If you are planning to market your product in the Kingdom of Saudi Arabia, the step of  registering a product in the Food and Drug Authority  is a crucial and mandatory step, and for this reason, we provide you with this comprehensive guide in which everything you need to know about registering products of all kinds in the Authority is presented in order for you to be able to import and market your product correctly. and legal within the Kingdom.

Introduction to the Food and Drug Authority

The Food and Drug Authority in the Kingdom of Saudi Arabia is one of the most important authorities responsible for ensuring and ensuring the safety of food, drug and cosmetic products, medical devices, nutritional supplements and other medical supplies in the Kingdom.

The authority requires the registration of products and the licensing of facilities before importing and marketing products in the Saudi market, in order to ensure the quality of products and their safety for human consumption. Therefore, obtaining a product registration certificate from the authority is necessary for its marketing and use in the Kingdom, and this step cannot be skipped.

Companies allowed to register products with the Food and Drug Authority

The Food and Drug Authority in the Kingdom of Saudi Arabia relies on strict standards for product registration, and stipulates some conditions for companies that are allowed to submit requests to register their products with them, including:

local companies

All local Saudi institutions and companies, whether they are distributors, agents or importers, who have a facility license from the Food and Drug General Authority, can apply to register products with the authority and obtain the necessary registration certificates for use in the process of marketing and selling the product, and this includes all products sold on Internet, provided that it is imported in commercial quantities and stored in the market before being delivered to the final consumer.

global companies 

International companies that wish to market their products in the Kingdom of Saudi Arabia can register their products with the Food and Drug General Authority, and these companies must provide all the required documents and their commitment to implement all laws and regulations issued by the Food and Drug General Authority in the Kingdom of Saudi Arabia, and they are divided into:

• A company without a Saudi agent:  It is allowed to register a product with the Food and Drug Authority through the assistance of a regulatory affairs consulting office licensed by the authority.
• A company that has a Saudi agent:  it is allowed to submit a  product registration application with the Food and Drug Authority  through local agents and distributors.
• Foreign investment companies:  Foreign companies licensed as foreign investors by the Ministry of Investment are allowed to operate in the Saudi market in the same manner as local companies, including the registration of products with the Authority.

Registering a product with the Food and Drug Administration

How to register a product with the Food and Drug Authority

The Food and Drug Authority seeks to develop the Saudi market, so it obliges all product owners with several criteria and requirements to register products and enter them into the Saudi market, and the method of registration differs according to each product according to the standards of the authority, and therefore we will explain in this guide how to register a product in the Food and Drug Authority for  each  product Separately.

First: Registering a food product

The mechanism for registering food products in the Kingdom of Saudi Arabia by the authority aims to regulate the movement of importing, exporting and selling products in the Saudi market. This mechanism takes place through the following steps:

1. Opening an electronic account through the FRCS electronic food platform .
2. Fill in all the required data, including attaching a copy of the commercial registration, and an authorization letter.
3. Register the food product by notifying the marketing from here .
4. Fill in all the data and attach a complete product card image from all sides, and the finished product image from the main interface.
5. Follow up on product requests from here .
6. Electronic clearance for imported food only, and the product must comply with the approved technical regulations and circulars issued by the authority.

Food registration period

The period for registering food products is calculated starting from the date of submission of the electronic application. This period is cumulative within the Food and Drug Authority and varies according to the type of products as follows:

• Fresh food: 90 working days.
• Food for special dietary uses: 90 working days.
• Food used for medical purposes: 90 working days.
• Infant and child food: 90 working days.
• Energy drinks: 10 business days.
• Dietary supplements: 10 working days.
• Other (traditional) foods: 5 working days.

Second: Registration of nutritional supplements and energy drinks

The mechanism for registering food supplements and energy drinks at the Food and Drug Authority differs from other food products, and the registration steps are as follows:

1. Submitting a product registration application (notification of marketing) in the same way as the mechanism for registering a food product.
2. The application is reviewed after filling in the data and attaching the product card, and an invoice is issued for the financial consideration that must be paid, then the application is returned, including the invoice number for the payment of the financial consideration, and the notes that must be amended on the product card or data, if any.
3. Pay the fees sent in the previous step, and amend the notes, if requested.
4. Attach the bank payment note to the product card image.
5. Then the application is reviewed and approved by the Authority.

In the event that additional information is requested by the Authority and the applicant did not complete it, he must quickly complete the request and amend the notes within a maximum period of 30 days starting from the date of the Authority’s response.

Third: Registering a cosmetic product 

A cosmetic product is any product that contains one or more substances prepared for external use of the human body such as hair, skin, nails… etc., based on the system of cosmetic products approved in the Kingdom, issued by Royal Decree No. M/49 dated 6/18/1436 AH, and its implementing regulations Issued by the Board of Directors of the Food and Drug General Authority, cosmetic products must be included and registered in the product registration system before they are allowed to be imported or circulated in the Kingdom. Article 6 of the system included this strict condition. The controls and requirements for listing/registering cosmetic products aim to explain and clarify the requirements of the system and its implementing regulations in this regard.

And the mechanism of registering a cosmetic product means registering the product in the records of the Food and Drug General Authority through the electronic listing system Ghad, through the following steps:

1. Create an account in the electronic system to list tomorrow’s beauty products .
2. List the manufacturer’s data for the cosmetic product.
3. Inclusion of the cosmetic product.
4. Fulfilling the requirements for clearing cosmetic products at customs outlets (imported products).

Cosmetic product registration requirements

• The product identification label, which is one or more clear images of the product label that can be published on the Food and Drug Authority’s website, showing its identity and components clearly and legibly.
• Adding the components of the product in the electronic system because it is one of the basic conditions in the cosmetic product registration process.
• A copy of the main commercial register of the establishment.
• A copy of the national identity of the owner of the facility and the company’s articles of incorporation.
• A copy of the investment commission license if the company is foreign or mixed.
• A copy of the national ID or Iqama of the person responsible for following up the application with the Authority.
• A copy of the legal agency or an authorization certified by the Chambers of Commerce for the person responsible for following up the application with the Authority.

Fourth: Registering a herbal product

The Saudi Drug Registration System (SDR) is an electronic system that aims to facilitate the process of registering medicinal and herbal preparations intended for human and veterinary use in the Kingdom of Saudi Arabia, through:

1. Create an account in the National System for Registration of Pharmaceutical Establishments (DENR) .
2. Fill out the application form to register a new herbal product through the Sidr platform .
3. Enter the relevant GCC certificate number in the CDR application form.
4. Add a copy of the GCC Certificate in Cover Letter 1.0.
5. Submit the latest approved documents for the product.
6. Upload the full file from Module 1/Part 1 of the selected documents as stated in the data requirements.
7. Receive a notification from the Sidr website after the registration process, whether by acceptance or rejection, and in case of rejection, an objection request must be submitted in accordance with the appeal policy.

Herbal product registration guides

• Submission data requirements for herbal and health products.
• Guidelines for submitting PIL information for herbal and health products.
• General rules for products containing vitamins and minerals.

Fifth: Registration of a human drug product

All procedures  for registering a medical product at the Food and Drug Authority  are carried out through the Sidr platform, which is specialized in registering medicinal products and herbal preparations. The mechanism for registering a human drug product takes place through the following steps:

• Create an account in the National System for Registration of Pharmaceutical Establishments (DENR) .
• Fill out the human drug registration application and submit it through the Sidr platform .
• Fill out and export the form with all the required data.
• Pay the application fee set by the Authority.
• Respond to an RFI evaluation inquiry when it is submitted.
• Receipt of the application review decision.
• Print the registration certificate.
• Managing the life cycle of the drug profile in terms of changes or renewals that occur to the product.

Evidence of human drug product registration

• Human drug registration file data requirements.
• Persistence guide.
• Drug Master File Guide to Active Substance (DMF).
• Internal leaflet guide for patients and practitioners of SPC and PIL.
• Medication Labeling Guide.
• Tamper assurance requirements and packaging guidelines.
• Graphic design guide for pharmaceutical packaging.
• Registration verification and bridging guide.
• Bioequivalence guide.
• Biosimilars Handbook.
• Investigational Drugs (IND) Screening Manual and Requirements.
• Reference Standards Guide.
• Bioequivalence study exception guide.
• Vaccine production and quality control guidelines.

Sixth: Registration of a veterinary medicinal product

All procedures for registering a veterinary medicinal product at the Food and Drug Authority are carried out through the Sidr platform, which is specialized in registering medicinal products, herbal preparations, and veterinary products. The mechanism for registering a veterinary medicinal product takes place through the following steps:

1. Create an account in the National System for Registration of Pharmaceutical Establishments (DENR) .
2. Fill out the veterinary drug registration application and submit it through the Sidr platform .
3. Fill out and export the form with all the required data.
4. Pay the application fee set by the Authority.
5. Respond to an RFI evaluation inquiry when it is submitted.
6. Receipt of the application review decision.
7. Print the registration certificate.
8. Managing the life cycle of the drug profile in terms of changes or renewals that occur to the product.

Veterinary drug product registration guides

• SFDA VNeeS specification for veterinary medicinal product.
• Data requirements for registration of veterinary medicinal products.
• Handbook of SPC practitioners’ internal leaflet and veterinary product labeling.

Seventh: Registration of a public health pesticide product

Pesticide products and public health pests are included in the procedures and conditions for registering a product with the Food and Drug Authority  in order to import, trade and use them in the Saudi market easily and conveniently, and this is done through the following steps:

1. Submitting a letter requesting registration or re-registration of a pesticide to the Commission containing (the name of the commercial pesticide – the name of the active substance – the concentration of the active substance – the registration number in the Kingdom – the expiry date of the registration – the producing company – the country of production).
2. Fill out a pesticide registration application form from here .
3. Attach an authorization letter from the manufacturer addressed to the facility to register the pesticide in the Kingdom.
4. Attach the pesticide registration certificate in the producing country, with a recent issuance from the specialized authorities.
5. Attach a statement of the names and percentages of the contents such as solvents, inert materials, active materials, etc.
6. Attach a recent certificate of origin for the active substance.
7. Fill in the information of the active substance (chemical name – common name – chemical group – pesticide group – chemical symbol and chemical structural formula – CAS number).
8. Attach a guarantee certificate from the manufacturer for the quality of the pesticide.
9. Attach a pesticide analysis certificate from an accredited laboratory, including pesticide components, density, specificity, and pH, certified by the Kingdom’s embassy.
10. Attach a storage certificate stating the method and conditions of the pesticide storage.
11.  Fill in the scientific data on the degree of toxicity in the pesticide and its impact on the environment and first aid SDS.
12.  Attach a copy of the product packaging label in the country of origin in either Arabic or English, and a copy of the proposed label for the pesticide to be approved.
13.  Attach a copy of the last registration certificate in case of requesting re-registration of the product.

Eighth: Registering a fodder product

The packing label requirements, specifications and regulations that are applied differ according to the type of feed, as the feed products are divided into the following:

• Raw fodder means fodder materials or raw materials that have not been mixed with other materials.
• Feed additives are the ingredients added in a form dependent on the feed for technical purposes, or for improvement, or to increase the nutritional value.
• Mixtures of feed additives It is a mixture of two or more feed additives.
• Compound fodder, which is a mixture of raw fodder with or without fodder additives added to it so that it is provided to the animal directly, such as: animal fodder such as poultry and cows … etc., mineral salts, milk substitutes, and special fodders.

As for the method of  registering a product in the Food and Drug Authority  from the list of feeds, the following steps must be followed:

1. Login to the AFNR system specialized in registering feed products.
2. Click on the product registration icon.
3. Fill in the feed registration data and choose the type of feed to be registered.
4. Enter detailed information and data related to the characteristics of the feed product.
5. Attach and upload all required documents.

Documents required to register a feed product

• Packing card according to the requirements of the Food and Drug Authority.
• Statement of product components or certificate of product analysis.
• scientific file.
• Technical file.
• Stability study.
• Post-marketing studies (effect on animals, the environment, humans).
• Product origin certificate (imported products).
• Newly issued freedom of sale certificate with a maximum of three years from the date of its issuance (for imported products).
• Health certificate (imported products).

Ninth: Register a medical product

The registration of a medical product in the Food and Drug Authority  is an approval that enables the marketing of medical devices and supplies, whether they are provided free of charge or are available for negotiation for a fee for use within the Kingdom of Saudi Arabia, and it is known as the (MDMA) document, which is the document issued by the authority, and allows it for any medical device or necessary for circulation In the Saudi market, the registration method is as follows:

1. Submitting the application through the local or foreign manufacturer or the authorized representative of the foreign factory after obtaining a factory license or accredited by the Ghad platform.
2. Fill out the marketing permission application for medical products and supplies from here .
3. Attach a document describing the medical device or product and its characteristics.
4. Attach a document showing all the information provided on the product by the manufacturer.
5. Make a checklist for a checklist of essential principles.
6. Demonstrate compliance with the Fundamental Principles.
7. Attach the risk management file.
8. Attach reports and post-marketing control plan.
9. Payment of the financial consideration.

Tips before registering a product with the Food and Drug Authority

Experts at 3rd Partner advise individuals and companies to follow the following tips before and during  product registration with the FDA :

• Start planning early to register a product with the Food and Drug Authority, as the period for registering products varies according to the product, and some take several months, so it should start before the time specified for launching the product.
• Obtaining all the information necessary to register the product with the Authority, including the necessary documents, certificates, and required technical standards.
• Adhere to the technical standards required for  product registration in the Food and Drug Authority , in order to ensure product quality and safety.
• Dealing with the responsible authorities in an effective and orderly manner, and responding to any inquiries or observations that may be raised by them.
• Seek advice from specialists in the field of product registration to obtain the necessary advice and advice in this regard.
• Physical readiness to pay the fees and expenses required to register the product with the Authority.
•  Adhere to the local regulations and legislation that govern the product registration process in the Kingdom of Saudi Arabia, and ensure compliance with all required laws and requirements.
•  Evaluation of all products to be registered by the Food and Drug General Authority in the Kingdom of Saudi Arabia, and this may require laboratory examinations and tests, so companies and individuals should prepare for that.
• Maintain an accurate record of all papers and documents required to register products, and maintain financial and accounting records related to the registration process.
• Regular follow-up of the product registration process, ensuring that the required documents are updated, and responding to any inquiries or observations that may be raised by the Food and Drug Authority.
• Registering products may require auditing and review by the Authority, so companies and individuals must prepare for this and provide the Authority with everything required.

Product Registration Guide at the Food and Drug Authority

The importance of complying with the requirements of registering a product with the Food and Drug Authority

Compliance with the requirements of the Food and Drug General Authority in the Kingdom is essential to ensure the safety and quality of products that are marketed in the Saudi market. The main objective of the authority is to protect the health and safety of consumers by ensuring the quality and safety of food and drug products and ensuring their compliance with international standards related to quality and safety.

In addition to the health and safety aspect, compliance with all  conditions for registering a product with the Food and Drug Authority  increases the chances of success of the product in the Saudi market, as it gives customers confidence in the product and enhances its reputation. It also allows companies and individuals to reach a large number of consumers in the Kingdom of Saudi Arabia.

Moreover, certification of products by the authority requires strict procedures and requirements to be followed, which leads to improving the quality and competitive advantage of products and enhancing export opportunities to global markets.

In conclusion,

all companies, institutions and individuals looking to  register a product with the Food and Drug Authority  must take the necessary measures to comply with the requirements of the authority and deal with it in an effective and orderly manner, to ensure obtaining the necessary approval and benefit from all the full advantages of registration with the authority, as registration is a strategic expenditure that must be That companies invest in it to ensure the quality and safety of their products, and improve the image of the market at the same time, and in the long term, compliance with all  conditions for registering a product in the Food and Drug Authority  contributes to increasing the chances of success, and improving the quality of products available in the market.