Therapeutic Goods Regulations 1990

Submitted by Richard_Li on Fri, 02/17/2023 - 00:42

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Distinguished Terms in this instrument

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Term(s)	Definition	Defined in Legislation	See Section(s)
2010 Amendment Regulations	means the Therapeutic Goods Amendment Regulations 2010 (No. 1) .	Therapeutic Goods Regulations 1990	Therapeutic Goods Regulations 1990 - 48A Definitions
2017 Amendment Regulations	means the Therapeutic Goods Legislation Amendment (2017 Measures No. 1) Regulations 2017 .	Therapeutic Goods Regulations 1990	Therapeutic Goods Regulations 1990 - 52 Definitions
active ingredient	, for a medicine, means a therapeutically active component in the medicineâs final formulation that is responsible for its physiological or pharmacological action.	Therapeutic Goods Regulations 1990	Therapeutic Goods Regulations 1990 - 2 Specific requirementsâdocument enclosed within packaging etc.
AHPRA number	, of a health practitioner, means the registration number published by the Australian Health Practitioner Regulation Agency in relation to the health practitioner.	Therapeutic Goods Regulations 1990	Therapeutic Goods Regulations 1990 - 2 Specific requirementsâdocument enclosed within packaging etc.
amending regulations	means the Therapeutic Goods Legislation Amendment (2019 Measures No. 1) Regulations 2019 .	Therapeutic Goods Regulations 1990	Therapeutic Goods Regulations 1990 - 69 Definitions
Amendment Regulations	means the Therapeutic Goods Legislation Amendment (2017 Measures No. 2) Regulations 2017 .	Therapeutic Goods Regulations 1990	Therapeutic Goods Regulations 1990 - 57 Definitions Therapeutic Goods Regulations 1990 - 64 Definitions
analysis	includes examination and testing.	Therapeutic Goods Regulations 1990	Therapeutic Goods Regulations 1990 - 2 Specific requirementsâdocument enclosed within packaging etc.
analyst	means a person appointed by the Secretary as an analyst (except an official analyst) under regulation 25.	Therapeutic Goods Regulations 1990	Therapeutic Goods Regulations 1990 - 23 Interpretation
antiseptic	means a substance:	Therapeutic Goods Regulations 1990	Therapeutic Goods Regulations 1990 - 2 Specific requirementsâdocument enclosed within packaging etc.
appointed member	means a member of the Committee appointed by the Minister under subregulation 42ZCD(1).	Therapeutic Goods Regulations 1990	Therapeutic Goods Regulations 1990 - 42ZCA Definitions for Division 3A Therapeutic Goods Regulations 1990 - 42ZCQ Definitions for Division 3B
appropriately fastened and sealed	: see subregulation (2).	Therapeutic Goods Regulations 1990	Therapeutic Goods Regulations 1990 - 23 Interpretation
Australian Approved Names List	means the document entitled Australian Approved Names List for Therapeutic Substances, as in force from time to time, published by the Therapeutic Goods Administration.	Therapeutic Goods Regulations 1990	Therapeutic Goods Regulations 1990 - 2 Specific requirementsâdocument enclosed within packaging etc.
authorised officer	, in relation to a provision of these Regulations, means an officer authorised by the Secretary to exercise powers under that provision.	Therapeutic Goods Regulations 1990	Therapeutic Goods Regulations 1990 - 2 Specific requirementsâdocument enclosed within packaging etc.
biological medicine	means:	Therapeutic Goods Regulations 1990	Therapeutic Goods Regulations 1990 - 2 Specific requirementsâdocument enclosed within packaging etc.
biologicals (priority applicant) determination	has the meaning given by subsection 32DEA(2) of the Act.	Therapeutic Goods Regulations 1990	Therapeutic Goods Regulations 1990 - 2 Specific requirementsâdocument enclosed within packaging etc.
business day	means a day that is not a Saturday, Sunday or public holiday in the Australian Capital Territory.	Therapeutic Goods Regulations 1990	Therapeutic Goods Regulations 1990 - 42ZCZI Definitions for Division 3D
C1 (section23) application	means an application made under section 23 of the Act to register an OTC medicine that is made in accordance with the form, or in the manner, approved by the Secretary under paragraph 23B(2)(a) of the Act for a C1 (section 23) application.	Therapeutic Goods Regulations 1990	Therapeutic Goods Regulations 1990 - 2 Specific requirementsâdocument enclosed within packaging etc.
C1 (section9D) application	means a request made under subsection 9D(1), (2) or (3) of the Act to vary information included in an entry in the Register for a registered OTC medicine, that is made in accordance with a form, and in the manner, approved by the Secretary under subsection 9D(6) of the Act for a C1 (section 9D) a	Therapeutic Goods Regulations 1990	Therapeutic Goods Regulations 1990 - 2 Specific requirementsâdocument enclosed within packaging etc.
C2 (section23) application	means an application made under section 23 of the Act to register an OTC medicine that is made in accordance with the form, or in the manner, approved by the Secretary under paragraph 23B(2)(a) of the Act for a C2 (section 23) application.	Therapeutic Goods Regulations 1990	Therapeutic Goods Regulations 1990 - 2 Specific requirementsâdocument enclosed within packaging etc.
C2 (section9D) application	means a request made under subsection 9D(3) of the Act to vary information included in an entry in the Register for a registered OTC medicine, that is made in accordance with a form, and in the manner, approved by the Secretary under subsection 9D(6) of the Act for a C2 (section 9D) application.<	Therapeutic Goods Regulations 1990	Therapeutic Goods Regulations 1990 - 2 Specific requirementsâdocument enclosed within packaging etc.