To complete the biologicals application form, you need to have correctly classified your biological. We strongly recommend you:
- Confirm your product is regulated as a biological
- classify your biological, refer to: Classification of biologicals
- if necessary, confirm your classification by completing the Request for advice on biologicals form and submit it to us for discussion with you.
Your application will only be accepted for evaluation if it has been classified appropriately.
Request a pre-submission meeting
Pre-submission meetings are available to all sponsors considering supplying a biological.
We highly recommend a pre-submission meeting with us for all Class 3 & 4 biologicals, including for CTA applications.