Release for supply – What every sponsor should know

^{Posted on November 13, 2015}

What is release for supply?

Every batch of medicine sold or supplied in Australia is required to have undergone a “release for supply” procedure. This applies to registered medicines, listed medicines as well as investigational medicinal products (phase 2 or later). Release for supply is a critical step in the manufacturing process, whereby an Authorised Person confirms that the batch was manufactured, tested, packaged in compliance with the requirements of the Therapeutic Goods Act 1989.

Who can perform release for supply?

Typically the finished product manufacturer performs release for supply, however this does not need to be the case.  Any site holding either a relevant Therapeutic Goods Administration (TGA) Licence or a relevant TGA Good Manufacturing Practice (GMP) Clearance (for overseas sites) may be registered to perform the release for supply step for a product. 

It should be noted that the site responsible for release for supply does not need to be located within Australia and the person performing the task does not need to be a Qualified Person (QP) as would be required for EU batch release. Rather, an employee whose level of education and expertise is appropriate and who has been authorised by the manufacturer, performs this step as the Authorised Person.

Why does a sponsor need to be concerned about release for supply?

Unless the sponsor is also completing the release for supply procedure, all sponsors of Australian products need to have a GMP agreement in place with the company performing the release for supply step for them, as this is the site responsible for ensuring the quality of every batch of their product supplied in Australia. The GMP agreement should clearly define mutual responsibilities between the sponsor and release for supply site, and should include responsibilities relating to registration updates, periodic product reviews, management of complaints as well as re-release of any product re-packaged by a third party.

Sponsors may also elect to perform a “release for distribution” of finished product batches. This may involve a review of paperwork obtained from the release for supply site as well as any transportation storage data, to ensure the quality of the batch as well as compliance with local requirements.

CEPL currently performs a recommendation for “release for distribution” activity on behalf of a number of our clients. This activity is often performed where our clients require an additional level of assurance prior to supply of their products in Australia and/or New Zealand.  We ensure that products have not encountered any adverse conditions during their transport and confirm that the products to be supplied match with the registered and approved details in either Australia or New Zealand as required.

This article was written by Colleen Turnbull from our Regulatory Services team.