National Controlled Cannabinoid Medical Research Pilot Programme
A lawful pathway
to controlled research.
A non-commercial, time-limited and fully traceable government framework for scientific characterisation—and only after separate approvals, pharmaceutical development and clinical evaluation.
DOCUMENT STATUSFormal submission draft
LEGAL POSITIONSubject to Mozambican legal opinion and government approval
VERSIONApproval Framework v1.0 · 29 July 2026
LEGAL LIMITATION
This programme is designed to obtain lawful authority. It does not grant authority.
No controlled activity may begin without an effective written authorisation and every applicable condition precedent.01 / Executive approval
Decision requested from Government
Approve the process.
Not the plant activity.
Phase 0 requests authority for legal, regulatory, institutional, site-screening and protocol-development work only. It does not request possession, cultivation, transport, extraction, manufacture, human administration, sale or supply.
Designate leadership
Appoint a lead government authority and establish an interministerial steering committee.
Confirm legal form
Direct Justice and the Attorney-General’s Office to determine the lawful enabling instrument.
Prepare the framework
Develop a narrow Council of Ministers decree or, if required, a legislative amendment.
Authorise Phase 0 only
Permit desk-based mobilisation, legal review, site screening and protocol preparation.
Invite a future application
After the framework is effective, invite a project-specific application from a recognised public research institution.
APPROVAL PRINCIPLE
One controlled act.
One controlled act.
One express permission.
Cultivation approval must never be treated as approval for transport, extraction, manufacture, human administration, sale, import or export.
No sale, supply, off-take, contract farming, advertising or patient access.
No seed, plant, extract, reference sample or cannabinoid product before all applicable gates are effective.
Public-source analysis does not replace certified Mozambican legal review or written government approvals.
02 / Approval architecture
A sequenced legal pathway
No gate is implied.
Every gate is evidenced.
The programme advances only when the responsible authority has issued the required written decision. A red or incomplete gate stops the associated activity.
Desk-based work only. No controlled material.
Government processPublished and effective legal framework.
No acquisition yetNamed acts, site, material, people and quantities.
No planting before readinessLand, environment, seed, plant-health and ABS permissions.
Cultivation only as licensedANARME classification, facility and activity permissions.
No manufacture before approvalEthics, INS, ANARME and clinical-trial permissions.
No recruitment or administrationAIM and separate commercial legal basis.
No automatic commercial rightCurrent lawful starting pointGate 0 · regulatory mobilisation
Every controlled inventory begins at zero.
03 / Legal foundation
Mozambican law first
Designed around law,
treaty and public custody.
Controlled-plant authority
Article 34 criminalises unauthorised cultivation. The programme does not infer a private licence from statutory silence or government partnership.
GCPCD coordination
GCPCD is an essential national coordinating participant. Its organic statute must not be mistaken for a cultivation licence.
International control
The framework must address licensed areas, quantities, crop control, stocks, transfer, estimates, statistics and INCB reporting.
Human research and trials
Lawful plant possession does not authorise manufacture or human use. Pharmaceutical, ethics and clinical-trial approvals remain separate.
RECOMMENDED LEGAL ROUTE
A published Council of Ministers decree establishing a narrow medical/scientific pilot, followed by a project-specific licence.
If Justice or PGR concludes that Law No. 3/97 provides insufficient delegated authority, the programme must wait for legislative amendment.
04 / Institutional custody
Public-interest governance
Controlled material remains
under public authority.
The safest custody model places all controlled material under a recognised Mozambican public institution. A private sponsor may fund and support non-controlled work but may possess controlled material only if separately named and authorised.
Council of Ministers
Policy mandate and enabling legal framework.
National control authority
Licensing, diversion prevention, inspection and treaty reporting.
Health / ANARME
Medicines, pharmaceutical facilities, trials and market decisions.
INS / CNBS
Health-research registration, scientific review, ethics and monitoring.
Agriculture + environment
Genetics, seed, phytosanitary, land, ABS and environmental controls.
Interior + Customs
Security, criminal-risk controls, approved movements and border control.
Public institutional licensee
Legal custody, scientific execution, records and compliance.
Independent compliance
Stop-work authority, reconciliation and direct regulatory reporting.
05 / Programme scope
A controlled progression
Regulate first.
Research second.
The pilot excludes commercial hectares, contract growing, off-takers, exports and revenue. Each phase produces evidence for a government decision—not an automatic right to proceed.
REGULATORY MOBILISATION
No controlled materialLegal instrument, institutional partners, site screening and dossiers.
LICENSING + READINESS
Readiness certificateObtain authorisations and qualify the facility.
CONTROLLED CHARACTERISATION
Validated research dataMinimal authorised cultivation and analytical profiling.
PRODUCT DEVELOPMENT
Nonclinical / CMC dossierStandardised investigational product under ANARME controls.
CLINICAL EVALUATION
Clinical evidence onlyOne defined indication under separate ethics and trial approvals.
CLOSE-OUT + POLICY
No commercial rightDestroy or transfer stocks, archive data and evaluate future law.
OUT OF SCOPE
No operational cultivation recipe, patient access, promotion, personal use, product sale, contract farming, commercial off-take or automatic market pathway forms part of this pilot.
06 / Controlled-substance system
Evidence-grade accountability
Every movement recorded.
Every variance escalated.
Perpetual inventory
Unique identifiers, immutable audit logs, daily transaction recording and dual-person verification.
Physical confirmation
Immediate escalation of any discrepancy and regulator-visible corrective action.
Named personnel only
Training, competency assessment, background controls and no unescorted visitors.
Protected evidence
Alarm, surveillance, evidence retention, incident command and approved transport.
Regulator-directed close-out
Approved methods, dual verification, certificates and environmental compliance.
Long-term traceability
Retained for the statutory period or at least ten years after close-out if the decree is silent.
STOP-WORK AUTHORITY
The independent compliance officer may quarantine material and stop activity without commercial approval. Any unlicensed controlled act triggers immediate suspension and regulatory notification.
07 / Government dossier
Approval-ready documentation
Eighteen controlled
submission components.
The dossier converts policy intent into inspectable legal authority, scientific limits, institutional accountability and a signed no-go framework.
08 / Planning horizon
Planning ranges—not promises
Government review
sets the pace.
No cultivation date should be announced unless every applicable approval is already effective.
FINAL APPROVAL POSITION
Phase 0 may begin.
Phase 0 may begin.
Controlled activity may not.
No seed, plant, extract, reference sample or cannabinoid product may be acquired, possessed, cultivated, transported, extracted, manufactured or administered until the exact activity is covered by an effective written authorisation and every applicable condition precedent has been satisfied.