Sponsor six monthly report - supply of unapproved therapeutic goods

The information in this document is provided for guidance only. It should not be relied on to address every aspect of the relevant legislation. You should seek your own independent legal advice to ensure that all of the legal requirements are met.

• It is a legal requirement for sponsors of therapeutic goods supplied under the Special Access Scheme (SAS) and Authorised Prescriber (AP) scheme to provide six monthly reports to the Secretary of the Therapeutic Goods Administration (TGA) under paragraph 47B(1)(c) of the Therapeutic Goods Regulations 1990.
• Sponsors must provide the report using the approved Six monthly report - supply of unapproved therapeutic goods by a sponsor form following the supply of therapeutic goods exempt, approved or authorised under the SAS and AP schemes. Specified reporting periods are outlined below.
• This form is not a requirement for products exempt or approved under the clinical trials schemes.
• It is an offence to provide false or misleading information to a Government agency.