Cannabinoid Drugs, Medicinal Cannabis and Opioid Drugs
Osterling Abogados / Peru
Key legal info on cannabinoid drugs, medicinal cannabis and opioid drugs in Greece. Prepared in association with Osterling Abogados, a leading global law firm, this is an extract from The Pharma Legal Handbook: Peru, available to purchase here for GBP 75.
Cannabinoid Drugs
1. Are Cannabinoid Drugs authorized in your country?
In our country, Cannabinoid Drugs are only allowed in the form of Medical Cannabis, for informed use, research, production, import and trade for medicinal and therapeutic purposes, as it is regulated by Law N°30681 and its Regulation. The possession, promotion, financing, export, import, production of Cannabinoid Drugs for other purposes is qualified as a crime, as indicated in our Criminal Regulation.
2. What are the regulatory authorities with jurisdiction over Cannabinoid Drugs?
The regulatory authorities with jurisdiction over Cannabinoid Drugs for medical and therapeutic purposes are the Ministry of Health through the General Direction of Medicines, Supplies, and Drugs (DIGEMID), and the National Health Institution (INS), and the Ministry of Agriculture and Irrigation through the National Service of Agricultural Sanity (SENASA) and the National Institute of Agriculture Innovation (INIA).
3. Is there a specific regulatory framework for the authorization, pricing, and reimbursement of Cannabinoid Drugs?
Law N° 360681 and its Regulation are the regulatory framework regarding Cannabinoid Drugs (Medical Cannabis). There is no regulation regarding its pricing and reimbursement.
4. Which are the cannabinoid drugs that have received market approval to date?
Only Medical Cannabis and its derivatives have received market approval.
5. Who can prescribe Cannabinoid Drugs?
Local Regulation indicates that only Medical Surgeons can prescribe Cannabinoid Drugs, and only, for medicinal and therapeutic purposes.
6. Is there a list of doctors authorized to prescribe Cannabinoid Drugs?
There is not an authorized list of doctors allowed to prescribe Cannabinoid Drugs.
7. What approvals or notifications are required to prescribe Cannabinoid Drugs?
Regarding production, a license, allowing for the acquisition of seeds and/or seedlings of Cannabis, planting, propagation, cultivation, harvest, post-harvest, and manufacture of Cannabis-derived products, as well as storage and transportation activities of seeds, seedlings, plants, flowers, and products derived from Cannabis for medicinal use, is required. In that regard, there are 3 type of licenses, one including farming, one not including farming and one including the production of seeds.
Regarding import, a commercialization and import license, previous compliance of the requirements established in the regulations of Law N° 30681, are required.
8. Which organizations are authorized to sell/distribute Cannabinoid Drugs available?
Any pharmaceutical establishment that has been granted a commercialization license, previous compliance of the requirements established in the regulations of Law N° 30681, are authorized to sell or distribute Cannabinoid Drugs for medical or therapeutic purposes, previous fulfilment of the conditions established in the Regulation of Pharmaceutical Establishments.
9. Is there a list of retailers/ distributors authorized to sell Cannabinoid Drugs?
There is a National Registry of Natural and Pharmaceutical Establishments, managed by DIGEMID, that are allowed to commercialize and/or import Cannabinoid Drugs and its derivatives.
10. Are there proposals for reform or significant change to the regulation of Cannabinoid Drugs?
In 2020, Bill 06532-2020-CR which aims to regulate the cultivation and processing of cannabis and its derivatives by patients and patient associations for exclusive medicinal and therapeutic use was filed.
This bill proposes that associations and natural persons that have a license to cultivate cannabis are exempted from criminal responsibility, as long as it is only for the exclusive use of a medical or therapeutic nature. For such purposes. Furthermore, it aims to modificate Law N° 360681 in order to permit self and associative cultivation.
11. When are they likely to come into force?
N/A
Medicinal Cannabis
12. Is Medicinal Cannabis authorized in the country?
Medical Cannabis is authorized for medicinal and therapeutic purposes, as it is indicated by Law N°30681 and its Regulation.
13. What are the regulatory authorities with jurisdiction over Medicinal Cannabis?
The Ministry of Heath through the General Direction of Medicines, Supplies, and Drugs (DIGEMID), and the National Health Institution (INS), and the Ministry of Agriculture and Irrigation through the National Service of Agricultural Sanity (SENASA) and the National Institute of Agriculture Innovation (INIA).
14. What is the regulatory framework for the authorization, pricing, and reimbursement of Medicinal Cannabis?
Law N° 360681 and its Regulation are the regulatory framework regarding Medical Cannabis. There is no regulation regarding its pricing and reimbursement.
15. How is the production and import of Medicinal Cannabis regulated and by which agencies/authorities?
The production and import of Medicinal Cannabis is regulated by Law N°30681 and its Regulation. The competent authority for the production is the Ministry of Health, through the General Direction of Medicines, Supplies, and Drugs (DIGEMID) and the National Health Institution (INS); and for the import is the Ministry of Agriculture and Irrigation through the National Service of Agricultural Sanity (SENASA) and the National Institute of Agriculture Innovation (INIA).
16. What approval or notifications are necessary to produce or import Medicinal Cannabis?
Regarding production, a license, allowing for the acquisition of seeds and/or seedlings of Cannabis, planting, propagation, cultivation, harvest, post-harvest, and manufacture of Cannabis-derived products, as well as storage and transportation activities of seeds, seedlings, plants, flowers, and products derived from Cannabis for medicinal use, is required. In the regard, there are 3 type of licenses, one including farming, one not including farming and one including the production of seeds.
Regarding import, a commercialization and import license, previous compliance of the requirements established in the regulations of Law N° 30681, is required.
17. What is the regulatory framework for the marketing and distribution of Medicinal Cannabis?
The regulatory framework of Medical Cannabis is regulated in Law N° 360681 and its Regulation.
18. How can patients obtain Medicinal Cannabis?
In order to acquire Medicinal Cannabis, any patient must be registered in the National Registry of Cannabis Patients. In order to be registered, the patient or his doctor must register the patient through a virtual affidavit in DIGEMID’s web page.
19. Who can prescribe Medicinal Cannabis?
Only Medical Surgeons can prescribe Medicinal Cannabis as it is indicated by article 21 of the Regulation of Law N°30681.
20. Is there a list of doctors authorized to prescribe Medicinal Cannabis?
There is no list of doctor authorized for prescribing Medicinal Cannabis.
21. What approvals or notifications are required to prescribe Medicinal Cannabis?
Only a Medical Surgeon can prescribe Medical Cannabis. Furthermore, a special recipe must be used in which identification information regarding both the patient and the doctor as well as information regarding the prescribed Cannabis according to the Regulation of Law N° 30681, must be consigned clearly and precisely, without leaving any blank space or amendments.
The receipt is valid for thirty (30) days.
22. Where is Medicinal Cannabis available?
Medicinal Cannabis is available in the pharmaceutical establishments, laboratories and drugstores that are certified and authorized by DIGEMID.
23. Is there a list of retailers authorized to sell Medicinal Cannabis?
There is a National Registry of Natural and Pharmaceutical Establishments managed by DIGEMID that are allowed to commercialize and/or import Cannabinoid Drugs and its derivatives.
24. Are there proposals for reform or significant change to the regulation of Medicinal Cannabis?
In 2020, Bill 06532-2020-CR which aims to regulate the cultivation and processing of cannabis and its derivatives by patients and patient associations for exclusive medicinal and therapeutic use was filed.
This bill proposes that associations and natural persons that have a license to cultivate cannabis are exempted from criminal responsibility, as long as it is only for the exclusive use of a medical or therapeutic nature. For such purposes. Furthermore, it aims to modificate Law N° 360681 in order to permit self and associative cultivation.
Opioid Drugs
25. Are Opioid Drugs authorized in your country?
The fabrication, import, export, commercialization, storing and distribution of Opioid Drugs as pharmaceutical products is authorized in our country.
26. What are the regulatory authorities with jurisdiction over Opioid Drugs?
The Ministry of Heath through the General Direction of Medicines, Supplies, and Drugs (DIGEMID), and the National Health Institution (INS) is the regulatory authority over Opioid Drugs.
27. Is there a specific regulatory framework for the authorization, pricing, and reimbursement of Opioid Drugs?
There is no specific regulatory framework for the authorization of Opioid Drugs since they are regulated as pharmaceutical products by Law N° 29459, Law of the Pharmaceutical Products, Medical Devices and Sanitary Products and its Regulations, Supreme Decree N° 16-2011-SA, Regulation for Registration, Control and Sanitary Vigilance of Pharmaceutical Products, Medical Devices and Sanitary Products and Supreme Decree N° 14-2011-SA, Regulation of Pharmaceutical Establishments.
28. Which are the Opioid drugs that have received market approval to date?
There is no list of Opioid drugs that have received market approval.
29. Who can prescribe Opioid Drugs?
Any medical professional that can prescribe pharmaceutical products can prescribe Opioid Drugs.
30. Is there a list of doctors authorized to prescribe Opioid Drugs?
There is no list of doctors authorized to prescribe Opioid Drugs.
31. What approvals or notifications are required to prescribe Opioid Drugs?
The only requirement to prescribe Opioid Drugs is to be a medical professional.
32. Which organizations are authorized to sell/distribute Opioid Drugs available?
Pharmaceutical Establishments are authorized to sell/distribute Opioid Drugs.
33. Is there a list of retailers/ distributors authorized to sell Opioid Drugs?
There is no list of retailers/distributors authorized to sell Opioid Drugs since the only requirement is to be registered as a Pharmaceutical Establishment.
34. Are there proposals for reform or significant change to the regulation of Opioid Drugs?
There are no proposals to reform or significantly change current regulation.
35. When are they likely to come into force?
N/A
