Applying for Licences to Manufacture Medicinal Cannabis API

Licence Applications for Medicinal Cannabis API. This blog discusses how to apply for licences to manufacture Medicinal Cannabis Active Pharmaceutical Ingredient (API).

Medicinal cannabis API refers to the active pharmaceutical ingredient used as the starting material in the process to manufacture a finished product. The API could be either an extract or powdered form of specific parts of the cannabis plant, or an extracted purified chemical (e.g. cannabinoid) from the cannabis plant.

What licences are required to manufacture medicinal cannabis API?

Two manufacturing licences will be required to manufacture medicinal cannabis API,  one from the Australian Office of Drug Control (ODC) and another from the Australian TGA. Note that this is different from other schedule 8 drugs, which typically don’t require a licence from the ODC.

 The following information needs to be provided with the application in order to obtain a licence from the ODC:

  • 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

Obtaining the TGA licence is far more complicated.

More information on Applying for Medicinal Cannabis Licences

The PIC/S Guide to GMP is the essential standard for those intending to manufacture medicines for supply within Australia. This standard is applicable to manufacturing Medicinal cannabis APIs – unless there is a special exemption under the Therapeutic Goods Act. Manufacturing specifically medicinal cannabis APIs requires PIC/S Part II compliance alongside relevant parts of the Annexes depending on the dosage form or the particular manufacturing process (e.g. if the product is a liquid or cream; if you use computerised systems, etc.). Refer to the TGA’s Technical guidance on the interpretation of the PIC/S Guide to GMP for the manufacturer of medicinal cannabis.

If your medicinal cannabis product is being used as an API in clinical trials, it will require PIC/S Part II chapter 19 compliance.

If you’re confused about hemp licencing vs medicinal cannabis licensing, read the article on the article explaining differences between hemp vs medicinal cannabis licence applications.

How we can help:

PharmOut are experts in designing and building manufacturing plants for medicinal products and in helping clients obtain licences from the ODC & TGA.

If you have any questions you want to ask or want assistance with licences, facility designs, GMP and GACP processes and other regulatory requirements your medicinal cannabis business and/or evidence-based research projects, please contact us at one of our offices.

Further reading:

What is the difference between GACP and GMP?
Regulations and Legal Status of Growing Cannabis in Australia
GMP e-Learning for Pharmaceutical Manufacturers
Orientation to online GMP training for Pharmaceutical Industry Employees including Medicinal Cannabis Manufacturing Sector Industry

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