Good Wholesaling Practices (GWP) for Pharmaceutical Products - Effective date 1 April 2011

Distribution forms an important activity of the integrated supply chain management of pharmaceutical and medical device products. Various persons and entities are often responsible for the handling, storage and distribution of such products. In some cases, however, a person or entity involved in the distribution of pharmaceutical and medical device products is only involved in and is responsible for certain elements of the distribution process. This document sets out appropriate steps to assist in meeting the responsibilities involved in the different aspects of the distribution process.

Australian regulatory guidelines for medical devices (ARGMD) Part 3–Post-market

Distribution

Under section 41FO of the Act sponsors of medical devices supplied in and exported from Australia are required to keep distribution records of the medical devices to:

• expedite any recalls of batches of the medical devices
• identify the manufacturer of each batch of devices

The Australian Code of Good Wholesaling Practice for Therapeutic Goods for Human Use, sets out appropriate procedures for wholesalers and/or distributors to ensure that there is effective, efficient and safe handling, storage and distribution of products. It is in the sponsor's interest to encourage their wholesalers to follow this Code.

Australian regulatory guidelines for medical devices (ARGMD)

Introduction to the regulatory guidelines.

The Australian Regulatory Guidelines for Medical Devices (ARGMD) has been developed to:

provide guidance to assist manufacturers and sponsors of medical devices in meeting the regulatory requirements for legally supplying a medical device in Australia

help ensure that medical device applications to the TGA meet all the necessary legislative requirements so that applications are processed with minimal delays

Code of Good Wholesaling Practice for Medicines in Schedules 2, 3, 4 & 8 - Apr 2011

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. The code applies to substances in Schedules 2, 3, 4 and 8 from raw materials to finished goods.

Wholesaling forms part of the supply chain for medicines in Schedules 2, 3, 4 and 8. Wholesalers are responsible for the effective, efficient and safe handling, storage and distribution of those medicines.

Code of Good Wholesaling practice for Therapeutic Goods for Human Use - DRAFT Update June 2006

This Code supersedes the November 1991 edition of the Australian Code of Good Wholesaling Practice for Therapeutic Goods for Human Use. The provisions of this Code are applied through applicable State and Territory therapeutic goods / drugs and poisons legislation, and/or State or Territory wholesaler licensing arrangements.

Good Distribution Practices (GWP) for Pharmaceutical Products 2005

Distribution forms an important activity of the integrated supply chain management of pharmaceutical products. Various persons and entities are often responsible for the handling, storage and distribution of such products. In some cases, however, a person or entity involved in the distribution of pharmaceutical products is only involved in and is responsible for certain elements of the distribution process. This document sets out appropriate steps to assist in meeting the responsibilities involved in the different aspects of the distribution process.

Code of Good Wholesaling Practice For Therapeutic Goods For Human Use - November 1991

Wholesaler distribution forms part of the supply chain of manufactured therapeutic goods. Wholesalers are responsible for the effective, efficient and safe handling, storage and distribution of such products. This Code of Practice sets out appropriate steps for meeting this responsibility. It applies to both classes of therapeutic goods - medicinal products ('drugs' in terms of the regulations to the Therapeutic Goods Act) and medical devices.