Procedures for issuing the Food and Drug Authority license for warehouses
Medical and food warehouses are an important place for storing and distributing pharmaceutical and food products , and play a crucial role in ensuring that these products reach the final consumer in a safe and efficient manner . Control of quality, safety and effectiveness in this field in the Kingdom of Saudi Arabia.
The procedures for issuing the Food and Drug Authority license for warehouses are vital and important and require a set of procedures and requirements that must be followed to obtain the license. These procedures and requirements vary depending on the type of warehouse and the products that are stored in it.
Therefore, in this article, we will talk about the procedures necessary to obtain a license from the Food and Drug Authority to establish and operate warehouses that store and distribute food and medical products, because it is an essential step for companies and institutions before starting any commercial activity in this field, and this includes the terms of the license and the documents required to obtain it and how to apply Apply for it, and we’ll go over some important tips to make this process easier and avoid potential problems.
What is the difference between licensing and product registration issued by the Food and Drug Authority?
The license of the Food and Drug Authority allows the institution to obtain permission to practice its commercial activities, such as import, distribution and storage, and this license is issued as a certificate or document after fulfilling all the required conditions, and it is valid for a specific period that must be renewed after its expiry.
The license issued by the authority differs from the registration of products, where a registration certificate is issued with different conditions for each product separately, and different fees are collected from the facility licensing fees. Therefore, companies and institutions must obtain the necessary license for the facility and register the products they wish to market to ensure compliance with safety and quality standards. determined by the Food and Drug Authority before starting any commercial activity.
Types of licenses of the Food and Drug Authority
The licenses of the establishments that the Food and Drug Authority specializes in vary according to the type of commercial activity practiced, and therefore the licenses of establishments can be divided into several types according to the type of commercial activity, as this includes licenses for warehouses, imports, exhibitions, physical stores, and electronic stores, and the types of licenses of the authority are:
First: food licenses
Food licenses are divided into three types, each type has its requirements and conditions that must be met in order to obtain the license easily without complication in accordance with the terms of a warehouse license from the Food and Drug Authority , and these types are:
Food warehouse license
A warehouse license is granted to establishments operating in the field of storing food and beverages, whereby goods are monitored and their safety and quality are ensured before being delivered to consumers. Obtaining this license requires that the warehouse comply with all required health conditions and standards.
Import license for a food store or exhibition
Import licenses are issued to stores and exhibitions that work in the field of food, where the health and technical conditions that must be met in imported products are determined, which are the quality and safety of food and their conformity with the specified specifications.
An import license for an online food store
Import licenses are granted to electronic stores that work in the field of food, where the health and technical conditions are determined for the products that are imported and must be met in those products, and these stores must adhere to the food safety standards and required health instructions, in order to confirm the quality and safety of the products that are provided to consumers.
Second: drug licenses
Drug licenses from the Food and Drug Authority include several types, and these types are:
Drug warehouse license (imported or distributed)
This license is issued to companies and institutions that wish to import and distribute medicines. The companies applying for this license are required to meet the conditions for storing medicines in warehouses, including the health, technical and security conditions necessary for storing and distributing medicines in a correct manner and following up on the progress of products accurately.
Marketing right holder (marketing company)
This license is granted to companies that work on marketing medicines and pharmaceutical preparations in the local market. The companies applying for this license are required to meet the necessary health, technical and security conditions to maintain the quality of the products.
Scientific office license
This license is granted to companies that conduct research and scientific studies related to drugs and pharmaceuticals. The companies applying for this license are required to have the necessary scientific and technical personnel to carry out these studies with high quality and in accordance with approved international standards.
A local agent or distributor of medicines
This license is issued to companies and individuals who distribute medicines in the local markets. Applicants for this license must meet the necessary health, technical and security conditions for distributing medicines in a correct manner and following up the progress of the products accurately.
Pharmaceutical factory license
This license requires the factory to comply with the quality, health and safety standards required for the production of medicines. The factory is evaluated and production processes, quality standards and audits required to obtain this license are examined.
Narcotics licensing
It is a license granted by the Food and Drug Authority to the facility for the production and marketing of narcotic drugs that are used in therapeutic health care and anesthesia, and this includes the evaluation and effectiveness of these drugs, and the necessary criteria for obtaining this license are determined.
Facility license in the DENR National Register
This license allows identifying and registering facilities that produce and market chemicals and products subject to the control of the Food and Drug Authority, and the facility must comply with the health and environmental standards necessary to obtain this license and remain within the national register.
Third: cosmetic licenses
Cosmetic products are one of the products that are subject to the supervision of the Food and Drug General Authority in the Kingdom, so they are divided into several types as follows:
Beauty store license
A permit granted to a warehouse that stores and distributes cosmetics after completing all health and environmental conditions and requirements required by the Food and Drug General Authority. All stored and distributed products must comply with safety, quality, effectiveness and chemical composition requirements.
Cosmetic factory license
A permit granted to factories that manufacture cosmetics. This license includes manufacturing procedures, analysis, quality control, risk and safety management, and compliance with quality and health safety standards set by the Food and Drug Authority.
Online store for cosmetics
A license issued to a website that allows customers to purchase cosmetics online, and the website must comply with all health and environmental requirements set by the Food and Drug Authority and electronic security requirements.
Beauty labs
It is a facility that specializes in conducting tests and analyzes for cosmetics. This facility obtains a license from the Food and Drug Authority, and it complies with international standards for the quality and safety of cosmetics.
Fourth: medical devices
Licenses for medical devices from the Food and Drug Authority in the Kingdom are divided into several types, all of which follow the terms of a warehouse license from the Food and Drug Authority, and their types are as follows:
Medical devices warehouse license / private or storage with third parties
This license allows warehouses to securely store and maintain medical devices such as electronic medical devices, surgical instruments and other devices used in the medical field, and also allows devices to be stored with third parties.
MDEL importer and distributor license
This license requires importers and distributors of medical devices and medical equipment to be registered in the (Medical Device Establishment License) and it is issued by the Food and Drug Authority. This license requires that the necessary quality conditions for medical devices and equipment be met and that the necessary certificates and documents are available.
MDIL Import License
This license allows importers to import medical devices and medical equipment, provided that quality certificates and necessary documents are available. Products need to obtain a license from the Food and Drug Authority before being used in the market.
Import license for an online store
This license allows electronic stores that sell medical devices and medical equipment to sell via the Internet, and the products need to be licensed by the Food and Drug Authority before they can be used in the market.
Medical devices factory license
A medical device factory license is a license from the Food and Drug Authority for any factory that produces or manufactures medical devices in the Kingdom of Saudi Arabia. This license is regulated in accordance with the quality, safety and effectiveness standards set by the Food and Drug Authority.
Fifth: veterinary medicines
All veterinary medicines in the Kingdom of Saudi Arabia are subject to work under the supervision of the Food and Drug General Authority according to clear standards and conditions for all, and the types of licenses for veterinary medicines are:
Veterinary medicine warehouse license
A permit that allows warehouses dealing with veterinary medicines to store and distribute these medicines in the Kingdom, after they fulfill all the requirements of the Food and Drug General Authority.
Marketed global veterinary company
A permit that allows international companies specialized in the production and marketing of veterinary medicines to sell their medicines in the Kingdom. Obtaining this permit requires that their products comply with the health standards and requirements imposed by the Saudi Food and Drug Authority.
Veterinary drug agent
A permit granted to individuals or companies to be able to distribute veterinary medicines within the Kingdom, provided that the agent is registered with the Food and Drug General Authority.
Veterinary medicine factory license
A permit that allows factories specialized in the production of veterinary medicines, after meeting all the requirements and standards imposed by the Saudi Food and Drug Authority, to manufacture and produce veterinary medicines in the Kingdom.
Sixth: pesticides
Pesticides are dangerous products that require a license from the Food and Drug Authority before working on their production and distribution, and they are divided into two types as follows:
License to import public health pesticides and disinfectants
It is the license of the Food and Drug Authority for companies that import and distribute pesticides and disinfectants, and the company must achieve the specified standards to ensure the quality of imported products and ensure public health safety.
Pesticide factory license
It is a permit issued by the Food and Drug General Authority for factories that produce pesticides. This license includes strict conditions and standards to ensure the quality of products and public health safety, in addition to the factory’s commitment to the procedures to be followed in the production, manufacturing, storage and distribution operations.
Seventh: fodder
Feed licenses from the Saudi Food and Drug Authority are divided into three types:
A license for a warehouse and distributor of feed / feed additives
It is a permit that allows the establishment to store and distribute foodstuffs designed for use in animal feed, including feed additives that are used to improve feed qualities and effectiveness.
Feed factory license / feed additives
It is a permit that allows the establishment to produce foodstuffs designed for use in animal feed, including feed additives that are used to improve feed qualities and effectiveness.
Feed warehouse license / feed additives
It is a permit that allows the establishment to store foodstuffs designed for use in animal feed, including feed additives that are used to improve the qualities and effectiveness of feed, without being produced in a warehouse.
Documents required to issue a license to the Food and Drug Authority
Each of the above-mentioned establishments differs in the way the Food and Drug Authority license is issued according to the requirements of each facility and the type of products they operate in, but they all need some documents and fixed documents, which are:
- A commercial register for the required activity.
- Quality System SOPs (Standard Operating Procedure Files).
- Owning a warehouse or renting a warehouse with others.
- Payment of fees.
Obtaining an import and distribution permit for most import and distribution activities requires obtaining a warehouse license for the Food and Drug Authority, as there must be an independent warehouse to obtain the license or a lease contract for space from another warehouse licensed to lease it to others, in order to enable the institution or company to engage in import and marketing activity. And distribution for the products to be entered, and after obtaining the authority’s permit, the establishment can register the products to complete the import and distribution process.
Requirements for a warehouse license from the Food and Drug Authority
Establishments that wish to obtain an FDA warehouse license for medicines, medical devices, or cosmetic products need to fulfill a set of requirements and conditions that are determined by the law and regulatory systems related to these industries, and these basic requirements include:
- Obtain a cover letter.
- Obtain a license form.
- Issuing a permit from the civil defense and the municipality.
- Appointment of a technical director.
- Providing a national identity.
- Providing a lease.
- Applying the requirements for good distribution and storage of medicines and cosmetics.
- Providing conditions for transporting and storing medical devices and products.
- Passing the warehouse inspection by the Authority’s specialists.
Documents required to initially issue the Food and Drug Authority license for warehouses
You must go to the website of the Food and Drug Authority, then choose the electronic services section, then click on the electronic services section for monitoring local markets, choose the service of licensing warehouses and food distribution centers, and fill out the following forms:
- Initial approval request letter to obtain a license for the Food and Drug Authority warehouse or food distribution center.
- Initial approval application form to obtain a license for the Food and Drug Authority warehouse or food distribution center.
- The authorization form certified by the Chamber of Commerce for the person authorized to follow up the application with the Authority and certified by the Chamber of Commerce.
- A copy of the national ID of the person authorized to follow up on the application with the Authority.
- A copy of the valid commercial registry showing the activity of selling / importing / exporting / storing foodstuffs.
- A copy of the national ID for Saudis or a copy of the residence permit for the foreign investor.
The course of procedures for issuing the Food and Drug Authority license for warehouses
- Submit the application on the Baladi website and the Ministry of Municipal and Rural Affairs.
- Send the request to the Food and Drug General Authority and the Ministry of Municipal and Rural Affairs.
- Issuing a municipal license for the warehouse from a distribution center and the Ministry of Municipal and Rural Affairs – Civil Defense.
- Issuance of a license to practice activity for a warehouse or distribution center from the Food and Drug General Authority.
Requirements and documents for renewing the Food and Drug Authority license for warehouses
Go to the Food and Drug Authority’s website, then choose the electronic services section, then click on the electronic services section for monitoring local markets, choose the license renewal service for the food and drug authority’s warehouse and food distribution centers, and fill out the following forms:
- Letter requesting approval to renew a food warehouse or distribution center license.
- The authorization form certified by the Chamber of Commerce for the person authorized to follow up the application with the Authority, and endorsed by the Chamber of Commerce.
- A copy of the national ID of the person authorized to follow up on the application with the Authority.
- A copy of the valid commercial registry showing the activity of selling / importing / exporting / storing foodstuffs.
- A copy of the municipal license.
- A copy of the civil defense license.
- A copy of the national ID for Saudis or a copy of the residence permit for the foreign investor.
- Submitting the application to the Food and Drug Authority.
- Review the application and ensure that the requirements are complete.
- Payment of fees.
- Passing the inspection visit by the inspectors of the Food and Drug General Authority to ensure that the facility applies the health requirements of the warehouse or distribution center.
- Obtaining a license to practice the activity from the Food and Drug General Authority.
In conclusion, we can say that the issuance of the Food and Drug Authority license for warehouses requires many procedures and requirements that must be met, in order to ensure the safety and quality of the products that are stored and distributed, and to ensure the protection of the health and safety of citizens, and therefore all those interested in dealing with this sector must adhere to the standards and procedures required to obtain To obtain a license from the Food and Drug Authority, to provide a suitable environment for storage and distribution, and to comply with the conditions and requirements that guarantee consumer safety and health, you can now contact the Third Partner team so that he can take all these procedures so that you can devote yourself to developing your business.
