Cannabinoid Drugs, Medicinal Cannabis and Opioid Drugs
Cannabinoid drugs, medicinal cannabis and opioid drugs in Saudi Arabia – a comprehensive legal overview.. Prepared in association with STA, an international law firm, this is an extract from The Pharma Legal Handbook: Saudi Arabia, available to purchase here for GBP 99.
1. Are Cannabinoid Drugs authorized in your country?
Cannabinoid Drugs are not authorized in Saudi Arabia.
2. What are the regulatory authorities with jurisdiction over Cannabinoid Drugs?
The concerned authorities are the Saudi FDA and the Saudi Customs Authority.
3. Is there a specific regulatory framework for the authorization, pricing, and reimbursement of Cannabinoid Drugs?
There is no regulation on cannabinoids.
4. Which are the cannabinoid drugs that have received market approval to date?
5. Who can prescribe Cannabinoid Drugs?
Not legally permissible.
6. Is there a list of doctors authorized to prescribe Cannabinoid Drugs?
7. What approvals or notifications are required to prescribe Cannabinoid Drugs?
Approvals are not given.
8. Which organizations are authorized to sell/distribute Cannabinoid Drugs available?
No authorized distributers or resellers within Saudi Arabia.
9. Is there a list of retailers/distributors authorized to sell Cannabinoid Drugs?
No, retailers and distributers are not authorized to sell cannabinoid drugs in Saudi Arabia.
10. Are there proposals for reform or significant change to the regulation of Cannabinoid Drugs?
Not as of present.
11. When are they likely to come into force?
Not known, Indefinite.
12. Is Medicinal Cannabis authorized in the country?
No, it is not authorized in Saudi Arabia.
13. What are the regulatory authorities with jurisdiction over Medicinal Cannabis?
There are none owing to its illegality in Saudi Arabia.
14. What is the regulatory framework for the authorization, pricing, and reimbursement of Medicinal Cannabis?
The authorization, pricing, and reimbursement of Medicinal Cannabis is not applicable in Saudi Arabia, as it is considered to be illegal in all its forms.
15. How is the production and import of Medicinal Cannabis regulated and by which agencies/authorities?
There is no production regulation.
16. What approval or notifications are necessary to produce or import Medicinal Cannabis?
17. What is the regulatory framework for the marketing and distribution of Medicinal Cannabis?
18. How can patients obtain Medicinal Cannabis?
19. Who can prescribe Medicinal Cannabis?
20. Is there a list of doctors authorized to prescribe Medicinal Cannabis?
There isn’t a formulated list for the same.
21. What approvals or notifications are required to prescribe Medicinal Cannabis?
22. Where is Medicinal Cannabis available?
23. Is there a list of retailers authorized to sell Medicinal Cannabis?
24. Are there proposals for reform or significant change to the regulation of Medicinal Cannabis?
25. Are Opioid Drugs authorized in your country?
Prescribed opioids may be permitted under the below mentioned:
Article (5): Clearance of Pharmaceutical Products for Personal Use
- It is illegal to import drugs or medical materials that are banned in Saudi Arabia or internationally.
- It is illegal to import drugs listed in Table 1 in Schedule D and Table 2 in Schedule A, as well as items listed in Article (4) of the Drugs and Narcotics Control Law (found at the website of the Saudi Food and Drug Authority.
- Request to import prescription drugs must be filed with the branch of the Saudi Food and Drug Authority at the port of entry to which the drugs will arrive.
- Drugs that are for personal use will be cleared for import into the Kingdom of Saudi Arabia provided the following conditions are met:
a. The prescription medications in question must be accompanied either:
+ Recent medical report (less than six months old) issued by the patient’s medical care provider and clearly stating the following:
- personal information of the patient.
- medical diagnosis;
- treatment plan;
- medical recommendations;
- generic name of the prescription drugs, dosage and dosage form;
+ A doctor’s prescription (less than six months old) in the name of the patient with the following information:
- medical diagnosis;
- generic name of the prescription drug, dosage and dosage form;
- drug usage instructions and prescribed duration of use; and
- official seal of the health care provider.
b. The person importing the prescription medications will be held personally responsible for its lawful use and agrees to limit its usage to the intended patient only.
c. Copy of patient identification document.
5. The amount of allowable prescription medicine to be cleared for import shall for the duration of the visit or one month’s supply, whichever is shorter. The prescription medications must remain valid for use during the clearance period and satisfy the following conditions:
a. In case the quantity of the cleared prescription medications were used up while the patient is in the Kingdom, he/she should visit a physician in a licensed medical facility to verify his/her need to continue on the same drug.
b. Should the physician confirm such need, a medical file for the patient should be opened at the medical facility before a prescription can be issued. The prescribed drug must then be dispensed by a local pharmacy, if available. This same procedure must be followed every time the patient’s condition requires medication.
c. If the prescription medications or its medically acceptable replacement is not available in the local market, the medical facility prescribing the medication may request permission from the Saudi Food and Drug Authority to import the medication from a pharmaceutical distributor.
6. If the prescription medication is used through injection, the clearance process should be completed on behalf of the patient by and under the supervision of a local medical institution. The cleared prescription medications should then be registered in the record of the medical institution for personal use in accordance with its medication management policy.
7. Should the quantity of the cleared medication exceed the medical need of the patient, unused medication must be disposed of in a proper manner.
8. With the exception of the conditions provided for under subsections (a), (b) and (c) of Sections (5) and (6), all other conditions shall similarly apply to those patients who are travelling outside the Kingdom of Saudi Arabia.
9. If the prescription drug is in the possession of someone other than the patient (spouse, parents, children, or siblings) a copy of that person’s identification must be submitted with the clearance application. However, if that person is not a relative he/she must submit a document showing patient’s consent or authorization for him/her to handle the patient’s medications along with a copy of his/her identification.
26. What are the regulatory authorities with jurisdiction over Opioid Drugs?
The regulatory bodies under concern are the Saudi FDA, Ministry of Health and the Saudi Ministry of Customs.
27. Is there a specific regulatory framework for the authorization, pricing, and reimbursement of Opioid Drugs?
Yes, there is specific regulatory framework for the authorization, pricing, and reimbursement of Opioid Drugs.
28. Which are the Opioid drugs that have received market approval to date?
Controlled medications refer to a group of medications that besides being internationally recognized scheduled drugs, includes other psychoactive drugs as defined by the Saudi Ministry of Health regulations.
Consultants, assistants, dentists, and fellows may prescribe controlled medications, only if the use of such drugs falls under their area of specialization or patient management.
- Residents.may initiate new or discharge orders, but they must write the attending consultant’s name and ID next to their signatures. Consultants must countersign such orders within 24 hours.
- Residents may renew or alter prescriptions initially written by consultants, assistants, or fellows for adjustments in dose or frequency based on clinical status of the patient.
- A maximum 90-day supply of controlled medications may be dispensed at any one time. The total quantity to be dispensed must not exceed the medically recommended maximum daily dose for 90 days. For Emergency Room patients, a maximum of 30 individual units or liquid doses shall be dispensed.
- Physicians are not to prescribe narcotics or controlled medications for self or direct family use but have to utilize family health or routine clinic system for such medications. All such prescriptions must be noted in the individual medical charts.
- Emergency clinic prescriptions for new patients without KFSH number/addressograph must have on the back of the prescription, the patient’s full name, address, and his national ID/lqama or passport number.
High-Alert medications are drugs that have a heightened risk of causing significant patient harm when they are used in error. Although mistakes may or may not be more common with these drugs, the consequences of an error are clearly more devastating to patients. High Alert meds have a higher risk of causing injectionury, either as a result of a narrow therapeutic range or due to a high incidence of reported serious errors. Methods to reduce error include strategies such as improving access to information about these drugs; limiting access to High-Alert medications; using Tallman lettering, using auxiliary labels and automated alerts; standardizing the ordering, storage, preparation, and administration of these products; and employing redundancies such as automated or independent double checks when necessary. New formulary medications and additional relevant safety information will be reviewed for inclusion on the High-Alert Medication list by the Pharmacy and Therapeutics committee.
The MOH Pharmacy and Therapeutics Committee, with the input of the Medication Safety Committee, has reviewed the formulary and trend analysis of medication errors to determine a list of High-Risk/High Alert medications. The primary objective is to provide the highest quality pharmaceutical care with the minimum number of medication errors and the lowest potential for patient risk. The primary goal is to promote the fact that medication safety should be a critical component in any hospital’s overall strategic plan. The tool also provides guidance for how to incorporate medication safety into the strategic planning process.
29. Who can prescribe Opioid Drugs?
Authorized practitioners may prescribe ‘opioids’ under the ambit of Saudi Law.
30. Is there a list of doctors authorized to prescribe Opioid Drugs?
Yes, there is a list of licensed doctors permitted to authorize the prescription of such drugs.
31. What approvals or notifications are required to prescribe Opioid Drugs?
The approval process has been elucidated above.
32. Which organizations are authorized to sell/distribute Opioid Drugs available?
Only government entities and government licensed entities may distribute such drugs.
33. Is there a list of retailers/distributors authorized to sell Opioid Drugs?
There isn’t an extensive list of distributors, especially in the retail space, as such medicines/ drugs are highly controlled.
34. Are there proposals for reform or significant change to the regulation of Opioid Drugs?
Yes, there are proposals to bring about change to the space on controlled medicines, however, the timeline or executionary means to its implementation are yet to be known.
35. When are they likely to come into force?
Currently unknown, indefinite.