Legal & Regulatory > Egypt > Cannabinoid Drugs, Medicinal Cannabis and Opioid Drugs

Cannabinoid drugs, medicinal cannabis and opioid drugs in Egypt – an overview. Prepared in association with Youssry Saleh Law Firm, a leading global law firm, this is an extract from The Pharma Legal Handbook: Egypt, available to purchase here for GBP 75.

Cannabinoid Drugs

1. Are Cannabinoid Drugs authorized in your country?

No, Cannabinoid Drugs are not authorized in Egypt, however, they are regulated by Law No. 182 of the year 1960 concerning combating drugs and regulating their use and trafficking.

2. What are the regulatory authorities with jurisdiction over Cannabinoid Drugs?

Ministry of Health and its departments, Addiction Control and Treatment Fund Organization and Egyptian Drug Authority.

3. Is there a specific regulatory framework for the authorization, pricing, and reimbursement of Cannabinoid Drugs?

With regards the Pricing:

Pricing of drugs is regulated through a pricing committee. Any price increases of the medicines and drug products are determined according to issued Ministerial Decrees.

Regarding the Reimbursement:

MOHP’s facilities and Health Insurance Organizations follow the reimbursement process provided by MOHP. There are other institutions or ministry-affiliated public facilities follow MOHP regulations but have their own budget and autonomy.

With regards the Authorization:

As per Article 4 of the said Law, the authorization of the drugs referred to above may be granted only to the following persons:

1. Managers of stores licensed to trade in narcotic drugs.
2. Administrators of pharmacies or shops intended for the manufacture of Pharmacopoeia preparations.
3. Managers of chemical or industrial analysis laboratories or scientific research.
4. Some of the Governmental entities and recognized scientific institutes.

The competent administrative authority may refuse the request for permission or reduce the required quantity.

The application shall indicate the name of the applicant, his work address, the full name of the substance, the nature of the drug, the quantity he wants to bring or export, along with the reasons that justify the import or export, as well as other data requested by the competent administrative authority.

Article 3 of the said Law, these drugs may not be brought or exported except under a written license from the competent administrative authority.

Moreover, Article 7 provides that the narcotic drugs may not be traded except after obtaining a license from the competent administrative authority in each of the two regions.

This license may not be granted to:

1. Person convicted of a felony.
2. Person convicted of one of the misdemeanours stipulated in this Law.
3. Person convicted of stealing or concealing stolen items, dishonesty, monument, giving a check without credit, falsifying or using forged papers, perjury or indecent assault, corrupting morals, homelessness or suspicion, as well as the convict for attempting to provide for one of these crimes.
4. Persons previously disciplined from public office for reasons of moral turpitude, unless three years have elapsed from the date of the final dismissal.

As per Article 8, it is not permitted to trade in narcotic drugs except in stores or warehouses in the cities of the governorates, the capitals of the districts and the rules of the regions and centres therein, except the governorates and the border centres. In such places, the conditions stipulated by a decision of the competent minister shall be met.

The warehouse shall not have a common entrance door with a dwelling, a medical clinic, an analytical laboratory, a commercial or industrial shop or any other place, nor shall it have any outlets related to any such thing. However, trafficking in narcotic drugs may be combined with trafficking in toxic substances in a single warehouse or warehouses.

Moreover, Article 9 stated that the applicant for the license shall submit to the competent administrative authority an application containing the data to be issued by a decision of the competent minister, accompanied by the papers and drawings concerned in that decision.

With regards the authorization for manufacturing:

It shall not be permissible in the pharmaceutical industry to make preparations containing narcotic drugs, except after obtaining the license provided for in Article 7 mentioned above. These factories shall not use its narcotic substances except in manufacturing its formulations which it produce and it shall follow the provisions of Articles 12 and 13 with regard to what it receives from the narcotic substances and the provisions of Articles 11, 12 and 13 with regard to what it produce from medical formulations which interfere in its composition one of the narcotic substances in any ratio.

With regards the pricing and reimbursement:

As per Articles 2 and 3 of Law N.499 for year 2012, the manufacturer apply to the competent administrative authority with the Medicinal product, and this Medicinal product will be discussed by the specialized panel.

4. Which are the cannabinoid drugs that have received market approval to date?

According to Table No. 2 of the Law No. 182 of the year 1960, the medicinal products based on cannabis extract or tincture that are for the outside use only have market approvals. Unlike all the drugs mentioned in Table No. 1, of the Law No. 182 of the year 1960, which are forbidden to produce, extract, or isolate any of the components mentioned in Table No. 1, including without limitation to the following:

a. Cannabis

1. All kinds and names such as kanmuja, banjo, marijuana, or any other names that may be called, produced, prepared or extracted from fruits, leaves, stems, roots or resin of the cannabis plant, its flowers or leaves, galenic lotions for cannabis (extract or dye).
2. Preparations based on cannabis extract or tincture.
3. Cannabis resin preparations (all preparations containing the active cannabis element, resin in any proportion).
4. Plant extract or any part of it such as cannabis oil.
5. Powders consisting of all or some parts of cannabis plants such as cannabis powder or in any other mixture.
6. Tunges resulting from the plant, whether in the form of pure or in the form of a mixture of any kind.

b. Classical cannabinoids. Dibenzopyran.

5. Who can prescribe Cannabinoid Drugs?

As per Articles 11 and 19 of the mentioned Law, managers of stores licensed to trade in such drugs may not sell, waive or dispose of such drugs in any capacity except to the following persons:

1. Managers of authorized stores in this trade.
2. Directors of pharmacies and pharmaceutical factories;
3. The directors of pharmacies of hospitals, clinics and dispensaries if they are pharmacists.

They may also sell, waive or relinquish these drugs under the license cards provided for in Article 19 to the following persons:

1. Doctors designated by hospitals, clinics and dispensaries without pharmacists.
2. Managers of chemical and industrial analysis laboratories and scientific research.
3. The interests of the Government and recognized scientific institutes.

And as per Article 19, pharmacies may dispose of such drugs under the license cards provided for the following persons:

1. Physicians, veterinarians and dentists with a diploma or a bachelor’s degree.
2. Physicians assigned by hospitals, clinics and dispensaries without pharmacists.

6. Is there a list of doctors authorized to prescribe Cannabinoid Drugs?

As per Articles 11 and 19 of the mentioned Law, managers of stores licensed to trade in such drugs may not sell, waive or dispose of such drugs in any capacity except to the following persons:

1. Managers of authorized stores in this trade.
2. Directors of pharmacies and pharmaceutical factories;
3. The directors of pharmacies of hospitals, clinics and dispensaries if they are pharmacists.

They may also sell, waive or relinquish these drugs under the license cards provided for in Article 19 to the following persons:

1. Doctors designated by hospitals, clinics and dispensaries without pharmacists.
2. Managers of chemical and industrial analysis laboratories and scientific research.
3. The interests of the Government and recognized scientific institutes.

And as per Article 19, pharmacies may dispose of such drugs under the license cards provided for the following persons:

1. Physicians, veterinarians and dentists with a diploma or a bachelor’s degree.
2. Physicians assigned by hospitals, clinics and dispensaries without pharmacists.

7. What approvals or notifications are required to prescribe Cannabinoid Drugs?

Articles 14 and 15 specifically provided that the pharmacists shall not disburse the narcotic substances except by a medical prescription from a doctor or dentist who holds a diploma or bachelor or by license card in accordance with the following provisions:

Prohibited for those to disbursed narcotic substances by a medical tickets if the quantity recorded in it is more than the quantity prescribed in Table (4), however if the patient’s condition necessitated the increase of such quantities so the doctor shall request a license card for these quantities for this purpose.

Moreover, Pharmacists shall not disburse medical tickets, which contain narcotic substances after five days from editing it. The competent minister shall issue a decision by the data and conditions needed to be provided in editing the medical tickets which disbursed by it the narcotic substances from the pharmacies with the exception of the pharmacies of the hospitals and clinics and dispensaries and the tickets which disbursed from the books stamped by the stamp of the competent administrative party delivered with the prices which determined by that party and its price shall not exceed two hundred penny for the single book, and the competent minister may determine the quantities which cannot exceed disbursing it for each patient per month

8. Which organizations are authorized to sell/distribute Cannabinoid Drugs available?

As per Articles 11 and 19 of the mentioned Law, managers of stores licensed to trade in such drugs may not sell, waive or dispose of such drugs in any capacity except to the following persons:

1. Managers of authorized stores in this trade.
2. Directors of pharmacies and pharmaceutical factories;
3. The directors of pharmacies of hospitals, clinics and dispensaries if they are pharmacists.

They may also sell, waive or relinquish these drugs under the license cards provided for in Article 19 to the following persons:

1. Doctors designated by hospitals, clinics and dispensaries without pharmacists.
2. Managers of chemical and industrial analysis laboratories and scientific research.
3. The interests of the Government and recognized scientific institutes.

And as per Article 19, pharmacies may dispose of such drugs under the license cards provided for the following persons:

1. Physicians, veterinarians and dentists with a diploma or a bachelor’s degree.
2. Physicians assigned by hospitals, clinics and dispensaries without pharmacists.

9. Is there a list of retailers/distributors authorized to sell Cannabinoid Drugs?

As per Articles 11 and 19 of the mentioned Law, managers of stores licensed to trade in such drugs may not sell, waive or dispose of such drugs in any capacity except to the following persons:

1. Managers of authorized stores in this trade.
2. Directors of pharmacies and pharmaceutical factories;
3. The directors of pharmacies of hospitals, clinics and dispensaries if they are pharmacists.

They may also sell, waive or relinquish these drugs under the license cards provided for in Article 19 to the following persons:

1. Doctors designated by hospitals, clinics and dispensaries without pharmacists.
2. Managers of chemical and industrial analysis laboratories and scientific research.
3. The interests of the Government and recognized scientific institutes.

And as per Article 19, pharmacies may dispose of such drugs under the license cards provided for the following persons:

1. Physicians, veterinarians and dentists with a diploma or a bachelor’s degree.
2. Physicians assigned by hospitals, clinics and dispensaries without pharmacists.

10. Are there proposals for reform or significant change to the regulation of Cannabinoid Drugs?

No.

11. When are they likely to come into force?

N/A.

Medicinal Cannabis

12. Is Medicinal Cannabis authorized in the country?

No, Medicinal Cannabis is not authorized in Egypt, however, they are regulated by Law No. 182 of the year 1960 concerning combating drugs and regulating their use and trafficking.

13. What are the regulatory authorities with jurisdiction over Medicinal Cannabis?

Ministry of Health and its departments, Addiction Control and Treatment Fund Organization and Egyptian Drug Authority.

14. What is the regulatory framework for the authorization, pricing, and reimbursement of Medicinal Cannabis?

With regards the Authorization:

As per Article 4 of the said Law, the authorization of the drugs referred to above may be granted only to the following persons:

1. Managers of stores licensed to trade in narcotic drugs.
2. Administrators of pharmacies or shops intended for the manufacture of Pharmacopoeia preparations.
3. Managers of chemical or industrial analysis laboratories or scientific research.
4. Some of the Governmental entities and recognized scientific institutes.

The competent administrative authority may refuse the request for permission or reduce the required quantity.

The application shall indicate the name of the applicant, his work address, the full name of the substance, the nature of the drug, the quantity he wants to bring or export, along with the reasons that justify the import or export, as well as other data requested by the competent administrative authority.

Article 3 of the said Law, these drugs may not be brought or exported except under a written license from the competent administrative authority.

Moreover, Article 7 provided that the narcotic drugs may not be traded except after obtaining a license from the competent administrative authority in each of the two regions.

This license may not be granted to:

1. Person convicted of a felony.
2. Person convicted of one of the misdemeanours stipulated in this Law.
3. Person convicted of stealing or concealing stolen items, dishonesty, monument, giving a check without credit, falsifying or using forged papers, perjury or indecent assault, corrupting morals, homelessness or suspicion, as well as the convict for attempting to provide for one of these crimes.
4. Persons previously disciplined from public office for reasons of moral turpitude, unless three years have elapsed from the date of the final dismissal.

As per Article 8, it is not permitted to trade in narcotic drugs except in stores or warehouses in the cities of the governorates, the capitals of the districts and the rules of the regions and centres therein, except the governorates and the border centres. In such places, the conditions stipulated by a decision of the competent minister shall be met.

The warehouse shall not have a common entrance door with a dwelling, a medical clinic, an analytical laboratory, a commercial or industrial shop or any other place, nor shall it have any outlets related to any such thing. However, trafficking in narcotic drugs may be combined with trafficking in toxic substances in a single warehouse or warehouses.

Moreover, Article 9 stated that the applicant for the license shall submit to the competent administrative authority an application containing the data to be issued by a decision of the competent minister, accompanied by the papers and drawings concerned in that decision.

With regards the authorization for manufacturing:

It shall not be permissible in the pharmaceutical industry to make preparations containing narcotic drugs, except after obtaining the license provided for in Article 7 mentioned above. These factories shall not use its narcotic substances except in manufacturing its formulations which it produce and it shall follow the provisions of Articles 12 and 13 with regard to what it receives from the narcotic substances and the provisions of Articles 11, 12 and 13 with regard to what it produce from medical formulations which interfere in its composition one of the narcotic substances in any ratio.

With regards the pricing and reimbursement:

As per Articles 2 and 3 of Law N.499 for year 2012, the manufacturer apply to the competent administrative authority with the Medicinal product, and this Medicinal product will be discussed by the specialized panel.

15. How is the production and import of Medicinal Cannabis regulated and by which agencies/authorities?

With regards importing:

As per Article 4 of the said Law, the authorization of the drugs referred to above may be granted only to the following persons:

1. Managers of stores licensed to trade in narcotic drugs.
2. Administrators of pharmacies or shops intended for the manufacture of Pharmacopoeia preparations.
3. Managers of chemical or industrial analysis laboratories or scientific research.
4. Some of the Governmental entities and recognized scientific institutes.

The competent administrative authority may refuse the request for permission or reduce the required quantity.

The application shall indicate the name of the applicant, his work address, the full name of the substance, the nature of the drug, the quantity he wants to bring or export, along with the reasons that justify the import or export, as well as other data requested by the competent administrative authority.

Article 3 of the said Law; these drugs may not be brought or exported except under a written license from the competent administrative authority.

With regards production:

It shall not be permissible in the pharmaceutical industry to make preparations containing narcotic drugs, except after obtaining the license provided for in Article 7 mentioned above. These factories shall not use its narcotic substances except in manufacturing its formulations which it produce and it shall follow the provisions of Articles 12 and 13 with regard to what it receives from the narcotic substances and the provisions of Articles 11, 12 and 13 with regard to what it produce from medical formulations which interfere in its composition one of the narcotic substances in any ratio.

16. What approval or notifications are necessary to produce or import Medicinal Cannabis?

With regards importing and trading, Article 3 provided that it is prohibited to bring narcotic substances or export it except by a written license from the competent administrative party. Prohibited to bring narcotic substances or export it except by a written license from the competent administrative party.

Article 7 provided that the narcotic substances may not be traded except after obtaining a license from the competent administrative authority in each of the two regions.

Moreover, it is mentioned in Articles 5 and 6 that the narcotic substances, which reach to the customs, shall not be delivered except by written permission to withdraw given by the competent administrative party to the licensee to bring or to the one who replaces him in his work. The customs department in the cases of bringing or exporting shall receive the permission to withdraw from the stakeholders and return it to the competent administrative party. It is not permitted to bring narcotic substances or export it or transport it in packages containing other substances and it shall be delivered (even as a sample) in insured packages, and shown on it the full name of the narcotic substances and its nature, quantity and ratio.

17. What is the regulatory framework for the marketing and distribution of Medicinal Cannabis?

As per Articles 11 and 19 of the mentioned Law, managers of stores licensed to trade in such drugs may not sell, waive or dispose of such drugs in any capacity except to the following persons:

1. Managers of authorized stores in this trade.
2. Directors of pharmacies and pharmaceutical factories;
3. The directors of pharmacies of hospitals, clinics and dispensaries if they are pharmacists.

They may also sell, waive or relinquish these drugs under the license cards provided for in Article 19 to the following persons:

1. Doctors designated by hospitals, clinics and dispensaries without pharmacists.
2. Managers of chemical and industrial analysis laboratories and scientific research.
3. The interests of the Government and recognized scientific institutes.

And as per Article 19, pharmacies may dispose of such drugs under the license cards provided for to the following persons:

1. Physicians, veterinarians and dentists with a diploma or a bachelor’s degree.
2. Physicians assigned by hospitals, clinics and dispensaries without pharmacists.

18. How can patients obtain Medicinal Cannabis?

Articles 14, 15, 16 and 17 specifically provided that the pharmacists shall not disburse the narcotic substances except by a medical prescription from a doctor or dentist who holds a diploma or bachelor or by license card in accordance with the following provisions:

Prohibited for those to disbursed narcotic substances by a medical tickets if the quantity recorded in it is more than the quantity prescribed in Table (4), however if the patient’s condition necessitated the increase of such quantities so the doctor shall request a license card for these quantities for this purpose.

Moreover, Pharmacists shall not disburse medical tickets, which contain narcotic substances after five days from editing it. The competent minister shall issue a decision by the data and conditions needed to be provided in editing the medical tickets by means of which the narcotic substances are being disbursed by it from the pharmacies with the exception of the pharmacies of the hospitals and clinics and dispensaries and the tickets which are disbursed from the books stamped by the stamp of the competent administrative party delivered with the prices determined by that party and its price shall not exceed two hundred penny. The competent minister may determine the quantities, which cannot be exceeded in disbursing for each patient per month. The medical tickets which contains narcotic substances shall not be replayed to its holder and prohibited to use more than once and it must be kept in the pharmacy and shows on it the date of disbursing the medicine and its registration number in the book of registering the medical tickets and its holder may request from the pharmacy to deliver him a copy of the ticket stamped by its seal and its prohibited to use the copy in obtaining narcotic substances or medicines that contains these substances.

19. Who can prescribe Medicinal Cannabis?

As per Articles 11 and 19 of the mentioned Law, managers of stores licensed to trade in such drugs may not sell, waive or dispose of such drugs in any capacity except to the following persons:

1. Managers of authorized stores in this trade.
2. Directors of pharmacies and pharmaceutical factories;
3. The directors of pharmacies of hospitals, clinics and dispensaries if they are pharmacists.

They may also sell, waive or relinquish these drugs under the license cards provided for in Article 19 to the following persons:

1. Doctors designated by hospitals, clinics and dispensaries without pharmacists.
2. Managers of chemical and industrial analysis laboratories and scientific research.
3. The interests of the Government and recognized scientific institutes.

And as per Article 19, pharmacies may dispose of such drugs under the license cards provided for the following persons:

1. Physicians, veterinarians and dentists with a diploma or a bachelor’s degree.
2. Physicians assigned by hospitals, clinics and dispensaries without pharmacists.

20. Is there a list of doctors authorized to prescribe Medicinal Cannabis?

As per Articles 11 and 19 of the mentioned Law, managers of stores licensed to trade in such drugs may not sell, waive or dispose of such drugs in any capacity except to the following persons:

1. Managers of authorized stores in this trade.
2. Directors of pharmacies and pharmaceutical factories;
3. The directors of pharmacies of hospitals, clinics and dispensaries if they are pharmacists.

They may also sell, waive or relinquish these drugs under the license cards provided for in Article 19 to the following persons:

1. Doctors designated by hospitals, clinics and dispensaries without pharmacists.
2. Managers of chemical and industrial analysis laboratories and scientific research.
3. The interests of the Government and recognized scientific institutes.

And as per Article 19, pharmacies may dispose of such drugs under the license cards provided for the following persons:

1. Physicians, veterinarians and dentists with a diploma or a bachelor’s degree.
2. Physicians assigned by hospitals, clinics and dispensaries without pharmacists.

21. What approvals or notifications are required to prescribe Medicinal Cannabis?

Articles 14 and 15 specifically provided that the pharmacists shall not disburse the narcotic substances except by a medical prescription from a doctor or dentist who holds a diploma or bachelor or by license card in accordance with the following provisions:

Prohibited for those to disbursed narcotic substances by a medical tickets if the quantity recorded in it is more than the quantity prescribed in Table (4), however if the patient’s condition necessitated the increase of such quantities so the doctor shall request a license card for these quantities for this purpose.

Moreover, Pharmacists shall not disburse medical tickets, which contain narcotic substances after five days from editing it. The competent minister shall issue a decision by the data and conditions needed to be provided in editing the medical tickets by means of which the narcotic substances are being disbursed by it from the pharmacies with the exception of the pharmacies of the hospitals and clinics and dispensaries and the tickets which are disbursed from the books stamped by the stamp of the competent administrative party delivered with the prices determined by that party and its price shall not exceed two hundred penny. The competent minister may determine the quantities, which cannot be exceeded in disbursing for each patient per month.

22. Where is Medicinal Cannabis available?

As per Articles 11 and 19 of the mentioned Law, managers of stores licensed to trade in such drugs may not sell, waive or dispose of such drugs in any capacity except to the following persons:

1. Managers of authorized stores in this trade.
2. Directors of pharmacies and pharmaceutical factories;
3. The directors of pharmacies of hospitals, clinics and dispensaries if they are pharmacists.

They may also sell, waive or relinquish these drugs under the license cards provided for in Article 19 to the following persons:

1. Doctors designated by hospitals, clinics and dispensaries without pharmacists.
2. Managers of chemical and industrial analysis laboratories and scientific research.
3. The interests of the Government and recognized scientific institutes.

And as per Article 19, pharmacies may dispose of such drugs under the license cards provided for to the following persons:

1. Physicians, veterinarians and dentists with a diploma or a bachelor’s degree.
2. Physicians assigned by hospitals, clinics and dispensaries without pharmacists.

23. Is there a list of retailers authorized to sell Medicinal Cannabis?

As per Articles 11 and 19 of the mentioned Law, managers of stores licensed to trade in such drugs may not sell, waive or dispose of such drugs in any capacity except to the following persons:

1. Managers of authorized stores in this trade.
2. Directors of pharmacies and pharmaceutical factories;
3. The directors of pharmacies of hospitals, clinics and dispensaries if they are pharmacists.

They may also sell, waive or relinquish these drugs under the license cards provided for in Article 19 to the following persons:

1. Doctors designated by hospitals, clinics and dispensaries without pharmacists.
2. Managers of chemical and industrial analysis laboratories and scientific research.
3. The interests of the Government and recognized scientific institutes.

And as per Article 19, pharmacies may dispose of such drugs under the license cards provided for the following persons:

1. Physicians, veterinarians and dentists with a diploma or a bachelor’s degree.
2. Physicians assigned by hospitals, clinics and dispensaries without pharmacists.

24. Are there proposals for reform or significant change to the regulation of Medicinal Cannabis?

No.

Opioid Drugs

25. Are Opioid Drugs authorized in your country?

No, Opioid Drugs are not authorized in Egypt, however, they are regulated by Law No. 182 of the year 1960 concerning combating drugs and regulating their use and trafficking.

26. What are the regulatory authorities with jurisdiction over Opioid Drugs?

Ministry of Health and its departments, Addiction Control and Treatment Fund Organization and Egyptian Drug Authority.

27. Is there a specific regulatory framework for the authorization, pricing, and reimbursement of Opioid Drugs?

With regards the Pricing:

Pricing of drugs is regulated through a pricing committee. Any price increases of the medicines and drug products are determined according to issued Ministerial Decrees.

Regarding the Reimbursement:

MOHP’s facilities and Health Insurance Organizations follow the reimbursement process provided by MOHP. There are other institutions or ministry-affiliated public facilities follow MOHP regulations but have their own budget and autonomy.

With regards the Authorization:

As per Article 4 of the said Law, the authorization of the drugs referred to above may be granted only to the following persons:

1. Managers of stores licensed to trade in narcotic drugs.
2. Administrators of pharmacies or shops intended for the manufacture of Pharmacopoeia preparations.
3. Managers of chemical or industrial analysis laboratories or scientific research.
4. Some of the Governmental entities and recognized scientific institutes.

The competent administrative authority may refuse the request for permission or reduce the required quantity.

The application shall indicate the name of the applicant, his work address, the full name of the substance, the nature of the drug, the quantity he wants to bring or export, along with the reasons that justify the import or export, as well as other data requested by the competent administrative authority.

Article 3 of the said Law, these drugs may not be brought or exported except under a written license from the competent administrative authority.

Moreover, Article 7 provided that the narcotic drugs may not be traded except after obtaining a license from the competent administrative authority in each of the two regions.

This license may not be granted to:

1. Person convicted of a felony.
2. Person convicted of one of the misdemeanours stipulated in this Law.
3. Person convicted of stealing or concealing stolen items, dishonesty, monument, giving a check without credit, falsifying or using forged papers, perjury or indecent assault, corrupting morals, homelessness or suspicion, as well as the convict for attempting to provide for one of these crimes.
4. Persons previously disciplined from public office for reasons of moral turpitude, unless three years have elapsed from the date of the final dismissal.

As per Article 8, it is not permitted to trade in narcotic drugs except in stores or warehouses in the cities of the governorates, the capitals of the districts and the rules of the regions and centres therein, except the governorates and the border centres. In such places, the conditions stipulated by a decision of the competent minister shall be met.

The warehouse shall not have a common entrance door with a dwelling, a medical clinic, an analytical laboratory, a commercial or industrial shop or any other place, nor shall it have any outlets related to any such thing. However, trafficking in narcotic drugs may be combined with trafficking in toxic substances in a single warehouse or warehouses.

Moreover, Article 9 stated that the applicant for the license shall submit to the competent administrative authority an application containing the data to be issued by a decision of the competent minister, accompanied by the papers and drawings concerned in that decision.

With regards the authorization for manufacturing:

It shall not be permissible in the pharmaceutical industry to make preparations containing narcotic drugs, except after obtaining the license provided for in Article 7 mentioned above. These factories shall not use its narcotic substances except in manufacturing its formulations which it produce and it shall follow the provisions of Articles 12 and 13 with regard to what it receives from the narcotic substances and the provisions of Articles 11, 12 and 13 with regard to what it produce from medical formulations which interfere in its composition one of the narcotic substances in any ratio.

28. Which are the Opioid drugs that have received market approval to date?

According to Table No. 2 of law No. 182 for year 1960, the medicinal products based on cannabis extract or tincture that are for the outside use only.

29. Who can prescribe Opioid Drugs?

As per Articles 11 and 19 of the mentioned Law, managers of stores licensed to trade in such drugs may not sell, waive or dispose of such drugs in any capacity except to the following persons:

1. Managers of authorized stores in this trade.
2. Directors of pharmacies and pharmaceutical factories;
3. The directors of pharmacies of hospitals, clinics and dispensaries if they are pharmacists.

They may also sell, waive or relinquish these drugs under the license cards provided for in Article 19 to the following persons:

1. Doctors designated by hospitals, clinics and dispensaries without pharmacists.
2. Managers of chemical and industrial analysis laboratories and scientific research.
3. The interests of the Government and recognized scientific institutes.

And as per Article 19, pharmacies may dispose of such drugs under the license cards provided for the following persons:

1. Physicians, veterinarians and dentists with a diploma or a bachelor’s degree.
2. Physicians assigned by hospitals, clinics and dispensaries without pharmacists.

30. Is there a list of doctors authorized to prescribe Opioid Drugs?

As per Articles 11 and 19 of the mentioned Law, managers of stores licensed to trade in such drugs may not sell, waive or dispose of such drugs in any capacity except to the following persons:

1. Managers of authorized stores in this trade.
2. Directors of pharmacies and pharmaceutical factories;
3. The directors of pharmacies of hospitals, clinics and dispensaries if they are pharmacists.

They may also sell, waive or relinquish these drugs under the license cards provided for in Article 19 to the following persons:

1. Doctors designated by hospitals, clinics and dispensaries without pharmacists.
2. Managers of chemical and industrial analysis laboratories and scientific research.
3. The interests of the Government and recognized scientific institutes.

And as per Article 19, pharmacies may dispose of such drugs under the license cards provided for the following persons:

1. Physicians, veterinarians and dentists with a diploma or a bachelor’s degree.
2. Physicians assigned by hospitals, clinics and dispensaries without pharmacists.

31. What approvals or notifications are required to prescribe Opioid Drugs?

Articles 14 and 15 specifically provided that the pharmacists shall not disburse the narcotic substances except by a medical prescription from a doctor or dentist who holds a diploma or bachelor or by license card in accordance with the following provisions:

Prohibited for those to disbursed narcotic substances by a medical tickets if the quantity recorded in it is more than the quantity prescribed in Table (4), however if the patient’s condition necessitated the increase of such quantities so the doctor shall request a license card for these quantities for this purpose.

Moreover, Pharmacists shall not disburse medical tickets, which contain narcotic substances after five days from editing it. The competent minister shall issue a decision by the data and conditions needed to be provided in editing the medical tickets by means of which the narcotic substances are being disbursed by it from the pharmacies with the exception of the pharmacies of the hospitals and clinics and dispensaries and the tickets which are disbursed from the books stamped by the stamp of the competent administrative party delivered with the prices determined by that party and its price shall not exceed two hundred penny. The competent minister may determine the quantities, which cannot be exceeded in disbursing for each patient per month.

32. Which organizations are authorized to sell/distribute Opioid Drugs available?

As per Articles 11 and 19 of the mentioned Law, managers of stores licensed to trade in such drugs may not sell, waive or dispose of such drugs in any capacity except to the following persons:

1. Managers of authorized stores in this trade.
2. Directors of pharmacies and pharmaceutical factories;
3. The directors of pharmacies of hospitals, clinics and dispensaries if they are pharmacists.

They may also sell, waive or relinquish these drugs under the license cards provided for in Article 19 to the following persons:

1. Doctors designated by hospitals, clinics and dispensaries without pharmacists.
2. Managers of chemical and industrial analysis laboratories and scientific research.
3. The interests of the Government and recognized scientific institutes.

And as per Article 19, pharmacies may dispose of such drugs under the license cards provided for in the following articles to the following persons:

1. Physicians, veterinarians and dentists with a diploma or a bachelor’s degree.
2. Physicians assigned by hospitals, clinics and dispensaries without pharmacists.

33. Is there a list of retailers/distributors authorized to sell Opioid Drugs?

As per Articles 11 and 19 of the mentioned Law, managers of stores licensed to trade in such drugs may not sell, waive or dispose of such drugs in any capacity except to the following persons:

1. Managers of authorized stores in this trade.
2. Directors of pharmacies and pharmaceutical factories;
3. The directors of pharmacies of hospitals, clinics and dispensaries if they are pharmacists.

They may also sell, waive or relinquish these drugs under the license cards provided for in Article 19 to the following persons:

1. Doctors designated by hospitals, clinics and dispensaries without pharmacists.
2. Managers of chemical and industrial analysis laboratories and scientific research.
3. The interests of the Government and recognized scientific institutes.

And as per Article 19, pharmacies may dispose of such drugs under the license cards provided for the following persons:

1. Physicians, veterinarians and dentists with a diploma or a bachelor’s degree.
2. Physicians assigned by hospitals, clinics and dispensaries without pharmacists.

34. Are there proposals for reform or significant change to the regulation of Opioid Drugs?

No.

35. When are they likely to come into force?

N/A.