SAHPRA S22A · All Three Tiers · GACP · INCB

Africa's most experienced cannabis licensing adviser.

SAHPRA Section 22A licensing across all three tiers, GACP site development in six countries, product dossiers, INCB compliance, and cannabis legislation advisory for five African Union governments — from a single specialist.

6
Countries with GACP sites
5
African governments advised
3
All SAHPRA tiers covered
30+
Years pharma expertise

Cannabis licensing services

Every tier. Every stage.

Mishonga provides integrated cannabis advisory covering the full value chain — GACP cultivation sites, SAHPRA licensing, GMP extraction and manufacturing, product dossier development, INCB compliance, and export authorisation across six jurisdictions.

01
GACP site design & development
End-to-end GACP site development — site selection, facility design, SOP development, staff training, and SAHPRA inspection readiness. Prefeasibility through full build-out.
GACPSite designSOPsInspection prepSAHPRA
02
SAHPRA Section 22A licensing
Full Section 22A licence preparation and submission for cultivation, processing, manufacturing, research, and export — across Tier 1 (hemp), Tier 2 (broad-spectrum), and Tier 3 (pharmaceutical THC).
S22ATier 1Tier 2Tier 3Schedule 7
03
Product dossier development
Pharmaceutical dossier preparation for cannabis-derived products — CBD isolate, THC distillate, dronabinol API, standardised extracts — for SAHPRA, EMA, MHRA, and TGA registration.
DossierCTDAPICBDTHCRegistration
04
INCB & international compliance
Single Convention compliance, INCB import/export authorisation, DEA documentation, and receiving-country import permit coordination for international cannabis shipments.
INCBSingle ConventionExport permitsDEA
05
Government legislation advisory
Advisory to African Union governments on cannabinoid legislation framework design, regulatory authority structure, licensing regime, and international treaty alignment.
GovernmentLegislationPolicyAUFramework
06
GMP manufacturing licensing
GMP cannabis manufacturing site setup and SAHPRA inspection preparation — facility design, equipment qualification, batch record systems, and QP services for Tier 2 and 3 operations.
GMPManufacturingQPInspectionCannabis

Cannabis licences & permits

Every cannabis authorisation — all three tiers.

Mishonga manages the complete cannabis licence application lifecycle across South Africa and partner jurisdictions — from hemp cultivation through pharmaceutical cannabis manufacturing and export.

Tier 1 — Hemp
Hemp cultivation licence
SAHPRA hemp cultivation licence applications for <0.3% THC industrial hemp — field and greenhouse production, SOP package and inspection readiness.
Tier 1 — Hemp
CBD product registration
SAHPRA CBD product registration — Schedule 4 applications for CBD isolate, oils, and topicals in the Tier 1 regulatory pathway.
Tier 2 — Broad spectrum
Section 22A processing licence
SAHPRA Section 22A processing and manufacturing licence for broad-spectrum cannabis derivatives — CBG, CBN, CBC, and nanoemulsion products.
Tier 3 — Pharmaceutical
Schedule 7 manufacturing licence
SAHPRA Schedule 7 pharmaceutical cannabis manufacturing licence — for THC distillate, dronabinol API, and THCA crystalline products under GMP.
Export
Cannabis export authorisation
SAHPRA cannabis export permit applications, INCB pre-export notification, and DEA/MHRA import coordination for pharmaceutical cannabis shipments.
International
GACP and import permits (multi-country)
Cannabis import and GACP licensing applications in Lesotho, Malawi, Ghana, Botswana, and Canada — managed from South Africa with in-country legal counsel.

Frequently asked

Common questions from clients.

How long does a SAHPRA Section 22A cannabis licence take?
Timelines vary by licence type — cultivation licences typically 3–6 months from submission; Tier 3 manufacturing licences 6–12 months given GMP inspection requirements. Mishonga's pre-submission strategy consistently achieves faster outcomes.
Can Mishonga advise on cultivation site and product registration?
Yes — this is one of Mishonga's key differentiators. We provide integrated advisory covering GACP site design and licensing, GMP extraction site setup, and product dossier development — avoiding the common gap between site compliance and product registration strategy.
Can Mishonga advise in other African jurisdictions?
Yes. Mishonga has established GACP sites in South Africa, Lesotho, Malawi, Ghana, Botswana, and Canada — and has advised the governments of Lesotho, Malawi, Eswatini, Liberia, and Zimbabwe on legislation. For new jurisdictions, we structure engagements with in-country legal counsel.
What does a cannabis GACP site development engagement cost?
Projects are scoped and priced on a milestone basis following a formal prefeasibility assessment — covering prefeasibility, detailed design, licensing, construction oversight, and inspection readiness. Contact us to arrange a prefeasibility discussion.

Start your cannabis licensing journey.

Tell us your tier, jurisdiction, and current stage — we'll respond with a scoped approach within 48 hours.

Request a proposal → Email Denver directly