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Forms for the biological industry
Relevant forms for those in the biological industry.
The list below are forms for the biologicals industry.
For a complete list of forms, see: Resources
Guidance and resources
- Exceptional release of biologicals (post-market)GuidanceRelease 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 - BiologicalsFormsThis 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 formFormsProposal form for a new Approved Cell and Tissue Name (ACN)
- Biologicals (priority applicant) determination, application formFormsApplication form to apply for biologicals (priority applicant) determination