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Focus: New code for pharmaceutical 'wholesalers'

17 November 2010

In brief: Businesses that handle, store and distribute certain medicines at the wholesale level should be aware of new standards about to be released by the Therapeutic Goods Administration. Partner Sarah Matheson (view CV), Senior Associate Ric Morgan and Lawyer Harry Evans report on the new Code of Good Wholesaling Practice for Medicines which provides additional guidance for the supply of pharmaceuticals beyond the Code of Good Manufacturing Practice.

• History
• The GWP Code
• Implementation of GWP Code
• Batch tracking
• Conclusion

History

In December 2000, the Galbally Review¹ suggested that the 1991 Australian Code of Good Wholesaling Practice for Therapeutic Goods for Human Use (the 1991 Code) should be amended to ensure the secure transport of controlled substances so as to:

• prevent poisoning;
• reduce the diversion of substances to illicit markets; and
• minimise the risks of supply that does not comply with legislative objectives and requirements.

In a long-awaited response to the Galbally Review, the National Coordinating Committee on Therapeutic Goods (NCCTG) released the GWP Code on 13 October 2010 following consultation with the Therapeutic Goods Committee, National Pharmaceutical Services Association, various law enforcement agencies and the public.

The GWP Code

The GWP Code is designed to ensure that the quality of medicines is maintained during their handling, storage and distribution within the wholesale supply chain.

The GWP Code will apply to 'wholesalers', which has been defined broadly to include manufacturers, wholesalers, manufacturers' agents, importers and distributors who store and/or supply medicines included in Schedules 2,3,4, and 8 of the Standard for the Uniform Scheduling of Drugs and Poisons (or other applicable state and territory poisons legislation).

The GWP Code contains a number of principles and practice standards relating to:

• buildings and grounds;
• storage facilities;
• personnel;
• stock handling and stock control;
• transport;
• management of complaints, return of unused and/or damaged goods and product recalls;
• management of records, documentation and standard operating procedures;
• cold chain medicines;
• security arrangements and procedures; and
• additional measures for the management of controlled drugs and other goods with high illicit value.

Compliance with the GWP Code will be possible using alternative practice standards to those contained in the GWP Code provided the alternative achieves equivalent or better outcomes.

In addition, the GWP Code applies to any requirement of the GMP imposed by the TGA and any other requirements imposed on sponsors, such as those under occupational health and safety, customs and excise and poisons regulations.

Implementation of GWP Code

The GWP Code does not come into effect until 1 April 2011, when it will supersede the 1991 Code. This delayed operation is to enable those involved in the pharmaceutical supply chain to review their operations and make any adjustments that are necessary to ensure compliance.

Importantly, the GWP Code is a code of practice and, on its own, does not have mandatory application. Its provisions will be applied through applicable therapeutic goods and drugs and poisons legislation together with state or territory wholesaler licensing arrangements. Consequently, there may be some variation in the application of the GWP Code between jurisdictions.

A number of issues considered important in the review have not been addressed in the GWP Code. According to the NCCTG, certain areas have been deliberately left for each jurisdiction to implement. They are:

• the provision of education programs;
• the performance monitoring requirements;
• the application of the GWP Code to animal feed manufacturers;
• the impact of the GWP Code on small businesses/pharmacies; and
• the application of the GWP Code to devices (in addition to medicines).

Batch tracking

The NCCTG chose not to include a requirement in the GWP Code that medicines be 'batch tracked' as it does not consider it feasible at this stage. Consequently, wholesalers will not be required to be able to readily identify pharmacies and other health services providers to which a particular batch of medicine has been provided. This is despite the potential that mandatory batch tracking has for improving the efficiency of product recalls.

The NCCTG notes that while it does not support mandatory batch tracking at this time, it may be included in the future and recommends that wholesalers explore means of undertaking batch tracking voluntarily in preparation.

Conclusion

All entities involved in the manufacturing and wholesaling supply chain for pharmaceuticals should take steps to review their operations to enable compliance with the GWP Code from 1 April 2011.

Close attention should be paid to existing licensing and the conditions of such licenses together with other state and territory measures that are likely to be used to mandate compliance with the GWP Code.

We also note that it is possible that entities that operate in more than one jurisdiction may be faced with varying compliance obligations in each jurisdiction. This issue was not addressed by the NCCTG in its feedback on the submissions the NCCTG received regarding the GWP Code.

Footnotes

1. National Competition Review of Drugs, Poisons and Controlled Substances Legislation.

For further information, please contact:

• Sarah MathesonPartner, Melbourne
  Ph: +61 3 9613 8579
  Sarah.Matheson@allens.com.au
• Andrew WisemanPartner, Sydney
  Ph: +61 2 9230 4701
  Andrew.Wiseman@allens.com.au
• Philip KerrPartner, Sydney
  Ph: +61 2 9230 4937
  Philip.Kerr@allens.com.au
• Richard HamerPartner, Melbourne
  Ph: +61 3 9613 8705
  Richard.Hamer@allens.com.au