The SFDA Dossier requirements differ for each application. What is important to note is that the CTD provides a format for an MAA (Marketing Authorization Applcication)
Also to be noted is that regional and national requirements may affect the content of a dossier and will not necessarily be identical for all regions.
Module 1 – Regional Administrative Information
Includes required regional information specific to GCC. For example, administrative information and certificates
Hardcopy And Softcopy Requirements
The selected documents of module 1 should be bound into one volume (flat file) having the following specifications
- Should be A4 and lightweight
- It should have a clear front and opaque back cover with removable title strip
- Should have a two-hole flat bar filing mechanism
- Should have a label clearly depicting the following information
- Reference number generated from the SDR system
- Company name
- Product trade name
- Product generic name
- Date of submission in DD/MM/YYYY format
- The type of submission – Initial, renew or variation
Softcopy (electronic based) Requirements
Each CD or DVD and the outer plastic cover should include the following label information, clearly printed on the media using 12 size Times New Roman font (or equivalent)
- The reference number
- The company name
- The product Trade name
- The product Generic name
- The submission type of each submission(s) contained on the CD/DVD – Initial, renew or variation
- The sequence number(s) of the submissions contained on the CD/DVD (e.g. 0003)
- Number of copies
- Applicants should submit:
- THREE (3) softcopies
- and ONE hardcopy of selected documents of Module 1 for all drug
- Applicants should submit:
- Submission types – Initial, renew or variation
Note that the submitted copies should be identical and in ONE media only (CD or DVD). For example, if the submission size is above 750MB then a DVD needs to be used instead of a CD.
Type of Media for the electronic submission:
- The electronic submission may only be submitted in single or dual layer CDs or DVDs
- The disc must not be a bootable DVD or have any auto-start programs
- Both CD-ROM and DVD ISO 9660 formats are accepted
Note that the SFDA will not accept any hardware (laptops, desktops, USB drives, hard drives etc.) as part of the electronic submission. Applicants need to only use the approved formats as noted above.
- The electronic submission must be directly readable and usable on SFDA hardware and software.
- Should be compatible with the latest windows operating systems and a reasonable number of earlier windows operating systems
The applicant is responsible for the physical security of the submission during transportation/transmission.
After receiving the submission, the SFDA will be responsible for the security and submission integrity and the SFDA will take appropriate measures to prevent any loss, unauthorized duplication and/or access or theft of regulatory information presented both on paper and electronic media distributed through the SFDA
Password protection or file level security of electronic submissions is not acceptable at the SFDA. The documents submitted should allow printing, annotations to the documents and selection of text and graphics contained in the document. The internal controls in the SFDA will maintain the integrity of the submitted files.
The applicant is responsible for checking the submission for viruses and malware.
An up-to-date and well-recognized Anti-virus application needs to be used to perform the virus checks.
The SFDA will at the time of submission perform a similar internal virus check and any form of virus or malware found will lead to a refusal of the electronic submission.
Legibility and Size:
All documents should be legible and easily readable. The layout of the documents including the page size and any tables must be uniform throughout the document
Appropriate Page divider or tab needs to be used to separate the sections in the documents as shown below:
All submitted information and documents regarding drug application – for example certificates and approval letters– must be either in Arabic or English. If they are in another language, then they must have a corresponding authorized translation to English and authentication from the Saudi embassy in the COO.
Also known as legalization – refers to the attestation and authentication of documents to the SFDA by the Health authority and/or the ministry of foreign affairs in the country of origin in addition to the Saudi Arabian embassy or consulate.
Read more about the standards followed by SFDA.
This information is being provided ‘As Is’ with no claims of suitability for a particular purpose. It represents just one possible interpretation of information available in the public domain or through membership organizations, and that interpretation is subject to change. This information does not constitute legal advice. Users must refer to the source material for the complete requirements and form their own interpretation before making business decisions. Please use the references below to follow the updates at the source.
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