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SAHPRA – FAQ – Cannabis South Africa

Mail & Guardian (M&G) will once again host an event, gathering the relevant stakeholders – government, private and public sector, businesses, professionals, consultants, legal, academia and civil society to come together to engage, clarify and debate on the future of cannabis, both for private and businesses purposes.

The event will take place at the Glenhove conference centre in Johannesburg.

Contact Wan or wanl@mgafrica.com or 11 250 7300 for more information, booking and for group discount.

To book your tickets click here.

According to international experts, South Africa’s dagga industry could be worth more than $7.1B (R107B) if legislation to legalise one of the continent’s biggest markets is passed. The World Health Organisation estimates SA is the third largest dagga producer in the world, with an estimated 900 000 dagga farmers.

So, after one year, what are the new developments, progress, implications and opportunities?

November 2019 – SA police and the SA Health Products Regulatory Authority (SAHPRA) are busy clamping down on illegal cannabis and cannabis-related products, sales of which have mushroomed online since the Constitutional Court decriminalised the possession, consumption and private cultivation of the herb at home.

According to them, the establishment of illegal dispensaries/outlets, online sites and social media platforms that were marketing and selling cannabis and cannabis-related products to the public was still illegal, except where it was specifically allowed in terms of the Medicines and Related Substances Act. The SAPS is mandated to and will act, not only against businesses that sell cannabis illegally, but also against the customers who buy these products.

The cultivation of cannabis for medicinal purposes on a commercial basis requires a licence issued in terms of section 22C(1)(b) from SAHPRA and a permit in terms of section 22A(9)(a)(i) from the Director-General.
In May of 2019, the Department of Health made the historic decision of making the cannabis derivate cannabidiol available for wholesale distribution in South Africa. The change comes in the form of a temporary resolution that will last 12 months and may be renewed in May of 2020. However, CBD products may only contain a maximum daily dose of 20 milligrams (mg) or less. These products are also only to be sold as symptom relievers and not cures.

Updates and clarity on regulator’s guidelines on cannabis, cannabis-containing medicines and oils

  • Provisions of the Medicines and Related Substances Act
  • What are the products that are legal to manufacture, sell, purchase, possess and consume?
  • Implications for importers, manufacturers and marketers of CBD
  • Guidelines for prospective growers of medical cannabis
  • Applications and inspections for domestic cultivation of cannabis for medicinal use and application for exemption – what you need to know
  • Handing out licenses to compliant facilities and restrictions
  • Working with regulators to create a viable, regulatory framework for future sale of legitimate CBD products

Momeena Omarjee, Manager: Names & Scheduling & Acting Deputy Director: Medical Devices, South African Health Products Regulatory Authority (SAHPRA)

There is no legalisation of growing, distribution or manufacture of Cannabis derived products by the Constitutional Court and the normal laws still apply to all of these and contravention of these laws can result in criminal prosecution and long jail sentences. The South African Police Service (SAPS) is mandated to and will act, not only against businesses that sell cannabis illegally, but also against the customers who buy these products. Provisions on dealing under the criminal law remain applicable, unless there is a cultivation licence from South African Health Products Regulatory Authority (SAHPRA).

Updates and clarity on current legislation surrounding cannabis, cannabis related products and clarity for all stakeholders

  • What is and what isn’t legal currently
  • Implications – what you should know, do and shouldn’t do for now
  • Cultivation for private use and sale of cannabidiol (CBD) products – CBD medicine, oil, foodstuffs, beverages and cosmetics in the open market
  • Necessary legislative amendments to allow for commercialisation of cannabis
  • Dealing in cannabis, private vs public use, in presence of children or non-consenting adults, definition of private places
  • How much is too much and driving under influence of cannabis
  • Police discretion, offence, arrests and what are your rights
  • Q&As

Paul-Michael Keichel, Partner, Schindlers Attorneys 

ARC’s role and updates on cannabis research and development to cultivate hemp for medicinal and other purposes
Dr Stephen Amoo, Specialist Researcher-Medicinal Plants & Indigenous Vegetables, ARC-Vegetable and Ornamental Plants, Agricultural Research Council

Analytical testing issues, needs and requirements 

  • Importance of potency testing and pharmaceutical label claims
  • Sample failures when tested against the USP general specification for solvents and heavy metals
  • Quantitative accurate testing compared to % area screening using GC-MS (Cheap Vs. Accurate)
  • Representative batch sampling and sample homogeneity issues
  • Q&As

Henrick Viviers, Laboratory Manager, National Analytics Forensic Services (NAFS)

PANEL DISCUSSION
Future of cannabis for South Africa – challenges, risks and opportunities

  • Challenges, best practices and opportunities in cultivation, manufacturing, processing and distribution of cannabis
  • Unlocking the economic potential of commercial cannabis farming and uplifting the rural poor
  • How can cannabis ultimately contribute to SA’s economy by creating jobs (medical and recreational), enterprise development, raising tax revenue and attracting tourists?
  • Collaboration between private and public sectors
  • Bridging regulation, partnerships, technology and innovation
  • Future business prospects for agriculture sector, medical health professionals, and lifestyle brands
  • Success stories and pitfalls to avoid
  • Q&As

Speaker panelists
Dr Ahmed Jamalooden, National Treasurer, Cannabis Development Council of South Africa (CDCSA)
Wayne Robinson, Director, Afriplex & Regulator & Technical Director, Health Products Association of Southern Africa’s (HPASA)

PANEL DISCUSSION
Critical elements of successful cannabis cultivation

  • Process, management and regulatory compliance – ensuring readiness for medical cannabis license application
  • Standards, quality, testing and certification
  • Best practices, risks and opportunities for expansion and growth
  • Q&As

Speaker panelists
Pierre van der Hoven, Founder & Chief Executive Officer, AfriCannaBiz
Henk Krebs, Chief Executive Officer, AgribioMed
Wesley Young, Director, Bio Leaf Technologies
Nico Kriek, Chief Executive Officer & Regulatory Pharmacist, Cannabis Compliance Bureau

Medical science behind cannabis – truth and evidence

  • Latest findings and developments from research studies uncovering new opportunities for cannabis ingredients and active pharmaceutical ingredients (APIs)
  • Case studies – risks vs benefits
  • What are the medicinal purposes and health benefits of treating patients with cannabinoids?
  • Creating healthy alternatives within the medical community
  • Q&As

Dr Shiksha Gallow, Medical Director, BioData 

PANEL DISCUSSION
Future of cannabis in healthcare and consumer products

  • Where are the opportunities and risks for achieving scale with cannabis-based medicine innovation?
  • Can cannabis oil cure everything?
  • Labelling and dispensary issues
  • Potential growth of CBD oil and CBD in food, beverages and cosmetics
  • Challenges, pitfalls to avoid and way forward

Speaker panelists
Tebogo Tlhopane, Managing Director, Biomuti & Acting Chairman, Cannabis Trade Association Africa (CTAA)
Anthony Cohen, Chief Executive Officer, Elixinol South Africa
David Bayever, Lecturer, University of Witwatersrand & Fellow, Pharmaceutical Society of South Africa (PSSA)

Speakers include:

  • Momeena Omarjee, Manager: Names & Scheduling & Acting Deputy Director: Medical Devices, South African Health Products Regulatory Authority (SAHPRA) 
  • Pierre van der Hoven, Founder & Chief Executive Officer, AfriCannaBiz
  • Wayne Robinson, Director, Afriplex & Regulator & Technical Director, Health Products Association of Southern Africa’s (HPASA)
  • Henk Krebs, Chief Executive Officer, AgribioMed
  • Dr Stephen Amoo, Specialist Researcher-Medicinal Plants & Indigenous Vegetables, ARC-Vegetable and Ornamental Plants, Agricultural Research Council (ARC)
  • Dr Shiksha Gallow, Medical Director, BioData
  • Wesley Young, Director, Bio Leaf Technologies
  • Tebogo Tlhopane, Managing Director, Biomuti & Acting Chairman, Cannabis Trade Association Africa (CTAA)
  • Nico Kriek, Chief Executive Officer & Regulatory Pharmacist, Cannabis Compliance Bureau
  • Dr Ahmed Jamalooden, Medical Doctor & National Treasurer, Cannabis Development Council of South Africa (CDCSA)
  • Anthony Cohen, Chief Executive Officer, South Africa, Elixinol
  • Henrick Viviers, Laboratory Manager, National Analytics Forensic Services (NAFS)
  • Paul-Michael Keichel, Partner, Schindlers Attorney
  • David Bayever, Lecturer, University of Witwatersrand & Fellow, Pharmaceutical Society of South Africa (PSSA)
    Event will be moderated by Michael Avery, Anchor, Classic Business, Classic FM

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1 thought on “SAHPRA – FAQ – Cannabis South Africa

  1. Interesting, will be there plus 2

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