South African
Health Products
Regulatory Authority
South African
FREQUENTLY Health Products
Regulatory Authority
ASKED
QUESTIONS
CANNABIS AND
RELATED SUBSTANCES
1 What is Cannabis? 2 What are Tetrahydrocannabinol
and Cannabidiol?
Cannabis refers to the plants in the
Between 60 and 100 chemicals called cannabinoids and
genus Cannabis, which includes
some 300 non-cannabinoid chemicals are produced by the
various species or sub-species.
cannabis plant. Delta-9 tetrahydrocannabinol (THC) and
Cannabis species in the genus
cannabidiol (CBD) are two of the many cannabinoids present
include C.sativa, C.indica and
in the cannabis plant, in varying concentrations. THC is
C.ruderalis.
psychoactive in nature and is the cannabinoid most sought
after by recreational users for the “euphoric” high. CBD, on
the other hand, is not psychoactive in nature.
3 What is the difference between marijuana and hemp?
These are colloquial terms often used to describe commonly referred to as marijuana, weed, ganja
different species, sub-species or strains of the or insangu.
same Cannabis plant. The cannabis plant can be
cultivated to contain varying concentrations of The low-THC-containing cannabis plant,
cannabinoids, such THC and CBD, dependant on cultivated for the production of fibre (included
the intended use. in such products as bricks, ceiling boards and
textiles) or seeds and the products produced
The high THC-containing cannabis plant, from the seed (such as cosmetics, oils, paint), is
generally utilised for recreational purposes, is commonly referred to as hemp.
4 What is the current status of cannabis in terms of the Medicines Act?
Cannabis (the whole plant or parts or Synthetic cannabinoid substances are also listed
products thereof) and THC are currently separately in Schedule 7.
listed as Schedule 7 substances
in terms of the Medicines and THC (also known as the synthetic
Related Substances Act, 1965 (Act variant, dronabinol) is listed in
101 of 1965) (the Medicines Act), Schedule 6, when intended for therapeutic
except when present in processed purposes.
hemp fibre and products thereof, in a form
not suitable for ingestion, smoking or inhaling CBD is listed as a Schedule 4 substance.
purposes, and containing not more than 0,1 % Certain CBD preparations have been excluded
THC; or when present in processed products from from the operation of the Schedules by the
cannabis seed containing not more than 0.001 % Minister of Health for a time-limited period, as
THC; or when separately specified in Schedule 6 per an exclusion notice (R.756) published in
for therapeutic use. Government Gazette No.42477 on 23 May 2019.
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South African
Health Products
Regulatory Authority
CONTINUED FROM PAGE 2 What is the current status of cannabis in terms of the Medicines Act?
This does not infer that CBD is excluded from other dispensing licence issued in terms of the Medicines
requirements of the Act. Act. However, refer to Question 20 in relation to
personal use of cannabis by an adult in private.
Schedule 7 substances are deemed to have no
legitimate medicinal use and can only be accessed SAHPRA is responsible for the registration and
by means of a permit issued by the Director- regulation of cannabis-containing medicines in
General of the National Department of Health South Africa.
(NDoH). Medicines and substances categorised as
Schedule 4 or Schedule 6 are only available on the Amendment of the entries for cannabis and
prescription of an authorised prescriber and can related substances in the Schedules is currently
only be obtained from a pharmacy or the holder of a undergoing consideration.
5 Are processed hemp fibre 6 Are processed cannabis
products excluded from seed products excluded
Schedule 7? from Schedule 7?
Processed hemp fibre products (e.g. Processed cannabis seed products
textiles, bricks, ceiling boards) are (e.g. hemp seed oil, cosmetics
specifically excluded from Schedule containing hemp seed oil) are
7 when: (a) the THC concentration is specifically excluded from Schedule 7
≤ 0,01 %, (b) the product is in a form when: (a) the THC concentration is ≤
not suitable for ingestion, inhalation or 0,001 % and (b) the product does not
smoking and (c) does not contain whole contain whole cannabis seeds.
cannabis seeds.
7 What is the difference between hemp seed oil and CBD oil?
Hemp seed oil is the oil obtained by cold pressing the using solvents or other means. Extraction of CBD
seeds of the Cannabis plant cultivated to contain a or THC from the Cannabis plant is considered to be
THC concentration of ≤ 0,001 %, for its fibre or seeds ‘manufacturing’ in terms of the Medicines Act and
(as mentioned above). Hemp seed oil does not contain requires a licence to manufacture issued in terms of
cannabinoids, such as CBD, apart from trace levels section 22C of the Act.,.
that may be present (typically less than 25 parts
per million). Hemp seed oil (if within the thresholds mentioned
above) is excluded from the Medicines Act. However,
CBD oil is an extract of the Cannabis plant. It may depending on the CBD and THC concentrations, and the
contain various cannabinoids such as CBD and THC, intended use, the hemp seed oil may be subject to the
in varying concentrations. CBD oil is obtained by the provisions of the Medicines Act.
separation of components from the Cannabis plant
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8 Is the cultivation of cannabis for industrial purposes excluded
from Schedule 7?
Although processed products are exempt from (i) of the Medicines Act. Refer to Question 20 in
Schedule 7 as explained in Questions 5 and 6, relation to the personal cultivation of cannabis
the cultivation of cannabis for industrial purposes for use by an adult in private.
(commonly referred to as hemp when containing
low concentrations of THC) may be undertaken by Amendments to the scheduling of cannabis
persons who hold a permit issued by the Director- and related substances are currently under
General of the NDoH in terms of section 22A(9)(a) consideration.
9 Are all CBD-containing medicinal products excluded from the
Schedules to the Medicines Act?
Only certain CBD preparations have been excluded either paragraph (a)
from the operation of the Schedules by the Minister or (b). This exclusion notice d
of Health for a time-limited period (12 months from oes not exclude any CBD-containing products
the date of publication of the exclusion notice, which contain any other active pharmaceutical
23 May 2019). Exemptions were made for those ingredients (APIs), including THC.
preparations that:
(a) contain a maximum daily dose of 20 mg CBD Any CBD-containing products that are outside the
with an accepted parameters of the exclusion notice or do not meet
low risk claim or health claim; or the criteria and requirements listed above, remain
(b) consist of processed products made from classified as Schedule 4 products, and are subject
cannabis raw plant material , where only the to the provisions of the Schedules and registration
naturally occurring quantity of cannabinoids as a medicine.
found in the source material are contained in
the product, and which contain not more than All medicines must be manufactured under Good
0,001 % of tetrahydrocannabinol (THC) and not Manufacturing Practice (GMP) conditions in a
more than 0,0075 % total cannabidiol (CBD). facility licensed in terms of Section 22C of the
Medicines Act. This requirement applies equally
CBD-containing preparations for medicinal to complementary medicines, including health
purposes must satisfy the conditions prescribed in supplements.
10 When are processed CBD-containing products excluded from the
provisions of the Schedules to the Medicines Act?
A processed product containing the naturally occurring trace amounts of THC (≤ 0,001 %) and
CBD (≤ 0,0075 %) is specifically excluded from the Schedules, when the product does not
contain whole cannabis seeds and does not make any medicinal claim. If such substances align
with the definition and annexures identifying health supplements, they may also be considered
as health supplements.
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South African
Health Products
Regulatory Authority
11 Can excluded processed 12 Can CBD be added to foodstuffs as an
CBD-containing products ingredient or additive?
be regarded as foodstuffs?
CBD as an additive or ingredient is not permissible in
A processed product e.g. hemp seed foodstuffs. Only the naturally occurring trace amounts
oil, hemp powder, containing the are allowed in foodstuffs. Refer to Question 11 above.
naturally occurring trace amounts of
THC (≤ 0,001 %) and CBD (≤ 0,0075 Section 5(1)(b) of the Foodstuffs, Cosmetics and
%) may be regarded as a foodstuff, Disinfectants Act, 1972 (Act 54 of 1972) prohibits the
provided the product does not sale of foodstuff which is “false or misleading as regards
contain whole cannabis seeds and its origin, nature, substance, composition, quality,
does not make any medicinal claim. strength, nutritive value or other properties or the time,
mode or place of its manufacture”.
13 Where can CBD-containing
medicinal products that
have been excluded by 14 Can any person manufacture and import
the Schedules to the CBD-containing medicinal products?
Medicines Act be
Any person who imports or manufactures a CBD-containing
purchased? medicine must be in possession of a licence issued in
terms of section 22C(1)(b) of the Act and comply with
These products are available for the relevant standards, including GMP standards. Such
general sale (Schedule 0) and can persons must be able to present verified assessment by
be purchased from general outlets, an accredited laboratory of the CBD and/or THC content of
including health shops, as well as any medicinal product, when requested to do so by
from pharmacies. the Authority.
15 Can any person manufacture and import processed products
containing CBD not intended for medicinal purposes?
Manufacturers and importers of CBD-containing processed products
which fall within the parameters of paragraph (b) of the exclusion
notice, and which are not intended for medicinal purposes,
do not require a licence to manufacture or import in terms
of section 22C of the Act, but must be able to provide
verifiable proof of the CBD and/or THC content of
the product and comply with the provisions of
other applicable legislation (for example, the
Foodstuffs, Cosmetics and Disinfectants Act,
1972 (Act 54 of 1972))
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16 Can any person import CBD as a raw active pharmaceutical ingredient?
CBD, as an active pharmaceutical ingredient Medicines Act, no person other than a pharmacist,
(API) intended for the production of a medicine, is pharmacist intern or pharmacist’s assistant acting
currently listed as a Schedule 4 substance in the under the personal supervision of a pharmacist,
Schedules to the Act and has not been excluded shall sell a Schedule 4 substance for analytical
except as described above. An importer of CBD, as purposes, the manufacture of foods or cosmetics,
an API or raw material, must be in possession of a for educational or scientific purposes, unless in
section 22C(1)(b) licence issued by SAHPRA. possession of a permit from the Director-General
of Health. The term “sell” includes importation and
However, in terms of section 22A(7)(a) of the sale by wholesale or retail.
17 How can the public access cannabis and cannabis-containing
medicinal products, other than as described above?
Other than the CBD-containing medicinal products that have been excluded from
the Schedules (see Questions 9, 10 and 11), cannabis and cannabis-containing
medicines can be accessed through specific permits.
Section 22A(9)(a)(i) of the Act allows for the acquisition, use, possession,
manufacture or supply of a Schedule 7 or 8 substance provided that a permit is
obtained from the Director-General of Health. A permit may be obtained for various
purposes including education, analysis, research or medicinal use by a medical
practitioner for the treatment or prevention of a medical condition in a particular
patient.
Permit applications can be accessed via the SAHPRA website or through the
Regulatory Compliance Unit of SAHPRA.
Section 21 of the Medicines Act read together with General Regulation 29 published
in terms of the Medicines Act, allows for an authorised practitioner to apply for
individual patient access to unregistered medicines. This includes medicines
containing cannabis, THC or CBD The application process is outlined in the SAHPRA
section 21 guidance document, accessible here.
(https://www.sahpra.org.za/documents/06b69aa69.113_Section_21_
Authorisation_Oct18_v2.pdf).
Electronic submissions can be made via the web portal: (https://goo.gl/forms/
RcM1Kbh6Q9tEUy5Z2).
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South African
Health Products
Regulatory Authority
18 Are there any registered
cannabis-containing medicines
in South Africa?
To date, there are no registered cannabis-
containing medicines in South Africa and any
access to these medicines is via the section
21 approval process described above.
19 What cannabis-containing 20 How does the Constitutional
registered medicines are Court judgement impact on
available globally? the Medicines Act?
Epidiolex oral solution, registered by the FDA The Constitutional Court found sections of the
and EMA, contains CBD and is indicated for Medicines Act, which restrict cannabis use, to be
treating seizures in very rare, but severe forms of unconstitutional in certain limited circumstances.
epilepsy in children – Lennox Gastaut and Dravet
syndromes. It is, therefore, not a criminal offence for an adult
person to:
Sativex spray, containing CBD and THC, registered a) use or be in possession of cannabis for his or
in the UK and Canada, is indicated for treating her personal consumption in private: and
spasticity symptoms in multiple sclerosis patients. b) to cultivate cannabis in a private place for his
or her personal consumption in private.
Marinol capsules, containing dronabinol (synthetic The court did not make a distinction between
THC), are registered in the USA and the UK, and using, possessing or cultivating cannabis for
indicated for use in chemotherapy-induced nausea recreational or medicinal use. Parliament is
and vomiting and to treat anorexia associated with required to pass new legislation or to amend the
weight loss in patients with AIDS. Marinol was Medicines Act within 24 months of the date of the
previously registered in South Africa, but is no judgment (18 September 2018).
longer marketed in this country.
21 Does the Constitutional Court judgement mean
that I can now grow my own cannabis legally?
Yes. However, cannabis cultivated in a private place for a
person’s own use may only be used by the grower/ cultivator
and may not be sold/supplied to others.
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22 How is cannabis used for 23 Is it legal to cultivate cannabis
medicinal purposes? for medicinal use on a
commercial basis?
Cannabis for medicinal use refers to the crude,
standardised and quality-assured cannabis plant
material that is cultivated, harvested, processed The cultivation of cannabis for medicinal purposes
and packaged to be used in the manufacture of on a commercial basis requires a licence issued
pharmaceutical preparations which are required in terms of section 22C(1)(b) from SAHPRA and
to meet the requisite quality, safety and efficacy a permit in terms of section 22A(9)(a)(i) from the
standards. Director-General. A licence can be issued for any
or all of the following activities, including to:
Cannabis-containing medicines cover a range of © grow and produce cannabis and cannabis
quality-assured cannabis preparations intended for resin;
therapeutic use, including as oils or tinctures or other © extract and test cannabis, cannabis resin and/
pharmaceutical dosage forms such as tablets and or cannabinoids;
suppositories. The dried flowering buds of the female © manufacture a cannabis-containing or
plant may also be presented as “flos”, which can cannabinoid-containing medicine;
also be presented in granular form. Pharmaceutical © import a cannabis-containing medicine or
preparations of cannabis contain specific active cannabinoid-containing medicine;
components (cannabinoids) in known amounts. © export a cannabis-containing medicine or
The dose and strength of the preparation can be cannabinoid-containing medicine; or
controlled and standardised, making it safer for © distribute a cannabis-containing medicine or
patients to use. cannabinoid-containing medicine.
24
What are the processes and requirements for permit and licence
applications for the cultivation of cannabis?
In November 2017, SAHPRA published a guideline The application forms for section 22A permits can be
on the “Cultivation of cannabis and manufacture of accessed via the SAHPRA website or by contacting the
cannabis- related pharmaceutical products for medicinal Regulatory Compliance unit of SAHPRA. The application
and research purposes” accessible here: (https://www. for a licence to cultivate, manufacture or import
sahpra.org.za/Publications/DownloadDoc/5576. cannabis for medicinal purposes is available here:
This document provides the framework for the cultivation https://www.sahpra.org.za/documents/ed469ea66.25_
and processing of cannabis as a herbal starting material Licence_application_Cannabis_Sept17_v1.pdf
for the production of registered medicines.
PHYSICAL ADDRESS POSTAL ADDRESS
CSIR South African Health Products
Reception Building 38a Regulatory Authority
Meiring Naudé Road Private Bag X828 South African
Health Products
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