Therapeutic Goods (Groups) Order No. 1 of 2001

Published in the Commonwealth of Australia Special Gazette, No. S 392, 26 September 2001

COMMONWEALTH OF AUSTRALIA

Therapeutic Goods Act 1989

Therapeutic Goods (Groups) Order No. 1 of 2001

I, TERRY SLATER, delegate of the Secretary of the Department of Health and Aged Care, make this Order under subsection 16(2) of the Therapeutic Goods Act 1989.

Dated: 21 September 2001

Terry Slater
National Manager
Therapeutic Goods Administration

Citation

1. This Order may be cited as Therapeutic Goods (Groups) Order No. 1 of 2001.

Commencement

2. This Order commences on gazettal.

Revocation

3. This Order revokes Therapeutic Goods (Groups) Order No. 1 of 1992. The amendments made by the latter Order to Clause 4 of Therapeutic Goods (Single Therapeutic Goods) Order No 1 of 1991 remain effective.

Interpretation

4. In this Order, unless the contrary intention appears:
   • "active ingredient" means the therapeutically active component in a medicine's final formulation that is responsible for its physiological or pharmacological action.
   • "existing medicine" means a medicine that is listed or registered.
   • "export only medicine" has the meaning given by subsection 3(1) of the Act.
   • "gazetted therapeutic goods group" has the meaning given by subsection 16(2) of the Act.
   • "listed" means listed in the part of the Register for goods known as listed goods.
   • "medicine" has the meaning given by subsection 3(1) of the Act.
   • "new medicine" means a medicine that is:
     1. required to be listed or registered; and
     2. listed in the Register by the Secretary or approved by the Secretary to be listed or registered.
   • "proprietary excipient" means a fragrance, flavouring, colouring, printing ink, film coating material, empty capsule shell, preservative premix or other excipient premix, which does not contain any active ingredients, supplied to a licensed manufacturer for further use in a medicine, and the formulation of which is confidential from the sponsor.
   • "registered" means registered in the part of the Register for goods known as registered goods.
   • "restricted ingredient" has the meaning given by subregulation 10A(2) of the regulations
   • "the Act" means the Therapeutic Goods Act 1989.
   • "the Register" means the Australian Register of Therapeutic Goods.
   • "the Regulations" means the Therapeutic Goods Regulations.

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Medicines - variation in excipients

5.1 A new medicine, and an existing medicine that is listed in relation to the same sponsor, together comprise a gazetted therapeutic goods group if:

1. the new medicine would, but for this Order, be taken to be separate and distinct from the existing medicine under subsection 16(1A) of the Act only because of:
   1. a change in the quantity or concentration of a restricted ingredient that is not an active ingredient; or
   2. the removal or addition of an ingredient that is used only for the purpose of fragrance, flavouring, printing ink or colouring; and
2. the new medicine is intended to replace the existing medicine in use.

5.2 A new medicine, and an existing medicine that is registered in relation to the same sponsor, together comprise a gazetted therapeutic goods group if:

1. the new medicine would, but for this Order, be taken to be separate and distinct from the existing medicine under paragraph 16(1)(a) of the Act only because of:
   1. a change in the quantity of an ingredient that is not an active ingredient; or
   2. the removal or addition of an ingredient that is used only for the purpose of fragrance, flavouring, printing ink or colouring; and
2. the new medicine is intended to replace the existing medicine in use.

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Listed medicines other than export only medicines - variation in proprietary excipient

6. A new medicine, and an existing medicine that is listed in relation to the same sponsor, together comprise a gazetted therapeutic goods group if:
   1. the new medicine and the existing medicine are not export only medicines; and
   2. the new medicine would, but for this Order, be taken to be separate and distinct from the existing medicine under subsection 16(1A) of the Act only because of a substance included in a proprietary excipient; and
   3. the dosage form of the new medicine is the same as the dosage form of the existing medicine; and
   4. the new medicine is intended to replace the existing medicine in use.

Allergen products

7. All allergen extracts that are:
   1. made from the same components; and
   2. entered in the Register in relation to the same sponsor;
   comprise a gazetted therapeutic goods group if the extracts differ from each other only in one or more of the following:
   3. strength;
   4. container type;
   5. indications for use.

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Medicines - Revised indications or directions for use

8. A new medicine, and an existing medicine that is listed or registered in relation to the same sponsor, together comprise a gazetted therapeutic goods group if:
   1. the new medicine differs from the existing medicine only in having:
      1. different indications for use; or
      2. different directions for use; or
      3. both different indications for use and different directions for use; and
   2. the new medicine will be listed or registered in place of the existing medicine.

Medicines listed for export only ¹ - concurrent use of different indications and directions for use

9.1 A new medicine that is intended only for export ² , and an existing medicine that is listed in relation to the same sponsor for export only, together comprise a gazetted therapeutic goods group if:

1. the new medicine and the existing medicine are not export only medicines ²; and
2. the new medicine and the existing medicine differ only in:
   1. the indications for use; or
   2. the directions for use; or
   3. both the indications and directions for use.

9.2 A new medicine that is produced as an export only medicine ², and an existing medicine that is listed in relation to the same sponsor for export only, together comprise a gazetted therapeutic goods group if:

1. the new medicine and the existing medicine are export only medicines; and
2. the new medicine and the existing medicine differ only in:
   1. the indications for use; or
   2. the directions for use; or
   3. both the indications and directions for use.

[NOTE

¹ Therapeutic goods produced in Australia for export only must be listed: see the Regulations, r11 and Item 1 of Schedule 4

² The difference in meaning between a medicine "intended only for export" and an "export only medicine" is that:

• "export only medicine" is defined in subsection 3(1) of the Act to cover medicines which have been designed specifically for an export market and are only eligible for listing on that basis alone; whereas
• "intended only for export" refers to medicines that are imported into Australia or manufactured in Australia and are listed only for export purposes on the basis that they do not need to be listed or registered for supply in Australia (although they potentially could be).

Clause 9.1 permits export medicines which are potentially eligible for listing for supply in Australia to be grouped with other medicines which meet this same criteria where the medicines differ only in indications, directions for use or both. Clause 9.2 permits export only medicines that would not be eligible for listing for supply in Australia, to be grouped with other export only medicines where the medicines differ only in indications, directions for use or both.]

Replacement of a medicine by another with a different name

10. A new medicine and an existing medicine that is listed or registered in relation to the same sponsor, together comprise a gazetted therapeutic goods group if:
    1. the only difference between the new medicine and the existing medicine is the name given to each of them by the sponsor; and
    2. the new medicine is intended to replace the existing medicine in use.

[NOTE: As to whether medicines must be listed or registered, see the Regulations, rr10 and 11, and Schedules 3 and 4.]

Medicines - different name for export purposes

11. A new medicine that is produced for export only and an existing medicine that is listed or registered in relation to the same sponsor, together comprise a gazetted therapeutic goods group if the only difference between the new medicine and the existing medicine is the name given to each of them.

Medical gases

12. Medical gases, being medical gases:
    1. required to be listed or registered; and
    2. approved by the Secretary to be listed or registered;
    that are mixtures of chemical elements or chemical compounds together comprise a gazetted therapeutic goods group if the medical gases:
    3. contain the same chemical elements or chemical compounds; and
    4. differ only in the proportions of each element or compound in the mixture; and
    5. are listed or registered in relation to the same sponsor.

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