Health Regulation 1996 Part 16 - Therapeutic Goods and other Drugs - Queensland

Service summary

The Health Regulation 1996 Part 16 - Therapeutic Goods and other Drugs aims to establish standards for goods of a therapeutic nature and to allow for sampling and testing of these goods. Sampling and testing is conducted to ensure that goods comply with standards, safety in packaging and truth in labelling and advertising.

Scope of this legislative Instrument

Part 16 of the Health Regulation 1996 prescribes controls for therapeutic goods and other drugs, as defined, in the areas of:

  • good manufacturing practice
  • distribution and storage
  • packaging and labelling
  • batch coding and expiry dating
  • cautionary and warning statements
  • product claims
  • instructions and dosage
  • prohibited claims
  • product standards.

The Health Regulation 1996 also further prescribes the requirements on specifications for premises where therapeutic goods are packed or manufactured.

Service type

Regulatory Obligation

An obligation defined in law. A business must comply with relevant services.

Definition of terms

Other drugs

Cosmetics, deodorants, dusting powders, soaps, tobaccos, unguents, other toilet articles and any other drugs declared by Order in Council to be drugs to which this Regulation applies.

Therapeutic use

Means a use for the purpose of or in connection with:

  • preventing, diagnosing, curing or alleviating any disease
  • influencing, inhibiting or modifying a physiological process in any person
  • testing the susceptibility of any person to a disease or ailment.

Additional information

The Health Regulation 1996 applies only to natural persons trading within Queensland. Interstate trading is subject to Commonwealth legislation administered by the Therapeutic Goods Administration.

Compliance and appeal mechanisms 

The Health Regulation 1996 Part 16 - Therapeutic Goods and other Drugs comes under the Health Act 1937 and is subject to the compliance mechanisms referred to in that Act. Fines are imposed for offences against the Regulation.

You are able to make an appeal to the Magistrates Court against a penalty imposed under The Health Regulation 1996 Part 16 - Therapeutic Goods and other Drugs.


 

Administering agency

Queensland Health

Contact details

Enquiries
Queensland Health
Public Health Regulation and Licensing

Mailing address:
PO Box 2368
Fortitude Valley
Queensland 4006

Phone:

07 3328 9310

Supporting information

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