR report-based checklist in your application dossier.

1.4Request for exclusive use of a new ingredient

If this will be a new ingredient, are you requesting exclusive use? Yes No

Part 2 Substance details

2.1Substance name

Scientific name
Known synonyms
Common or trade names

2.2Australian approved names

Is the substance name an:

  • Australian Approved Name (AAN) Yes No
  • Australian Biological Name (ABN) Yes No
  • Australian Herbal Name (AHN) Yes No

Note:For substances not listed in the TGA approved terminology for medicines complete and submit the relevant application form (AAN, ABN or AHN) as part of this application.

Part 3 Purpose for the substance

Record the intended purpose of the substance as either an active ingredient and/orexcipient ingredient.

3.1Active ingredient

Therapeutic use
(e.g. relief of sinus pain)
Route of administration
Dose form
Dose range
(include frequency & duration)
Restrictions
(e.g. dosage, target age group)

3.2Excipient ingredient

Role
(e.g. sweetener)
Route of administration
Dose form
Restrictions
(e.g. dosage, target age group)

Part 4 Type of substance

4.1Simple and complex substances

Is the application for a single constituent substance that can be readily characterised (e.g. a purified amino acid)?

Yes(simple complementary substance)

No(complex complementary substance)

Is the substance the subject of a current monograph?

Yes(Type 1 complementary substance)

No(Type 2 complementary substance)

If yes, tick which pharmacopoeia:

  • British Pharmacopoeia (BP)
  • European Pharmacopoeia (Ph.Eur.)
  • United States Pharmacopeia – National Formulary (USP)

If no, have you included in your submission dossier a draft compositional guideline for the substance?

Yes

No

4.2Type 2 substance application

Provide a definition, description and/or structure if the substance has been determined as a Type 2 substance.

4.3 COR report-based process

An assessment report from a COR covering all Information required to demonstrate the quality of a new complementary medicine substance is included with the application (IN1 or IN3 applications).

Yes No

Part 5 Manufacturer details

Name
Street address
GMP licence/clearance number
(when held)
Other evidence of GMP
(if available)

Part 6 Checklist – Safety data included in submission dossier

6.1Literature search

Has a literature search been conducted for data to support the safety of the substance?

Yes No

6.2History and patterns of previous human use

Does the substance have a traditional dietary use? Yes No

Does the substance have a traditional therapeutic use? Yes No

Is the substance available for commercial use in Australia? Yes No

Is the substance available for commercial use in other countries? Yes No

If yes, is it available as a:

  • Food component
  • Dietary supplement ingredient
  • Therapeutic good ingredient
  • Other. Provide details.

6.3Biological activity

Have studies been conducted to investigate the biological activity or physiological role of the substance or any closely related substance?

Yes No

6.4Toxicology

Have any studies been conducted to investigate the toxicity or toxicological profile of the substance or any closely related substances?

Yes No

6.5Clinical trial

Have any clinical trials addressing safety been conducted with the substance or any closely related substances?

Yes No

6.6Adverse reactions

Have any adverse reactions to therapeutic goods containing the substance or any related substances occurred?

Yes No

6.7Adventitious agent safety of medicines

Is the substance of animal or human origin? Yes No

If yes, have you included data to support the viral and mycoplasma safety for all materials of animal origin?

Yes No

Have you included data to support the transmissible spongiform encephalopathy safety for materials of ruminant origin?

Yes No

6.8 COR report-based process

An assessment report from a COR covering all Information required to demonstrate safety of a complementary medicine substance for use in listed medicinesis included with the application(IN1 or IN2 applications).

Yes No

Part 7 Fees

Please ensure that the fees paid are based on the appropriate application category.

Are you paying by:

Cheque? Yes No

If yes, ensure that you submit the cheque with the completed application form and the submission dossier to the Complementary and OTC Medicines Branch.

Credit card? Yes No

If yes, after the application has been received, you will be sent an application reference number to include on the TGA credit card authorisation form.

Electronic funds transfer? Yes No

If yes, after the application has been received, an invoice for the estimated fee entered above will be sent to you.

Part 8 Declaration

I acknowledge that it is a serious offence to give false or misleading information to the Therapeutic Goods Administration (the TGA) for the purposes of making this application requesting evaluation under section 26BEof the Therapeutic Goods Act 1989.*

I declare I have read the Guidance for completing the application for evaluation of a newsubstance for use in listed complementary medicines and completed this application form in accordance with the instructions in that guidance.

I declare that the information provided in this application form, including the COR checklist,and in the submission dossier accompanying the application is to the best of my knowledge, complete, current and correct.

I understand that my application will be processed by the TGA in accordance with the procedures set out in the Australian Regulatory Guidelines for ComplementaryMedicines.

*Giving false or misleading information is a serious offence under Australian Government law.

Name of authorised officer:
Position/relationship to applicant:
Email:
Telephone: / Fax:
Signature / Date:

Application form - Application for evaluation of a substance for use in listedcomplementarymedicines (April 2018)
For official use onlyPage 1 of 8