Therapeutic Goods (Groups) Order No. 1 of 1992

Published in the Commonwealth of Australia Gazette, 1992

Please note that the majority of this Order has been revoked by Therapeutic Goods (Groups) Order No. 1 of 2001. However, Section 11 of this Order, which includes amendments to Clause 4 of Therapeutic Goods (Single Therapeutic Goods) Order No. 1 of 1991, remains effective.

COMMONWEALTH OF AUSTRALIA

Therapeutic Goods Act 1989

Therapeutic Goods (Groups) Order No. 1 of 1992

I, STUART HAMILTON, Secretary to the Department of Health, Housing and Community Services, make the following Order under section 16 of the Therapeutic Goods Act 1989.

Dated 5th August 1992.

Secretary

Citation

1. This Order may be cited as Therapeutic Goods (Groups) Order No. 1 of 1992.

Commencement

2. This Order commences on the day on which it is published in the Gazette.

Interpretation

3. In this Order, unless the contrary intention appears:
   • "drug" has the same meaning as in the Regulations;
   • "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;
   • "registered" means registered in the part of the Register for goods known as registered goods;
   • "the Act" means the Therapeutic Goods Act 1989;
   • "the Regulations" means the Therapeutic Goods Regulations.

Non-Schedule - 10 drugs - variation in excipients

4.  
   1. In this clause:"approved drug" means a non-Schedule - 10 drug that is:
      1. required to be listed or registered; and
      2. approved by the Secretary to be listed or registered;
      "entered drug" means a non-Schedule - 10 drug that is listed or registered;
      "non-Schedule - 10 drug" means a drug other than a drug of a kind referred to in Schedule 10 to the Regulations.
   2. An approved drug, and an entered drug that is listed or registered in relation to the same sponsor, together comprise a gazetted therapeutic goods group if the approved drug:
      1. would, but for this Order, be taken to be separate and distinct from the entered drug under paragraph 16 (1) (a) of the Act only because of:
         1. a change in the quantity of an ingredient that does not have a therapeutic action; or
         2. the removal or addition of an ingredient that is used only for the purpose of fragrance, flavouring or colouring; and
      2. the approved drug is intended to replace the entered drug in use.

Allergen products

5. All allergen extracts that are:
   1. 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.

Drugs-revised indications or directions for use

6.  
   1. In this clause: "approved drug" means a drug that is:
      1. required to be listed or registered; and
      2. approved by the Secretary to be listed or registered,
      "entered drug" means a drug that is listed or registered.
   2. An approved drug and an entered drug that is listed or registered in relation to the same sponsor together comprise a gazetted therapeutic goods group if the approved drug:
      1. differs from the entered drug 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. will be listed or registered in place of the entered drug.

Drugs for export only - concurrent use of different indications and directions for use

7.  
   1. In this clause: "approved drug" means a drug that is:
      1. required to be listed; and
      2. approved by the Secretary to be listed.,
      "entered drug" means a drug that is listed.
   2. An approved drug that is produced for export only, and a drug that is listed in relation to the same sponsor for export only, together comprise a gazetted therapeutic goods group if the approved drug and the entered drug differ only in:
      1. the indications for use; or
      2. the directions for use; or
      3. both the indications and directions for use.

[NOTE: Therapeutic goods produced in Australia for export only must be listed: see the Regulations, r. 11 and Item 1 of Schedule 4.]

Drugs-Replacement of a drug by another with a different name

8.  
   1. In this clause: "approved drug" means a drug that is:
      1. required to be listed or registered; and
      2. approved by the Secretary to be listed or registered;
      "entered drug" means a drug that is listed or registered.
   2. An approved drug and an entered drug that is listed or registered in relation to the same sponsor together comprise a gazetted therapeutic goods group if:
      1. the approved drug is intended to replace the entered drug in use; and
      2. the only difference between the approved drug and the entered drug is the name given to each of them by the sponsor.

[NOTE: As to whether drugs must be listed or registered. see the Regulations, rr.10 and 11, and Schedules 3 and 4.)

Drugs-different export name

9.  
   1. In this clause: "approved drug" means a drug that is:
      1. required to be listed or registered; and
      2. approved by the Secretary to be listed or registered;
      "entered drug" means a drug that is already listed or registered.
   2. An approved drug that is produced by a sponsor for export only, and an entered drug that is listed or registered in relation to the same sponsor, together comprise a gazetted therapeutic goods group if the only difference between the approved drug and the entered drug is the name given to each of them.

Medical gases

10. 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.

Amendment of Therapeutic Goods (Single Therapeutic Goods) Order No. 1 of 1991.

11. Clause 4 of the Therapeutic Goods (Single Therapeutic Goods) Order No. 1 of 1991 is amended by omitting subclauses (1), (2), (3) and (4).

[NOTE: The Therapeutic Goods (Single Therapeutic Goods) Order No. 1 of 1991 dated 15 February 1991 (STG1/1991) was published in Commonwealth of Australia Gazette No.S44 of 15 February 1991.]