Drug Import Regulations in Saudi Arabia

Saudi Arabia is a rapidly developing country in the Middle East with a robust and stringent regulatory framework. The Saudi Food and Drug Authority (SFDA), Saudi Arabia’s National Regulatory Authority (NRA), has been assessed by the World Health Organization (WHO) as operating at Maturity Level 4 (ML4), the highest level of the WHO Global Benchmarking Tool. Consequently, the country has become an increasingly attractive market for international pharmaceutical companies seeking to establish a presence and expand their operations in Saudi Arabia.

Whether you are an exporter seeking access to the Saudi market, understanding drug import regulations in Saudi Arabia is essential to ensure compliance with SFDA requirements.

In this article, you will learn about drug import regulations in Saudi Arabia, including SFDA requirements and conditions for obtaining permits for drugs, cosmetics, and pharmaceutical products and how Pharmaknowl helps you obtaining these permits.

Table of Content

• Mechanism for Importing Unregistered Human Pharmaceutical Products 
• Circumstances That Automatically Cancel Import Approvals
• Request for tenders
• Mechanism for Importing Pharmaceutical Products for Compassionate Use
• Mechanism for Importing Pharmaceutical Products and Supplies for Clinical Trials
• Mechanism for Importing Chemicals
• How should stakeholders apply?

Mechanism for Importing Unregistered Human Pharmaceutical Products 

Conditions for Import requests for government and private hospitals 

The general conditions for importing unregistered products are: 

• Prior to consignment, obtaining the Authority’s approval to import unregistered drugs is mandatory. 
• No registered alternative for the requested product should be available in Saudi Arabia. If a registered alternative is available, then the Authority must be reported through the electronic reporting system for drug shortages. 
• An SFDA-accredited agent should be assigned for all such activities. 
• The manufacturing company must be registered with the Authority and GMP compliant. Products from a non-registered manufacturer will only be considered when the product is unavailable from the registered manufacturer. 
• The product must be marketed in the country of origin. 
• The requested quantity by the requesting entity must be sufficient for a period of six months. 
• The products must not be sold or lent to any party other than the importing entity with SFDA’s approval. 
• The quantity of samples and time required for the analysis must be mentioned in the contract, with a commitment to provide the samples and documents to the laboratory. 
• The product package must contain all the necessary information as required by the authority. 
• Pharmaceutical products must be transported and stored in refrigerated containers in accordance with the recommendations of the manufacturing company. 

Read more: Named Patient Program for Unregistered drugs

Requirements for Obtaining an Import Permit for an Unregistered Product 

• If prior approval for the import of an unregistered drug has not been obtained, the beneficiary entity must submit the required form through the electronic IBRCS system for approval by the Authority. 
• If approval has already been obtained, a letter addressed to the Import and Export Permits Administration is sufficient to secure import authorization. 
• The letter must include complete product details, the names and nationalities of the manufacturing and marketing companies, and the supplier’s name. 
• A justification for requesting the product, including a therapeutic rationale demonstrating its benefits compared with existing or alternative treatments. 
• If a registered alternative to the requested drug is available, provide reasons for not obtaining it and attach the report submitted through the electronic drug-shortage reporting service. 
• A certificate confirming the product’s marketing and registration status in its country of origin. 
• The agent is responsible for the requested product’s safety, quality, and efficacy and must provide a statement confirming this responsibility on the establishment’s official letterhead. 

Mechanism for Submitting the Import Request 

The mechanism for submitting the import request varies from case to case. The import request can be made in three ways:

1. Direct request from beneficiary entity 
2. Through a local SFDA-licensed supplier 
3. Through the agent 

Circumstances That Automatically Cancel Import Approvals

• Registration of the approved product(s). 
• Issuance of a decision or circular declining to register the approved product(s). 
• Issuance of a decision to suspend the product(s) or anything preventing their supply. 
• Issuance of a decision to suspend the manufacturing company, the marketing company, or the supplier. 

Request for tenders 

The agent submits an import-permit request through the IBRCS system for unregistered drugs related to the Gulf Tender or the National Unified Procurement Company (NUPCO) tender. 

Mechanism for Importing Pharmaceutical Products for Compassionate Use

The Authority’s Clinical Department approves drugs for compassionate use, subject to the following requirements:

• A letter from the beneficiary entity addressed to the Import and Export Permits Administration. 
• The purpose of importing the pharmaceutical products, specifying the names of the patients who will use them. 
• Complete data on the pharmaceutical products to be imported and the name of the supplier. 
• A copy of the Authority’s valid approval of the compassionate-use program for the pharmaceutical products. 

Mechanism for Importing Pharmaceutical Products and Supplies for Clinical Trials 

The following are the conditions and requirements for the drugs to be used for clinical trials: 

• The labeling and packaging of the pharmaceutical product used in clinical trials must comply with the SFDA’s requirements. 
• A valid approval to conduct the clinical trial, issued by the Drug Sector. 
• A letter from the entity conducting the clinical trial, addressed to the Import and Export Permits Administration in the Operations Sector. 
• Purpose of importing the pharmaceutical products/supplies, specifying the relevant clinical trial. 
• Complete data on the pharmaceutical products/supplies to be imported and the name of the supplier. 
• Submission of the Release Form of Drug/Material(s) for Clinical Trials Use. 
• A copy of the Authority’s valid approval of the clinical trial. 

Mechanism for Importing Chemicals 

• The Operations sector is responsible for importing and clearing chemicals used for health purposes or included in the product composition. 
• The clearance of chemical materials for pharmaceutical or cosmetic factories, pharmacies, and laboratories is issued by SFDA and health sectors. 
• The import and clearance of chemical precursors is done through the Narcotic Drugs Administration at the Drug Sector headquarters in Riyadh.

How should stakeholders apply?

Importing a drug and then getting it clearance from the Saudi ports is a time-consuming process and requires effort and extensive documentation, but with expert opinion and experience, this could be easily handled. We at Pharmaknowl have experience importing products, obtaining Importer of Record (IOR) status, handling shipments, and clearing them in accordance with the SFDA’s requirements. Contact us today to stay up to date on the latest SFDA regulations.