1/3 Submitting a license application that specifies the type of activity and its location, and filling out the relevant forms.

2/3 Providing a copy of the Commercial Register indicating the activity of the establishment.

3/3 Obtaining the necessary licenses from the relevant authorities.

4/3 The pharmaceutical consultation center must occupy an independent location if the center's activity includes bioequivalence and bioavailability studies or a laboratory for analyzing pharmaceutical and herbal products.

5/3 Meeting the technical requirements specific to each activity as published on the Authority's website.

6/3 Meeting the technical requirements and conditions stated in the Private Laboratories Licensing Guide in the case of licensing the activity of analyzing pharmaceutical and herbal products.

7/3 Fulfilling any other conditions, requirements, or circulars specified by the Authority and published on its website.

1/4 The Environment Authority is responsible for granting licenses for wholesale warehouses dealing in pharmaceutical and herbal products, after fulfilling the licensing requirements published on the Authority's website.

2/4 In the case where the warehouse trades in narcotic substances and psychotropic substances, a licensed Saudi pharmacist must be appointed as the warehouse manager, who will be responsible for it. If the warehouse manager is a pharmacist, there is no objection to appointing a licensed Saudi pharmacy technician who will be responsible for the narcotic substances and psychotropic substances.

3/4 The warehouse must comply with the requirements of the Code of Good Distribution and Storage Practices.

4/4 The branches of the warehouse must meet the same conditions as the original warehouse.

5/4 Approval from the Authority must be obtained when wishing to make any changes to the name, address, location, or responsible manager of the warehouse.

6/4 The licensing conditions stipulated in this law and its executive regulations must be met in the case of sale, waiver, transfer of ownership of the warehouse, or any other transaction.

7/4 The warehouse must sell medications to all licensed establishments authorized to sell pharmaceutical and herbal products in a balanced manner that prevents the monopolization of a specific item at certain pharmacies or herbal product selling establishments to the exclusion of others.

8/4 The warehouse must have a comprehensive electronic system integrated with the electronic tracking system approved by the Authority.

9/4 The necessary licenses must be obtained from the relevant authorities.

10/4 Compliance with the provisions and responsibilities between the lessor and the lessee, as well as the special storage conditions for others published on the Authority's website, is required.

11/4 Fulfillment of any conditions, requirements, or other circulars specified by the Authority and published on its website.

1/5 The Authority grants licenses for pharmaceutical and herbal product factories after fulfilling the licensing requirements published on the Authority's website.

2/5 The technical manager must be a licensed Saudi pharmacist dedicated to practicing the profession, as determined by the Authority and published on the Authority's website.

3/5 A qualified person must be appointed to release the operations according to what the Authority specifies and publishes on its website.

4/5 Pharmaceutical and herbal product factories must adhere to the principles of good manufacturing practice published on the Authority's website.

5/5 In the case of manufacturing narcotic substances or psychotropic substances, a licensed Saudi pharmacist must be appointed to be responsible for monitoring them.

6/5 The Authority must be notified when there is a desire to expand the factory or carry out construction work on the production lines.

7/5 The licensing conditions stipulated in this law and its executive regulations must be met in the event of sale, waiver, transfer of ownership of the factory, or any other disposition.

8/5 The branch of the factory must meet the same conditions as the original factory.

9/5 Approval from the Authority must be obtained when there is a desire to change the name of the factory, its address, location, or technical manager.

10/5 The factory must have a comprehensive electronic system integrated with the electronic tracking system approved by the Authority.

11/5 The necessary licenses must be obtained from the relevant authorities.

12/5 Fulfillment of any other conditions, requirements, or circulars specified by the Authority and published on its website.

1/7 The duration of the License for the pharmacy establishment is calculated from the date of its issuance.

2/7 The owner of the pharmacy establishment must submit a request for the renewal of the granted License at least three months before its expiration.

3/7 The authority shall renew the License for the pharmacy establishment after the completion of the Justifications and regulatory requirements, and the establishment shall not bear any responsibility for the delay in renewing the License if it submits the renewal request within the regulatory period and completes the Justifications for renewal.

1/9 A pharmacy establishment may not employ pharmacists, pharmacy technicians, or other healthcare practitioners unless they have obtained a license to practice the profession from the competent authority. 

2/9 The percentage of Saudi pharmacists from the total number of pharmacists working in pharmacy establishments owned by the same owner is subject to the standards set by the Ministry of Human Resources and Social Development in the professional categories according to regions and governorates.

3/9 Healthcare practitioners working in the pharmacy establishment must comply with the Law on the Practice of Health Professions and its executive regulations.

4/9 The owner of the pharmacy establishment must notify the authority in the event that the manager of the establishment wishes to leave their position, and a new manager must be appointed for the establishment in accordance with the provisions of this law and its executive regulations within a period not exceeding ninety days. The operation of the pharmacy establishment is prohibited after this period if there is no manager.

5/9 Except for the exception stated in Article (4/9), the operation of the pharmacy establishment without a manager is prohibited.

6/9 If the custodian wishes to leave their position, they must hand over the controlled substances and psychotropic materials in their custody in accordance with the procedures and regulations regarding controlled substances and psychotropic materials.

1/10 The roles of employees in the field of advertising and promotion of pharmaceutical and herbal products are limited to Saudi pharmacists, provided that the mechanism for localizing the jobs of employees in the field of advertising and promotion of pharmaceutical and herbal products issued by the authority and published on the authority's website is adhered to.

2/10 Employees in the field of advertising and promotion of pharmaceutical and herbal products are obligated to comply with the provisions of the Saudi Code of Ethics for Marketing Pharmaceutical Products in the Kingdom of Saudi Arabia, which is published on the authority's website.

3/10 Fulfillment of any conditions, requirements, or other circulars specified by the authority and published on its website.

1/11 The Authority shall determine the price of the pharmaceutical or herbal product according to the mechanism outlined in the Pricing Rules for Pharmaceutical and Herbal Products.

2/11 The Authority shall review the prices of pharmaceutical and herbal products and reprice them according to the mechanism outlined in the Pricing Rules for Pharmaceutical and Herbal Products.

1/13 The packaging of samples of pharmaceutical and herbal products must clearly state in Arabic and English the phrase "Free Sample".

2/13 The distribution of free samples must be limited to the introduction of the medication to doctors and pharmacists, and they may not be sold or dispensed to patients, nor distributed to the public. They are not allowed to be kept in pharmacies and establishments selling herbal products.

3/13 The distribution or circulation of free samples of narcotic drugs or controlled substances is prohibited.

4/13 The free samples allowed for distribution must not exceed 1% of the quantity imported or locally manufactured of the pharmaceutical or herbal product.

5/13 Licensed healthcare practitioners at a pharmacy establishment are prohibited from receiving any material or in-kind benefits from companies, agents, distributors, or warehouses for the purpose of promoting, marketing, or directing a patient to a product with a specific trade name.

1/14 The Authority shall determine the list of pharmaceutical and herbal products that can be sold outside pharmacies and establishments selling herbal products.

2/14 The Authority shall specify the locations and conditions required for the sale of pharmaceutical and herbal products outside pharmacies and establishments selling herbal products.

3/14 All establishments selling pharmaceutical and herbal products are required to report transactions in the Trace system and ensure that their sales systems are integrated with the electronic Trace system approved by the Authority.