The Food and Drug Authority in the Kingdom of Saudi Arabia is one of the most important bodies that regulate and monitor the pharmaceutical industry, as it contributes to ensuring the quality and safety of medicines and medical supplies. This article aims to clarify the necessary procedures for importing medicines into the Kingdom, which importers must abide by to maintain  quality  . Safety and avoiding potential problems, in line with the controls and standards set by the Food and Drug Authority in the Kingdom.

The main role of the Food and Drug Administration

The Food and Drug Authority plays a major role in controlling the quality and safety of imported medicines in the Kingdom. It monitors and examines all imported pharmaceutical preparations to ensure their compliance with international and local standards, and to determine whether or not they are safe for human or veterinary use.

In the event of non-compliance with the necessary controls and procedures, the authority takes punitive measures against importers, including preventing  the import of future medicines  and imposing fines and other penalties. These measures are applied to ensure the safety of patients and consumers and to preserve the Kingdom’s reputation as a major destination for import and export of medicines and pharmaceutical products.

Importers legal responsibility

Importers must abide by the legal responsibility related to the import, storage, distribution and marketing of medicines in the Kingdom of Saudi Arabia, and in the event that the necessary controls and procedures are not adhered to, importing companies can face legal problems such as fines and other penalties, including preventing the import of future medicines.

In order to avoid these problems, importers must adhere to the instructions issued by the Food and Drug Authority, ensure the quality and safety of imported medicines, avoid using expired medicines, and cooperate with the competent official authorities to facilitate the import and marketing process. They should also contract with reliable and licensed companies to facilitate the import and distribution process. Ensure the availability of all necessary documents and certificates for medicines.

Conditions for importing medicines into Saudi Arabia 

There are many conditions, controls, and standards for importing medicines into the Kingdom of Saudi Arabia, according to the Food and Drug Authority, and in detail these  conditions for importing medicines into Saudi Arabia  are divided into:

First: Importing a personal medicine 

The Food and Drug Authority approves several conditions for importing medicines for personal use by express mail, and the applicant must make sure that he buys from reliable sources a quantity that is used for a period of three months only, and the application is not allowed during this period.

Mechanism for clearing the import of prescription drugs for human use

The service of importing personal medicines takes five working days, and it is possible to communicate via the following e-mail (import.drug@sfda.gov.sa) designated for this service by the authority. As for the mechanism and papers required for submission, they are as follows:

1. Fill in the data of the personal clearance or export application form on the Authority’s website through the forms page.
2. Attach a copy of the medical report with all the details of the medical condition, the required medication, the dose, and the treatment period.
3. Attach a copy of the identity proof of the applicant (the patient).
4. Attach a copy of the purchase invoice.
5. Attach a copy of the bill of lading.

Mechanism for clearing and importing prescription drugs for veterinary use

The service  of importing  veterinary prescription medicines takes five working days, and it is possible to communicate via the following e-mail (import.drug@sfda.gov.sa) designated for this service by the authority. As for the mechanism and papers required for submission, they are as follows:

1. Fill in the personal clearance or export request form from the Forms page on the Food and Drug Authority website.
2. Attach a copy of the veterinary medical report showing the disease, the type of treatment required, the prescribed dose, and the duration of treatment, provided that it does not exceed 6 months since its issuance.
3. Attach a document from the Ministry of Agriculture proving the type and number of animals owned, in case the number of required packages exceeds 15 packages for personal use.
4. Attach a copy of the identity proof of the applicant.
5. Attach a copy of the purchase invoice.
6. Attach a copy of the bill of lading.

Mechanism for clearing and importing human and veterinary OTC medicines

The service of   importing non-prescription human and veterinary medicines takes five working days and includes (vitamins, health and herbal preparations, and nutritional supplements). Communication can be made via the following e-mail (import.drug@sfda.gov.sa) designated for this service by the authority. As for the mechanism and required papers To apply, they are as follows:

1. Fill in the personal clearance or export request form from the Forms page on the Food and Drug Authority website.
2. Attach a copy of the veterinary medical report showing the disease, the type of treatment required, the prescribed dose, and the duration of treatment, provided that it does not exceed 6 months since its issuance.
3. Attach a document from the Ministry of Agriculture proving the type and number of animals owned, in case the number of required packages exceeds 15 packages for personal use.
4. Attach a copy of the identity proof of the applicant.
5. Attach a copy of the purchase invoice.
6. Attach a copy of the bill of lading.

Mechanism for clearing and importing cosmetic products for personal use

The Food and Drug Authority allows the import of a quantity not exceeding 20 packages of cosmetic products for personal use out of the total imported quantity, provided that its weight does not exceed 15 kg. The requirements are:

1. Fill in the personal clearance and export application form found on the forms page on the Authority’s website.
2. Attach a copy of the identity proof of the applicant.
3. A copy of the purchase invoice.
4. A copy of the bill of lading.

Second: Importing cosmetics with passengers (travelers)

The Food and Drug Authority does not allow the entry of preparations with misleading medical claims and unproven scientifically, such as preparations bearing sexual claims, dom derivatives and vaccines, medicines that must be used under medical supervision, herbal mixtures and combinations of unknown ingredients and source.

The mechanism of narcotic and controlled medication

1. Filling out the personal export or clearance request form located within the forms page on the website of the Food and Drug General Authority.
2. Attach a detailed medical report containing (personal information about the disease – medical diagnosis – treatment plan and duration – medical recommendations – scientific drug name – pharmaceutical form – prescribed dose).
3. Attach a medical prescription in the name of the patient approved by the same treatment institution, provided that the date of its issuance does not exceed 6 months, and it must contain (diagnosis of the disease – the scientific name of the drug – the pharmaceutical form – the prescribed dose – the method of use – the duration of treatment – the seal of the treatment institution) .
4. Attach a copy of the identity proof of the applicant (the patient).

Mechanism for importing unregistered medicines and preparations

1. Fill out the personal clearance or export application form from the forms page on the Authority’s website.
2. Attach a copy of the medical prescription or medical report stating the medical condition, the medication required for treatment, and the recommended dose, provided that it does not exceed 6 months after its issuance period.
3. Attach a copy of the identity proof of the applicant.

Third: Importing medicine for health authorities

The process of  importing medicines  for health authorities is vital in the field of health care. In addition to ensuring the provision of necessary medicines for patients, the import process can relieve pressure on the local health sector and save significant financial costs, but this requires adherence to the conditions and controls specified by the concerned authorities, including Including the Food and Drug Authority in the Kingdom of Saudi Arabia, and this service takes 3 working days, and the letter is delivered and sent through:

• The e-mail of the beneficiary without a local resource, Communications.Adm@sfda.gov.sa.
•  Or the e-mail of the beneficiary via a local supplier licensed by the authority IMPORT.drug@sfda.gov.sa.

Mechanism for importing medicines for government and private hospitals

1. Submit the original submission letter to the e-mail assigned to the beneficiary.
2. Submitting an import permit application through the (IBRCS) system through the supplier company or agent based on the letter of the beneficiary, with a copy of the letter attached.

Mechanism for importing pharmaceuticals for compassionate use

1. Sending a letter from the beneficiary to the Department of Import and Export Permits in the Operations Sector, requesting approval for import, to be submitted at the headquarters of the Food and Drug Authority.
2. Attach a document stating the purpose of importing the preparations, specifying the names of the patients who used them.
3. Attach the names of pharmaceuticals in English.
4. Attach the concentration of the required pharmaceutical preparations and their pharmaceutical form.
5. Determine the quantity, quantity unit, and package size.
6. Mention the name and nationality of the manufacturer in English.
7. Mention the name of the supplier.
8. Attach a copy of the Authority’s valid approval of the Compassionate Use Program for Cosmetics.

Mechanism for importing pharmaceutical preparations and supplies for clinical studies

1. Obtaining a letter addressed to the Department of Import and Export Permits, Operations Sector, from the agency executing the clinical study, including a request for approval of import at the Authority’s headquarters.
2. Determining the purpose of importing the preparations, and defining the relevant clinical study.
3. Mention the names of the preparations in English.
4. Mention the concentration of the required pharmaceutical preparations and their pharmaceutical form.
5. Determine the quantity, quantity unit, and package size.
6. Mention the name and nationality of the manufacturer in English.
7. Mention the name of the supplier.
8. Submitting a release form for pharmaceutical preparations and supplies related to clinical studies.
9. Attach a copy of the Authority’s valid clinical studies approval.

Mechanism of importing unregistered veterinary products

An import permit must be submitted in an official letter in PDF format to the Director of the Import and Export Permits Department through the administrative communications email (Communications.Adm@sfda.gov.sa), then send a copy to the special email for importing veterinary preparations (VDIM@sfda.gov). sa) 30 days before the arrival of the consignment, and the following is indicated in it:

1. The actual purpose of import, for example, if it is for an animal wealth project, a copy of a valid project license certificate issued by the Ministry of Environment and Agricultural Water must be attached.
2. Mention the name of the producing company and its nationality, and the name and nationality of the exporting company, if any.
3. Mention the trade name, the scientific name, the size of the package, and the number of packages to be imported.
4. Attach scientific brochures about the products to be imported and issued by the manufacturer.

 Advice for importers before importing medicines, according to the Food and Drug Authority

The experts at 3rd-partner give some general advice that importers can follow to avoid potential problems and ensure proper controls and procedures are adhered to. These tips are:

• Ensure that products comply with approved quality and safety standards.
• Read the regulations and legislation related to import, and comply with them fully.
• Cooperate with the responsible authorities and submit the required papers and documents correctly and in a timely manner.
• Ensure that information related to products, suppliers and shipments is correct.
• Maintain accurate and detailed records of import, export and inventory operations.
• Employing a qualified team specialized in health and commercial matters to deal with logistical and customs operations such as the 3rd-partner.
• Benefit from the support and assistance available from the responsible authorities, such as the Food and Drug Authority and Customs, to achieve full compliance with controls and procedures.

In conclusion,  the import of medicines  in accordance with the controls and procedures of the Food and Drug Authority in the Kingdom of Saudi Arabia is a sensitive process that requires adherence to strict standards and continuous updates to maintain the safety of patients and consumers, so importers must be careful and follow the necessary procedures to avoid problems and serious legal consequences, and by applying the instructions and advice that Mentioned in this article, importers can achieve success and confidence in  importing medicines  and meeting the needs of the health market in Saudi Arabia.

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