(Pictured here: Zimbabwe president Emmerson Mnangagwa visiting a Swiss-backed cultivation site at Mount Hampden, West Province).
INTRODUCTION
Zimbabwe has taken another significant step in regulating the medicinal cannabis industry through the promulgation of the Dangerous Drugs (Production of Cannabis for Medicinal and Scientific Use) (Amendment) Regulations, 2026 (No. 2), published as Statutory Instrument 108 of 2026.
It is important to appreciate that Statutory Instrument 108 of 2026 does not repeal and replace the Dangerous Drugs (Production of Cannabis for Medicinal and Scientific Use) Regulations, 2018 in its entirety. The Dangerous Drugs (Production of Cannabis for Medicinal and Scientific Use) Regulations, 2018 remain the principal Regulations governing the production of cannabis for medicinal and scientific purposes in Zimbabwe.
Statutory Instrument 108 of 2026 simply amends the existing regulatory framework by repealing certain provisions, substituting others and inserting new provisions where necessary. Accordingly, the provisions of the Dangerous Drugs (Production of Cannabis for Medicinal and Scientific Use) Regulations, 2018 continue to apply except to the extent that they have been amended by Statutory Instrument 108 of 2026.
The amendments introduced by Statutory Instrument 108 of 2026 affect a wide range of matters, including licensing, cultivation standards, security requirements, quality assurance, laboratory testing, exports, inspections and regulatory oversight.
Collectively, these amendments strengthen the legal framework governing the production of medicinal cannabis in Zimbabwe while imposing more rigorous compliance obligations on licensed producers.
This article examines the key amendments introduced by Statutory Instrument 108 of 2026, explains their practical implications and analyses what they mean for farmers, investors, legal practitioners and the general public.
WHAT IS CANNABIS?
Section of the Dangerous Drugs (Production of Cannabis for Medicinal and Scientific Use) (Amendment) Regulations, 2026 (No. 2) amends section 2 of the Dangerous Drugs (Production of Cannabis for Medicinal and Scientific Use) Regulations, 2018 by substituting the definition of a “cannabis plant.” The substituted definition provides that a cannabis plant includes the whole plant, or any part of the plant, whether green or dry.
The substituted definition further recognises that cannabis is commonly known by several different names, including Indian hemp, bhang, camba, dagga, mbanje and intsangu. These are not merely colloquial expressions. In terms of section 155 of the Criminal Law (Codification and Reform) Act [Chapter 9:23], these names are recognised in Zimbabwean law as referring to cannabis. Consequently, whether the substance is referred to as mbanje, dagga, Indian hemp, bhang, camba or intsangu, it is treated as cannabis for purposes of Zimbabwean law.
However, the substituted definition also makes it clear that certain products do not constitute a cannabis plant for purposes of the Regulations. These include processed seeds that are incapable of germination, fibre used in the manufacture of products such as rope and canvas, fixed oil extracted from cannabis seeds and certain low tetrahydrocannabinol cannabis products specified in the Regulations.
These exclusions are significant because they distinguish products that remain subject to strict regulation from those that fall outside the scope of particular regulatory requirements.
THE LEGAL FRAMEWORK GOVERNING CANNABIS IN ZIMBABWE
The cultivation, production and use of cannabis in Zimbabwe is governed by a number of statutes that must be read together.
The primary legislation is the Dangerous Drugs Act [Chapter 15:02], which regulates dangerous drugs and empowers the Minister of Health and Child Care to make regulations governing the production of cannabis for medicinal and scientific purposes. It is pursuant to this Act that the Dangerous Drugs (Production of Cannabis for Medicinal and Scientific Use) Regulations, 2018, as amended by the Dangerous Drugs (Production of Cannabis for Medicinal and Scientific Use) (Amendment) Regulations, 2026 (No. 2), were promulgated.
The criminal law governing cannabis is principally contained in the Criminal Law (Codification and Reform) Act [Chapter 9:23], which criminalises the unlawful possession, cultivation, production, sale and dealing in cannabis, subject to the exceptions created under the Dangerous Drugs Act and the Regulations made thereunder.
It is important to appreciate that Statutory Instrument 108 of 2026 does not legalise the recreational use of cannabis. Rather, it regulates the production of cannabis strictly for medicinal and scientific purposes by persons who have been granted producer’s licences.
Accordingly, any person wishing to cultivate medicinal cannabis must comply not only with the licensing requirements prescribed in the Regulations but also with the broader legal framework governing dangerous drugs in Zimbabwe.
WHAT EXACTLY HAS CHANGED UNDER THE DANGEROUS DRUGS (PRODUCTION OF CANNABIS FOR MEDICINAL AND SCIENTIFIC USE) (AMENDMENT) REGULATIONS, 2026 (NO. 2) / SI 108 OF 2026?
Statutory Instrument 108 of 2026 introduces sweeping changes to the regulation of medicinal cannabis.
The amendments affect almost every stage of the production process, including—
- the designation of the Medicines Control Authority of Zimbabwe as the principal regulator;
- licensing procedures;
- cultivation methods;
- greenhouse and indoor production;
- farm security requirements;
- quality assurance;
- irrigation and fertiliser management;
- pest control;
- harvesting and post-harvest handling;
- laboratory testing;
- export requirements;
- licence suspension and cancellation; and
- appeals against regulatory decisions.
Viewed collectively, these amendments demonstrate a deliberate policy shift towards stricter regulation, enhanced product quality and greater accountability within Zimbabwe’s medicinal cannabis industry. Their overarching objective is to ensure that medicinal cannabis produced in Zimbabwe is safe, traceable, consistently produced and capable of meeting the quality standards expected in international pharmaceutical markets.
KEY CHANGES
A: THE MEDICINES CONTROL AUTHORITY OF ZIMBABWE IS NOW THE PRINCIPAL REGULATOR
One of the most significant amendments introduced by the Dangerous Drugs (Production of Cannabis for Medicinal and Scientific Use) (Amendment) Regulations, 2026 (No. 2), published as Statutory Instrument 108 of 2026, is the designation of the Medicines Control Authority of Zimbabwe as the principal regulator of the medicinal cannabis industry.
Section 3 of the Dangerous Drugs (Production of Cannabis for Medicinal and Scientific Use) (Amendment) Regulations, 2026 (No. 2) inserts a new section 3A into the principal Regulations. In terms of section 3A(1), the Minister of Health and Child Care is required to designate the Medicines Control Authority of Zimbabwe as the Authority responsible for the administration and enforcement of the Regulations.
Although the Authority must perform its functions in consultation with the Minister in terms of section 3A(2), the day-to-day regulation of the industry now rests with the Medicines Control Authority of Zimbabwe.
The Authority’s responsibilities extend beyond licensing. Under section 3A(3), it may establish a Committee to oversee the regulation of cannabis, while section 3A(4) empowers it to establish an inspectorate team responsible for carrying out compliance inspections and monitoring licensed production sites.
The Authority’s role is further strengthened by section 5 of the Statutory Instrument 108 of 2026, which amends section 6 of the principal Regulations. The Authority, after examining the application and in consultation with the Minister, is responsible for issuing producer licences.
Similarly, section 6 of the Statutory Instrument 108 of 2026 amends section 7 of the principal Regulations by empowering the Authority, in consultation with the Minister, to refuse the issue, renewal or amendment of a producer’s licence in the circumstances specified in that section.
Practical Implications?
The designation of the Medicines Control Authority of Zimbabwe as the principal regulator signifies a move towards a more structured and compliance-driven regulatory framework. Licensed producers should expect more frequent inspections, closer regulatory supervision and stricter enforcement of licence conditions. More importantly, the administration of the medicinal cannabis industry has been entrusted to a specialised statutory body with expertise in the regulation of medicines, thereby promoting consistency, accountability and regulatory certainty.
B: Producer’s Licences Now Have a Five-Year Lifespan|
Section 7 of the Statutory Instrument 108/26 repeals and substitutes section 8 of the principal Regulations. Under the new section 8(1), a producer’s licence remains valid for five years, after which it may be renewed before expiry.
However, section 8(2) introduces an important qualification. Where a licensed producer fails to commence operations during the entire validity period of the licence, the Authority may refuse to renew that licence.
Section 9 of the Statutory Instrument inserts a new section 14(5) into the principal Regulations. The amendment provides that where an application for renewal is submitted after the licence has expired, the application will be treated as an entirely new application. Consequently, the applicant must comply with all the requirements applicable to first-time applicants.
Practical implications
Licence holders should monitor the expiry dates of their licences carefully. Failure to renew a licence before its expiry could result in additional costs, delays and the need to repeat the entire licensing process.
C: STRONGER POWERS TO SUSPEND LICENCES
Section 10 of Statutory Instrument 108 of 2026 repeals and substitutes section 17 of the principal Regulations. Under the new provision, the Authority may temporarily suspend a licence where—
- the licence conditions have not been complied with;
- the licence holder is unlawfully dealing in, supplying or possessing cannabis;
- the licence holder has been convicted of an offence involving dishonesty; or
- suspension is considered to be in the public interest.
Importantly, section 17(2) requires the Authority to notify the licence holder of the reasons for the proposed suspension and afford the licence holder an opportunity to show cause why the licence should not be suspended.
Practical Implications
While the Authority has been given broader enforcement powers, the Regulations also preserve procedural fairness. The requirement to notify the licence holder and invite representations before suspension reflects the principles of natural justice and administrative fairness. It ensures that producers are afforded an opportunity to be heard before adverse regulatory action is taken.
D: SECURITY REQUIREMENTS HAVE BECOME MORE STRINGENT
Given that cannabis remains a controlled substance under Zimbabwean law, Statutory Instrument 108 of 2026 significantly strengthens the security requirements applicable to licensed production facilities.
Section 11 of the Statutory Instrument 108 of 2026 repeals and substitutes section 23 of the principal Regulations. The new section 23(1) requires every licensed production site to be designed in a manner that prevents unauthorised access.
Where cannabis is cultivated outdoors, section 23(2) requires the perimeter fence to possess specific security features, including—
- a minimum height of 2.1 metres;
- high-strength construction;
- anti-climb protection;
- anti-crawl features;
- anti-cut design; and
- any further requirements determined by the Authority.
In addition to the perimeter security required by section 23, section 28 requires the actual cultivation area to be protected by an electrified security fence incorporating similar anti-climb and anti-cut features.
Why these changes matter
These security requirements demonstrate that medicinal cannabis is not treated as an ordinary agricultural crop. Because cannabis remains a controlled substance under Zimbabwean law, Government has imposed rigorous security standards aimed at preventing diversion into the illicit market and protecting licensed production sites from theft and criminal activity.
For prospective producers, compliance with these security requirements is likely to represent one of the most significant capital costs associated with establishing a medicinal cannabis operation.
E: CULTIVATION STANDARDS: GREENHOUSES BECOME THE NORM
One of the most notable amendments introduced by Statutory Instrument 108 of 2026 concerns how and where medicinal cannabis may be cultivated.
Section 22 of the Statutory Instrument 108 of 2026 repeals and substitutes section 34 of the principal Regulations.
In terms of the new section 34(1), every licensed producer must apply Good Agricultural Practices (GAP) in the cultivation of cannabis. These practices are to be determined by the Minister responsible for Agriculture and are intended to ensure that cannabis is cultivated safely, consistently and in a manner that produces high-quality medicinal products.
More significantly, section 34(2) now provides that cannabis must be cultivated in a controlled environment, namely an indoor facility or greenhouse.
This marks a significant departure from the previous regulatory framework. The Regulations now make controlled-environment cultivation the general rule rather than the exception.
However, the law recognises that outdoor cultivation may, in appropriate circumstances, still be possible. The proviso to section 34(2) empowers the Medicines Control Authority of Zimbabwe to exempt a licensed producer from the greenhouse or indoor cultivation requirement where sufficient justification is provided. The producer must satisfy the Authority, among other things, that—
- the proposed cultivation site is located at least 15 kilometres from the nearest cannabis or industrial hemp farm;
- adequate security measures prescribed under Part II of the Regulations have been implemented; and
- any additional requirements imposed by the Authority have been met.
Why has this change been introduced?
From a regulatory perspective, greenhouse and indoor cultivation offer several important advantages over open-field farming. Controlled environments enable producers to regulate temperature, humidity, lighting and ventilation. They also reduce contamination by pests, dust and environmental pollutants while allowing greater consistency in cannabinoid concentrations.
For export markets, consistency is essential. International pharmaceutical buyers demand products that meet strict quality specifications. Greenhouse production helps achieve those standards.
For farmers considering entry into the medicinal cannabis industry, this amendment signals that medicinal cannabis should no longer be viewed as an ordinary field crop. It is increasingly being regulated as a pharmaceutical product rather than a conventional agricultural commodity.
F: IMPROVED WATER MANAGEMENT
Water quality has also received considerable attention. Section 13 of the Statutory Instrument 108 of 2026 repeals and substitutes section 36 of the principal Regulations. The new provision requires irrigation practices that optimise plant growth while minimising unnecessary water consumption and environmental harm.
Importantly, section 36(2) requires irrigation water to be regularly tested for contaminants, including—
- faecal contamination;
- heavy metals;
- herbicides;
- pesticides; and
- other toxic substances.
Section 36(3) further requires irrigation practices to be integrated with nutrient management to optimise plant nutrition while preventing nutrient leaching.
Why is this important?
Medicinal cannabis is ultimately consumed by patients, often in the treatment of serious medical conditions. Poor-quality irrigation water may introduce contaminants that compromise both product safety and public health.
The amendments therefore seek to ensure that every stage of production complies with internationally accepted pharmaceutical quality standards.
H: TIGHTER CONTROLS ON PESTICIDES
Section 14 of the Statutory Instrument 108 of 2026 repeals and substitutes section 37 of the principal Regulations. The amendment significantly strengthens controls over the use of pesticides.
Under the new section 37(1), cannabis plants, seeds and harvested cannabis may only be treated with pest control products authorised under the Plant Pests and Diseases Act [Chapter 19:08].
The Regulations go even further. Section 37(2) requires licensed producers to implement Integrated Pest Management (IPM) strategies designed to minimise pesticide use.
Rather than relying primarily on chemical pesticides, producers are encouraged to adopt farming methods that prevent pest infestations through good agricultural management.
The amendments also strengthen record-keeping obligations. In terms of section 37(3), every licensed producer must maintain detailed records of all pesticides applied, including the product used, its active ingredients, the application rate, the date of application and the pests targeted.
Why does this matter?
Many countries impose strict limits on pesticide residues in medicinal cannabis. Failure to comply with these standards may result in export consignments being rejected. The amendments therefore protect not only consumers but also Zimbabwe’s reputation in international medicinal cannabis markets.
I: HARVESTING AND POST-HARVEST HANDLING
Section 15 of the Statutory Instrument 108 of 2026 repeals and substitutes section 38 of the principal Regulations.
The new provision regulates what happens after cannabis reaches maturity. In terms of section 38(1), cannabis must be harvested at the optimal stage of maturity to achieve the desired cannabinoid and terpene profile for the intended medicinal product.
Sections 38(2) to 38(5) require harvesting methods that minimise contamination and plant damage while ensuring proper drying, curing, trimming and storage.
Licensed producers must also maintain detailed records of harvesting activities, including environmental conditions during the post-harvest process.
Practical implications
These requirements recognise that product quality depends not only on cultivation but also on proper harvesting and storage. Poor post-harvest handling may reduce potency, encourage mould growth and ultimately render medicinal cannabis unsuitable for pharmaceutical use.
J: DRYING STANDARDS BECOME MORE SCIENTIFIC
Section 16 of the Statutory Instrument 108 of 2026 repeals and substitutes section 39 of the principal Regulations.
The amended provision introduces detailed scientific standards governing the drying process. Cannabis must now be dried under controlled conditions that promote uniform drying while preventing mould growth (section 39(1).
The Regulations also require—
- monitoring of temperature, humidity and airflow (section 39(3);
- monitoring of moisture content (section 39(4);
- proper drying racks where open-air drying is used (section 39(5); and
- preventative measures to control microbial contamination (section 39(6).
Why is this amendment important?
Drying is one of the most critical stages of medicinal cannabis production. Improper drying can result in fungal contamination, loss of active ingredients and failure to meet export quality standards. By prescribing detailed drying standards, the Regulations seek to ensure that medicinal cannabis produced in Zimbabwe consistently meets international pharmaceutical expectations.
K: STRONGER PROTECTION AGAINST CONTAMINATION
Protecting medicinal cannabis from contamination is another key objective of the amendments.
Section 17 of the Statutory Instrument 108 of 2026 repeals and substitutes section 40 of the principal Regulations. The new provision requires licensed producers to implement both Good Agricultural Practices (GAP) and Good Manufacturing Practices (GMP) to minimise microbial and chemical contamination throughout cultivation, harvesting, processing and packaging.
Section 40(2) further requires cannabis products to undergo regular testing by accredited laboratories, while section 40(3) obliges producers to maintain records of all testing results and any corrective measures taken.
What does this mean?
This amendment reinforces a fundamental principle of pharmaceutical regulation: if a product cannot be shown to be safe, it cannot be considered suitable for medicinal use.
L: MAXIMUM THC LEVELS WILL DEPEND ON THE DESTINATION MARKET
Another noteworthy amendment introduced by Statutory Instrument 108 of 2026 concerns the permissible concentration of tetrahydrocannabinol (THC) in medicinal cannabis products.
Section 18 of the Statutory Instrument repeals and substitutes section 42 of the principal Regulations.
Unlike the previous position, the amended Regulations do not prescribe a fixed THC limit applicable to all cannabis products. Instead, sections 42(1), (2) and (3) provide that the maximum quantity of delta-9-tetrahydrocannabinol (THC) permitted in cannabis oil, active pharmaceutical ingredients (APIs) and capsule dosage forms shall be determined by the requirements of the destination market.
Why is this significant?
This amendment recognises an important commercial reality. Medicinal cannabis produced in Zimbabwe is primarily intended for export, and different countries have different pharmaceutical standards regarding THC concentrations.
For example, a country importing medicinal cannabis may prescribe THC limits that differ from those applicable in another jurisdiction. By allowing THC concentrations to be determined by the destination market, Zimbabwe’s regulatory framework becomes more adaptable and commercially responsive.
M: MANDATORY REGULATORY TESTING BEFORE EXPORT
One of the most important quality assurance measures introduced by the amendments is found in section 19 of the Statutory Instrument 108 of 2026, which inserts a new section 44A into the principal Regulations.
In terms of the new section 44A (1), the Authority is now responsible for carrying out regulatory analytical testing on all cannabis.
Section 44A (2) specifies the circumstances under which such testing must be undertaken. These include—
- prior to export, to verify THC levels and other quality requirements;
- during post-market surveillance; and
- whenever there is a complaint concerning product quality or a suspected product defect.
Why has mandatory testing been introduced?
Testing serves several important purposes. First, it protects patients by ensuring that medicinal cannabis products meet prescribed quality standards.
Secondly, it protects Zimbabwe’s reputation as an exporter of medicinal cannabis. International buyers are more likely to source products from jurisdictions where robust quality assurance mechanisms exist.
Thirdly, mandatory testing promotes accountability. Producers are aware that products may be independently analysed by the Authority before export, thereby encouraging compliance with prescribed standards throughout the production process.
For farmers and investors, laboratory testing should not be viewed as an administrative burden but rather as an essential component of quality assurance that enhances market confidence.
N: STANDARD OPERATING PROCEDURES ARE NOW A LEGAL REQUIREMENT
Section 20 of Statutory Instrument 108 of 2026 inserts a new section 48A into the principal Regulations. This provision requires every licensed producer to develop, implement and maintain detailed Standard Operating Procedures (SOPs) covering every stage of production.
In terms of section 48A (1), SOPs must address matters including—
- cultivation;
- harvesting;
- post-harvest handling;
- processing;
- packaging;
- labelling;
- storage; and
- distribution.
Furthermore, the new section 48A(2) requires those procedures to comply with internationally recognised Good Agricultural and Collection Practices (GACP) and Good Manufacturing Practices (GMP).
The Regulations go even further. Under section 48A(3), SOPs must be documented, reviewed, approved and distributed to relevant personnel.
Section 48A (4) requires producers to conduct regular employee training to ensure compliance with those procedures, while section 48A(5) requires periodic review and revision of SOPs whenever regulations, technology or industry standards change.
Why are SOPs important?
Standard Operating Procedures ensure that production processes are carried out consistently regardless of who performs the work. They reduce human error, improve product quality and enable inspectors to verify whether production is being conducted in accordance with the law.
For investors seeking international certification or export opportunities, properly documented SOPs are often indispensable.
O: CANNABIS THAT IS NOT EXPORTED WITHIN TWELVE MONTHS MUST BE DESTROYED
Perhaps the most far-reaching amendment introduced by Statutory Instrument 108 of 2026 is contained in section 22, which inserts new sections 77A, 77B and 77C into the principal Regulations.
These provisions impose strict obligations regarding cannabis that remains unexported after harvesting. Under section 77A(1), where a licensed producer fails to export cannabis within twelve months of harvesting, the producer must notify the Medicines Control Authority of Zimbabwe within seven days after the expiry of the twelve-month period.
The Regulations also encourage regulatory vigilance. In terms of section 77A(2), any person who reasonably suspects that cannabis has remained unexported beyond twelve months may notify the Authority.
Upon receiving such notification, section 77A(3) requires the Medicines Control Authority of Zimbabwe to inspect the premises within seven days.
If the Authority is satisfied that the cannabis has exceeded the prescribed period, sections 77A(4) and 77A(5) require the Authority to order its destruction.
In addition, section 77A(6) empowers the Medicines Control Authority of Zimbabwe to suspend or cancel the producer’s licence for failure to comply with these obligations.
Is there any protection for licence holders?
Yes.
The new Section 77B introduces an important procedural safeguard.
Before suspending or cancelling a licence, the Medicines Control Authority of Zimbabwe must notify the licence holder in writing of its intention, provide reasons for the proposed action and invite written representations within 30 days. Only after considering those representations may the Authority decide whether to suspend or cancel the licence.
This provision reflects the constitutional principles of administrative justice and procedural fairness by ensuring that affected licence holders have an opportunity to be heard before adverse action is taken.
P: IMMEDIATE DESTRUCTION FOR NON-COMPLIANCE
Statutory Instrument 108 of 2026 also introduces another significant enforcement mechanism. Under section 77C, where the Medicines Control Authority of Zimbabwe establishes that a licensed producer has failed to comply with the conditions of the licence, it may order the immediate destruction of the cannabis concerned.
This is a particularly severe sanction. It demonstrates that compliance with licence conditions is not merely a regulatory formality but a continuing legal obligation throughout the life of the licence.
From a commercial perspective, the destruction of a crop may result in substantial financial losses. Producers must therefore ensure ongoing compliance with every condition attached to their licences.
Q: APPEALS AGAINST DECISIONS OF THE AUTHORITY
Recognising that regulatory decisions may occasionally be disputed, the amendments also revise the appeal procedure.
Section 25 of the Statutory Instrument repeals and substitutes section 83 of the principal Regulations.
The new provision establishes a clear three-tier appeal process. First, any person dissatisfied with a decision of the Medicines Control Authority of Zimbabwe may appeal to the Minister within 30 days in terms of section 83(1).
Secondly, section 83(2) empowers the Minister to confirm, vary or set aside the Authority’s decision within thirty days after receiving the appeal.
Finally, where a party remains dissatisfied with the Minister’s decision, section 83(3) permits a further appeal to the Administrative Court within 21 days.
Why is this important?
The appeal mechanism strengthens accountability. Although the Medicines Control Authority of Zimbabwe has been granted extensive regulatory powers, its decisions are not final. They remain subject to ministerial oversight and, ultimately, judicial scrutiny by the Administrative Court.
This layered system promotes transparency, fairness and confidence in the administration of the medicinal cannabis regulatory framework.
CONCLUSION
Statutory Instrument 108 of 2026 represents far more than a routine amendment to the 2018 Regulations. It reflects Zimbabwe’s intention to develop a medicinal cannabis industry that is professionally regulated, internationally competitive and capable of meeting pharmaceutical-grade standards.
Ultimately, the success of these amendments will depend not only on effective enforcement by the Medicines Control Authority of Zimbabwe, but also on the willingness of producers to embrace a culture of compliance, quality assurance and continuous improvement. If properly implemented, Statutory Instrument 108 of 2026 has the potential to strengthen Zimbabwe’s position as a competitive producer of medicinal cannabis for medicinal and scientific purposes in both regional and international markets.
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