Therapeutic goods regulations 1990 pdf

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Therapeutic goods regulations 1990 pdf
Therapeutic Goods Act 1989 Act No. 21 of 1990 as amended This compilation was prepared on 4 March 2005 taking into account amendments up to Act No. 8 of 2005
57 Regulations 42 58 Transitional provisions 43 PART 10—REPEALS AND CONSEQUENTIAL AMENDMENTS 44 59 Repeal of Therapeutic Goods (Victoria) Act 1994 44 60 Repeal of Part 10 44 ═══════════════ ENDNOTES 45 INDEX 46 . 1 Therapeutic Goods (Victoria) Act 2010† No. 25 of 2010 [Assented to 1 June 2010] The Parliament of Victoria enacts: PART 1—PRELIMINARY 1 …
This licence is subject to the requirements of the Therapeutic Goods Actl 989, and its Regulations. Section 40(4) of the Therapeutic Goods Act 1989 and Regulation 19, 20, 21 and 22 of the Therapeutic Goods Regulations 1990 impose various statutory conditions on all licences to
13 The Panel deals with the Therapeutic Goods Advertising Code, the Therapeutic Goods Act 1989 (Cth) and the Therapeutic Goods Regulations 1990 (Cth). 14 See for example Chiropractic Board of Australia v Hooper (Review and Regulation) [2013] VCAT 878;
Section 40(4) of the Therapeutic Goods Act 1989 and Regulation L9,20,21 and 22 of the Therapeutic Goods Regulations 1990 impose various statutory conditions on all licences to manufacture therapeutic goods.
Regulations means the Therapeutic Goods Regulations 1990. stated content, in relation to each active ingredient in a medicinal cannabis product, means the quantity or proportion of each active ingredient that is:
Therapeutic Goods Regulations 1990 (Cth) Research Ethics and Governance ealth Service Directive: HSD035 – H Frequently Asked Questions • Standard Operating Procedures for Q ueensland Health HREC Administrators • Standard Operating Procedures for Queensland Health RGOs • Therapeutic Good Administration Access to Unapproved Therapeutic Goods – Clinical Trials in …
and Therapeutic Goods Regulations 1990. In order to assist in understanding our Policy in regards to these products, please see below: Access to Practitioner-Only Products To purchase Practitioner-Only products and any information for such products (product catalogues, websites etc), you must have a recognised tertiary qualification or be a current member of a recognised Australian association
in therapeutic goods supplied in accordance with the therapeutic goods act 1989, except when: it is in a product to which item 4, 8, 10, 11 or 12 of schedule 5a to the therapeutic goods regulations 1990 …

Therapeutic Goods Act 1989 (the Act) and the Therapeutic Goods Regulations 1990 (the TG Regulations), Seek feedback on three potential options for achieving greater clarity on the operation of the regulatory framework; either development of product specific guidance or one or both of two possible regulatory measures for the collection, manufacture and supply of FMT material. Faecal microbiota
The Therapeutic Goods Administration is a Commonwealth Government agency that regulates medical devices and drugs. Prescription medicines and over-the-counter medicines which meet Australian standards of quality, safety and efficacy are included on the Australian Register of Therapeutic Goods.
Therapeutic Goods Regulations 1990 Therapeutic Goods (Medical Devices) Regulations 2002 . 4. RELATED NATIONAL AND WA HEALTH POLICIES National Health and Medical Research Council (NHMRC) Australian Guidelines for the Prevention and Control of Infection in Healthcare (2010) 5. FURTHER ACTIONS THAT ARE REQUIRED OF ALL WA PUBLIC HEALTH FACILITIES. All public …

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The Therapeutic Goods Regulations 1990 (Cth) The TG Act and regulations establish two schemes for clinical trials involving therapeutic goods that have not received marketing approval for supply in Australia (i.e. they are ‘unapproved’), these are:
Goods Act 1989, Therapeutic Goods Regulations 1990 and the Therapeutic Goods Advertising Code 2007 (all as amended from time to time) as well as all other …
1990 – no. 363 (2) For the purposes of section 7 (3) (b) of the Act, the prescribed fee is 0 to be paid at the time of lodgment of printed labels and
Guidelines for advertising of regulated health services Contents (cont) 6.4 Advertising of qualifications and titles 6 6.5 Advertising of price information 7 6.6 Use of gifts or discounts in advertising 8 6.7 Use of scientific information in advertising 8 7 Advertising of therapeutic goods 8 7.1 Therapeutic Goods Advertising Code 2007 8 7.2 Advertising of scheduled medicines 8 7.3 …
Whilst normally the Therapeutic Goods Regulations 1990 excludes medicines that are extemporaneously compounded by practitioners from the requirement to be included on the Australian Register of Therapeutic Goods (ARTG) and to be subject to GMP manufacturing
WA Health Research Governance Policy and Procedures, Research Development Unit, Department of Health, Perth. Important Disclaimer: All information and content in this Material is provided in good faith by the Department of Health, Western Australia and is based on sources believed to be reliable and accurate at the time of development. The State of Western Australia, the Department of Health
Regulation 12A of the Therapeutic Goods Regulations 1990. With the exceptions of drugs prohibited by Customs legislation or injectable drugs that contain material of human or animal origin, unless an import permit has been obtained.
This is a compilation of the Therapeutic Goods Regulations 1990 that shows the text of the law as amended and in force on 1 July 2017 (the compilation date). The notes at the end of this compilation (the endnotes ) include information about amending laws and the …
Schedule 8(4) of the Therapeutic Goods Regulations 1990. This provides an exemption from This provides an exemption from the operation of Part 3-3 of the Therapeutic Goods Act 1989 (manufacturing of therapeutic
the Therapeutic Goods Regulations 1990 (the Regulations) have been met, through submission of the online CTN form together with payment of the relevant fee to the TGA, the clinical trial is deemed to have been notified.


Section 40(4) of the Therapeutic Goods Act 1989 and Regulations 19, 20 and 21 of the Therapeutic Goods Regulations 1990, the conditions specified below have been imposed on this licence under Section 40 of the Therapeutic Goods Act
Chemical Legislation, Standards and Related Codes of Practice Current Version: 3.1, 09/03/2016 HS667 and Related Codes of Practice CHEMICAL Legislation, Standards Legislation (Commonwealth) Industrial Chemicals (Notification and Assessment) Act 1989 Industrial Chemicals (Notification and Assessment) Regulations 1990 Therapeutic Goods Act 1989 Legislation (NSW) Work Health and …
to Unapproved Therapeutic Goods – Clinical Trials in Australia”2 should be consulted. Application for trial approval to an ethics committee is usually in a standardised format, with a number of essential elements, which will be discussed later in this handbook.
Therapeutic Goods Regulations 1990 (Cth) Statements, Papers and Guidelines National Health and Medical Research Council (NHMRC): o Australian Code for the Care and Use of Animals for Scientific Purposes 8th Edition 2013 o Australian Code for the Responsible Conduct of Research 2007 o Guidelines to Promote the Wellbeing of Animals Used for Scientific Purposes 2008 o National …
1.12 complementary medicines –is defined as per Therapeutic Goods Regulations 1990. 1.13 compositional guidelines –is a summary of descriptions, tests and limits that define the composition and characteristics of a substance approved for use in . Guideline for the Quality and Safety of Raw Materials Used in Complementary Medicines Version 1 Issued January 2012 Page 5 of 19 Listed …
pdf and Therapeutic Goods (Medical Devices) Regulations 2002 Part 5. Listing of medical devices: Yes Details: The Australian Therapeutic Good Register (ARGT) captures all …


Advertisements for therapeutic goods in Australia are subject to the requirements of the Therapeutic Goods Act 1989, Therapeutic Goods Regulations 1990, the Therapeutic goods advertising code and the Price information code of practice (collectively the ‘therapeutic goods legislation’) and other relevant laws including the Competition and Consumer Act 2010.
AUSTRALIA I, *// 11 , Therapeutic Goods Act 1989 Act No. 21 of 1990 as amended This compilation was prepared on 28 March 2012 takinointo account amendments up to Act No. 77 of 2011
provision of the Therapeutic Goods Advertising Code, which had existed before August 2005, prohibiting health care professionals from endorsing therapeutic goods in advertisements to consumers.
THERAPEUTIC GOODS ACT 1989 No. 21 of 1990 THERAPEUTIC GOODS ACT 1989 No. 21 of 1990 – TABLE OF PROVISIONS TABLE TABLE OF PROVISIONS PART 1 – PRELIMINARY Section 1. Short title 2. Commencement 3. Interpretation 4. Object of Act 5. Act to bind Crown 6. Operation of Act 7. Goods may be declared to be or not to be therapeutic goods 8. Power to obtain information with respect to therapeutic goods …
the Therapeutic Goods Regulations 1990 (the Regulations) in response to the proposed amendment to change the current Poisons Standard to create a new Schedule 4 entry for cannabidiol (CBD)for therapeutic use with consideration of
, 5A and 5G & 5H of the Customs (Prohibited Imports) Regulations 1956 in accordance with the provisions of the Special Access Scheme (SAS). Under Australian therapeutic goods legislation, medical practitioners can request access to
• Therapeutic Goods Regulations 1990 (Cth) • Therapeutic Goods (Medical Devices) Regulations 2002 (Cth) • Transplantation and Anatomy Act 1979

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Therapeutic Goods Regulations 1990 Statutory Rules 1990 No. 394 as amended made under the Therapeutic Goods Act 1989 This compilation was prepared on 13 June 2003
interpretation of the Therapeutic Goods Act 1989, or Therapeutic Goods Regulations 1990 should be referred to the TGA. Category B: For patients who do not fit the definition of Category A.
ORIGINAL PAPER Sunscreen Safety: The Precautionary Principle, The Australian Therapeutic Goods Administration and Nanoparticles in Sunscreens Thomas Faunce & Katherine Murray&
c) in therapeutic goods supplied in accordance with the Therapeutic Goods Act 1989, except when: i) it is in a product to which item 4, 8, 10, 11 or 12 of Schedule 5A to the Therapeutic Goods Regulations 1990 …
Regulations/Codes • Therapeutic Goods Advertising Code 2015 • Therapeutic Goods Act 1989 • Therapeutic Goods Regulations 1990 Respondents Outputs • Publish: Determinations • Publish: Notifications of Withdrawn Complaints • Publish: Annual Complaints Summary • Refer: Complaints to the TGA • Refer: Complaints to other bodies Complaints No Powers of Enforcement • Publish outcome
• Therapeutic Goods Regulations 1990 • Therapeutic Goods (Medical Devices) Regulations 2002 In particular, it covers requirements related to the re-manufacture of single use medical devices (SUDs). In December 2003 the Commonwealth Therapeutic Goods Administration (TGA) implemented the regulation of the remanufacture of SUDs. This means that any facility wishing to remanufacture a …

Therapeutic Goods Administration of Australia (TGA

10 Section 2 Part 1 of the Therapeutic Goods Regulations 1990 11 Section 20 part II of the PIC/S Guide to GMP Jan 2009 12 Section 20 part II of the PIC/S Guide to GMP Jan 2009
Therapeutic Goods Regulations 1990 The regulatory framework is based on a risk management approach designed to protect public health and safety, while avoiding
Section 40(4) of the Therapeutic Goods Act 1989 and Regulation 19, 20, 21 and 22 of the Therapeutic Goods Regulations 1990 impose various statutory conditions on all licences to manufacture therapeutic goods.

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b) imported as therapeutic goods, or for use in therapeutic goods, for supply, in accordance with the Therapeutic Goods Act 1989 ; and/or c) in therapeutic goods supplied in accordance with the Therapeutic Goods
Therapeutic Goods Regulations 1990; Therapeutic Goods (Medical Devices) Regulations 2002 ; Section 19 of the Australian regulatory guidelines for medical devices (ARGMD). SA Health also has a fact sheet on the Safe Use of Anaesthetic Equipment and Prevention of Cross Infection (PDF 108KB) which outlines the infection control requirements for reprocessing of these specific items, several of
Under reg 12A of the Therapeutic Goods Regulations 1990 (Cth) (“TGA”) people can apply to use unapproved medicines if death is reasonably likely within a matter of months or premature death is reasonably likely to occur in the absence of treatment
Therapeutic Goods Act 1989, section 42C and 42D, Therapeutic Goods Regulations Part 2 Division 2. Broadcasting Services Act 1992 , Schedule 2, section 6. Therapeutic Goods Regulations 1990, Part 2 Division 3 and Division 4.
11.91 The advertising of genetic IVDs is already subject to the restrictions contained in the Therapeutic Goods Act, the Therapeutic Goods Regulations and the Therapeutic Goods Advertising Code. These restrictions also apply to Internet advertising. For example, it is an offence to …
In Australia, the Therapeutic Goods Administration (TGA) is responsible for administering the Therapeutic Goods Act 1989 (the Act) and the accompanying Therapeutic Goods Regulations (the Regulations). The object of the legislation is to establish and maintain a national system of controls for the quality, safety, efficacy and timely availability of ‘therapeutic goods’ that are used in or

This submission is made on behalf of the NMCUA under


The Australian Clinical Trial Handbook Alfred Health

Manager Therapeutic Goods Administration, immediately the action or information is known to the sponsor. Preparations, for the purpose of Item 3, Part 1 of Schedule 4 to the Therapeutic Goods Regulations 1990 (the Regulations), that contain ‘deer velvet
• The TGA administers the Therapeutic Goods Act 1989 (the Act), applying a risk management approach designed to ensure therapeutic goods supplied in Australia meet acceptable standards of quality, safety and efficacy (performance), when necessary.
This is not the only Pretorius product that does not fulfil the Therapeutic Goods Regulations 1990 definition of a homoeopathic product. 7,8 In addition, there are those from other companies, for example: 9

Schedule 8 drugs Drugs of addiction – Pharmaceutical

1990 – NO. 642 THERAPEUTIC GOODS AND COSMETICS ACT 1972 – REGULATION (Relating to application and licence fees) NEW SOUTH WALES [Published in Gazette No. 120 of 28 September 1990]
Therapeutic Goods Act 1989 Therapeutic Goods Regulations 1990 Decision under Regulation 9 of the Therapeutic Goods Regulation 1990 in relation to an advertisement about the product “Virility Pills VP-RX” (Complaint No 2010-12-020) Background On 28 November 2012, the delegate of the Secretary to the Department of Health and Ageing (the Delegate) for the purposes of section 9(1) of the
20 Therapeutic Goods Regulations 1990 (Cth) pt 6 div 3 sub-div 1. 21 Therapeutic Goods Advertising Code 2007 (Cth) cl 3(1)(b). 22 The controls over advertising do …
Therapeutic Goods (Charges) Regulations 1990 (the Charges Regulations) prescribe varied levels of charges for different classes of therapeutic goods, based on the level of risk of the type of good. Post market compliance and monitoring functions include the following activities: • Management and processing of adverse drug reaction reports • Management and processing of recalls of
Clinical trials using “unapproved therapeutic goods” in Australia, being goods which have not been entered into the Australian Register of Therapeutic Goods ( ARTG ), are required to make use of the Clinical Trial Notification or Clinical Trial Exemption schemes.
There are currently no TGA registered electronic cigarettes (11) and importation, exportation, manufacture and supply of unregistered therapeutic goods is a criminal offence under the Therapeutic Goods Act 1989 (Cth) (9). Where the nicotine electronic cigarette is represented as being for recreational purposes only (that is, not for therapeutic use), the nicotine is classified as a 2
The TG Act is supported by the Therapeutic Goods Regulations (TG Regulations) and various orders and determinations, which provide further details of the TG Act (see Section 1.5 of these guidelines).
The guidelines provide details about the classes of medical devices, safety, risks, performance and the clinical evidence needed to support the application for the inclusion of a medical device on the Australian Register of Therapeutic Goods.
The Therapeutic Goods Act, Regulations and Orders set out the requirements for inclusion of therapeutic goods in the Australian Register of Therapeutic Goods, including advertising, labelling, product appearance and appeal guidelines.
• In my opinion the patient above is a Category A patient as defined in regulation 12A of the Therapeutic Goods Regulations 1990 /regulation 7.2 of the Therapeutic Goods (Medical Devices) Regulations 2002 (delete as appropriate);


Therapeutic Goods Regulations 1990 Start Date 1/01/1999 End Date Amending Item Therapeutic Goods Amendment Regulations 1998 (No. 3)
Page 4 of 9 Therapeutic Good (Medical Devices) Regulations 2002 (Cth) Therapeutic Goods Regulations 1990 (Cth) Transplantation and Anatomy Regulation
o Radiation Control Act 1990 o Radiation Control Regulation 2013 o Gene Technology Act 2003 o Dangerous Goods (Road and Rail Transport) Act 2008 o Dangerous Goods (Road and Rail Transport) Regulation 2014 o Poisons and Therapeutic Goods Act 1966 o Poisons and Therapeutic Goods Regulation 2008 Federal: o Australian Code for the Transport of Dangerous Goods by Road & Rail …
Regulation 5F of the Therapeutic Goods Regulations 1990 specifies that applications for pre-approval of advertisements m ust be made to the Secretary in writing, in a form approved by the Secretary.
Regulations 1990 and the Therapeutic Goods Advertising Code (TGAC). Advertising must also conform to the Australian Consumer Law. The history of the …
Australia TGA Medical Device Regulations All documents listed below are available from the Australian Therapeutic Goods Administration (TGA) website. Please …

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Category A form Special Access Scheme

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Clinical Trial Notification (CTN) scheme requirements


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Re-use of Single Use Devices (SUDs) WA Health

Sunscreen Safety The Precautionary Principle The
Bills Digest No. 7 2000-01 Therapeutic Goods Amendment

Page 4 of 9 Therapeutic Good (Medical Devices) Regulations 2002 (Cth) Therapeutic Goods Regulations 1990 (Cth) Transplantation and Anatomy Regulation
57 Regulations 42 58 Transitional provisions 43 PART 10—REPEALS AND CONSEQUENTIAL AMENDMENTS 44 59 Repeal of Therapeutic Goods (Victoria) Act 1994 44 60 Repeal of Part 10 44 ═══════════════ ENDNOTES 45 INDEX 46 . 1 Therapeutic Goods (Victoria) Act 2010† No. 25 of 2010 [Assented to 1 June 2010] The Parliament of Victoria enacts: PART 1—PRELIMINARY 1 …
This licence is subject to the requirements of the Therapeutic Goods Actl 989, and its Regulations. Section 40(4) of the Therapeutic Goods Act 1989 and Regulation 19, 20, 21 and 22 of the Therapeutic Goods Regulations 1990 impose various statutory conditions on all licences to
Therapeutic Goods Regulations 1990; Therapeutic Goods (Medical Devices) Regulations 2002 ; Section 19 of the Australian regulatory guidelines for medical devices (ARGMD). SA Health also has a fact sheet on the Safe Use of Anaesthetic Equipment and Prevention of Cross Infection (PDF 108KB) which outlines the infection control requirements for reprocessing of these specific items, several of
Regulation 12A of the Therapeutic Goods Regulations 1990. With the exceptions of drugs prohibited by Customs legislation or injectable drugs that contain material of human or animal origin, unless an import permit has been obtained.
1990 – no. 363 (2) For the purposes of section 7 (3) (b) of the Act, the prescribed fee is 0 to be paid at the time of lodgment of printed labels and
The TG Act is supported by the Therapeutic Goods Regulations (TG Regulations) and various orders and determinations, which provide further details of the TG Act (see Section 1.5 of these guidelines).
Regulations/Codes • Therapeutic Goods Advertising Code 2015 • Therapeutic Goods Act 1989 • Therapeutic Goods Regulations 1990 Respondents Outputs • Publish: Determinations • Publish: Notifications of Withdrawn Complaints • Publish: Annual Complaints Summary • Refer: Complaints to the TGA • Refer: Complaints to other bodies Complaints No Powers of Enforcement • Publish outcome
1990 – NO. 642 THERAPEUTIC GOODS AND COSMETICS ACT 1972 – REGULATION (Relating to application and licence fees) NEW SOUTH WALES [Published in Gazette No. 120 of 28 September 1990]
10 Section 2 Part 1 of the Therapeutic Goods Regulations 1990 11 Section 20 part II of the PIC/S Guide to GMP Jan 2009 12 Section 20 part II of the PIC/S Guide to GMP Jan 2009

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provision of the Therapeutic Goods Advertising Code, which had existed before August 2005, prohibiting health care professionals from endorsing therapeutic goods in advertisements to consumers.
Regulations 1990 and the Therapeutic Goods Advertising Code (TGAC). Advertising must also conform to the Australian Consumer Law. The history of the …
Therapeutic Goods Regulations 1990 (Cth) Research Ethics and Governance ealth Service Directive: HSD035 – H Frequently Asked Questions • Standard Operating Procedures for Q ueensland Health HREC Administrators • Standard Operating Procedures for Queensland Health RGOs • Therapeutic Good Administration Access to Unapproved Therapeutic Goods – Clinical Trials in …
the Therapeutic Goods Regulations 1990 (the Regulations) have been met, through submission of the online CTN form together with payment of the relevant fee to the TGA, the clinical trial is deemed to have been notified.
• Therapeutic Goods Regulations 1990 (Cth) • Therapeutic Goods (Medical Devices) Regulations 2002 (Cth) • Transplantation and Anatomy Act 1979
o Radiation Control Act 1990 o Radiation Control Regulation 2013 o Gene Technology Act 2003 o Dangerous Goods (Road and Rail Transport) Act 2008 o Dangerous Goods (Road and Rail Transport) Regulation 2014 o Poisons and Therapeutic Goods Act 1966 o Poisons and Therapeutic Goods Regulation 2008 Federal: o Australian Code for the Transport of Dangerous Goods by Road & Rail …
AUSTRALIA I, *// 11 , Therapeutic Goods Act 1989 Act No. 21 of 1990 as amended This compilation was prepared on 28 March 2012 takinointo account amendments up to Act No. 77 of 2011
Regulations means the Therapeutic Goods Regulations 1990. stated content, in relation to each active ingredient in a medicinal cannabis product, means the quantity or proportion of each active ingredient that is:
Therapeutic Goods Regulations 1990 Therapeutic Goods (Medical Devices) Regulations 2002 . 4. RELATED NATIONAL AND WA HEALTH POLICIES National Health and Medical Research Council (NHMRC) Australian Guidelines for the Prevention and Control of Infection in Healthcare (2010) 5. FURTHER ACTIONS THAT ARE REQUIRED OF ALL WA PUBLIC HEALTH FACILITIES. All public …
b) imported as therapeutic goods, or for use in therapeutic goods, for supply, in accordance with the Therapeutic Goods Act 1989 ; and/or c) in therapeutic goods supplied in accordance with the Therapeutic Goods
This is not the only Pretorius product that does not fulfil the Therapeutic Goods Regulations 1990 definition of a homoeopathic product. 7,8 In addition, there are those from other companies, for example: 9
1990 – NO. 642 THERAPEUTIC GOODS AND COSMETICS ACT 1972 – REGULATION (Relating to application and licence fees) NEW SOUTH WALES [Published in Gazette No. 120 of 28 September 1990]
The TG Act is supported by the Therapeutic Goods Regulations (TG Regulations) and various orders and determinations, which provide further details of the TG Act (see Section 1.5 of these guidelines).
The Therapeutic Goods Regulations 1990 (Cth) The TG Act and regulations establish two schemes for clinical trials involving therapeutic goods that have not received marketing approval for supply in Australia (i.e. they are ‘unapproved’), these are:

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• Therapeutic Goods Regulations 1990 • Therapeutic Goods (Medical Devices) Regulations 2002 In particular, it covers requirements related to the re-manufacture of single use medical devices (SUDs). In December 2003 the Commonwealth Therapeutic Goods Administration (TGA) implemented the regulation of the remanufacture of SUDs. This means that any facility wishing to remanufacture a …
Therapeutic Goods Act 1989, section 42C and 42D, Therapeutic Goods Regulations Part 2 Division 2. Broadcasting Services Act 1992 , Schedule 2, section 6. Therapeutic Goods Regulations 1990, Part 2 Division 3 and Division 4.
Therapeutic Goods Regulations 1990 (Cth) Statements, Papers and Guidelines National Health and Medical Research Council (NHMRC): o Australian Code for the Care and Use of Animals for Scientific Purposes 8th Edition 2013 o Australian Code for the Responsible Conduct of Research 2007 o Guidelines to Promote the Wellbeing of Animals Used for Scientific Purposes 2008 o National …
Therapeutic Goods (Charges) Regulations 1990 (the Charges Regulations) prescribe varied levels of charges for different classes of therapeutic goods, based on the level of risk of the type of good. Post market compliance and monitoring functions include the following activities: • Management and processing of adverse drug reaction reports • Management and processing of recalls of