Federal Register of Legislation - Australian Government

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No. 1 of 2011 Determinations/Other as made
This instrument determines that specified monographs in the United States Pharmacopoeia-National Formulary are exempt for the purposes of paragraph (d) of the definition of 'standard' in subsection 3(1) of the Act.
Administered by: Health
Registered 25 Oct 2011
Tabling HistoryDate
Tabled HR31-Oct-2011
Tabled Senate31-Oct-2011






Therapeutic Goods (Exempting monographs of pharmacopoeias) Determination No. 1 of 2011



I, Rohan Hammett, delegate of the Minister for Health and Ageing for the purposes of section 3C of the Therapeutic Goods Act 1989 (‘the Act’) and acting under subsection 3C(1) of the Act, having consulted with the Therapeutic Goods Committee, HEREBY DETERMINE that the following specified monographs of the United States Pharmacopeia‑National Formulary are exempt for the purposes of paragraph (d) of the definition of “standard” in subsection 3(1) of the Act:



Anthrax Vaccine Adsorbed

BCG Vaccine

Influenza Virus Vaccine

Measles Virus Vaccine Live

Measles, Mumps and Rubella Virus Vaccine Live

Measles and Rubella Virus Vaccines Live

Mumps Virus Vaccine Live

Poliovirus Vaccine Inactivated                   

Rabies Vaccine

Rubella Virus Vaccine Live

Smallpox Vaccine

Yellow Fever Vaccine

Diphtheria and Tetanus Toxoids Adsorbed

Tetanus and Diphtheria Toxoids Adsorbed for Adult Use

Tetanus Toxoid Adsorbed

Tetanus Toxoid






Rho (D) Immune Globulin

Antithrombin III Human

Antihemophilic Factor

Cryoprecipitated Antihemophilic Factor

Factor IX Complex

Hepatitis B Immune Globulin

Immune Globulin                                                   

Pertussis Immune Globulin

Plasma Protein Fraction

Rabies Immune Globulin

Tetanus Immune Globulin

Vaccinia Immune Globulin

Varicella-Zoster Immune Globulin                        



This Order commences on the day after the day it is registered on the Federal Register of Legislative Instruments.



Dated this 18th day of October 2011





(signed by)


Rohan Hammett

Delegate of the Minister for Health and Ageing