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Process Guides

Regulatory Workflows

Step-by-step process diagrams for cannabis regulatory procedures across 38 jurisdictions. Click any step to see detailed requirements.

178

Workflows

38

Jurisdictions

🇦🇷

Argentina

(5)

Regulatory Hierarchy

Argentine regulatory structure for medicinal cannabis

Regulatory Structure

Import Authorization

ANMAT import authorization for medicinal cannabis into Argentina

Import / Export

Domestic Production (REPROCANN)

REPROCANN domestic cultivation pathway for medicinal cannabis in Argentina

Product Registration

GMP requirements for cannabis products entering or produced in Argentina

Product Registration

ANMAT product registration for medicinal cannabis in Argentina

Product Registration

🇦🇺

Australia

(6)

Import Authorization

TGA import permit and ODC license process for medicinal cannabis

Import / Export

Regulatory Hierarchy

Federal and state regulatory structure for medicinal cannabis

Regulatory Structure

TGA GMP requirements for products entering the Australian market

Product Registration

ARTG registration or SAS/AP unregistered access pathway

Product Registration

Export from Australia

ODC export permit process for Australian-manufactured cannabis

Import / Export

In-line & Release Testing

TGA QC requirements from cultivation through batch release

🇧🇪

Belgium

(4)

Regulatory Hierarchy

Belgian regulatory structure for medicinal cannabis — FAMHP and magistral preparation

Regulatory Structure

Import Authorization

FAMHP import authorization for medicinal cannabis into Belgium

Import / Export

EU-GMP requirements for cannabis imports into Belgium

Patient access pathways for medicinal cannabis in Belgium

🇧🇷

Brazil

(5)

Regulatory Hierarchy

Brazilian regulatory structure for medicinal cannabis

Regulatory Structure

Import Authorization

ANVISA import authorization for medicinal cannabis into Brazil

Import / Export

Product Registration

ANVISA product registration for medicinal cannabis in Brazil

Product Registration

GMP requirements for cannabis products entering or produced in Brazil

Domestic Production License

ANVISA manufacturing license for domestic cannabis production in Brazil

Product Registration

🇨🇦

Canada

(6)

Licensed Producer (LP) Authorization

Health Canada LP license application and compliance

Regulatory Hierarchy

Federal and provincial cannabis regulatory structure

Regulatory Structure

GPP / GMP Pathway

Health Canada Good Production Practices requirements

Export Authorization

Health Canada export permit process for cannabis

Import / Export

Product Registration

Health Canada product registration under Cannabis Act

Product Registration

In-line & Release Testing

Health Canada GPP QC requirements

🇨🇱

Chile

(3)

Regulatory Hierarchy

Chilean regulatory structure from Ministry of Health to patient

Regulatory Structure

Import Authorization

ISP per-shipment import authorization for medical cannabis

Import / Export

GMP requirements for medical cannabis in Chile — import and domestic pathways

🇨🇴

Colombia

(6)

Colombian Cannabis License

INVIMA and MinJusticia license process for cannabis

Regulatory Hierarchy

Colombian regulatory structure for cannabis production and export

Regulatory Structure

BPM / GMP certification for Colombian cannabis export

Export Authorization

INVIMA and MinJusticia export process for Colombian cannabis

Import / Export

Product Registration

INVIMA product registration for Colombian market

Product Registration

In-line & Release Testing

INVIMA and export market QC requirements

🇭🇷

Croatia

(3)

Regulatory Hierarchy

Croatian regulatory structure for medicinal cannabis

Regulatory Structure

Import Authorization

HALMED import authorization for medicinal cannabis

Import / Export

GMP requirements for cannabis imports into Croatia

🇨🇾

Cyprus

(3)

Regulatory Hierarchy

Cypriot regulatory structure for medicinal cannabis

Regulatory Structure

Import Authorization

Pharmacy and Drug Services import authorization for medicinal cannabis

Import / Export

GMP requirements for cannabis imports into Cyprus

🇨🇿

Czech Republic

(6)

Import Authorization

SÚKL import authorization process for medicinal cannabis

Import / Export

Regulatory Hierarchy

Czech regulatory structure from MOH to pharmacy

Regulatory Structure

EU-GMP requirements for the Czech market

Product Registration

SÚKL product authorization for the Czech market

Product Registration

Export / Import Process

End-to-end shipment to the Czech Republic

Import / Export

In-line & Release Testing

SÚKL and EU-GMP QC requirements

🇩🇰

Denmark

(6)

Import Authorization

DKMA import license process for medicinal cannabis

Import / Export

Regulatory Hierarchy

Danish regulatory structure for medicinal cannabis

Regulatory Structure

EU-GMP requirements for the Danish market

Product Approval

DKMA approved product list process

Product Registration

Export / Import Process

End-to-end shipment to Denmark

Import / Export

In-line & Release Testing

DKMA and EU-GMP QC requirements

🇫🇮

Finland

(3)

Regulatory Hierarchy

Finnish regulatory structure for medicinal cannabis

Regulatory Structure

Import Authorization

FIMEA ERN import authorization for medicinal cannabis

Import / Export

GMP requirements for cannabis imports into Finland

🇫🇷

France

(5)

Regulatory Hierarchy

French regulatory structure for medicinal cannabis

Regulatory Structure

Import Authorization

ANSM import authorization for medicinal cannabis into France

Import / Export

EU-GMP requirements for the French market

Patient Access (ATU)

French patient access via ATU framework — Autorisation Temporaire d'Utilisation

Export / Import Process

End-to-end import process for medicinal cannabis into France

Import / Export

🇩🇪

Germany

(6)

Import Authorization

BtMG §3 per-shipment authorization process from BfArM

Import / Export

Regulatory Hierarchy

EU to pharmacy — who regulates what in Germany

Regulatory Structure

Which GMP standard applies based on product type and origin

Product Registration

From product specs to AMG authorization for the German market

Product Registration

Export / Import Process

End-to-end shipment from origin country to German pharmacy

Import / Export

In-line & Release Testing

QC checkpoints from cultivation through QP batch release

🇬🇷

Greece

(5)

Regulatory Hierarchy

Greek regulatory structure for medicinal cannabis

Regulatory Structure

Import Authorization

EOF import authorization for medicinal cannabis

Import / Export

EU-GMP requirements for the Greek market

Cultivation Licensing

EOF cultivation license process under Law 4523/2018

Export / Import Process

EOF export authorization for Greek-manufactured cannabis

Import / Export

🇮🇪

Ireland

(4)

Regulatory Hierarchy

Irish regulatory structure for medicinal cannabis — MCAP and HPRA framework

Regulatory Structure

Import Authorization

HPRA import authorization for medicinal cannabis into Ireland

Import / Export

EU-GMP requirements for cannabis imports into Ireland

Patient Access (MCAP)

Medical Cannabis Access Programme pathway for Irish patients

🇮🇱

Israel

(6)

Export Authorization

IMFA export permit process for Israeli medical cannabis

Import / Export

Regulatory Hierarchy

Israeli regulatory structure from MOH to patient

Regulatory Structure

IMFA GMP certification and international recognition

Domestic Product Registration

IMFA product registration and domestic patient access

Product Registration

Import into Israel

IMFA import authorization for foreign cannabis products

Import / Export

In-line & Release Testing

IMFA QC requirements from cultivation through batch release

🇮🇹

Italy

(5)

Regulatory Hierarchy

Italian regulatory structure for medicinal cannabis

Regulatory Structure

Import Authorization

AIFA import authorization for medicinal cannabis into Italy

Import / Export

EU-GMP requirements for the Italian market

Product Registration

AIFA product registration for medicinal cannabis in Italy

Product Registration

Export / Import Process

End-to-end import process for medicinal cannabis into Italy

Import / Export

🇯🇲

Jamaica

(4)

Regulatory Hierarchy

Jamaican regulatory structure for cannabis under the Dangerous Drugs Amendment Act 2015

Regulatory Structure

Cannabis License (CLA)

CLA cannabis licensing process under the Dangerous Drugs Amendment Act 2015

Export / Import Process

CLA export permit process for Jamaican cannabis

Import / Export

GMP certification pathways for Jamaican cannabis export

🇱🇺

Luxembourg

(4)

Regulatory Hierarchy

Luxembourg regulatory structure for medicinal cannabis

Regulatory Structure

Import Authorization

Ministry of Health import authorization for medicinal cannabis

Import / Export

EU-GMP requirements for the Luxembourg market

Home Cultivation (Recreational)

Luxembourg recreational home cultivation — first EU country to legalize

🇲🇹

Malta

(6)

Import Authorization

Medicines Authority and MMCA import process

Import / Export

Regulatory Hierarchy

Maltese dual regulatory structure — medical and industrial cannabis

Regulatory Structure

Medicines Authority and EU-GMP requirements for Malta

MMCA Export License

Malta's industrial cannabis export pathway via MMCA

Import / Export

Export / Import Process

End-to-end shipment to Malta

Import / Export

In-line & Release Testing

Medicines Authority QC requirements

🇲🇽

Mexico

(4)

Regulatory Hierarchy

Mexican regulatory structure for cannabis under COFEPRIS and Ley General de Salud

Regulatory Structure

Import Authorization

COFEPRIS import authorization for cannabis into Mexico

Import / Export

GMP certification pathways for cannabis in Mexico

Cannabis License (COFEPRIS)

COFEPRIS manufacturing permit for cannabis in Mexico

🇲🇦

Morocco

(3)

Regulatory Hierarchy

Moroccan regulatory structure for cannabis — cultivation and export

Regulatory Structure

Cultivation License

ANRAC cultivation license process under Law 13-21

ANRAC export authorization for Moroccan cannabis products

Import / Export

🇳🇱

Netherlands

(6)

Import Authorization

CCBM authorization and OMC process for medicinal cannabis imports

Import / Export

Regulatory Hierarchy

Dutch regulatory structure from IGJ and CCBM to pharmacy

Regulatory Structure

IGJ and EU-GMP requirements for the Dutch market

OMC Tender Process

How to participate in the Dutch government cannabis tender

Export from Netherlands

CCBM export authorization for Dutch-manufactured cannabis

Import / Export

In-line & Release Testing

IGJ and EU-GMP QC requirements for the Dutch market

🇳🇿

New Zealand

(5)

Regulatory Hierarchy

NZ regulatory structure for medicinal cannabis under the NZ Medicinal Cannabis Scheme

Regulatory Structure

Import Authorization

MCA import permit process for medicinal cannabis into New Zealand

Import / Export

MQS and GMP requirements for products entering the New Zealand market

Product Registration

MCA product approval under the NZ Medicinal Cannabis Scheme

Product Registration

Export / Import Process

MCA import/export process for medicinal cannabis shipments

Import / Export

🇳🇴

Norway

(4)

Regulatory Hierarchy

Norwegian regulatory structure for medicinal cannabis

Regulatory Structure

Import Authorization

NoMA per-patient import authorization for medicinal cannabis

Import / Export

GMP requirements for cannabis imports into Norway

Patient Access (Named-Patient)

Named-patient access pathway for medicinal cannabis in Norway

🇵🇪

Peru

(3)

Regulatory Hierarchy

Peruvian regulatory structure from Ministry of Health to patient

Regulatory Structure

Import Authorization

DIGEMID per-shipment import authorization for medical cannabis

Import / Export

GMP requirements for medical cannabis in Peru — import and domestic pathways

🇵🇱

Poland

(6)

Import Authorization

URPL import authorization for medicinal cannabis in Poland

Import / Export

Regulatory Hierarchy

Polish regulatory structure for medicinal cannabis

Regulatory Structure

EU-GMP requirements for the Polish market

Product Registration

URPL product authorization for Poland

Product Registration

Export / Import Process

End-to-end shipment to Poland

Import / Export

In-line & Release Testing

URPL and EU-GMP QC requirements for Poland

🇵🇹

Portugal

(6)

Regulatory Hierarchy

Portuguese regulatory structure for medicinal cannabis

Regulatory Structure

Import Authorization

INFARMED import authorization for medicinal cannabis

Import / Export

Export / Import Process

INFARMED export authorization for Portuguese-manufactured cannabis

Import / Export

EU-GMP requirements for the Portuguese market

Cultivation Licensing

INFARMED GACP cultivation license process

Product Registration

INFARMED product registration for domestic sale

Product Registration

🇷🇴

Romania

(3)

Regulatory Hierarchy

Romanian regulatory structure from Ministry of Health to patient

Regulatory Structure

Import Authorization

ANMDM per-shipment import authorization for cannabis-based medicines

Import / Export

GMP requirements for cannabis-based medicines in Romania (EEA member)

🇷🇼

Rwanda

(3)

Regulatory Hierarchy

Rwandan regulatory structure for cannabis — export-oriented program

Regulatory Structure

Cultivation License

Rwanda FDA cultivation license process for export-oriented cannabis production

Rwanda FDA export authorization for medical cannabis

Import / Export

🇿🇦

South Africa

(5)

Regulatory Hierarchy

SA regulatory structure for cannabis under SAHPRA and the Medicines Act

Regulatory Structure

Import Authorization

SAHPRA Section 21 and product registration pathway for cannabis imports

Import / Export

SAHPRA GMP and PIC/S alignment for South African cannabis production and export

Cultivation Licensing

SAHPRA Schedule 7 license and personal cultivation under Constitutional Court ruling

Export / Import Process

SAHPRA export authorization for South African cannabis

Import / Export

🇰🇷

South Korea

(3)

Regulatory Hierarchy

South Korean regulatory structure for cannabis — extremely restrictive

Regulatory Structure

Import Authorization

MFDS import authorization — specific approved products only

Import / Export

GMP requirements for pharmaceutical cannabis in South Korea

🇪🇸

Spain

(4)

Regulatory Hierarchy

Spanish regulatory structure for medicinal cannabis

Regulatory Structure

Import Authorization

AEMPS import authorization for pharmaceutical-grade cannabis

Import / Export

EU-GMP requirements for the Spanish market

Magistral Formula (Fórmula Magistral)

Primary patient access pathway in Spain — pharmacy compounding

🇨🇭

Switzerland

(6)

Import Authorization

Swissmedic and fedpol authorization process for medicinal cannabis

Import / Export

Regulatory Hierarchy

Swiss federal and cantonal regulatory structure

Regulatory Structure

Swissmedic GMP requirements and EU recognition

Product Registration

Swissmedic MA or cantonal exceptional authorization pathway

Product Registration

Export / Import Process

End-to-end shipment to and from Switzerland

Import / Export

In-line & Release Testing

Swissmedic QC requirements aligned with EU-GMP

🇹🇭

Thailand

(6)

License to Produce / Export

Thai FDA licensing for medical cannabis production and export

Import / Export

Regulatory Hierarchy

Thai regulatory structure for medical cannabis

Regulatory Structure

Thai FDA GMP requirements and international recognition

Thai FDA export framework — new 2026 pathway

Import / Export

Product Registration

Thai FDA product registration for medical cannabis

Product Registration

In-line & Release Testing

Thai FDA QC requirements for medical cannabis

🇬🇧

United Kingdom

(6)

Import Authorization

Home Office Schedule 1 import license process for medical cannabis

Import / Export

Regulatory Hierarchy

UK regulatory structure from MHRA to dispensing pharmacy

Regulatory Structure

MHRA GMP requirements for the UK market post-Brexit

Product Registration

MHRA marketing authorization or specials route for CBMPs

Product Registration

Export / Import Process

End-to-end shipment from origin country to UK pharmacy

Import / Export

In-line & Release Testing

QC requirements from manufacture through RPi batch release

🇺🇾

Uruguay

(4)

Regulatory Hierarchy

Uruguayan regulatory structure for cannabis under Law 19.172

Regulatory Structure

Three Access Channels

Uruguay's three legal adult-use cannabis access channels under Law 19.172

Import Authorization

MSP import authorization for cannabis into Uruguay

Import / Export

GMP certification pathways for cannabis in Uruguay