Application for an evaluation of a new complementary medicine substance

27 November 2013

The completed application form provides the TGA with the necessary information required to begin the processing of a request for the approval of a new substance for use in listed complementary medicines. For detailed instructions for completing the application form, see: Guidance for completing the application for a new substance for use in listed complementary medicines.

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Application for an evaluation of a new complementary medicine substance (pdf,177kb)

Application for an evaluation of a new complementary medicine substance (Word document,137kb)

Guidance for completing the application for a new substance for use in listed complementary medicines

This guidance is intended for applicants applying for approval of a new substance for use in listed complementary medicines.

Accompany the application form with the submission dossier.

Contents

Part 1. Applicant and agent details

Applicants and agents can be either a person or a commercial/legal entity.

1.1 Applicant details

How to complete this information

Record the information requested in the spaces provided.

Provide both addresses where the postal address differs from the street address.

What else do I need to do?

If you do not have a client ID, apply for a client ID through eBusiness services before lodging your application.

Ensure the nominated contact person is available throughout the evaluation process, to respond to any questions the TGA may have.

If the contact persons or the contact information changes during the pre-submission/evaluation processes, contact the TGA at complementary.medicines@tga.gov.au and advise of the change.

If the primary contact is the agent, include a statement to that effect in the space provided.

Note: In the subject line include: PATS ID - and Applicant name.

1.2 Agent details

How to complete this information

Complete this section only if you are an agent acting on behalf of the applicant/company seeking approval for the substance.

Record the information requested in the spaces provided.

What else do I need to do?

If you are an Australian-based agent and do not have a client ID, apply for a client ID through eBusiness services before lodging your application.

If you are not an agent based in Australia, or your relationship with the client is not recorded in eBusiness services, attach a letter with the application form indicating that the company being represented provides permission for such representation.

Part 2. Substance details

2.1 Substance name

How to complete this information

Record the information requested in the spaces provided.

Scientific name

  • For an animal or plant derived substance, include the Latin binomial (scientific name) of the relevant species (e.g. Ginkgo biloba) in addition to any other relevant information (e.g. plant part, type of preparation)
  • For single chemical entities (simple complementary substances), use the scientific name (International Non-proprietary Name) and/or CAS number if available.
  • For complex complementary substances that are highly processed but are not simple chemical entities, propose a relevant name which may include some of the information noted above.

Note: Propose a name that is consistent with the conventions in the TGA approved terminology for medicines.

Note: Be aware that the names initially proposed may require changing as a result of evaluation of the substance. You will be consulted on this.

Known synonyms

Provide all known synonyms for the substance.

Common or trade names

Provide known common and trade names.

2.2 Approved Australian names

How to complete this information

Tick 'YES' or 'NO' in the boxes provided.

What else do I need to do?

If the substance is not included in the TGA approved terminology for medicines complete and attach the relevant application form to this application:

Part 3. Purpose for the substance

3.1 Active ingredient

How to complete this information

Complete this section only if the substance is intended to be used as an active ingredient.

Record the information requested in the spaces provided.

3.2 Excipient ingredient

How to complete this information

Complete this section only if the substance is intended to be used as an excipient ingredient.

Record the information requested in the spaces provided.

Part 4. Type of substance

4.1 Simple and complex substances

How to complete this information

  • Tick a box to indicate whether the substance is a:
    • Simple complementary substance
      Or
    • Complex complementary substance
  • Tick boxes to indicate whether there is a relevant monograph in a pharmacopoeia recognised as a default standard under s. 3 of the Therapeutic Goods Act 1989.

What else do I need to do?

In the submission dossier accompanying this application form, include all relevant information for simple and complex complementary substances as detailed in:

In the submission dossier accompanying this application form, include a draft compositional guideline for Type 2 substances.

Note: A Type 2 substance is not the subject of a current monograph in the British Pharmacopoeia (BP), the European Pharmacopoeia (Ph.Eur.) or the United States Pharmacopeia - National Formulary (USP).

Related information, guidance and template

4.2 Type 2 Substance application

How to complete this information

Complete this section only if the substance has been determined as a Type 2 substance.

Record the information requested in the space provided.

Part 5. Manufacturer details

How to complete this information

Record the information requested in the spaces provided.

What else do I need to do?

Include the Good Manufacturing Practice (GMP) licence number for Australian manufacturers.

Include the GMP clearance number for overseas manufacturers, if available.

If any other relevant GMP evidence is included in the dossier, identify the type of evidence that is included.

Part 6. Checklist - Safety data included in submission dossier

6.1 Literature search

How to complete this information

Tick 'YES' or 'NO' in the boxes provided.

What else do I need to do?

Ensure the literature search is consistent with Part III, Section 5.1.2, Safety - Australian Regulatory Guidance for Complementary Medicines (ARGCM).

Ensure the submission dossier includes information as set out in Part III, Section 5.1.2, Safety - Australian Regulatory Guidance for Complementary Medicines (ARGCM).

6.2 Other sections

The following instructions applies to these sections:

  • History and patterns of previous human use
  • Biological activity
  • Toxicology
  • Clinical trial
  • Adverse reactions
  • Adventitious agent safety of medicines

How to complete this information

Tick 'YES' or 'NO' in the boxes provided.

What else do I need to do?

Ensure the submission dossier includes information as set out in Part III, Section 5.1.2, Safety - Australian Regulatory Guidance for Complementary Medicines (ARGCM).

Related information and guidance

Part 7. Fees

There is no application fee. The evaluation fee is based on a page count of all data and references directly relevant to the safety of the substance.

How to complete this information

Tick 'YES' or 'NO' in the boxes provided.

What else do I need to do?

Provide the requested information and make your evaluation fee payment.

Make your own assessment of the evaluation fee payable based on the page count of all directly relevant safety data/literature, i.e. directly relevant information submitted in response to Part 6 of this application, excluding literature search details and results.

In your submission dossier, provide a reference list of the safety data/literature, clearly showing how each item does or does not count towards the evaluation fee.

Note: If you believe that certain safety information should not count towards the evaluation fee, then provide a clear justification in the reference list.

Note: If you are paying by credit card, you will be issued with a reference number once the application has been received by the TGA. When you have this number, complete the credit card authorisation form. This reference is needed so that your payment can be linked to the application.

Note: If you are paying by electronic funds transfer, you will be issued with a reference number and an invoice once the application has been received by the TGA. This reference is needed so that the payment can be linked to the application.

Related information and guidance

Part 8. Declaration

How to complete this information

Read the statements and conditions.

What else do I need to do?

Check the corresponding box.

Complete the remaining fields.

An application form will not be accepted unless it has been completed and is accompanied by a submission dossier.

Submitting an application form provides a declaration of understanding and agreement to satisfy the requirements for an effective submission.

Ensure the submission dossier contains the full data set to be evaluated.