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Frequently Asked Questions (FAQs) |
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Q. What is the DENR? |
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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. |
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Q. If the establishment is registered in DENR does it mean that it is licensed
to work? |
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A. No. |
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Q. Who should register in DENR? |
A.
The followings should register in DENR:
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Pharmaceutical Companies,
• Pharmaceutical Manufacturers,
• Agents.
• Wholesale distributors.
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Q. Is it necessary to register the establishment in DNER system even if it was
registered at Ministry of Health (MOH)? |
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A. YES |
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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
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Q. How to apply? |
A. It is easy to do by following the steps:
1. Go to the link:
http://denr.sfda.gov.sa/
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. |
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Q. What is the required documents for registration? |
A.
- 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.
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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
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Q. Do I need to update my profile? |
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A. Yes, you should update your profile as needed. |
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Q. Who to contact if I need assistance? |
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A. If you need assistance, call SFDA using the following number: 19999 |
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