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production of medical cannabis in Greece

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production of medical cannabis in Greece

Production of cannabis for the sole purpose of producing finished medicinal cannabis products

Law 4523/2018 (Government Gazette 41/07-03-2018) – Granting of permits for the establishment and operation of processing and production units for the manufacture of finished medicinal cannabis products (Cannabis Sativa L (THC) > 0.2%). 51483/700/F.15 (Government Gazette 1692/15-05-2018) – Terms and conditions for the cultivation and processing of medicinal cannabis. and related amendments: M.A. no. οικ. 118694/1485/F15 (Government Gazette 5129/15-11-2018) M.A. no. οικ. οικ. 103057/1342/F15 (FEK 4426/05-10-2018)

Clarification Circular 18010/12-2-2019 M.A. No. D3(c)52588 (Government Gazette 2840/16-07-2018 – Terms and conditions for the production and circulation of finished medicinal cannabis products

The novelty of the regulation

Exceptionally, natural and legal persons are granted the possibility of producing cannabis for the sole purpose of producing finished medicinal cannabis products for the supply of the state monopoly and their distribution to patients or their export for medical purposes.

Access to cannabis of a specific species (Cannabis Sativa L with a tetrahydrocannabinol (THC) content of more than 0,2 %) and exclusively for medical purposes

Cannabis remains in the cycle of addictive substances, and therefore the authorisation to establish and/or operate is granted under strict terms and conditions

Authorisation for the production, possession, transport, storage, supply of raw materials and substances, as well as the establishment and operation of a processing plant for the processing and production of finished medicinal cannabis products is granted by joint decision of the Ministers of Development & Investment, Health and Rural Development and Food. The approval is non-transferable

Storage, safety and transport requirements for the finished product

Benefits of the legislation:

Access of the country’s patients to finished medicinal cannabis products, given the therapeutic properties of cannabis in specific cases

Natural and legal persons to cultivate hemp varieties for the processing of raw materials and, in general, of these substances for the sole purpose of producing finished medicinal hemp products in Greece, investing in the provision of space and the creation of a new production site for the production of medicinal hemp products 

the establishment of cultivation and processing facilities

Creation of new jobs, which will contribute to the growth of the economy in a cutting-edge sector that exploits the country’s comparative, productive advantages

Economic benefits for the State from exports of finished medicinal hemp products and taxation of economic activities in the sector

Beneficiaries:

Natural or legal persons, whether resident in Greece or abroad, provided that:

They or the persons involved in their administration or management (in the case of legal persons) or the workers in cultivation sites and in processing, treatment and storage facilities or the drivers of means of transport used for transport have not been convicted or sentenced by final judgment for a felony or any sentence for specific crimes (l. e.g. theft, embezzlement, fraud, extortion, forgery, etc.) and are not under judicial assistance (deprivation of liberty or subsidiary, full or partial)

Beneficiaries

Natural or legal persons, whether resident in Greece or abroad, provided that:

they or the persons involved in their administration or management (in the case of legal persons) or the workers in cultivation areas and in processing, treatment and storage facilities or the drivers of means of transport used for transport have not been convicted or sentenced by final judgment of a felony or any other penalty for specific crimes (e.g. theft, embezzlement, fraud, extortion, forgery, etc.) and are not under legal aid (deprivation of liberty or subsidiary, full or partial)

Beneficiaries:

Legal entities with a registered office abroad have declared a tax representative and counterpart in Greece. Persons from non-EU countries must reside permanently in Greece or have a registered office in Greece.

the area of the activity must be uniform, at least 4 hectares in area, enclosed and the cultivated area must be enclosed

Procedure for obtaining approval for establishment

Submission of the questionnaire of Annex I of the Decree (No 51483/700/F.15) to the Business and Business Park Licensing Department of the General Secretariat for Industry

Submission of supporting documents in digital and paper form

The Licensing Directorate of the General Secretariat of the Ministry of Agriculture and Food, the Ministry of Health/EOF and the Hellenic Police, will forward to the competent services of the Ministry of Rural Development and Food, a digital copy accompanied by a copy of the questionnaire submitted 

The approval of the establishment is granted by decision of the Ministers of Development & Investment, Health and Rural Development and Food within 30 days of the submission of a complete dossier and is valid for five (5) years.

Conduct an on-site inspection within fifteen (15) days of the granting of the facility approval by the Licensing Department

Documents to be submitted for the approval of the installation

1. a certificate of land use from the competent Building Department accompanied by the submitted topographical diagram used for its issue

2. Environmental Conditions Approval Decision (EIA) or Standard Environmental Commitments (SMC), where required.

3. A copy of the identity card or valid passport of the applicant natural persons or of the natural persons involved in the administration or management of the applicant legal entities. For legal persons, the above document must be provided: for all the members of the board of directors (SA) or for all the partners (SPE, EIA, IKE) or for all the joint venture members (joint venture) 

4.Certificate of no legal representation of the applicant natural persons or natural persons participating in the administration or management of the applicant legal persons 

5. A copy of the general criminal record of the applicant natural persons or those involved in the management of the applicant legal persons

6. An affidavit of non-execution of a final conviction for the offences referred to in par. 5 of Article 24 of Law No. 4139/2013 of the applicant natural persons or natural persons who participate in the administration or management of the applicant legal persons 

7. Responsible declaration of the applicant natural persons or those involved in the management of the applicant legal persons as to the

status as ‘beneficiaries’, in accordance with the requirements of the law

8. Certificate of no bankruptcy, no bankruptcy petition, no petition for composition – reorganisation, no petition for dissolution and no dissolution of the legal entity

9. Tax and insurance certificates of the applicant natural or legal person

10. Certificate of permanent residence for persons subject to the obligation (persons from non-EU countries)

11. Declaration of tax representative and counterpart, in case the applicant is established abroad

12. Declaration by the applicant natural person or the legal representative of the applicant legal person that there is no school within a distance of less than 1000 m from the boundaries of the land of the facility to be licensed

13. A fee of ten thousand (10,000) euros, deposited in the account number 1450189001 (Other Fees) in favour of the General Secretariat for Industry (Ministry of Development & Investments)

14. For applicants from countries outside Greece, the submission of documents 5 and 6, and in their absence, an equivalent document issued by a competent judicial or administrative authority of the Member State or country of origin of the applicant, officially translated into Greek, is required. If the Member State or country in question does not issue such a document or certificate, the document or certificate may be replaced by a sworn statement or, where no such statement is provided for, by a solemn declaration made by the person concerned before a competent judicial or administrative authority, a notary or a competent professional or trade body of the Member State or country of origin or of the country where the natural person is established

Procedure for issuing an operating licence

After submitting the questionnaire, the interested party submits the supporting documents to the Licensing Directorate of the GGV, in paper and electronic form. The operating licence is granted within 30 days of the submission of a complete file and is valid for ten (10) years.

The Licensing Directorate of the GGM shall forward a digital copy to the competent services of the Ministry of Rural Development and Food, the Ministry of Health/EOF and the Hellenic Police. The operating licence is granted by decision of the Ministers of Development & Investment, Health and Rural Development and Food within 30 days of the submission of a complete file and is valid for ten (10) years.

Within two (2) months of the issuance of the operating licence, the Licensing Directorate of the General Secretariat of the Ministry of Agriculture carries out an on-site inspection to ascertain whether or not the conditions for granting the operating licence have been met

Documents to be submitted for the issue of an operating licence

1. certified title of ownership or a lease or free concession certified by the competent tax office

2. Map of the premises

3. Certificate from the relevant Security Sub-Directorate or Security Department that the terms and conditions of safe custody have been complied with

4. Greenhouse type permit, where required, and a topographical diagram showing the location and area of the cultivated area

5. A declaration by the entity that it is responsible for compliance with the legal requirements for persons connected with any employment relationship with the entity

6. Responsible statement by a legally competent engineer regarding the structural adequacy, the industrial-industrial use of the building, the installation of the mechanical equipment in a space of main use (not ancillary or common use), the number of the existing building permit, and the non-requirement of issuing a new building permit.

7. A declaration by the operator stating how many and what type of technicians will be used and what their specialisation is by law

8. a declaration by the engineers, where applicable, of the relevant specialisation, that the installation has been carried out in accordance with the installation approval granted and that the planned works have been carried out in accordance with the approved studies

9. Responsible declaration of the commissioning – assumption of the supervision, operation and maintenance of the installation by the owner of the installation and the legally responsible technician respectively

10. Copy of the building permit, where required

11. Responsible declaration that the prescribed fire protection measures and means have been taken

12. Certificate of acceptance and valid inspection certificate for the steam boilers of the installation, where required

13. Certificate of inspection in force for LPG tanks,

14. A declaration by a legally competent engineer that the traffic connection of the installation was carried out in accordance with the approved plans

15. Water use permit, if required

16. Permit for the construction of a port project and the use of the seashore and beach, if required

17. Permit for a generating set, in case of existence and/or use of the generating set

18. A fee of ten thousand euros (10.000 €), deposited in the account number 1450189001 (Other Fees) in favour of the General Secretariat of Industry (Ministry of Development & Investments)

The export of finished medicinal cannabis products of cannabis varieties of the Cannabis Sativa L species with a tetrahydrocannabinol (THC) content of more than 0,2 % for medicinal purposes is carried out from the Piraeus Customs and the Thessaloniki Free Zone upon presentation of a licence from the competent authorities of the country to which they are to be sent, endorsed by the Greek consular authorities, stating that they may be imported into that country, that they are to be used for medical purposes, the name and address of the consignee, their quantity and the time limit within which they must be imported.

Medicinal cannabis: Over 135 licences for production – The partnerships and the big names

In Central Greece most of the companies for its production. 

The 138 have reached, at least at the time of writing, the number of authorizations granted by the General Secretariat of Industry for the establishment of units for cultivation, processing, processing and production of finished products of medicinal cannabis throughout Greece, with the Region of Central Greece leading the way with 34 companies, which are mainly located in the region of Boeotia and Chalkida.

This is followed by the Region of Central Macedonia with 29 businesses, the Region of Thessaly with 24, the Region of Peloponnese with 16, the Region of Western Greece with 15, while the remaining 11 have been granted to the Regions of Attica, Eastern Macedonia and Thrace, South Aegean and Crete.

Contact the best lawyers for licensing and production of medical cannabis in Greece of Economou & Economou Law Office in Athens Greece at +30 2103603824 or send us an email at econlaw@live.com

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