GWP Compliance Services

GWP is concerned with ensuring that quality is maintained during wholesaling and it sets out appropriate standards to be applied.

In short, medicines in Schedules 2, 3, 4 and 8 need to be stored and distributed in accordance with the label requirements of the sponsor, State and Territory legislation and GPW.

The term “wholesaler” also includes providers of in-house and third party logistics and distribution.

We can assist you achieve GWP compliance in your logistics and warehouse processes.

Code of Good Wholesale Practice (GWP)

This Code is applicable to wholesalers, including manufacturers, manufacturer’s agents, importers and distributors who store and/or supply by wholesale substances and preparations (referred to in the standard 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.

  Code of Good Wholesale Practice (GWP - April 2011)

Wholesale Licence

A person or company located in New South Wales may not supply by wholesale any substance which is for therapeutic use in humans or animals and which is included in Schedule 2, 3, 4 or 8 of the NSW Poisons List, unless they are licensed by the NSW Ministry of Health to do so.

Applications for supply by wholesale a poison and/or restricted substance for therapeutic use are handled by the Private Health Care Unit of the Ministry of Health.

The Regulation and Compliance Unit is responsible for the administration of licences under the Poisons and Therapeutic Goods Act 1966.

Good Distribution Practice of Medicinal Products for Human use (GDP)

The Commission has published EU Guidelines on Good Distribution Practice (GDP) in 1994

Revised guidelines were published in March 2013 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.

  Good Distribution Practice of medicinal products for human use. (GDP)

Therapeutic Goods (Medical Devices)

Therapeutic Goods Amendment(Medical Devices and Other Measures) Act 2009. An Act to amend the Therapeutic Goods Act 1989, and for related purposes.

  Therapeutic Goods (Medical Devices) Regulations - 2009 update

Overview of the new regulatory framework for in vitro diagnostic medical devices (IVDs)

A new regulatory framework commenced on 1 July 2011 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.

  Overview of the new regulatory framework for in vitro diagnostic medical devices (IVDs)

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.

  Australian regulatory guidelines for medical devices(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.

  Therapeutic Goods Act 1989

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