Medicines Guidelines

Follow the links below to find guidelines on using and prescribing medicines.

Reviewed June 2009

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13 Resources Found
Results 1 to 13 displayed.
Title:   Australian regulatory guidelines for OTC medicines (ARGOM)
Publisher:   Australian Government Department of Health and Ageing
Description:   These Guidelines describe the information to be supplied with an application for registration of OTC (over-the-counter) medicines in the Australian Register of Therapeutic Goods (ARTG).
Date:   Dec 2008
Title:   Guidelines for the National Drugs and Poisons Schedule Committee
Publisher:   Australian Government Department of Health and Ageing
Description:   Includes Guidelines for committee procedures, Guidelines for application and information requirements, Guidelines for classification of medicines and poisons, Guidelines for public consultation, Guidelines for use of confidential information.
Date:   Feb 2008
Title:   Ensuring best practice in the notification of prescription medical product discontinuations: TGA and Medicines Australia conjoint best practice guidelines
Publisher:   Australian Government Department of Health and Ageing
Description:   Discontinuing a medicine is a decision that most pharmaceutical companies will take at some point. Best practice guidelines have been developed, which are an adaptation of the equivalent guidelines adopted by the Association of the British Pharmaceutical Industry (ABPI) and the UK Department of Health.
Date:   Oct 2007
Title:   Guidelines for preparing submissions to the Pharmaceutical Benefits Advisory Committee (version 4.0)
Publisher:   Australian Government Department of Health and Ageing
Description:   The Pharmaceutical Benefits Advisory Committee (PBAC) endorsed this edition of its Guidelines in November 2006. It follows an extensive consultation process and provides guidance for all stakeholders involved in or affected by submissions to the PBAC or listings on the Pharmaceutical Benefits Scheme or the National Immunisation Program.
Date:   Dec 2006
Title:   Best practice guideline on prescription medicine labelling
Publisher:   Australian Government Department of Health and Ageing
Description:   The Drug Safety and Evaluation Branch (DSEB) of the Therapeutic Goods Administration (TGA) and stakeholders have prepared this best practice guideline to guide pharmaceutical sponsors and TGA assessors in the design and review of the acceptability of prescription medicine labelling.
Date:   Nov 2005
Title:   Exporting Medicines from Australia - Operational Guidelines
Publisher:   Australian Government Department of Health and Ageing
Description:   The aim of these guidelines is to enhance transparency in the operations of the Export Medicines Unit of the TGA and ensure consistency in the administrative processes which support the Therapeutic Goods legislation.
Date:   Sep 2004
Title:   ASCIA EpiPen prescription guidelines
Publisher:   Australasian Society of Clinical Immunology and Allergy (ASCIA)
Description:   An EpiPen should only be prescribed within the context of a comprehensive anaphylaxis management plan. This page describes risk factors for anaphylaxis and steps in a management plan.
Date:   Jan 2004
Title:   Adverse Drug Reactions: Frequently Asked Questions
Publisher:   Australian Government Department of Health and Ageing
Description:   Frequently asked questions on adverse drug reactions.
Date:   Sep 2002
Title:   Guidelines for levels and kinds of evidence to support indications and claims
Publisher:   Australian Government Department of Health and Ageing
Description:   These guidelines have been developed to assist sponsors in determining the appropriate evidence to support indications and claims made in relation to Listable medicines. In particular, they relate to complementary medicines, sunscreens and other Listable medicines.
Date:   Sep 2001
Title:   Guidelines for brand advertising of substances included in Schedule 3 of the Standard for the Uniform Scheduling of Drugs and Poisons (SUSDP)
Publisher:   Australian Government Department of Health and Ageing
Description:   These guidelines describe the process for determining whether a substance in Schedule 3 of the SUSDP may be advertised.
Date:   Nov 2000
Title:   Cosmetic claims guidelines
Publisher:   Australian Government Department of Health and Ageing
Description:   This document is intended to provide guidance in relation to the cosmetic/therapeutic interface in respect of product claims. It provides examples covering the most common areas of comparison.
Date:   May 1997
Title:   Guidelines for prescribing psychotropic drugs
Publisher:   Ministry of Health (MoH) (New Zealand)
Description:   These guidelines, based on those drawn up by the Quality Assurance Committee of the Royal Australian and New Zealand College of Psychiatrists, have been adopted by the Ministry of Health of New Zealand to promote good practice in the prescribing of psychotropic drugs in this country.
Date:   Feb 1996
Title:   TGA laboratories' guidelines for assessing the results of microbiological tests on non-sterile pharmaceuticals for human use
Publisher:   Australian Government Department of Health and Ageing
Description:   Guidelines produced by the Therapeutic Goods Administration (TGA) Laboratories for assessing the results of microbiological tests on non-sterile pharmaceuticals.
Date:   Nov 1994
Results 1 to 13 displayed.