Cannabinoid Drugs, Medicinal Cannabis and Opioid Drugs
Calavros Law Firm / Greece
All legal aspects surrounding cannabinoid drugs, medicinal cannabis & opioid drugs in Greece. Prepared in association with Calavros Law Firm, a leading global law firm, this is an extract from The Pharma Legal Handbook: Greece, available to purchase here for USD 99.
Cannabinoid Drugs
1. Are Cannabinoid Drugs authorized in your country?
By virtue of article 1 of recent Law 4523/2018, article 2A has been introduced to Law 4139/2013 on Narcotics, providing for the possibility to obtain exceptional authorization for the production, possession, transport, storage and supply of the raw materials and substances derived from Cannabis Sativa L varieties with a tetrahydrocannabinol (THC) content of more than 0.2%. Authorization may equally be obtained for the installation and operation of a processing and production unit of final products of medicinal cannabis for the sole purpose of either supplying the state monopoly in view of their disposal for medical purposes or their export. Implementing Ministerial Decision Δ3(γ)52588 Government Gazette Β 2840 2018 on the Terms and Requirements for the production and marketing of final products of medicinal cannabis, provides for the particular approval procedure applicable to the marketing authorization, as well as the export or import of final products of medicinal cannabis, Final products are strictly defined in Article 2 of said Ministerial Decision as a product containing as its sole active substance, for the indications specifically and restrictively provided in article 4 of the same, a derivative of Cannabis Sativa L varieties with a tetrahydrocannabinol (THC) content of more than 0.2%, falling within the scope of L. 4523/2018.
2. What are the regulatory authorities with jurisdiction over Cannabinoid Drugs?
Par. 9 of article 2A Law 4139/2013 provides for the jurisdiction of EOF regarding all matters related to the production and marketing authorization of the final products of medicinal cannabis derived from Sativa L varieties with a tetrahydrocannabinol (THC) content of more than 0.2%. The Ministry of Health retains, of course, jurisdiction over narcotics by virtue of the same law, which makes it the competent authority as regards imports of cannabinoid drugs.
3. Is there a specific regulatory framework for the authorization, pricing, and reimbursement of Cannabinoid Drugs?
Par. 9 of article 2A Law 4139/2013 provides for the application of all provisions relevant to the requirements and procedure of obtaining marketing authorization for pharmaceutical products in force as regards the production and marketing of the final products of medicinal cannabis; the above-mentioned implementing Ministerial Decision Δ3(γ)52588 Government Gazette Β 2840 2018 on the Terms and Requirements for the production and marketing of final products of medicinal cannabis specifies marketing authorization requirements for final products of medicinal cannabis, as strictly defined therein.
4. Which are the cannabinoid drugs that have received market approval to date?
No cannabinoid drug has received market approval by EOF yet. The Greek Ministry of Health recently approved the import of specific quantities of Sativex for the needs of the State Monopoly of Narcotics.
5. Who can prescribe Cannabinoid Drugs?
No exception has been provided as regards the prescription of Cannabinoid Drugs, which are regarded as medicines as far as authorization and marketing requirements are concerned; no legal basis, therefore, exists for their prescription by any other than medical doctors.
6. Is there a list of doctors authorized to prescribe Cannabinoid Drugs?
No list of doctors specifically authorized to prescribe Cannabinoid Drugs exists under Greek law.
7. What approvals or notifications are required to prescribe Cannabinoid Drugs?
No specific provisions related to the prescription procedure of Cannabinoid Drugs have been adopted under Greek law.
8. Which organizations are authorized to sell/distribute Cannabinoid Drugs available?
No specific provisions related to the sale and distribution of authorized Cannabinoid Drugs have yet been adopted; as is the case of all prescription medicines, Cannabinoid Drugs may be sold / distributed through pharmacies, hospitals or private clinics.
9. Is there a list of retailers/distributors authorized to sell Cannabinoid Drugs?
No specific list of authorized retailers/ distributors of Cannabinoid Drugs exists.
10. Are there proposals for reform or significant change to the regulation of Cannabinoid Drugs?
No specific proposals under examination have been announced, but the regulatory framework has plenty of scope to develop as the newly-adopted provisions relevant to the possibility of production, possession, transport, storage and supply of the raw materials and substances derived from Cannabis Sativa L varieties with a tetrahydrocannabinol (THC) content of more than 0.2%, as well as of production of final products based on the substance count no more than a few months’ implementation.
11. When are they likely to come into force?
N/A.
Medicinal Cannabis
12. Is Medicinal Cannabis authorized in the country?
By virtue of article 1 of recent Law 4523/2018, article 2A has been introduced to Law 4139/2013 on Narcotics, providing for the possibility to obtain exceptional authorization for the production, possession, transport, storage and supply of the raw materials and substances derived from Cannabis Sativa L varieties with a tetrahydrocannabinol (THC) content of more than 0.2%. Authorization may equally be obtained for the installation and operation of a processing and production unit of final products of medicinal cannabis for the sole purpose of either supplying the state monopoly in view of their disposal for medical purposes or their export. Implementing Ministerial Decision Δ3(γ)52588 Government Gazette Β 2840 2018 on the Terms and Requirements for the production and marketing of final products of medicinal cannabis, provides for the particular approval procedure applicable to the marketing authorization, as well as the export or import of final products of medicinal cannabis, Final products are strictly defined in Article 2 of said Ministerial Decision as a product containing as its sole active substance, for the indications specifically and restrictively provided in article 4 of the same, a derivative of Cannabis Sativa L varieties with a tetrahydrocannabinol (THC) content of more than 0.2%, falling within the scope of L. 4523/2018.
13. What are the regulatory authorities with jurisdiction over Medicinal Cannabis?
Par. 9 of article 2A Law 4139/2013 provides for the jurisdiction of EOF regarding all matters related to the production and marketing authorization of the final products of medicinal cannabis derived from Sativa L varieties with a tetrahydrocannabinol (THC) content of more than 0.2%. The Ministry of Health has general jurisdiction over narcotics by virtue of the same law, which makes it the competent authority as regards imports of medicinal cannabis.
14. What is the regulatory framework for the authorization, pricing, and reimbursement of Medicinal Cannabis?
Par. 9 of article 2A Law 4139/2013 provides for the application of all provisions relevant to the requirements and procedure of obtaining marketing authorization for pharmaceutical products in force as regards the production and marketing of medicinal cannabis; an implementing decision by the Minister of Health following an opinion by the President of EOF specifying marketing authorization requirements is announced by virtue of the same but still pending.
15. How is the production and import of Medicinal Cannabis regulated and by which agencies/authorities?
By virtue of article 1 of recent Law 4523/2018, article 2A has been introduced to Law 4139/2013 on Narcotics, providing for the possibility to obtain exceptional authorization for the production, possession, transport, storage and supply of the raw materials and substances derived from Cannabis Sativa L varieties with a tetrahydrocannabinol (THC) content of more than 0.2%. Authorization may equally be obtained for the installation and operation of a processing and production unit of final products of medicinal cannabis for the sole purpose of either supplying the state monopoly in view of their disposal for medical purposes or their export. Said authorization is provided by virtue of an Interministerial Decision by the Minister of Finance and Development, the Minister of Health and the Minister of Rural Development and Food. Implementing Ministerial Decision Δ3(γ)52588 Government Gazette Β 2840 2018 on the Terms and Requirements for the production and marketing of final products of medicinal cannabis, provides for the particular approval procedure applicable to the marketing authorization, as well as the export or import of final products of medicinal cannabis, Final products are strictly defined in Article 2 of said Ministerial Decision as a product containing as its sole active substance, for the indications specifically and restrictively provided in article 4 of the same, a derivative of Cannabis Sativa L varieties with a tetrahydrocannabinol (THC) content of more than 0.2%, falling within the scope of L. 4523/2018. All matters related to the production and marketing authorization of the final products of medicinal cannabis fall within the jurisdiction of EOF, while the Ministry of Health having general jurisdiction over narcotics is the competent authority as regards imports of medicinal cannabis.
16. What approval or notifications are necessary to produce or import Medicinal Cannabis?
Implementing Interministerial Decision 51483/700/Government Gazette Β 1692 2018 on the Terms and requirements of the cultivation and processing of medicinal cannabis, provides for the specific procedure of obtaining approval, encompassing all aspects of the processing and exploitation related to the product, i.e. the single authorization for the production, possession, transport, storage, supply of raw materials and the derivative substances of Cannabis Sativa L varieties with a tetrahydrocannabinol (THC) content of more than 0.2%, the production, the import and trade of propagating material, as well as the establishment and the operation of a processing and production unit with the exclusive purpose of either the supply of the state monopoly or the disposal of final products for medicinal purposes or their export.
In order to obtain approval for the establishment of a processing and production unit, the interested party first submits its answers to the questionnaire contained in Annex I of the Interministerial Decision to the Business and Business Parks Licensing Division of the General Secretariat of Industry of the Ministry of Finance and Development; the latter must, within three (3) working days, present the interested party with a list of documents among those listed in the Interministerial Decision, required in view of the establishment and the operation of the processing and production unit under examination. The single authorization is granted by virtue of an Interministerial Decision by the Minister of Finance and Development, the Minister of Health and the Minister of Rural Development and Food within thirty (30) days of the submission of the supporting file and is issued for a validity period of five (5) years. Within fifteen (15) days of the issuance of the authorization, an on-site control of the premises is held by the Business and Business Parks Licensing Division; in case of any deviations with respect to the questionnaire and the associated supporting file, a deadline is set for the unit operator to comply with requirements; in case compliance is not possible, the authorization is revoked. The documents compiled in the supporting file of the authorization must be updated annually and submitted by 31th December of each year following the issuance of the authorization and throughout its validity period.
The Public Security Division of the Hellenic Police Headquarters is competent for the supervision and coordination of all other Hellenic Police Departments as regards safety-related matters, of both unit installations and the transport of finished products.
17. What is the regulatory framework for the marketing and distribution of Medicinal Cannabis?
Par. 9 of article 2A Law 4139/2013 provides for the application of all provisions relevant to the requirements and procedure of obtaining marketing authorization for pharmaceutical products in force as regards the production and marketing of medicinal cannabis; the above-mentioned implementing Ministerial Decision Δ3(γ)52588 Government Gazette Β 2840 2018 on the Terms and Requirements for the production and marketing of final products of medicinal cannabis specifies marketing authorization requirements for final products of medicinal cannabis, as strictly defined therein.
18. How can patients obtain Medicinal Cannabis?
Patients may obtain Medicinal Cannabis following prescription by a Medical Doctor.
19. Who can prescribe Medicinal Cannabis?
No exception has been provided as regards the prescription of Medicinal Cannabis as opposed to medicines in general; no legal basis, therefore, exists for its prescription by any other than medical doctors.
20. Is there a list of doctors authorized to prescribe Medicinal Cannabis?
No list of doctors specifically authorized to prescribe Medicinal Cannabis has yet been created nor is such a prospect under examination to our knowledge.
21. What approvals or notifications are required to prescribe Medicinal Cannabis?
No approvals or notifications are required in order to prescribe Medicinal Cannabis; possession of a license to exercise the medical profession in Greece is the sole prerequisite, as is the case regarding all medicines marketed in Greece.
22. Where is Medicinal Cannabis available?
Medicinal Cannabis is only available through pharmacies, as are all prescription drugs under Greek law.
23. Is there a list of retailers authorized to sell Medicinal Cannabis?
No, Medicinal Cannabis is only available to the public through pharmacies.
24. Are there proposals for reform or significant change to the regulation of Medicinal Cannabis?
No specific proposals under examination have been announced, but the regulatory framework has plenty of scope to develop as the newly-adopted provisions relevant to the possibility of production, possession, transport, storage and supply of the raw materials and substances derived from Cannabis Sativa L varieties with a tetrahydrocannabinol (THC) content of more than 0.2%, as well as of production of final products based on the substance count no more than a few months’ implementation.
Opioid Drugs
25. Are Opioid Drugs authorized in your country?
Opioid Drugs are regarded as narcotics falling within the scope of Law 4139/2013. They may be prescribed either in the form of pharmaceutical preparations or proprietary medicinal products under the conditions and following the procedure provided by virtue of specific Decisions by the Minister of Health following an opinion by the Narcotics Board.
26. What are the regulatory authorities with jurisdiction over Opioid Drugs?
Opioid Drugs being classified as narcotics fall within the general jurisdiction of the Minister of Health for the supervision of the State Monopoly. Their prescription must respect the conditions set by virtue of specific decisions by the Minister of Health.
27. Is there a specific regulatory framework for the authorization, pricing, and reimbursement of Opioid Drugs?
All aspects relevant to the sale of narcotics, including Opioid Drugs, which is undertaken by the Special Drug Management Division of the Ministry of Health, are regulated by virtue of specific decisions by the Minister of Health. Narcotics may only be sold to pharmacies, hospitals, clinics and rural medical doctors, in regions lacking pharmacies, following approval by the Minister of Health with the consent of the Narcotics Board, specifying the exact maximum quantity per substance to be supplied annually, according to the needs of each of the above interested parties. Article 3 of Presidential Decree 148/2007 provides for the price of opium and that the retail price of State Monopoly Narcotics is set at this specific price plus 35% plus VAT. The sale price of the Narcotics belonging to the State Monopoly are set by virtue of a decision by the Minister of Health following an opinion by the Narcotics Board.
28. Which are the Opioid drugs that have received market approval to date?
Opioid Drugs having received market approval in Greece – not necessarily present in the Greek market today – include the following: ROMIDON/Relyo, ZIDERON/Norma (active substance: Dextropropoxyphene Hydrochloride), LONALGAL (active substances: Paracetamol – Codeine phosphate hemihydrate), LONARID-N (active substances: Paracetamol – Codeine phosphate hemihydrate – Caffeine), MONGOL, MORFICONTIN (active substance: Morphine sulfate), NALBUPHINE (active substance: Nalbuphine hydrochloride), TRAMAL, TROPIUM, VIBRALIS (active substance: Tramadol hydrochloride), ABSTRAL, BREAKYL, DEMOGYL, DOLFEN, DUROGESIC, EFFENTORA, FENTADUR, INSTANYL, VELLOFENT (active substance: Fentanyl citrate).
29. Who can prescribe Opioid Drugs?
As is the case of all medicines under Greek law, only Medical Doctors may prescribe Opioid Drugs.
30. Is there a list of doctors authorized to prescribe Opioid Drugs?
No list of doctors specifically authorized to prescribe Opioid Drugs exists.
31. What approvals or notifications are required to prescribe Opioid Drugs?
Opioid Drugs must in principle be prescribed and sold at the dosage specified by Greek Pharmacopoeia as issued by EOF, even if the relevant prescription indicates an increased dosage; in the latter case, specific approval for the execution of the specific prescription must be issued by the Minister of Health, following an opinion by the Narcotics Board.
32. Which organizations are authorized to sell/distribute Opioid Drugs available?
Opioid Drugs may only be sold / distributed by pharmacies, hospitals, clinics and rural medical doctors, in regions lacking pharmacies. Pharmaceutical preparations based on opium are exclusively manufactured by and sold through pharmacies.
33. Is there a list of retailers/distributors authorized to sell Opioid Drugs?
There is no list of retailers/distributors specifically authorized to sell Opioid Drugs; pharmacies may but are not obliged to obtain Opioid Drugs from the State Monopoly in view of selling those to the public.
34. Are there proposals for reform or significant change to the regulation of Opioid Drugs?
No specific proposals for reform as regards Opioid Drugs have been announced.
35. When are they likely to come into force?
N/A.
