You can use the NeeS format for:
- biologicals
- over-the-counter medicines
- registered complementary medicines
- assessed listed medicines
- ingredients for listed medicines.
You cannot use NeeS for:
- prescription medicine applications (including master files) where eCTD has been mandated
- medical devices
- Good Manufacturing Practice (GMP) applications.
Before you submit
You'll need a TGA Business Services client account. See TGA Business Services: getting started with the TGA.
Data requirements
Prepare your sequence using the technical requirements outlined in the TGA NeeS Module 1 v2.0.1 specification.
Content requirements for sequences vary by therapeutic good and application type. Refer to relevant therapeutic area guidance for details:
- CTD Module 1: Administrative information and prescribing information for Australia.
- Australian regulatory guidelines for biologicals (ARGB)
- Australian regulatory guidelines for OTC medicines (ARGOM)
- Australian Regulatory Guidelines for Listed Medicines and Registered Complementary Medicines
- Understanding the application requirements for an assessed listed medicine.
Submit your sequence
Follow the same process as eCTD to submit your NeeS sequence. For more information, read Submit data in electronic Common Technical Document (eCTD) format.
Get help
For help with submitting a sequence, email eSubmissions@health.gov.au.
For help with eCTD specifications, email EDR@health.gov.au.
Product types