— LICENSING PROCESS
Licensing for Medical Cannabis Activities
The Agency administers the application documentation, which is reviewed and evaluated by the Licensing Commission for Activities Related to Medical Cannabis.
Activities included in
the Licence
Activities included in the Licence
01
CULTIVATION
Cultivation and production of cannabis plants for medical purposes.
02
TRANSPORT
Transportation of cannabis seeds, plants, products and by-products for medical purposes within the territory of the Republic of Albania.
03
EXPORT
Export of cannabis plants, products and by-products for medical purposes.
Key Licence Conditions
01
Licence Period
The licence is granted for a period of 15 years, with the right to renewal upon request.
02
Area
The area of the licensed unit may not be less than 5 hectares and may not exceed 10 hectares.
03
National Limit
The total area authorised for cultivation may not exceed 200 hectares nationwide.
04
Units
If the entity is licensed for more than one unit, the units must be adjacent to each other and may not exceed 4 units.
05
Non-transferable
The licence is issued only in the name of the entity and is non-transferable and non-assignable.
06
Reassessment
Every 3 years, the licence conditions are reassessed by the Agency to verify compliance with the conditions and criteria.
Licensing Procedure
01
Submission of the Application
The entity submits the application to the Agency together with the required documentation and pays the application fee of ALL 100,000.
Step 1/5
02
Verification of Documentation
The Agency verifies the completeness of the documentation and the fulfilment of the legal requirements by the applicant.
Step 2/5
03
Assessment of Requirements
The Licensing Commission assesses compliance with the technical criteria, integrity requirements and the proposed development plan.
Step 3/5
04
Decision-Making
The Commission makes the decision to grant or refuse the licence based on the criteria established by law.
Step 4/5
05
Issuance of the Licence
Following approval by the Minister responsible for Health, the licence is issued specifying the authorised activities, units and the geographical coordinates of the location.
Step 5/5
Responsibilities of Commission
01
Administers and verifies the documentation submitted by entities applying to obtain a license.
02
Assesses compliance with the requirements relating to the premises, equipment and personnel for obtaining a license.
03
Prepares the list and the relevant report concerning the applicant entities, and prepares the proposal for granting or refusing the license.
04
Where violations are identified, proposes to the Minister responsible for health the imposition of the administrative measure of suspension or revocation of the license.
INFORMATION
Important Information
Application Fee
To obtain a licence, the applicant shall pay, upon submission of the application, a fee in the amount of:
100.000 Lekë
Licence Renewal
No later than 6 months before the expiry of the licence, the entity may apply for its renewal.
- Meets the licensing requirements
- Submits the application 6 months in advance
- Complies with the licence conditions throughout its validity
Application Fee
To obtain a licence, the applicant shall pay, upon submission of the application, a fee in the amount of:
ALL 100,000
Licence Renewal
No later than 6 months before the expiry of the licence, the entity may apply for its renewal.
- Meets the licensing requirements
- Submits the application 6 months in advance
- Complies with the licence conditions throughout its validity
Type of Area
Minimum Area
Maximum Area
National Limit
200 ha
What Should the Application File Contain?
A complete list of documents ensures a prompt and uninterrupted review of your application.
Documentation of the Applicant Entity
- Licence application and proof of payment of the application fee.
- Documentation relating to the cultivation/production unit, including the geographical coordinates, legal title to the land and site layout.
- Technical documentation, including the business development plan, the security plan and the internal operating regulations.
- Legal documentation regarding the registration of the entity with the National Business Centre (NBC).
- Industrial Security Certificate (ISC).
- Financial documentation demonstrating the company's minimum capital, the financial statements for the last three (3) years and compliance with tax obligations.
- Documentation proving the legal standing of the entity, including the absence of compulsory enforcement proceedings and bankruptcy proceedings.
- Documentation demonstrating the professional experience and capacity of the entity, as well as compliance with Good Manufacturing Practices in accordance with EU-GMP or FDA/cGMP standards.
Documentation Required for Integrity Verification
- Curriculum Vitae (CV).
- Self-declarations in accordance with the relevant forms, including consent to the processing of personal data and verification of integrity, criminal record, conflict of interest and disciplinary measures.
- Identification documents, including the identity card/passport and the family and personal civil status certificate.
- Documentation proving integrity, including the criminal record certificate, certificates issued by the prosecution office, the court and the Special Structure Against Corruption and Organised Crime (SPAK).
- Health documentation, including a medical certificate and a certificate issued by the Institute of Forensic Medicine (IFM) confirming that the applicant is not a drug user.
- Documentation proving education, professional experience and qualifications, including a notarised copy of the higher education diploma, a copy of the employment record book and any other document proving the qualifications, training or assessments included in the Curriculum Vitae.
What Should the Application File Contain?
A complete list of documents ensures a prompt and uninterrupted review of your application.
Documentation of the Applicant Entity
- Licence application and proof of payment of the application fee.
- Documentation relating to the cultivation/production unit, including the geographical coordinates, legal title to the land and site layout.
- Technical documentation, including the business development plan, the security plan and the internal operating regulations.
- Legal documentation regarding the registration of the entity with the National Business Centre (NBC).
- Industrial Security Certificate (ISC).
- Financial documentation demonstrating the company's minimum capital, the financial statements for the last three (3) years and compliance with tax obligations.
- Documentation proving the legal standing of the entity, including the absence of compulsory enforcement proceedings and bankruptcy proceedings.
- Documentation demonstrating the professional experience and capacity of the entity, as well as compliance with Good Manufacturing Practices in accordance with EU-GMP or FDA/cGMP standards.
Documentation Required for Integrity Verification
- Curriculum Vitae (CV).
- Self-declarations in accordance with the relevant forms, including consent to the processing of personal data and verification of integrity, criminal record, conflict of interest and disciplinary measures.
- Identification documents, including the identity card/passport and the family and personal civil status certificate.
- Documentation proving integrity, including the criminal record certificate, certificates issued by the prosecution office, the court and the Special Structure Against Corruption and Organised Crime (SPAK).
- Health documentation, including a medical certificate and a certificate issued by the Institute of Forensic Medicine (IFM) confirming that the applicant is not a drug user.
- Documentation proving education, professional experience and qualifications, including a notarised copy of the higher education diploma, a copy of the employment record book and any other document proving the qualifications, training or assessments included in the Curriculum Vitae.
