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Medicinal cannabis manufacture

Technical guidance on the interpretation of the PIC/S Guide to GMP

10 December 2019

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Manufacture of medicinal cannabis

If you want to become involved in the manufacture of medicinal cannabis, you should ensure that you have the relevant:

  • approvals
  • licences or GMP certification or clearance
  • permits under each of the relevant legislative frameworks.

This includes relevant state or territory government licences or approvals.

You must consider:

  • a manufacturing licence under the Therapeutic Goods Act 1989 (if the manufacturer resides in Australia) or GMP certification or clearance (if the manufacturer resides overseas)
  • a manufacturing and cultivation licence and associated permits under the Narcotic Drugs Act 1967
  • relevant state or territory government licences or approvals

You may need TGA and ODC manufacturing licences

There are two licences that may be required if you are manufacturing medicinal cannabis in Australia. These serve different purposes and operate under different legislation:

and/or

A GMP licence focuses on quality, whereas the narcotic manufacture licence specifies what drug may be produced and in what quantities.

A GMP licence does not remove the requirement for a narcotic manufacture licence and vice versa.

Table 1: Licences required for manufacturing medicinal cannabis products in Australia
Licence name Issued under Regulator Contact
Licence to manufacture therapeutic goods (GMP) Therapeutic Goods Act 1989 Therapeutic Goods Administration (TGA)

Email: gmp@tga.gov.au

Website: TGA website

Narcotic manufacture licence Narcotic Drugs Act 1967 Office of Drug Control (ODC)

Email: dcs@health.gov.au

Website: ODC website

TGA licencing and certification requirements

The TGA requires you to hold either:

  • a current licence to manufacture therapeutic goods (GMP) (if manufacturer is based in Australia)

OR

  • be covered by a current GMP clearance or certification (if manufacturer is based overseas)

Australian manufacturing licences and overseas GMP certification guidance provides more information about the process for applying for a manufacturing licence or GMP certification.

Licence to manufacture therapeutic goods (GMP)

A licence issued under the Therapeutic Goods Act 1989 regulates matters such as quality and compliance with standards for activities such as:

  • manufacture of an Active Pharmaceutical Ingredient (API)
  • market authorisation
  • production, processing, assembling, packaging, labelling, storage, sterilisation, testing, release for supply
  • clinical trials

You need a licence to manufacture therapeutic goods for both medicinal cannabis products included in the ARTG as a prescription medicine and for medicinal cannabis products that are unapproved therapeutic goods, available through the access pathways.

If you have been granted a licence to manufacture therapeutic goods under the Therapeutic Goods Act 1989, you are likely to also need a licence to manufacture narcotic drugs under the Narcotic Drugs Act 1967.

Inspections

Upon receiving an application for a GMP licence in Australia, we typically conduct an on-site inspection within 3 months if the manufacturing site is ready. The time from inspection to licensing will vary depending on how quickly/effectively the manufacturing site addresses any deficiencies identified during the inspection.

You can find more information on the process at Manufacturer inspections.

GMP clearance and certification for overseas manufacturers

Only Australian manufacturing sites can obtain a manufacturing licence.

For overseas manufacturers of medicines, sponsors will need to obtain GMP clearance. This can be done through three different pathways:

  • Mutual Recognition Agreement (MRA) desktop assessment
  • Compliance Verification (CV) desktop assessment
  • TGA on-site inspection (GMP certification)

GMP certification is usually only requested if it is not possible to obtain GMP clearance via the MRA or CV pathways (for example, due to lack of evidence). GMP certification applications are required to be submitted by the Australian sponsor or an agent acting on the Australian sponsor's behalf.

Australian manufacturing licences and overseas GMP certification guidance provides more information about the process for applying for a manufacturing licence or GMP certification.

Other TGA manufacturing requirements

All manufacture of medicinal cannabis products must also be in compliance with the most current PIC/S Guide to GMP. More detailed information about the PIC/S Guide to GMP can be found below.

Therapeutic Goods (Standard for Medicinal Cannabis) (TGO 93) Order

A medicinal cannabis product supplied in Australia needs to conform with the Therapeutic Goods (Standard for Medicinal Cannabis) (TGO 93) Order unless synthetically prepared (not manufactured from natural origins).

The manufacturer is required to review their raw material and finished product specifications against the requirements of TGO 93.

If you are satisfied that your unapproved medicinal cannabis product(s) meet the requirements of the standard, you should complete the declaration form available on the TGA website to declare that your medicinal cannabis product(s) meets this standard.

The TGA may ask for a representative certificate of analysis for review to ensure compliance with TGO 93. Medicinal cannabis products, like all therapeutic goods, may be subject to testing by the TGA to confirm compliance with applicable standards.

Marketing authorisation

If you intend for your medicinal cannabis product to be included on the ARTG as a prescription medicine, then you must consider marketing authorisation requirements.

The Australian Regulatory Guidelines for Prescription Medicines (ARGPM) contains further information about marketing authorisation requirements.

Data management and data integrity

TGA has specific guidance relating to data management and data integrity. Refer to: Data Management and Data Integrity (DMDI) Guidance

Exemptions associated with the access pathways

SAS or authorised prescriber scheme

You may be exempt from holding a licence to manufacture and comply with GMP if you meet the exemption(s) under Schedule 8 of the Therapeutic Goods Regulations 1990.

Clinical trials

In the clinical trial space, there are exemptions from requiring a licence to manufacture therapeutic goods, but they must comply with GMP. This is the requirement of the ICH Guideline for Good Clinical Practice.

Pharmacists manufacturing medicinal cannabis products for supply in clinical trials are required to hold a licence to manufacture therapeutic goods and comply with GMP unless they meet the exemption(s) under Schedule 7 of the Therapeutic Goods Regulations 1990.

In addition to Schedule 7, there are certain persons or goods exempt from holding a manufacturing licence issued by the TGA:

  • pharmacists who manufacture goods in a pharmacy where the pharmacist practices and the pharmacy is open to the public and the goods are supplied from those premises (other than by wholesale) i.e. to individual patients (item 2, Schedule 8, Therapeutic Goods Regulations 1990)
  • pharmacists employed by a public hospital or public institution who manufacture goods for supply to patients in hospitals/public institutions in the same State or Territory (item 3, Schedule 8, Therapeutic Goods Regulations 1990)

ODC licencing requirements

A licence issued under the Narcotic Drugs Act 1967 regulates the quantities and types of drugs manufactured in order to manage national stock levels, ensuring accumulation of the drug does not occur, and that the manufacture is consistent with the requirements of the Single Convention. Matters will also include examination of the probity of licence holders and the security of the facilities.

Narcotic manufacture licence

A narcotic manufacture licence is required under the Narcotic Drugs Act 1967 for any or all of the following activities:

  • obtaining an extract (including tinctures) from cannabis or from cannabis resin
  • separating, or obtaining cannabinoids (e.g. cannabidiol, THC) from the extract
  • converting or transforming cannabinoids present in the extract into another drug

A narcotic manufacture licence does not cover matters such as:

  • cultivation or production of cannabis (a licence for this activity under the Narcotic Drugs Act 1967 is referred to as a Medicinal Cannabis licence)

Other than in its dried form, a narcotic manufacture licence is not required where the cultivated and trimmed cannabis has not been through a solvent based extraction step. Note that this exemption does not negate the need for cultivation licence under the Narcotic Drug Act 1967 to cultivate cannabis.

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