Marken Regulatory Update: Australia Releases New Guidance on Release for Supply for Medical Product Manufactures, Clarifying GMP Responsibilities of the Authorized Person


Australia’s Therapeutic Goods Agency (TGA) added another guidance document to their already robust list of industry guidelines. The Guidance covering Release for Supply for Medical Product Manufactures, published on January 23, 2015, clarifies the TGA’s position on Australia’s GMP polices and specifically addresses the role and responsibilities of the GMP Authorized Person.

The TGA pointed out that their guidance document was necessary because the Australian system of Release for Supply by an Authorized Person (AP) is different from the European system of batch release by a Qualified Person (QP).  As a result, the agency felt that an informational gap existed between Annex 16 of the current EU GMP on the Qualified Person and Australia’s policies on GMP for Release for Supply of medicinal products. 

The newly issued guidance document offers clarification on the role and responsibilities of the Authorized Person as it relates specifically to the Release of Supply for medicines. In addition, the guidance provides commentary on some of the more recent Australian GMP requirements, such as the need to prepare regular Product Quality Reviews (PQR) and to practice on-going stability testing, which were introduced in 2013 when Australia adopted the PIC/S Guide to GMP into the country’s Therapeutic Goods (Manufacturing Principles) Determination No 1 policy document.

Australia’s GMP requires that each batch of finished medicinal product, including investigational medicines, be released for supply by an Authorized Person (AP) certifying that each production batch has been produced and controlled in accordance with the requirements of the marketing authorization and any other regulations relevant to the production, control and release of medicinal product. Release for Supply applies to:

Finished product batch for supply:

A. to the Australian market or

B. for export from Australia

C. for use in a Phase 2 or later in human clinical studies

The TGA also reminds the industry that Release for supply is a licensable step in manufacturing process so Australian manufacturers, including third-party Authorized Persons, are required to obtain a license to manufacture therapeutic goods (sometimes referred to as GMP license).

Additional information or questions regarding Australia’s guidance on this subject can be addressed to:

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