OFFICIAL GOVERNMENT GAZETTE
OF THE HELLENIC REPUBLIC
7 March 2018 FIRST ISSUE Circular Number 41
LAW No 4523
Provisions for the production of finished medicinal cannabis products and other provisions.
THE PRESIDENT OF THE HELLENIC REPUBLIC
We issue the following law voted by Parliament:
Article 1
Article 2A is added after article 2 of Law 4139/2013 (A΄ 74) as follows:
“Article 2A
1. Exceptionally, it is approved as a whole the manufacture, possession, transport, storage, supply of raw materials and substances of cannabis varieties of the Cannabis Sativa L plant species with a tetrahydrocannabinol (THC) content of more than 0.2 % as well as the establishment and operation of a manufacturing plant for the processing and production of finished medicinal cannabis products for the exclusive purpose of either the procurement of the State monopoly and their distribution for medical purposes, or for their export.
2. This approval is issued on a non-transferable basis and excludes the assignment and concession of any activity, at any stage of paragraph 1, to third parties and is provided with a joint decision of the Ministers of Economy and Development, Health and Rural Development and Food for all the activities stated in paragraph 1 pursuant to the provisions of Law 3982/2011 (Α΄ 143) and particularly case j of article 43, par. 1 of Law 4442/2016 (Α΄ 230), and the decision by the Alternate Minister of Development, Competitiveness and Shipping under no. hom.483/35/F.15/2012 (Β΄ 158), unless otherwise stipulated in this article, under the following terms and conditions:
a. Approval is granted to individuals, for whom the legal impediments of paragraph 5 do not apply upon, or to legal entities to whose administration or management participate individuals for whom the legal impediments of paragraph 5 do not apply upon, upon submission of an application and the payment of a fee, which is accompanied by the supporting documentation of the following subparagraphs. If the legal entity is based abroad, it shall be required to declare a tax representative and proxy in Greece. In any case, the persons originating from countries outside the EU are required to permanently reside in Greece or be based in Greece.
b. The area, within which all the activities referred to in paragraph 1 for which the authorization is granted take place, is single, shall be measuring at least 4 stremmas (4,000 m2) and shall be proven with the submission of a certified ownership title or lease contract or free land concession duly endorsed by the competent tax authority.
c. The single area of the activity shall be fenced and the cultivation area shall be closed.
d. The application shall be accompanied by a copy of the identity card or valid passport, a certificate that an individual is not subject to judicial guardianship, copy of a general use criminal record and a solemn declaration that a final bill of indictment has not been issued for the offences of paragraph 5, cases a, b, and c of the applying individuals, or the individuals participating in the administration or management of the applying legal entities.
e. The application shall also be accompanied by a non-bankruptcy certificate, certificate of non-filing a bankruptcy petition, certificate of non-filing of a request for conciliation-resolution, certificate of non-filing for liquidation and non-dissolution of the legal entity.
f. The application shall be accompanied by tax and social security clearance certificates in the name of the applying individual or legal entity issued no later than one month prior to the submission of the application.
g. The application shall be accompanied by a certificate from the relevant security subdirectory or the security department that the terms and conditions for the safe custody are observed in relation to the cultivation areas, the manufacturing unit’s facilities, the storage spots of the raw materials, the substances and the finished medicinal cannabis products of the cannabis varieties of Cannabis Sativa L plant species with a tetrahydrocannabinol (THC) content of more than 0.2 % and the transportation procedure, as these are defined in the decision of paragraph 4.
3. The supporting documents above shall be updated and submitted annually and a control shall be performed at least once a year to verify the continuation of compliance with the terms and conditions for granting the approval. In case the terms and conditions for the granting of the approval are breached, the competent Ministers of paragraph 2 revoke it after prior setting a thirty-(30)-day compliance deadline. The approval is revoked without a compliance deadline being set in the event of a breach of safe custody, as defined in case g and the decision of the following paragraph.
4. By decision of the Ministers of Interior, Economy and Development, Justice, Transparency and Human Rights, Health and Rural Development and Food, further terms and conditions shall be defined concerning particularly the granting of approval, the submission of additional supporting documentation, the amount of the fee, the guarding and security specifications of the cultivation areas, the storage spots and the processing plants, the transportation procedures, the storage time limit which cannot exceed five (5) years, the approval method for the importing of seeds for sowing, the controlling procedure for compliance with the terms and conditions for the granting of approval, the procedure for the regular and exceptional controls to continue compliance with the terms and conditions for the granting of approval at any stage of the cultivating and processing procedure as well as any other relevant subject.
5.The approval of paragraph 2 shall not be not granted to individuals or legal entities to whose administration or management participate individuals who:
a) Were convicted of a felony and of any penalty for theft, misappropriation joint and of public monies, fraud, extortion, forgery, lawyer’s breach of trust, bribery, bribe-taking, breach of trust in public service, breach of duty, as well as any crime against sexual freedom or a crime of economic exploitation of sexual life.
b) They are charged with for a felony with a final bill of indictment or have been charged with for a misdemeanor of case a'.
c) They are in custodial judicial guardianship (full or partial), in subsidiary judicial guardianship (full or partial) or in both situations.
The legal impediments of case a΄are removed only with the adoption of the presidential decree under Article 47 paragraph 1 of the Constitution which removes the consequences of the penalty.
The legal impediments of cases a΄, b΄ and c΄ also apply to workers and employed in cultivation areas and manufacturing, processing and storage facilities as well as to drivers of means of transport used for transportation. The legal impediments apply in particular for the Chairman and Managing Director in case of public limited companies, the manager in case of limited liability companies and Private Capital Company and for all the partners in case of general partnership and limited partnership companies. The legal impediments are checked at the time of recruitment or appointment of the persons above, as well as at any later time.
6. For the issue of the above ministerial decisions the opinion of the Narcotics Commission is not required.
7. For the import of seed to be sowed and propagating material of cannabis varieties of the Cannabis Sativa L plant species with a tetrahydrocannabinol (THC) content of more than 0.2 % for medicinal purposes as well as for the export of finished cannabis medicinal products of the cannabis varieties of Cannabis Sativa L plant species containing more than 0,2% of tetrahydrocannabinol (THC), the approval referred to in paragraph 2 is sufficient. The import, supply and export of raw materials and substances as well as the disposal and export of seed and propagating material of cannabis varieties of Cannabis Sativa L plant species with a tetrahydrocannabinol (THC) content of more than 0,2% is prohibited.
8. The export of finished medicinal products of cannabis varieties of the Cannabis Sativa L plant species with a tetrahydrocannabinol (THC) content of more than 0,2% for medical purposes is conducted by the Customs Office of Piraeus and the Free Zone of Thessaloniki with the presentation of a license from the competent authorities of the country to which they are to be sent, duly endorsed by the Greek consular authorities, which states that they are allowed to be imported into that country, that they are to be used for medical purposes, the name and address of the recipient, the quantity of them and the period within which the import has to take place.
9. The National Organization for Medicines (NOM) approves the production and circulation of finished medical cannabis products of cannabis varieties of Cannabis Sativa L plant species containing more than 0,2% of tetrahydrocannabinol (THC) for medicinal purposes under the terms and conditions laid down in the provisions of Law 1316/1983 (Α' 3) and the order No DY3a / G.P. 32221/2013 of the Joint Ministerial Decision (B '1049), and in particular from the provisions of case d΄of article 3 par. 1 of Law No 1316/1983 (A΄3), articles 57 to 76 and articles 133 to 159 of the order No. 32221/2013 of the Joint Ministerial Decision (Β '1049), applicable accordingly, as shall be determined in particular by decision of the Minister of Health, at the proposal of the National Organization for Medicines (NOM).
10. Articles 11, 17, 18 and 19 of this Law do not apply in the case where the approval of paragraph 1 and 2 of Article 2A of this Law has been granted. "
*** “10. Approval for the purposes of paragraph 1 is granted in areas of statutory production facilities and in areas where processing or farming activities and holdings are authorized”.
Note *** With paragraph 2 of article 58 of Law 4554/2018 (GG A΄ 130 / 18.7.2018), paragraph 10 to the Article 2A of Law 4139/2013 (A' 74) is added.
I, Elias Dinopoulos, Lawyer of the Athens Bar Association (no 20652), being fluent and competent in both the English and the Greek language, according to article 36 par. 2c of the Lawyers' Code of Conduct Law 4194/2013, hereby confirm that I have translated Article 2A of Law 4139/2013 “Provisions for the production of finished medicinal cannabis products” (GG A΄ 41), as it applies, and certify that this is a true and full translation from Greek to English to the best of my knowledge and belief.
Athens, 08-02-2019
The Translating and Certifying Lawyer
