Forms for the biological industry

Guidance and resources

• Exceptional release of biologicals (post-market)

  26 August 2022

  Guidance

  Release on non-conforming biologicals is only permitted under prescribed circumstances and for an individual patient. Access to the request form and instructions are within the guidance document.

• Request for advice - Biologicals

  6 January 2020

  Forms

  This form guides you through the classification of biologicals and captures sufficient information about your product for us to provide advice

• Proposal for a new Approved Cell & Tissue Name (ACN) application form

  29 March 2021

  Forms

  Proposal form for a new Approved Cell and Tissue Name (ACN)

• Biologicals (including tissues), human blood and blood components report form

  Forms

• Notification of a change in sponsorship

  19 August 2016

  Forms

  Change of sponsor name forms are now available

• Biologicals (priority applicant) determination, application form

  Forms

  Application form to apply for biologicals (priority applicant) determination