11 March 2019 - NW12
Singh, Mr N to ask the Minister of Health
(a) What are the details of the guidelines that have been issued by the SA Health Products Regulatory Authority in respect of greenhouse requirements for the granting of a medical cannabis licence and (b) is there a limit on the amount of medicinal cannabis that can be (i) grown, (ii) cultivated and (iii) manufactured in terms of current licencing regulations?
a) Granting of the cultivation license of cannabis for medicinal use in SA is not limited to greenhouse cultivation. Cultivation can take place in various settings either, indoor or outdoor. The applicant should meet the good agricultural practices as determined by the Department of Agriculture, Forestry and Fisheries (DAFF) for food producing plants intended for human consumption. Measures to be considered during cultivation include but are not limited to:
• Soil and fertilizer or alternative growth medium/ substrate
• The reliance on irrigation
• The appropriate use of approved herbicides and pesticides
The applicant should ensure that crop integrity is maintained. This will ensure the correct quality control and identification of specific marker compounds at pre-determined concentrations for the Cannabis species. The applicant should ensure that cross-pollination of outdoor crops or where an enclosed air filtration system is not present have appropriate minimisation strategies in place. Furthermore, volunteer plants or rogue plants should be eradicated to ensure that the permitted crop size is not contaminated.
Security arrangements deployed at the proposed site will form an integral part of the conditions to be considered prior to the SAHPRA licence being issued and the Department of Health permit being granted. In addition, manufacturing of the products must be done in line with Good Manufacturing Practice (GMP) applicable to medicines which are further described in the SAHPRA Guideline, Guide to Good Manufacturing Practice (GMP) for Medicines in South Africa. Applicants are invited to scrutinise specifically Annexure 7 which deals with the agricultural aspects relating to the production of starting materials derived from a plant.
(b) No limit has been determined yet. The applicant has to state in the application the size of the land to be cultivated which is linked to the off take agreement which have to be in place between the applicant and their customers. The customers will also be assessed for the suitability of handling the product.
The quantity required by the applicant as reflected in the off take agreements will then be used to determine the country requirements of medicinal cannabis which will eventually be used to feed into the International Narcotics Control Board (INCB) quota. INCB is an international body responsible for the control of narcotics and psychotropic substances which are required for therapeutic and research purposes.