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Note: For more details please, refer to:
- Regulatory Framework for Drug Approvals.
- Guidance for Submission.
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Q.
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What is the SDR?
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A.
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The Saudi Drug Registration (SDR) System is an electronic system which aims to facilitate
the registration of medicinal, herbal and health products for both Human & Veterinary
use.
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Q.
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How can I access SDR?
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A.
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You need to have an account in the Drug Establishment National Registry (DENR).
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Q.
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If the establishment is not registered in the DENR, can I use the SDR?
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A.
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No, you cannot.
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Q.
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Who should use the SDR?
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A.
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All the companies that are interested in marketing the drug in Saudi Arabia.
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Q.
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When I can login or access the SDR?
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A.
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You can login or access anytime during the day & night.
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Q.
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What are the required information & documents?
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A.
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Please, refer to the "Guidance for Submission".
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Q.
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How to submit an application?
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A.
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To submit an application, you will have to do the following:
- Choose the appropriate application.
- Complete all the required information.
- Then, you can submit the application.
- Afterwards, choose the available appointment to hand the drug file over to the drug
registration building
"Note that you can save the application at any section and complete it later. Also,
you can edit any information in the application before submitting It.” For more
information please refer to the “Guidance to Use the Saudi Drug Registration (SDR)
System”.
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Q.
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What happens after taking an appointment?
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A.
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On the appointment day you have to be on time and to bring with you all the required
documents For more information please refer to the” Guidance for Submission.”
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Q.
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Can I postpone my appointment that I have chosen?
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A.
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Yes, you can do that one week before the appointment.
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Q.
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What happens if I missed my appointment?
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A.
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The SDR automatically will reschedule for a new appointment.
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Q.
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Who to contact if I need assistance?
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A.
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For help please send an email to
sdr.drug@sfda.gov.sa Or call SFDA on the following number: 1999 call Center.
5349 or 5324 or 5360 or 5358.
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