Ministerial Order relating to the Cannabis and Cannabis Products


Rwanda

Ministerial Order relating to the Cannabis and Cannabis Products

Ministerial Order 3 of 2021

The Minister of Health,Pursuant to the Constitution of the Republic of Rwanda of 2003 revised in 2015, especially in Articles 121, 122 and 176;Pursuant to Law n° 03/2012 of 15/02/2012 governing narcotic drugs, psychotropic substances and precursors in Rwanda, especially in Article 7;After consideration and approval by the Cabinet, in its meeting of 12/10/2020;ORDERS:

Chapter One
General provisions

Article one – Purpose of this Order

This Order determines the following for medical and research purposes:establishments and other places where operations related to cultivation, processing, distribution and use of cannabis and cannabis products are carried out;issuance of licence of cultivation, processing, distribution and use of cannabis and cannabis products;security rules applicable to cultivation, processing, distribution and use of cannabis and cannabis products.

Article 2 – Definitions

In this Order, the following terms have the following meanings:cannabis: the flowering or fruiting parts, leaves and other parts of the cannabis plant. It also includes seeds of cannabis for agriculture purpose;cannabis products: the cannabis that has undergone a process whereby the plant material has been transformed into a concentrate, including, but not limited to, concentrated cannabis, edible products, ointments, tinctures, and topical product containing cannabis or cannabis concentrate and other ingredients;processing: a series of mechanical or chemical operations performed on cannabis or cannabis products in order to change or preserve them. It means any method used to prepare cannabis or cannabis products, including packaging, and extraction of active ingredients to make concentrates or pharmaceutical products;competent authority:a)a national authority in charge of regulating narcotics and drugs from seeds, plants and processed pharmaceutical products from cultivation as well as their importation, harvesting, processing and export; orb)an organ in charge of security observation in regards to narcotics abuse.specialist medical doctor: a medical doctor to whom the Ministry of Health has given, in writing, the authority to prescribe cannabis and cannabis products.

Article 3 – Establishments and other places where operations intended for use of cannabis or cannabis products are conducted

The operations related to cultivation, distribution and use of cannabis and cannabis products are performed in private or public establishments that have been given a licence thereof from the competent authority and must be performed at the places of business of those establishments or at such other place as may be approved by the competent authority.

Chapter II
Issuance of licence of cultivation, processing, distribution and use of cannabis

Article 4 – Eligibility for obtaining a licence

The eligible person for the activities provided for by this Order is an investor or any other person who is committed to perform any activity of cultivation, processing, importation, export and use of cannabis and cannabis products, for medical or research purposes.

Article 5 – Type of licences, permits and certificate

Types of licences, permits and certificate are the following:the cultivation licence;the import permit for seeds, genetic materials and other planting material;the export permit for seeds, genetic materials and other planting materials;the cannabis and cannabis products processing licence;the cannabis and cannabis products import permit;the cannabis and cannabis products export permit;the finished cannabis and cannabis products registration certificate;the research licence.

Article 6 – Cultivation licence

The cultivation licence covers the following activities:development of genetic materials;establishment of nurseries;cultivation;harvesting;post-harvest handling.

Article 7 – Import or export permit

Only an operator that holds a cultivation licence is allowed to apply for an import or export permit for cannabis seeds, genetic materials and other planting material.A person who intends to import or export cannabis seeds, genetic materials and other planting materials requests a permit thereof from the competent authority for each import or export.

Article 8 – Cannabis and cannabis products processing licence

The cannabis and cannabis products processing licence also covers research and development activities beyond genetic materials development activities.

Article 9 – Finished cannabis and cannabis products registration certificate

An operator that holds the cannabis and cannabis product processing licence must register each type of finished cannabis and cannabis products with the competent authority, and they are issued with a certificate thereof.

Article 10 – Cannabis and cannabis products import or export permit

A person who intends to import or export cannabis or cannabis products applies for the permit to the competent authority for each importation or export.

Article 11 – Research licence

A person who intends to undertake research on cannabis and cannabis products applies for a licence to the competent authority.

Article 12 – Validity of licences

The licence provided for in this Order is granted for a period of five (5) years renewable.

Article 13 – Requirements

The competent authority determines and publishes the requirements to obtain a licence or permit mentioned in Article 5 of this Order.

Article 14 – Medical use

Medical use of cannabis and cannabis products can only be made on the condition that they are prescribed by a specialist medical doctor.

Chapter III
General security requirements

Article 15 – Basic security measures

An operator of activities related to cannabis and cannabis products provides a security plan to the Rwanda National Police for approval.The security plan indicates that at least the operator of activities related to cannabis and cannabis products will ensure the implementation of the following measures:having double layered fencing;ensuring patrol control in between the two layers of the fence;hiring a licensed private security service company that must be securing outside 24 hours per day, 7 days a week;security lighting;video surveillance cameras;watchtowers;an intrusion detection system;a communication control room;bright signage;10°having access control system of staff and any other authorized persons at the entry and exit of the facility;11°ensuring that the staff and any other persons authorized to enter the facility wear personnel protective equipment without pockets that are kept in dedicated areas;12°keys and locks management.The Rwanda National Police may establish other security measures in addition to those provided for in Paragraph 2 of this Article.The Rwanda National Police conducts regular audits of the security plan.

Article 16 – Security of cannabis farm and processing facility of cannabis and cannabis products

The security of cannabis plantation and processing facility of cannabis and cannabis products is provided in a coordinated framework encompassing three layers, namely the inner, middle and outer layers.The inner layer security is the responsibility of the licencee and the licenced private security service provider he or she employs.The middle layer and outer layer security is the responsibility of the Rwanda National Police.

Article 17 – Security accountability and cooperation

An operator of activities related to cannabis and cannabis products, a private security service company, the Rwanda National Police, the Rwanda Defence Force, public institutions in charge of issuing licences, permits or certificates as well as decentralised administrative entities ensure that security requirements are respected, and cooperate in exchange of information and for security management.

Chapter IV
Administrative sanctions

Article 18 – Suspension of a licence

The competent authority suspends a licence if the licence holder does not comply with provisions of this Order and those of relevant laws or regulations.The operator whose licence has been suspended may appeal to the competent authority within a period of one (1) month from the date of notification of the decision of suspension of the licence.

Article 19 – Revocation of the licence

The competent authority may revoke the operator’s licence, if the licence holder does not comply with provision of this Order or those of relevant laws or regulations.The operator whose licence has been revoked may appeal to the competent Authority within a period of one (1) month from the date of notification of the decision of revocation of the licence.

Article 20 – Administrative fine

An operator of activities related to cannabis and cannabis products who violates the licence conditions commits a fault. Without prejudice to provisions of Article 18 and Article 19 of this Order, the competent authority imposes on him or her an administrative fine of not less than one million Rwandan francs (FRW 1,000,000) and not more than fifty million Rwandan francs (FRW 50,000,000) that is deposited on the account of the competent authority.In case of recidivism, the administrative fine provided for in Paragraph One of this Article is doubled.

Chapter V
Miscellaneous and final provisions

Article 21 – Transport

Any transport of cannabis and cannabis products must be done by an operator of activities related to cannabis and cannabis products or a licensed transport company authorised thereto by the Rwanda National Police.The security of cannabis or cannabis products in transport is ensured by the operator of activities related to cannabis and cannabis products and the authorized private security service company employed by the operator.Cannabis and cannabis products in transport must be transported in a manner ensuring that their quality is maintained and they are traceable by a cargo tracking system throughout transportation.The competent authority determines other requirements for transportation of cannabis and cannabis products including packaging, labelling and storage.

Article 22 – Traceability and records keeping

An operator of activities related to cannabis and cannabis products must properly document the entire supply and value chains processes of cannabis and cannabis products.The competent authority issues regulations on the implementation of provisions of Paragraph One of this Article.

Article 23 – Reporting

An operator who holds a licence to carry out activities related to cannabis and cannabis products must submit reports to the competent authority in accordance with the requirements set up by that competent authority.

Article 24 – Commencement

This Order comes into force on the date of its publication in the Official Gazette of the Republic of Rwanda.
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History of this document

28 June 2021 this version
25 June 2021
Assented to