The TGA have published new guidance on exporting medicines form Australia. This is a NEW and comprehensive guidance document on exporting medicines form Australia and should be reviewed by all sponsors and persons exporting medicines.
The guidance replaces all previous guidance about the export of medicines from Australia.
The guidance covers topics including:
- Exporting medicines for commercial supply including listings, exemptions, certificates and importing country expectations, TGA assessment criteria, applications, changes, and a wide range of other regulatory matters
- Exporting medicinal cannabis
- Exporting unapproved goods
- Export certification for medicines - Australia's medicine export certification process, the World Health Organization (WHO) Certification Scheme and Types of export certificates
- Application process and applications that do not meet requirements, applications put on hold
- Non-commercial export - Exporting medicines for donation; Exporting for personal use, family or friends
Please read today’s full technical alert for more information and contact CMA with any concerns about information or processes included in the document. Please also note the TGA are still receiving feedback on this publication in case any changes are required.