Overview: How do I get a cannabis cultivation Licence in South Africa?
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- Опубліковано 25 лип 2024
- In this webinar we do an overview of key considerations as it relates to how to secure a cannabis cultivation licence/license in South Africa.
1. We review the required application forms and fees required along with SMF (Site Master File) that needs to be submitted.
2. We discuss timelines on the application process with what to expect from SAHPRA regarding deadlines and response from inspection.
3. We unpack the SMF (Site Master File) requirements when submitting for a licence application.
4. We review SOPs (standard operating procedures), Quality Manual, Validation Master Plan.
5. Validation of the air and water quality in your facility.
6. Questions on the day of my SAHPRA audit?
Guest Speaker: Ross McPhail
Mobile: +27 82 535 5965/Local 082 535 5965
Host: Jeff Verlinden
Mobile: +27 63 291 3334/Local 063 291 3334
Email: jeff@separations.co.za
Key topics touched on: GACP (good agricultural and collection practices), GAP, GMP (good manufacturing practice), SMF, SLA (service level agreements), SOPs, QbD, site deficiencies and findings, responsible pharmacist, cultivation, propagation, cloning, harvesting, drying, curing, packing, security plan, validation master plan, calibration, recalls, compliance, RO (reverse osmosis), microbiological, testing, air handling, dehumidification, HVAC, HEPA, pressure cascade, air changes, ISO, cannabis inspection, GXP, SANAS, scheduled substance, transport and distribution plan, destruction plan, medical cannabis, cannabis education, hemp, hemp permit, low THC cannabis, CBD, INCB, cultivation, agricultural and industrial applications, cannabis commercialization, global, Europe, Asia, Africa, South America, Australia, botanical medicine, strain, flower, marijuana, weed, endocannabinoid, cannabis oil, pharmaceutical, API, scheduled, cannabis facility.
Feel free to ask any licensing questions that you felt weren't covered in this video.
Where can I find the application for a cannabis growing business? I live in the US will I be able to start a business in South Africa?
They should legalize Cannabis for the poor people too. Legalize Marijuana.
SOP omg what a process! I just want to cry
Very comprehensive in the timeslot. Thanks for sharing. Another great video to inspire some ideas while dreaming during an IT/Internal Audit/Accounting consulting role day job. One day!!! 😀
Curing over a LG from my harvest, grew at home and no one cared, police saw it twice (there for separate issues) and just said it looks cool.
Like 2 and a half-3 years ago, a friend got busted (I was with him), but some guy lied and set him up, the police were looking for meth or whatever they caught this guy with.
So when we stop to give the guy his herbs, a bunch of vans come and dogs and the guy picking up was undercover...
It was only 200 worth and they just searched everything and spoke to us (the undercover knew me from hospital) and after they found nothing else, they let him go with the weed.
So laws can be laws and police can enforce them, however some decide it's not worth it and concentrate on other drugs that ruin lives.
How does this relate to off-take agreements - or rather, how would one establish the required connections to make sure that there are indeed buyers for the product you are licensed for?
Hi found your video very interesting, can I get a liscense captivating at home in my private home? Will really be helpful if u can assist, like which liscense is required, were can I get application forms? Thank you for your video to share to south africans for free
What are the requirements of the site to get approved?
Are they people that can help you draft the file?. The video is very helpful. Thank you
Sounds like occupational hygienists can also assist in this industry, airflow, heat stress, lighting surveys, etc.
Definitely seen a variety of professionals entering and supporting the industry since legalisation.
Most of the 'airflow' and 'lighting with heat stress' situations are indoor exclusively (maybe greenhouse too, but that's a waste of time).
Outdoor (which is what most of the weed will be) needs more of an agricultural scientist type to check soil, pesticides, if it's doing any damage to surrounding flora and wildlife and if it's healthy.
This check only needs to happen once a month or maybe twice at most (this is someone you hire, not the government oversight). The government will probably do unannounced checks from time to time to make sure you follow regulation.
The most important occupation will be the grower(s) and crucially, the seeds they use (1st generation, feminized), nutrients they use and the location of the growth. Also, outdoor only grows once a year, but is much more affordable and gives a tenfold larger harvest (vs indoor).
I've acquired a land next to Verena, that Im planning to grow, manufacture and sell hemp products. My question is must I first get a permit, from government to do so before working on my land?
This video is been very helpful. Thank you so much.
Hi Thembisile, yes you will need to get a hemp cultivation permit from DALRRD before initiating cultivation. I will include a link to their resources page.
www.dalrrd.gov.za/Branches/Agricultural-Production-Health-Food-Safety/Plant-Production/Hemp-Low-THC-Cannabis-Regulatory-System
Nice video, very informative. I have one question, is there companies or consultants out there that assist people in compiling the SMF file? I work in the Health and Safety industry and have a vast experience in writing procedures and compiling files in line with regulations. Would love to know if i could get involved in this industry.
There are definitely a few companies and consultants around who help clients with the SMF and QMS (quality management system) mostly in alignment with traditional pharmaceutical regulations but also in alignment with GAP/GACP. Hope that helps 👍
Kindly provide the names of the consultants or companies that assist
how does one open a cannabis shop like the 420 shops all over the country?
Great video. Any quality management problems faced by cannabis cultivators?
Testing in for slightly higher than desired heavy metals does happen every so often.
@@SouthAfricanCannabisExtraction Are you saying our testing laboratories are inferior ? Also which export markets are hard to access due differences in regulatory requirements ?
@@paulerdosdaughterAny country that doesn't have legal hemp/weed, and if they do, you need to create a plan that will detail why and how, etc…
You need to follow the laws and regulations and yes, most countries with legal weed/hemp products/ medicinal weed have extensively superior testing, like for THC/CBD ratios and percentages, infections/ pesticides/ etc…
@South Africa cannabis extraction, do you have training or initiative programs that you do for people, esp those who want to venture in the hemp business more esp for job creation?
Hi Thembisile, I know I will have a few guests on this year to discuss the sustainability and viability of hemp cultivation and agroprocessing in South Africa. A big concern is the current 0.2% THC limit on hemp in South Africa. In addition perhaps the team at Cheeba Africa Training Academy would have more on hemp related courses.
Where are the forms please!!!!!! I've beeeeen looking for them
The information on the SAHPRA licence applications can be found here: www.sahpra.org.za/wp-content/uploads/2021/02/Application-for-Licence_Medicinal-Cannabis-00000002.pdf
If you are looking for the recently released regulations for hemp (low THC cannabis less than 0.2%) you can find the guidelines here: www.dalrrd.gov.za/Branches/Agricultural-Production-Health-Food-Safety/Plant-Production/Hemp-Low-THC-Cannabis-Regulatory-System
@@SouthAfricanCannabisExtractionthank you so much!!
What is the smallest scale for commercializing.. thiis industry.... Does municipal bylaws allow U to zone a small space within residential area and what will that size be... Entrants for new individuals could start there... this sound as if no consideration is given for poor people this is only for people with big money... there has to be some entrant consideration.. regulations and controls considerd
How many companies have licenses in South Africa?
At present there are more than 40 approved cannabis cultivators with a SAHPRA licence.
Can these cannabis cultivators sell locally in South Africa?
Most of these cultivators produce cannabis for export markets like Australia, Israel, UK, Malta, Germany etc. That said there is scope to provide cannabis locally as an unregistered medicine via a section 21 application with SAHPRA and DOH.
Obviously receiving the license is one thing, I’m assuming you would still have to register as a business under the CIPC as a registered business then the license is separate?
Correct, you would need to apply to SAHPRA for your licence as a registered business.
Sorry, so you’re saying that i would not need to register as a business from the CIPC, so by obtaining the license I would be recognised as a registered business?
@@chizamadj You would need to already be a registered business when applying. Hope that clarifies.
@@SouthAfricanCannabisExtraction yes, that’s clear thank you.
how much is the application fee?
I know for 2021 it was an application fee of R25,200 with SAHPRA, they might update it for 2022. Will post here when they update.
Are the contact details still up to date?
Hi Lutho, you will still be able to reach me on 063 691 3334, Ross is currently busy on contract in Zimbabwe so that might be more challenging. Happy to field your call.
How can one apply for a tobacco license?
Poor are always segregeted