Information to Stakeholders regarding confidentiality of ingredient and manufacturer details on the Australian Register of Therapeutic Goods
The Therapeutic Goods Administration (TGA) intends to discontinue the practice of allowing formulation and manufacturer details to be made confidential from the sponsor of a product.
However, the excipient quantities and the manufacturer details of a product will remain confidential from the public view of the Australian Register of Therapeutic Goods (ARTG).
This change will come into effect on 1 July 2008.
This practice applies to both listed and registered non-prescription medicines and occurs predominantly in applications for clone products. However, listed products currently do not have to declare excipient quantities on the ARTG, except where the excipient is restricted by quantity, and this will not change.
At present, the formulation and manufacturer details can be made confidential from a clone sponsor. There are other similar circumstances which also result in the sponsor of the product having no knowledge of the manufacturers recorded for that product in the ARTG record.
Formulation details
Sponsors of products registered or listed on the ARTG are legally responsible for the ongoing safety, efficacy and quality of their products, as well as conforming to applicable standards and complying with requirements such as acceptable presentation and appropriate labelling. The sponsor must have the capacity to fully investigate any adverse events related to their product and this can require knowledge of the formula of the product. Therefore, in order that sponsors can fulfil their responsibilities, it is necessary that they know the full formula of their products.
Manufacturer details
Standard conditions of listing/registration of therapeutic goods imposed under Section 28 of the Therapeutic Goods Act 1989 (the Act) require sponsors to ensure that all manufacturers of the goods are appropriately licensed, keep relevant records and Good Manufacturing Practice agreements, and provide such documents to the TGA upon request.
Section 28(5)(c) requires sponsors to keep records of batches and all manufacturers involved in the manufacture of that batch. Under Section 28(5)(d) sponsors must provide for inspection of any records relating to the manufacture of a product either immediately or at a time specified by the TGA.
Section 30(1)(da) provides grounds for the cancellation of a registration if the sponsor fails to make available the manufacturing details requested by the TGA under Section 28(5)(d) within the specified timeframe, which if the information was requested to be made available immediately is 24 hours after the request was made.
Address: PO Box 100 Woden ACT 2606 Website: www.tga.gov.au
Telephone: 02 6232 8444 Facsimile: 02 6232 8605 ABN 40 939 406 804

Summary
The TGA is concerned that the practice of keeping product formulation and manufacturer details confidential, means that certain sponsors are unable to fulfil their legal obligations under the Act. The TGA intends to amend ELF, OPAL and the ARTG so that product formulation and manufacturer details, as outlined above, are no longer confidential from the sponsor of a product, commencing 1 July 2008. However, in line with existing policy, this information will continue to remain confidential on the public view of the ARTG.
Please forward any comments to otc.medicines@tga.gov.au