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 Frequently Asked Questions (FAQs)
Q. What is the DENR?
A. Drug Establishments National Registry (DENR) is An electronic system aims to build-up a national database for all drug establishments including companies, manufacturers, agents and wholesale distributor in Saudi Arabia.
Q. If the establishment is registered in DENR does it mean that it is licensed to work?
A. No.
Q. Who should register in DENR?
A. The followings should register in DENR:
          • Pharmaceutical Companies, 
          • Pharmaceutical Manufacturers, 
          • Agents. 
          • Wholesale distributors.
Q. Is it necessary to register the establishment in DNER system even if it was registered at Ministry of Health (MOH)?
Q. Why registering in DENR is so important?
A. It is important for the following reasons: 
          • To build-up a database for all establishments in Saudi Arabia. 
          • The registered establishments will be able to use other drug sector electronic systems 
          • To improve communications between SFDA & Establishments
Q. How to apply?
A. It is easy to do by following the steps: 
          1. Go to the link:
          2. Press the button “Create a New Account”.
          3. Create a user ID and password.
          4. Choose the type of your establishment.
          5. Complete the form and submit it.
          6. A code will be sent to your email to activate your account.
          7. After activation, complete the full information.
          8. Submit the form.
Q. What is the required documents for registration?
- For International Company: 
          1. A copy of manufacturer registration certification. 
          2. A copy of technical contract with the agent which represent the company. 
          3. A copy of manufacturer license from Ministry of Health/SFDA.

- For Local Company: 
          1. A copy of commercial Record. 
          2. A copy of manufacturer registration certification. 
          3. A copy of technical contract with the agent which represent the company. 
          4. A copy of manufacturer license from ministry of Health/SFDA. 
          5. A copy of direction sketch for factory location.

- For Agent/Wholesale Distributor: 
          1. A copy of commercial Record. 
          2. A copy of warehouse certificate issued by the ministry of health/SFDA. 
          3. For Agent only, a copy of technical contract for companies represented by the agent.
          4. A copy of warehouse license.
Q. What happens after submitting the registration request?
A. Once the registration request has been submitted, the applicant will receive an e-mail confirming the submission. Then, the applicant will receive on e-mail of the SFDA decision concerning his/her application. The decision will be one of the followings:
          • Accepted: your application has been approved. 
          • Incomplete: the applicants will be required to submit the missing information within 
             2 weeks; otherwise the application will be rejected. 
          • Rejected: if the application contains false data, the application will be rejected
Q. Do I need to update my profile?
A. Yes, you should update your profile as needed.
Q. Who to contact if I need assistance?
A. Applicants who need assistance could go to “contact us” on the home page menu or send an email to or call SFDA on the following number: 0112038222 EXT. 5335 or 5371