The Final Dosage Form (FDF) of a medicinal cannabis product will not undergo any other changes prior to patient administration, e.g. in a tablet, tincture, capsule, oil, etc.
What licences are required for the manufacture medicinal cannabis FDF?
Two manufacturing licences are required for the manufacture of medicinal cannabis FDF – one from the Australian Office of Drug Control (ODC) and another from the Australian TGA. This is different from other schedule 8 drugs which typically don’t require a licence from the ODC.
To obtain a licence from the ODC to manufacture medicinal cannabis FDF, the following information needs to be provided with the application:
- drugs proposed to be manufactured
- proposed end use of the manufactured drugs
- starting materials
- maximum number of drugs that are proposed for manufacture
- maximum number of drugs necessary to have in possession or control at any time
- period during which the drugs will be manufactured
- how the applicant will comply with sections of the Act regulating the end use of the drug
Getting the TGA licence requires a bit more work.
The PIC/S Guide to GMP is the essential standard for those intending to manufacture medicines for supply within Australia. Unless there is a special exemption under the Therapeutic Goods Act, manufacturing specifically medicinal cannabis FDF will require PIC/S Part I compliance. Depending on the dosage form and the particular manufacturing process, compliance to the relevant PIC/S Annexes are also required, (e.g. if your FDF is a cream or ointment; if you use computerised systems, etc.) as well as relevant product standards such as TGO 77 (Microbiological) and TGO 93 (Medicinal Cannabis).
How we can help:
PharmOut has years of experience in designing and building pharmaceutical manufacturing sites in Australia. We are also experts in supporting licence applications to the TGA and ODC. contact us at one of our offices around the world to discuss your needs or to ask any questions you may have.
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