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Version number 1.0 30/12/2009 2 هـ ١٣/١/١٤٣١تاريخ ١.٠اإلصدار رقم

Log in to the web site:

http://sdr.sfda.gov.sa

Click on :

Create New Applications

Choose the application according to the type of drug:

a. Human Drugs b. Veterinary Drugs c. Herbal & Health

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1-Type of Application:

Select the type of application:

1. New Drug 2. Generic 3. Biological 4. Radiopharmaceutical

Then complete the required information as shown in the screen.

After you complete the required information Click on save icon.

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In filling out the application form it is not required to be in order.



2-Application Details:

2.A: Names and ATC Code.

Active Substance: Fill in the fields and then click on add icon.

Excipient: Fill in the fields and then click on add icon.

ATC Code: Click on:

And search for the drug After you complete the required information Click on save icon.

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2- Application Details:

2.B:Product Information:

After you complete the required information Click on save icon.


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2.C:Contact Information:

Please fill in the four sections as shown in the image opposite ,then click on save icon.


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2.D: Manufacturers:

Please fill in the three sections as shown in the image opposite, then click on save icon.


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2.E: Certificate of a pharmaceutical Product:

Answer the question then click on save icon


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2.F: Animal Source Material:

If any component of the product contain any animal source material, then check the box and complete the required information ,then click save icon

Otherwise, skip this section.


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3-Scientific Advice:

Complete the required information then click on save icon.

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4‐ Pediatric Development Program:


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5 Application Status:

Select the application status ,then complete the required information then click on save icon.

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6- Fee Due Statement:


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Please refer to the circular No. 3993 dated 15/10/1430 H regarding the service fees which is available in the link below:

http://www.sfda.gov.sa/NR/rdonlyres/0656EFD7-A2DE-4724-8AB6-892398B157C6/0/تعميمالمقاباللماديللخدماتالدوائية.pdf



7- Scheduling:

After choose the meeting from the schedule the time of the meeting it will appear in the bottom of this page , click twice on the time then click on print icon.

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7- Scheduling:

After the click on print icon this window will appear choose from Drop‐down list select Acrobat (PDF) file.

Then, click on Export to save the file in computer then print the application form.

Then, Close this window for continue .


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7- Scheduling:

After printing click on scheduling icon for confirm the meeting.


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8- Inquiries:

This section is specific to the application in which any questions or inquiries from SFDA, the applicant will receive and answer here.

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ance to use sdr system א א א - sfda guidance version 1.0.pdf · guidance to use sdr system א א...

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