Posted 07 March 2017
The MCC has published a draft guideline for comment entitled “Cultivation of Cannabis and Manufacture of Cannabis-related Pharmaceutical Products for Medicinal and Research Purposes”, accessible at http://www.mccza.com/Publications/DownloadDoc/5500.
The closing date for comment is 30 March 2017.
This is an extensive document, arranged as follows:
(Thanks to Andy Gray for his synopsis)
TABLE OF CONTENTS
2 LEGAL STATUS OF CANNABIS
3 APPLICATIONS FOR GROWING OF CANNABIS FOR MEDICINAL PURPOSES
4 PERSONNEL REQUIREMENTS
4.1 Suitable Fit and Proper Requirements: Applicant
4.3 Personnel Training
5 SECURITY REQUIREMENTS
5.1 Mandatory Requirements
5.2 Risk of Diversion
5.3 Key Security Measures
5.4 Transportation of Cannabis
6 BUILDINGS AND FACILITIES
8 PRODUCTION AND MANUFACTURING
8.1 Seeds and Labelling Material
9 STORAGE AND DISTRIBUTION
10 SPECIAL PROVISIONS FOR THE PRODUCTION OF CANNABIS INTENDED FOR PROCESSING INTO A STANDARDISED HERBAL MEDICINE
11.1 Record Keeping and Reporting
12 GOOD MANUFACTURING PRACTICES (GMP) RELATED TO MEDICINAL CANNABIS AND RELATED PRODUCTS
12.1 Compliance with Good Manufacturing Practice (GMP), Good Laboratory Practice (GLP) and Good Agricultural and Collection Practices (GACP)
12.2 Quality and Safety
13 COMPLIANCE AND ENFORCEMENT
14 ACCESS TO UNREGISTRED CANNABIS FOR MEDICINAL USE FOR PATIENTS
16 UPDATE HISTORY
ANNEX A: SECURITY
ANNEX B: RECORD KEEPING AND REPORTING
Importantly, the guideline defines “Medicinal Cannabis” as including:
- Cannabis materials,
- Cannabis preparations and
- Finished Cannabis products
Some key excerpts:
* ” To date, patient access to unregistered pharmaceutical products containing cannabinoids has been enabled by the MCC through importation of these products. In order to ensure availability of standardised quality-assured medicinal Cannabis grown locally for the manufacture of suitable pharmaceutical products, the Department of Health and the MCC may permit the cultivation of Cannabis solely for medicinal and research purposes. This framework, developed in consultation with the Department of Agriculture, Forestry and Fisheries (DAFF), is intended to control the cultivation, production and manufacturing of Cannabis products for medicinal use in South Africa. Licensed domestic cultivation of Cannabis for medicinal use is aimed at ensuring sufficient local supply for medical, scientific and clinical research purposes and the implementation of control measures necessary to prevent diversion and misuse, as well as to ensure patient safety.
This guideline provides information to Applicants relating to the standards required for the production and processing of Cannabis as a herbal starting material and identifies the critical production steps that are needed to ensure a product of reliable and reproducible quality.”
* ” Under the Medicines Act, and in line with the Single Convention, cultivation, production, manufacture and use of medicinal Cannabis products may only occur through a licence issued by the MCC and a permit issued by the Department of Health. These conditions allow Government to limit quantities of cultivated and manufactured products based on quotas from the INCB, thus meeting a key obligation of preventing accumulation of Cannabis material.”
* ” The Medicines Act allows for the acquisition, use, possession, manufacture and supply of medicinal use Cannabis in order to provide a medical practitioner, analyst, researcher or veterinarian therewith for the treatment or prevention of a medical condition in a particular patient, or for purposes of education, analysis or research, provided that a permit is obtained from the Director-General of Health.
Consumer and patient access to medicines and Scheduled substances in South Africa is dependent on the Schedule of the substance. Cannabis is a prohibited substance listed under Schedule 7 of the Schedules to the Medicines Act. However, medicines which have been registered by the MCC containing Cannabis, Cannabis extracts, and Cannabis-derived substances such as cannabinoids which are intended for therapeutic use, may be rescheduled and listed in Schedule 6 to align these products with the scheduling status of other restricted medicines. This measure allows patients to access medicinal Cannabis products by means of a prescription issued by a medical practitioner where the product may be dispensed at pharmacy level. Cannabis products that are not registered by the MCC will remain in Schedule 7.
In addition, the Medicines Act allows the MCC to issue a licence to manufacture either a medicine or a Scheduled substance (Active Pharmaceutical Ingredient/API). Section 22C(1)(b) of the Medicines Act enables the cultivation and manufacture of Scheduled substances and ensures the required oversight of the MCC in regulating these activities. This allows the MCC to license growers of Cannabis when intended for medicinal use and enables regulatory oversight in a way that is compliant with South Africa’s international obligations.
The legislative framework addresses three regulatory aspects:
- Authorise Cannabis production domestically, for medicinal and research purposes.
- Satisfy the requirements of South Africa’s international obligations, under the Single Convention.
- Align the access of Cannabis for medicinal purposes with that of other controlled medicines.
Cannabis is a prohibited narcotic substance in South Africa, and cultivation for any purpose other than that explicitly allowed for through the licence and permit system under the Medicines Act, is a criminal offence. Likewise, cultivation by non-licensees remains a criminal offense under this legislation.”
* ” An Applicant may apply to the MCC for a licence in terms of the provisions of Section 22C(1)(b) of the Medicines Act for any or all of the following activities:
- Cultivate/grow and produce Cannabis and Cannabis resin;
- Extract and test Cannabis, Cannabis resin and/or cannabinoids;
- Manufacture a medicine containing cannabinoids.
In addition to the licence application to the MCC, Applicants will also be required to apply to the Director-General of Health for a permit in terms of the provisions of Section 22A(9)(a)(i) of the Medicines Act to acquire, possess, manufacture, use or supply Cannabis.”
* ” There are no restrictions on the number of licences that the MCC may issue, except that the overall quantities of substance produced in South Africa may not exceed the quota allocated by the INCB. There is, therefore, a need for strict controls on the amount of Cannabis produced for medicinal use for the local market in order for South Africa to comply with its international commitment to the Single Convention on Narcotic Drugs, which requires control of the quantity of medicinal Cannabis produced locally and to prevent diversion into the illicit market.
The permit system managed by the Department of Health will ensure that quotas issued by the INCB are adhered to. Permits will be managed relative to the expected usage in the country in order to prevent accumulation of Cannabis or Cannabis products. The MCC, together with the Department of Health, will order destruction of any Cannabis produced by a licence holder when the quantity conditions of the licence are not adhered to.”
*” In this guideline, herbal medicine is understood to mean any medicine that contains exclusively herbal substance or herbal preparations as active ingredients. A herbal medicine or preparation is regarded as one active entity in its entirety whether or not all the constituents with therapeutic activity are known. Herbal medicine preparations are comminuted or powdered herbal preparations, extracts, tinctures, fatty or essential oils, expressed juices, processed resins or gums, etc., prepared from herbal preparations that are produced through fractionation, purification or concentration. As a departure from the above, chemically defined isolated constituents or their mixtures are not considered herbal medicine preparations. Herbal medicine preparations may contain other components such as solvents, diluents and preservatives.
If the Cannabis is intended for processing into a standardised herbal medicine, the Cannabis must be cultivated under such standardised conditions that the content of the constituents is constant. Protocols of the operations undertaken during the cultivation must be kept available. The content of the main constituents, which includes Δ-9-tetrahydrocannabinol (Δ-9-THC) and cannabidiol (CBD), is determined quantitatively. For a selection of the other constituents, fingerprinting with a suitable technique, such as GC-MS, GC, HPLC or TLC will be acceptable.”