Pharma 2020 KSA
1. What are the main laws governing the manufacture and sale of pharmaceuticals in the jurisdiction?
Pharmaceutical Establishments in Saudi Arabia are governed by the Law of Pharmaceutical Establishments and Preparations issued by Saudi Arabia Royal Decree No. M31/1425 dated 01/06/1425H (corresponding to 18/07/2004) (the PE Law).
2. Are there any significant differences in this area of law in this jurisdiction compared to jurisdictions like the US and EU?
For dispensing pharmacies, ownership is restricted to Saudi nationals by the PE Law. However, there are no restrictions on foreign citizens, generally to own and start a business. The process of starting a business does not vary based on citizenship status.
The regulation most European countries share is that foreigners intending to open a business do not need a work permit or any other type of visa. They need a residency permit in the country where they intend to establish their business. These residency permits, temporary at first, convert to a long-term residency permit depending on the success of the business venture.
3. Who are the main regulators governing the licensing, the sale, or the manufacture of pharmaceuticals in this jurisdiction?
The Ministry of Health regulates the healthcare sector in Saudi Arabia. The other critical public body is the Saudi Food and Drug Authority (SFDA) which grants licenses for pharmaceuticals and pharmaceutical manufacturing.
4. When new drugs are created, which agency is responsible for giving the permission for the sale/manufacture in this jurisdiction?
The Ministry of Health and the Saudi Food and Drug Authority.
5. What steps must a pharmacist take before being allowed to practice in this jurisdiction?
A Pharmacist is defined under Article 1 of Saudi Arabia Royal Decree No. M31/1425 as a person holding a Doctor of Pharmacy (PharmD) degree or a bachelor's degree in Pharmaceutical Sciences from a Saudi Pharmacy College or equivalent. A Licensed Pharmacist is a pharmacist licensed to practice the profession in the Kingdom.
Under Article 11 of Saudi Arabia Royal Decree No. M31/1425, only a full-time licensed Saudi pharmacist holding a practice license may work in the field of introducing and advertising pharmaceutical and herbal preparations. The Minister of Health may grant exemption from the nationality condition in the absence of an adequate number of Saudi pharmacists.
6. What are the requirements involving ownership and licensing of a pharmacy in this jurisdiction?
A pharmaceutical establishment must obtain the required license from the Ministry in the name of the owner.
The ownership of a pharmacy will be restricted to Saudis and granting a license to them will be subject to the following conditions:
- The owner, or one of the partners, must be a pharmacist holding the practice license. The Minister of Health may consider the nationality condition sufficient in remote areas specified by the Implementing Regulations.
- The manager of the pharmacy must be a full-time Saudi pharmacist holding a practice license. The Minister of Health may grant exemption from the nationality condition in the absence of a sufficient number of Saudi pharmacists.
- The pharmacy will satisfy the conditions and specifications set out in the Regulations.
- An applicant for a pharmaceutical establishment license or renewal of it will pay the prescribed fees for the pharmacy of 1,000 Riyals.
7. What rules govern the dispensing of prescription of drugs in this jurisdiction?
The pharmaceutical establishments may not possess any amount of pharmaceutical and herbal preparations without having the documents which establish their purchase origin and quantities.
The pharmaceutical and herbal preparations may not be circulated before registration with the Ministry.
8. Are there rules on the pricing on prescription drugs in this jurisdiction?
Medicines will be priced based on factory price or price of export to Saudi Arabia in the country of origin's currency or any other currency as designated by the Ministry. The Ministry will review the prices of medicines periodically.
A profit margin will be added to the prices of medicines for a wholesale pharmaceutical preparations sale store and pharmacy; Sale Store Profit Margin (SSPM) (based on factory or export price) and Pharmacy Profit Margin (PPM) (based on pharmaceutical sale store price) Factory or Export Price.
- 50 Riyals or les-SSPM of 15% and PPM of 20%.
- More than 50 Riyals and not exceeding 200 Riyals-SSPM of 10% and PPM of 15%.
- More than 200 Riyals-SSPM of 10% and PPM of 10%.
9. What rules apply when importing controlled substances and prescription drugs into the country?
It is illegal to import drugs or medical materials which are banned in Saudi Arabia or internationally. The Ministry of Health may, if necessary, approve the import of unrestricted pharmaceutical and herbal preparations before registration.
Pharmaceutical and herbal preparations sale stores may import registered pharmaceutical and herbal preparations if not made available by the factory, based on the approval by the Ministry of Health.
For import requests by Government and private hospitals, the following points have to be considered.
- The imported product must be important and not having a registered alternative in Saudi Arabia.
- The manufacturer should be registered with SFDA unless the product could not be obtained from the registered manufacturer.
- The country of origin must market the product.
- The required quantity must be sufficient for a maximum of six months.
- The imported product will not be sold or loaned to any other party, without drug sector permission.
10. What are the penalties for contravention of these import rules?
The committees formed under the Law of Private Health Institutions issued by Saudi Arabia Royal Decree No. M40/1423 dated 03/11/1423H will consider violations of the provisions of the PE Law. The Committee may, without prejudice to any severer penalty prescribed by another law, impose one or more of the following penalties:
- Fine not exceeding 100,000 Riyals;
- Close the establishment for up to sixty days; and/or
- Revoke the establishment's license.
The Committee decisions will be approved by the Minister of Health and may be appealed within sixty days to the Board of Grievances. The final decision imposing the penalty may be published at the expense of the violator in three local newspapers.
11. Do rules on import of controlled substances and prescription drugs come into play when drugs are brought into the country having been purchased overseas on the internet or having been brought into the country in transit?
Clearance of Pharmaceutical Products for Personal Use
The request to import prescription drugs must be filed with the branch of the SFDA at the port of entry where the drugs will arrive.
Drugs which are for personal use will be cleared for import into Saudi Arabia provided:
- The prescription medications must be accompanied with:
- A medical report (less than six months old) issued by the patient's medical care provider or a doctor's prescription (less than six months old) in the name of the patient. The prescription and the report must fulfil and mention the details required.
- The importer of the prescription medications will be personally responsible for its lawful use responsible to limit its usage to only the intended patient.
- Copy of patient identification document.
- The allowable prescription medicine to be cleared for import will for the duration of the visit or one month's supply, whichever is shorter.
12. What are the main laws protecting intellectual property in the pharmaceutical industry? Are there any significant allowances in the way things work compared to jurisdictions such as the US and EU?
Law Number 159 on the Protection of Patents, Layout Designs of Integrated Circuits, Plant Varieties, and Industrial Models. Saudi Arabia has established the Saudi Authority for Intellectual Property (SAIP), which consolidates all the different Intellectual Property (IP) departments under one umbrella and provides an overall strategic direction and coordinates IP policy.
Saudi Arabia has also adopted the unified GCC Trademark Law and is also a member of the GCC Patent Law and GCC Customs Law which helps harmonise IP practices in Saudi Arabia, the UAE and other GCC members. In Saudi Arabia, patent registration and registering trademarks is granted on a first-to-file basis.
The availability of IP rights and their scope of protection may strongly differ to the US and EU. Most rights must be registered in Saudi Arabia, under local laws, in order to be enforced. A US trademark registration or the US patent will not be protected in Saudi Arabia.
Saudi Arabia has granted domestic companies the marketing approvals to produce generic versions of pharmaceutical products in the GCC which are under patent protection in other countries. This approval has raised various concerns. These approvals conflict with Saudi Arabia's domestic law and raise significant questions about the transparency of marketing approvals and the predictability of patent protection in Saudi Arabia.
13. Are health supplements, vitamins or other non-prescription drugs regulated in any
For Shipments Clearance of any Over the Counter Medication, Vitamins, Herbal Products, Food Supplements or Cosmetics, the following documents are required by the SFDA:
I. The application form which must be filled out clearly.
II. An attached copy of medical reports or prescriptions, if requested.
III. An attached copy of Identification (Iqama or Passport).
IV. An attached copy of invoice.
V. An attached copy of the bill of lading.
14. Are there any significant rules on the packaging of drugs in this jurisdiction?
There is a Guidance for Graphic Design of Medication Packaging issued by the SFDA. The guidance is applicable to SFDA registered or under-registration medicinal products intended for human use in Saudi Arabia. The guidance is complementary to the GCC Guidance for Presenting the SPC (Summary of Product Characteristics), PIL (Patient Information leaflet) and Labelling Information with more illustrations and details to minimise medication errors. It is intended for solid oral dosage forms, which are the most common type of primary packaging and secondary packaging used on the container label. It also should be used for all injectable medicines as well. The design considerations and principles outlined in the guidance can also be applied to other products dosage forms.
15. Are those involved in virtual medicine allowed to prescribe or sell drugs to patients?
The Telemedicine Regulations govern this area in Saudi Arabia. The Regulations mention telemedicine will be used for consultation, diagnostics, screening, triage, obtaining a medical opinion from a healthcare practitioner (HCP) and the monitoring of any medical conditions.
The Regulations also define the term telemedicine as 'medical practice using information and communication technology (ICT) from a remote place involving a live or virtual interaction between the healthcare personnel and the patient. The location of two parties in the consultation will be different and involve Artificial Intelligence or robotics to come under the ambit of telemedicine. Teleconsultations between a patient and healthcare personnel or between two healthcare personnel must involve video calls and not exclusively audio to qualify as telemedicine.
An HCP practising telemedicine may deliver an online prescription or medical investigation, which will comply with the medical prescription and investigation regulations applied in Saudi Arabia. The HCP will be responsible for the prescription and/or medical investigation delivered in line with professional responsibility.
16. Are there any rules governing the advertising of drugs?
Advertising pharmaceutical and herbal preparations in the media will be subject to controls set out in the Implementing Regulations. Under Article 11 of the PE Law, only a full-time licensed Saudi pharmacist holding a practice license may work in the field of introducing and advertising pharmaceutical and herbal preparations. The Minister of Health may grant exemption from the nationality condition in the absence of an adequate number of Saudi pharmacists.
17. What is the main legislation governing legal possession of controlled substances?
The Saudi law of Narcotics control is enacted through Saudi Arabia Royal Order No. 4/B/966/1407 dated 10/07/1407H.
18. Are laboratories carrying out research with drugs required to be registered? If so, who is the regulator and what are the main steps?
The Executive Directorate of Laboratories is responsible for supervising and managing the pharmaceutical laboratories which belong to SFDA's drug sector to assure their conformity with the requirements of the international quality and competence standards along with analysing imported or locally manufactured drugs in order to ensure their compliance with the authority's national standards as well as the standards of international pharmacopoeia and world health organisation.
The Clinical Trials administration aims to provide evaluation, registration and monitoring of the Clinical Trials conducted in Saudi Arabia, contribute to the protection of clinical trial subjects and strengthen the capacity of the regulatory body, legislative and oversight functions.
All the clinical trials involving drugs must be registered with the SFDA Drug Sector's Clinical Trials Department through the Saudi Clinical Trials Registry (SCTR). However, the registration of a clinical trial will not indicate approval.
The researcher, sponsor, and CRO must adhere to the regulations of Research Ethics Code on Living Creatures issued by Saudi Arabia Royal Decree No. M59/1431 on 14/9/1431 H.
It is mandatory to adhere to SFDA memos E/15481 and E/15482 (13/5/1434 H) in regard to the registration of local institutional review boards (IRBs). The researcher, sponsor and CRO must adhere to good clinical practice (GCP) in line with the ICH-E6 guideline. According to the memo E/9699 (23/4/1432 H), the sponsor or CRO must pay 15,000 Riyals for each submitted trial as an evaluation fee for the clinical trial, excluding phase IV from these fees.
19. Are there any specific health and safety rules governing the operation of laboratories
handling dangerous materials and disposal of waste substances?
The medical waste management programme at the Ministry of Health is responsible for the application of the medical waste programme in the health facilities in line with the unified law for managing the healthcare waste in the Cooperation Council for the Arab States of the Gulf (CCASG) and implementing regulations issued by Saudi Arabia Ministerial Decision No. 60567/2/22 on 12 August 2006.
20. Are there any specific rules governing testing of pharmaceuticals on humans or animals?
The study needs to be approved by both the Ministry of Health and the Saudi Food and Drugs Authority (SFDA).
21. Do rules on dispensing drugs to animals differ from those in dispensing to humans?
Veterinary medicines are prescribed by a veterinary in the same way as a doctor would issue a prescription.
22. Do the rules on practicing as a pharmacist or selling drugs differ in the free zones?
23. Do the rules on manufacturing pharmaceutical products or pharmaceutical research differ in the free zones?
24. How do product safety and personal injury legislation operate in situations where a patient has been injured as a result of drug which was dispensed or manufactured in this jurisdiction?
The complaint could be filed in the Ministry of Health using the online portal. Article 27 of the Law of Practising Healthcare Professions (2005) deals with Civil Liability and states any healthcare professional who is committing malpractice, causing harm to a patient will be held liable for indemnification.
25. Are there any drugs or therapies which are barred or have restrictions on their dispensing because of religious reasons?
The basis for Saudi Arabia's constitution is Islam and the Holy Quran. The Government tends to decide the legality of actions based on Islamic law or on the basis of whether or not it will lead people away from Islam. The laws in Saudi Arabia prohibit alcohol in the Kingdom as they are against Islam. Drug trafficking is always punished by death.
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