As the sponsor (the market authorisation holder), your responsibilities related to release for supply include:
- sharing information with a contracted manufacturer or authorised person
- shared responsibilities with the manufacturer include:
Sponsors wanting to conduct RFS have additional responsibilities.
Sponsors also need to share all relevant information in the marketing authorisation with all manufacturers in the supply chain.
Licencing and certification guidance:
- GMP clearance guidance
Information for sponsors seeking to obtain GMP clearance for an overseas manufacturing site - Sponsor responsibilities related to GMP clearance and certification
Guidance on sponsor's responsibilities when supplying medicines manufactured overseas. - Australian manufacturing licences and overseas GMP certification
Information for Australian manufacturers seeking TGA licence or Australian sponsors applying for GMP certification of overseas manufacturers
Sharing information with a contracted manufacturer or authorised person
RFS is a licensable step in manufacture within Australia. This requires the manufacturer performing RFS to have access to the relevant information in the marketing authorisation, where applicable.
If you are reluctant to share this information with a (contract) manufacturer performing RFS, for example due to confidentiality issues, you could do one of the following:
- implement a confidentiality agreement with the manufacturer, or include confidentiality statements in the GMP agreement
- contract out the RFS manufacturing step to a different manufacturer who holds the relevant licence, GMP clearance or GMP certification
- obtain a TGA licence to act as manufacturer yourself for the RFS step
You can consider alternative options as long as they do not impede prompt recall and access to data required for compliance to regulatory requirements and responsibilities.
You can only contract out release for supply to an independent authorised person if the authorised person holds or works under a TGA licence or a current GMP clearance that includes release for supply.
Sponsors wanting to conduct RFS
Release for supply is a manufacturing step that requires a TGA licence. If a sponsor wants to perform release for supply they must:
- hold a TGA manufacturing licence
- be authorised within the marketing authorisation for that step in manufacture
- meet the responsibilities of a release for supply manufacturer