New ComplementaryMedicine SubstancesA roadmap for the approval of new complementarymedicine substances for listed or registered productsin the Australian Register of Therapeutic Goods.

Notes to the Chart1. Forms are available through the TGA Publications Office, phone (02) 6232 8610. For further information on how to

apply, contact the Therapeutic Goods Administration Chemicals and Non-prescription Medicines Branch of the TGA,phone (02) 6289 8634.

2. For more information on the operation of the National Drugs and Poisons Committee (NDPSC), see the Overviewbooklet in this information kit.

3. If an application is unsuccessful, appeal provisions apply. Sponsors will receive notification of the decision, the reasonsfor non-approval, and the appeal mechanisms available to them. Information on appeal provisions can be found insection 60 of the Therapeutic Goods Act 1989 and section 48 of the Therapeutic Goods Regulations. Also see the WhereDo You Get It? booklet.

4. Details of new complementary medicine substances approved for inclusion in listed or registered products are publishedin the Commonwealth Gazette (including any conditions which may apply).

5. A preliminary check of the application will be conducted and the applicant advised of any significant deficiencies.

DisclaimerInformation in this roadmap may be affected by subsequent amendments to legislation. Check the TGA websitehttp://www.health.gov.au/tga for updates to regulatory requirements and processes. THE DISCLAIMER AT THECOMMENCEMENT OF THE OVERVIEW BOOKLET (IN THIS INFORMATION KIT) ALSO APPLIES IN FULL TO THIS ROADMAP.

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Roadmap

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This roadmap outlines the process for the evaluation of a new complementary medicine substance for use in listed/registered products in the Australian Register of Therapeutic Goods (ARTG).

See the Overview booklet in this information kit for more detail.

Notes relating to the boxes on the chart can be found on the back of this roadmap. It is important to read these.

See LISTED

Roadmap

See NON PRESCRIPTION(Low Risk) RegisteredRoadmap

START

HERE

SPONSOR applies to TGA for evaluation of a new

complementary medicine substance

Business Management Unit• Fees and Charges Schedule

available from the BMU• Fees vary with application type• BMU acknowledges receipt by

issuing a TGAIN (identificationnumber) to sponsor

Office of Complementary Medicines • Part of the Chemicals

& Non-prescriptionMedicines Branch

• Application checked to ensure it contains all the necessaryinformation

CMEC • Makes recommendations on whether

the new complementary medicinesubstances should be permitted inproducts in the ARTG and on anyrestrictions that might apply.

Appeal provisions apply

3

Further information may be required

APPLICATION

NOT

APPROVED

New complementary medicine substances are:• intended for use in a complementary medicine;• of a kind described in Schedule 14 of the Therapeutic Goods Regulations;• not already described in Part 4 of the Therapeutic Goods Regulations;• usually evaluated by the Office of Complementary Medicines;• subject to approval for inclusion in registered or listed medicines

(depending on the substance and the claims made);• See also the Overview booklet.

Application lodged on

appropriate form

Application forwarded to

Business Management Unit of TGA

1

Application forwarded to

Office of Complementary

Medicines of TGA

2

YES YES

YES

NO

NO

NO

4

5

YES

Referred to National Drugs & Poisons Schedule

Committee (NDPSC)

Is thesubstance/likelyto be Scheduled under the SUSDP

guidelinesSubstance

gazetted for inclusion in REGISTERED

medicines

Complementary Medicines Evaluation Committee

(CMEC)

Application approved by

Office of Complementary

Medicines?

Substance gazetted for

inclusion in listed medicines

New Complementary Medicine Substances A roadmap for approval of new complementary medicine substancesfor use in goods listed or registered in the ARTG

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