Code of Good Wholesale Practice (GWP)
This Code is applicable to wholesalers who, for the purposes of this Code, are defined as persons or organisations, including manufacturers, wholesalers, manufacturer’s agents, importers and distributors who store and/or supply by wholesale substances and preparations (referred to in this document as “medicines”) included in Schedules 2, 3, 4 and 8 of the Standard for the Uniform Scheduling of Drugs and Poisons or other applicable State or Territory poisons legislation. The term “wholesaler” also includes providers of third party logistics and distribution.
GWP April 2011
Good Distribution Practice of medicinal products for human use. (GDP)
The Commission has published EU Guidelines on Good Distribution Practice (GDP) in 1994 ( 2 ). Revised guidelines were published in March 2013 ( 3 ) in order to take into account recent advances in practices for appropriate storage and distribution of medicinal products in the European Union, as well as new requirements introduced by Directive 2011/62/EU ( 4 ).
GDP EU Nov 2013
Therapeutic Goods (Medical Devices) Regulations 2009 update
Therapeutic Goods Amendment(Medical Devices and Other Measures) Act 2009. An Act to amend the Therapeutic Goods Act 1989, and for related purposes
Medical Device Regulation 2009 update
Overview of the new regulatory framework for in vitro diagnostic medical devices (IVDs)
A new regulatory framework commenced on 1 July 2010 that ensures all IVDs will undergo a level of regulatory scrutiny that is commensurate with the risks associated with their use. The framework adopts the philosophies and recommendations of the Global Harmonization Task Force (GHTF) for IVDs, ensuring that requirements are internationally aligned.
IVD's Regulations 2011
Australian regulatory guidelines for medical devices(ARGMD)
The Therapeutic Goods Administration (TGA) is part of the Australian Government Department of Health and Ageing, and is responsible for regulating medicines and medical devices.
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.
ARGMD May 2011
Therapeutic Goods Act 1989
This compilation was prepared on 4 March 2005 taking into account amendments up to Act No. 8 of 2005. Prepared by the Office of Legislative Drafting and Publishing, Attorney-General's Department, Canberra
TGA ACT 1989