Conditions of application for a cannabis licence in Cyprus

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Conditions of application for a cannabis licence in Cyprus

Conditions of application for a cannabis license in Cyprus

What is Cannabis?
Cannabis is a genus of flowering plant native to Central Asia and the Indian Peninsula, whose main psychoactive ingredient is tetrahydrocannabinol (THC). Despite the fact that this plant is widely utilised in industry, as well as in medicine, because of its psychoactive properties it is included in lists of controlled substances in the majority of countries, consequently making its production and use illegal. According to the data presented in the UNODC World Drug Report 20161, drafted by the United Nations Office for Drugs and Crime, cannabis is the world’s leading illegal substance when it comes to cultivation, production, sale and the number of users. However, the Report also notes that, during the last four years, the use of cannabis for recreational purposes has been legalised in Uruguay and the United States, i.e. in federal states of Alaska, California, Colorado, Maine, Massachusetts, Oregon and Washington. When it comes to European countries, recreational use of cannabis is legal in Netherlands and Spain, while a number of other countries have decriminalised its use. Unlike the recreational use of cannabis, its utilisation for medical purposes has been subject to an entirely different legislative treatment, and is legally allowed in a significantly larger number of countries. Certain derivatives and synthetic preparations obtained from this plant (i.e. cannabinoids) are used for treatment of a number of medical conditions, such as nausea and vomiting caused by chemotherapy for cancer patients, or stimulating appetite within treatments of anorexia or weight loss of AIDS patients. However, the use of cannabis and its derivatives is currently most common as a part of therapy for relieving pain and muscle spasms, particularly those caused by the multiple sclerosis, in which its efficiency has been confirmed by a number of medical studies .

 

Who can apply for a cannabis licence in Cyprus?
According to the Law of the Republic of Cyprus (Drugs and psychotropic substances law, 1977-2019, and Drugs and psychotropic substances (medical cannabis) Regulations,2019, in comply with the articles 8,11,28,28A an 36 of the Law, both natural and legal persons can apply for a cannabis license in Cyprus.

 

What are the Conditions of applying for a cannabis licence in Cyprus?
Cannabis for personal recreational use is illegal. Medical cannabis is strictly controlled by the Ministry of Health of Cyprus. The conditions for obtaining a production license allowing the producer to cultivate and produce (including packaging and labelling) medical cannabis are almost the same for both natural and legal persons.

 

What are the Conditions that a natural person must meet in order to apply for a cannabis licence in Cyprus?
1. An adult with residence in the Republic of Cyprus or in another Member State.
2. At least five years of experience in the cultivation and production of pharmaceutical cannabis on the world market – “experience on the world market means engaging in any other country or countries” .
3. Submitting an application to the Minister of Health (or any other person duly authorized by him) with the following information:
(a) The name with which he will carry out the activities for which he/she is applying for the license, the date of birth and the sex of the individual.
(b) The work address, the telephone number, the fax number and e-mail address, where applicable, of the proposed establishment for which the application is filed and, where applicable, any place in the establishment where the activities for which the application is filed will take place.
(c) The address of the establishment for which the application is filed and, where applicable, for any place in the establishment where the activities for which the application is filed will take place, if it is different from the address mentioned in paragraph (b).
(d) The name, the date of birth and the sex of the proposed person in charge, the proposed supervisor and, where applicable, the proposed alternative supervisor.
(e) The name and the sex of each person authorized by the applicant to make an order for cannabis.
(f) The activities for which the application is filed and the purposes of such activities.
(g) A detailed description of the security measures in the proposed establishment for which the application is filed, as provided in the Part 4 of the Regulations.
(h) A detailed description of the method that the applicant proposes to apply for the record keeping, which allows the compliance with the requirements of Part IX of the Regulations, the inspection of the activities of the licensed producer in relation to medicinal cannabis by the competent authority and the reconciliation of the orders for pharmaceutical cannabis, the sending and the recording of the quantities of pharmaceutical cannabis.
4. If the applicant intends to carry out his activities in more than one establishment, he shall submit a separate application for each proposed installation.
5. The application must be signed and dated by the applicant.

6. The application must be accompanied by the following:
a) A declaration signed and dated by the applicant stating that all the information and documents submitted are correct and complete.
b) A statement signed and dated by the applicant submitting that the proposed person in charge, the supervisor and, where applicable, the alternative supervisors are aware of the provisions of the Law and the Medicines for Human Use (Quality, Supply and Prices Control) Law, applicable to the license.
c) A certificate of ownership title indicating whether the applicant is the owner of the proposed establishment / If the applicant is not the owner of the establishment, a declaration that the owner consents to its use by the applicant for the activities for which the application is filed, accompanied by the rental document / If the applicant at the time of the application is not yet the owner or tenant of the proposed establishment, a statement signed and dated indicating the proposed establishment and the future legal relationship linking the applicant to that.
d) A declaration signed and dated by the applicant that the establishment for which the application is filed is not a house.
e) A statement signed and dated by the applicant that the notifications to the local authorities were filed in accordance with the provisions of Regulation 33 and the dates on which they were filed, accompanied by any notice.
f) A document signed and dated by the quality assurance officer, which includes: (1) a description of his / her qualifications in relation to the specialisation of a Chemist or a Pharmacist and statement that he has at least two years experience with regard to the requirements of the Part V of the Regulations (“Good Production practices”); (2) a report demonstrating that the facilities, equipment and hygiene program that will be used in carrying out the proposed activities referred in the Part V of the Regulations comply with the requirements of that Part and (3) plans and detailed description of the proposed installation.

7. Payment of the following fees:
a)€9.000 for the processing and examination of the application.
b)€500.000 for the issue of the producer’s license.
c)€30.000 each year, during the period of validity of this license.
d)€1.000 for amending, supplementing or extending the producer’s license .

8. A Clean Criminal Record Certificate for the following persons: (a) the person in charge, (b) the supervisor person in charge, (c) where is applicable, the alternative supervisor, (d) the person authorized by the applicant to make an order for cannabis, (e) the natural person applying for the producer’s license.

 

What are the Conditions that a legal person must meet in order to apply for a cannabis licence in Cyprus?
1. Incorporation in accordance with the Laws of the Republic of Cyprus or another Member State.
2. A Registered office or work place in the Republic of Cyprus.
3. Both staff and directors are adults.
4. At least five years of experience in the cultivation and production of pharmaceutical cannabis on the world market – “experience on the world market means engaging in any other country or countries”.
-The legal person is deemed to have the required experience if it is active for at least five years in the field of cultivation and production of pharmaceutical cannabis on the world market; or
-the holding or subsidiary company of the legal person or other subsidiary company of the holding company of the legal person is active for at least five years in the field of cultivation and production of pharmaceutical cannabis on the world market;
-at least two natural persons with a key position within the legal person have been active for at least five years in the field of cultivation and production of medicinal cannabis on the world market (Key position means – 1. Member of the board of directors, 2. Shareholder holding more than 10% of the voting rights of the legal person, 3. Person in charge, 4. Supervisor, 5. Alternative supervisor, 6.Quality assurance officer) .
5. Submitting an application to the Minister of Health (or any other person duly authorized by him) with the following information:
(a) The name of the legal person with which he will carry out the activities for which it is applying for the license and also, the name, the date of birth and the sex of the secretary, the director and each member of the Board of Directors.
(b) The work address, the telephone number, the fax number and e-mail address, where applicable, of the proposed installation for which the application is filed and, where applicable, any place in the establishment where the activities for which the application is filed will take place.
(c) The address of the establishment for which the application is filed and, where applicable, for any place in the establishment where the activities for which the application is filed will take place, if it is different from the address mentioned in paragraph (b).
(d) The name, the date of birth and the sex of the proposed person in charge, the proposed supervisor and, where applicable, the proposed alternative supervisor.
(e) The name and the sex of each person authorized by the applicant to make an order for cannabis.
(f) The activities for which the application is filed and the purposes of such activities.
(g) A detailed description of the security measures in the proposed establishment for which the application is filed, as provided in the Part 4 of the Regulations.
(h) a detailed description of the method that the applicant proposes to apply for the record keeping, which allows the compliance with the requirements of Part IX of the Regulations, the inspection of the activities of the licensed producer in relation to medicinal cannabis by the competent authority and the reconciliation of the orders for pharmaceutical cannabis, the sending and the recording of the quantities of pharmaceutical cannabis.

6. Where the applicant intends to carry out his activities in more than one establishment, he shall submit a separate application for each proposed establishment.

7. The application must be signed and dated by the applicant.
8. The application must be accompanied by the following:
a) A declaration signed and dated by the applicant indicating that all the information and documents submitted are correct and complete.
b) A statement signed and dated by the applicant submitting that the proposed person in charge, the supervisor and, where applicable, the alternative supervisors are aware of the provisions of the Law and the Medicines for Human Use (Quality, Supply and Prices Control) Law, applicable to the license.
c) A true copy of the certificate of incorporation of the company.
d) A certificate of ownership title indicating whether the applicant is the owner of the proposed establishment / If the applicant is not the owner of the establishment, a declaration that the owner consents to its use by the applicant for the activities for which the application is filed, accompanied by the rental document / If the applicant at the time of the application is not yet the owner or tenant of the proposed establishment, a statement signed and dated indicating the proposed establishment and the future legal relationship linking the applicant to that.
e) A declaration signed and dated by the applicant that the establishment for which the application is filed is not a house.
f) A statement signed and dated by the applicant that the notifications to the local authorities were filed in accordance with the provisions of Regulation 33 and the dates on which they were filed, accompanied by any notice.
g) A document signed and dated by the quality assurance officer, which includes: (1) a description of his / her qualifications in relation to the specialisation of a Chemist or a Pharmacist and statement that he has at least two years experience with regard to the requirements of Part V of the Regulations; (2) a report demonstrating that the facilities, equipment and hygiene program that will be used in carrying out the proposed activities referred in the Part V of the Regulations comply with the requirements of that Part and (3) plans and detailed description of the proposed establishment.

9. Payment of the following fees:
a)€9.000 for the processing and examination of the application.
b)€500.000 for the issue of the producer’s license.
c)€30.000 each year, during the period of validity of this license.
d)€1.000 for amending, supplementing or extending the producer’s license .

10. A Clean Criminal Record Certificate for the following persons: (a) the person in charge, (b) the supervisor person in charge, (c) the alternative supervisor, where is applicable, (d) the person authorized by the applicant to make an order for cannabis, (e) the secretary, the director and each member of the Board of Directors of the Company .