Government Notice No. 756 of 2019

Medicines and related Substances Act (101/1965) » Exclusion of certain preparations containing Cannabidiol...

Title	Medicines and related Substances Act (101/1965) » Exclusion of certain preparations containing Cannabidiol (CBD) from operation of certain provisions of the Act
Department	Health
Gazette	Regulation Gazettes, No. 42477 of 23 May, 2019, 5 page(s), 1.4Mb

GOVERNMENT NOTICE
                                             DEPARTMENT OF HEALTH

16    No. 42477                GOVERNMENT GAZETTE, 23 MAY 2019

NO.                                                                                 2019
                                                DEPARTMENT OF HEALTH
          NO. R. 756                                                                               23 MAY 2019
          R. 
             EXCLUSION OF CERTAIN PREPARATIONS CONTAINING CANNABIDIOL (CBD) FROM

OPERATION OF CERTAIN PROVISIONS OF THE MEDICINES AND RELATED SUBSTANCES
             ACT, 1965 (ACT NO. 101 OF 1965)

I, Dr Aaron Motsoaledi, Minister of Health, in terms of section 36(1) of Medicines and Related
             Substances Act, 1965 (Act No.101 of 1965) and on the recommendation of the South African
             Health Products Regulatory Authority (the Authority), hereby exclude from the operation of the

Schedules to the Act published in terms of section 22A(2) of the Medicines and Related
             Substances Act, 1965, preparations containing cannabidiol (CBD) that-

a) contain a maximum daily dose of 20 mg cannabidiol (CBD) with an accepted low risk claim

or health claim which only refer to:

i.     General health enhancement without any reference to specific diseases;
                       ii.     Health maintenance; or

iii.    Relief of minor symptoms (not related to a disease or disorder); or
                b) Consist of processed products made from cannabis raw plant material and processed
                    products, where only the naturally occurring quantity of cannabinoids found in the source
                    material are contained in the product, and which contain not more than 0,001 % of

tetrahydrocannabinol (THC) and not more than 0,0075 % total cannabidiol (CBD).

This exemption is effective immediately for a period not exceeding twelve (12) months from the

date   _ signature of this Notice.

(DR A MOTSOALEDI, MP

MINIST R OF EALTH
            DATE

Type your email for free alerts on latest Department of Health notices as they are published

greengazette

Government Notice No. 756 of 2019

Links

Publications

Insight