Product Information and Packaging Translation in Pharmaceutical Registration
This guide focuses on product-information, labeling, and packaging materials in the Saudi Food and Drug Authority (SFDA) pharmaceutical registration context, rather than every company record or every pharmaceutical document. The registration rules specify that the Patient Information Leaflet (PIL) is provided in Arabic and English and the Summary of Product Characteristics (SPC) in English, with both uploaded to the Saudi Drug Information (SDI) platform. The registration review includes Arabic translation of the leaflet, label, and carton. Medication packaging guidance names Arabic and English for storage conditions and includes recommendations on information placement, text direction, and readability. Requirements may vary by product class, registration pathway, guidance version, and product-specific SFDA request, so current instructions should be checked before submission. The available materials do not establish a sworn-translator requirement, fee, deadline, or guaranteed acceptance.
- Patient Information Leaflet (PIL) in Arabic and English
- Summary of Product Characteristics (SPC) in English
- Product or package leaflet
- Product label
- Carton or secondary-package text
- Primary-packaging or container label, subject to applicable guidance
- Storage-condition statements in Arabic and English
- Generic name, brand name, strength, dosage form, and quantity text
- Warnings and over-the-counter indications appearing on packaging, subject to product type
- Approved package image or artwork used in the submission, treated as controlled artwork
Identify the product, product class, and applicable registration pathway, because the pathway and requirements may vary under current instructions.
Prepare the Patient Information Leaflet in Arabic and English and the Summary of Product Characteristics in English as specified by the registration rules.
Prepare the Arabic leaflet, label, and carton materials, noting that the registration review includes the Arabic leaflet, label, and carton.
Include storage conditions in Arabic and English and review information placement, text direction, generic-name and strength clarity, and differentiation between strengths under applicable guidance.
Upload the required materials to SDI or the current application service according to portal instructions. If a registered product changes, submit a change application under the applicable variation requirements.
| Document type | Common use | Note |
|---|---|---|
Must the Patient Information Leaflet be in Arabic and English?
Yes. The registration rules say the Patient Information Leaflet must be provided in Arabic and English.
What language does the rule specify for the SPC?
The registration rules specify English for the SPC.
Where does the rule say the PIL and SPC are uploaded?
To the Saudi Drug Information (SDI) platform; current portal instructions should be verified.
Does SFDA review the Arabic translation of the leaflet, label, and carton?
Yes. Yes, the registration review includes these Arabic materials.
Does review mean acceptance is guaranteed?
No. Review does not guarantee acceptance.
Does this guide require a sworn translator or prescribe a translator list?
No such requirement is established by this guide.
Must every pharmaceutical document be translated into Arabic?
Do not generalize; the confirmed evidence concerns the specified product-information, labeling, and packaging materials.
May the leaflet be omitted from the package?
The registration rules say it may not be included where distribution is limited to hospitals according to the CPP.
Which two languages are named for storage-condition statements?
Arabic and English.
How does the packaging guidance address Arabic and English text direction?
It recommends left alignment for English and right alignment for Arabic.
Should critical information appear on only one face?
No. The guidance recommends the same field of vision on at least three non-opposing faces, with one side for Arabic and one for English.
Do the packaging recommendations prove that every text must be bilingual?
No. They should not be extended beyond the specified elements and design guidance.
What happens when a registered product changes?
A registered-product change requires submitting a change application under the variation requirements guideline.
Does this guide set a translation fee, deadline, or file-size limit?
No. None of those details should be invented.
Which text controls if the English and Arabic regulation texts differ?
The Arabic version controls if the two regulation texts differ.
This guide is for general information and is not legal or consular advice. Always verify current requirements with the receiving authority.