Pharmaceutical regulatory translation for manufacturers, marketing authorisation holders, local agents and distributors in the UAE: patient information leaflets, product information, label and artwork text, dossier sections and the certificates behind a registration, translated between Arabic and English by an MOJ-licensed legal translation office.
Trusted Credentials
Why Regulatory Teams Use Us
Medicines, devices, supplements and cosmetics reach UAE patients and shoppers with Arabic text on the pack and in the leaflet. Errors there are costly to fix once artwork is printed.
Federal Decree-Law 38 of 2024 on medical products made the Emirates Drug Establishment (EDE) the main federal authority for marketing authorisations, import permits, advertising approvals and pharmacovigilance, taking over from MOHAP. MOHAP moved many of the related services to the EDE portal from 29 December 2025, while some remain with MOHAP. The law also brings food supplements and cosmetics within its scope. Executive regulations were still awaited in the sources we checked, so confirm current requirements with the EDE before you finalise a file.
Bilingual Arabic and English product information is standard practice in the UAE, and consumer-protection rules expect mandatory label information in Arabic. The exact wording, placement and which parts must be in Arabic depend on the product type and current EDE or emirate guidance. We translate to match your approved English text; your regulatory team confirms the format.
The active ingredient, dosage form, storage condition and warnings must read the same in the leaflet, on the carton, on the blister foil and in the product information. We build a product glossary at the start and use it across every component, so an Arabic reviewer never sees two names for one thing.
A Certificate of Pharmaceutical Product, GMP certificate, free sale certificate, power of attorney or agency agreement issued abroad is a legal document. It is usually attested first, then translated with every stamp and endorsement. As an MOJ-licensed legal translation office, we deliver certified translations of these alongside the technical files.
Regulatory Files We Translate
Arabic⇄English as standard, and from 50+ source languages. Clinical trial files and device IFUs are covered in our clinical trial and medical device guide.
Package leaflets in plain, readable Arabic that keep every dose, contraindication, side effect and warning exactly as approved.
Summaries of product characteristics and prescribing information, in the precise register healthcare professionals expect.
Carton, blister, bottle and tube text, sent back as clean copy for your artwork studio, with an Arabic check of the final proof on request.
Administrative Module 1 documents, quality summaries, stability statements and other sections the authority or your agent needs in Arabic or English.
Certified legal translation of attested certificates, including every stamp, signature block and endorsement.
Distributor, local agent and authorised representative agreements and powers of attorney, with liability and recall clauses rendered precisely.
Ingredient lists, directions, warnings and claims for cosmetics and food supplements, where label rules vary by product and emirate.
Safety communications, direct healthcare professional letters, adverse event narratives and recall notices, prioritised when time is short.
How It Works
Send the source files (Word preferred), any existing Arabic for related products, and tell us which items need certified translation. We quote per page before work starts.
We fix the Arabic for the product name, active ingredient, dosage form, storage and key warnings, and confirm it with your regulatory contact.
A specialist translator translates, and every figure, unit, dose and negation is checked against the source.
You receive editable files and certified copies where needed. Send us the artwork proof and we check the Arabic before it goes to print.
Who Reads Your Regulatory Files
Transparent Pricing
Excl. 5% VAT
We translate; we are not a regulatory consultancy and do not prepare or submit registration files, quote EDE fees or predict approval. Large dossiers are quoted as a fixed price after we see them.
FAQ
The Emirates Drug Establishment (EDE). Under Federal Decree-Law 38 of 2024 it took over from MOHAP as the main federal authority for marketing authorisations, import permits, advertising approvals and pharmacovigilance. MOHAP moved many of the related services to the EDE portal from 29 December 2025, while some remain with MOHAP. Check the EDE website for current procedures.
Bilingual Arabic and English product information is the usual practice, and consumer-protection rules expect mandatory label information in Arabic. We have not found an EDE text setting the exact leaflet rule for every product type, so confirm the requirement for your product with the EDE or your local agent before printing.
Certificates and legal documents issued abroad, such as a CPP, GMP certificate, free sale certificate or power of attorney, are usually attested and then translated by an MOJ-licensed translator when an authority asks for Arabic. Leaflet and label text is usually not stamped; it has to match the approved product information.
Yes. Send the PDF proof and we check that the Arabic matches the approved translation and that letters are joined and read right to left. Broken Arabic from design software is one of the most common artwork faults. If your studio needs Arabic layout, see our Arabic typesetting service.
Yes. The 2024 medical products law brought cosmetics and food supplements within its scope, while emirate-level product registration (for example in Dubai) also applies to many products. Label-language rules vary by product and authority, so we translate the text and you confirm the format with the registering body.
Arabic⇄English is AED 60 per 200-word page, excluding 5% VAT. Other source languages follow our pricing page. Short labels are counted on their actual words, and full dossiers get a fixed quote once we see them.
Yes. We translate from 50+ languages, so a certificate or product file from the country of manufacture can be translated into Arabic or English.
Yes. Informed consent forms, protocols and device instructions for use are covered in our clinical trial and medical device translation guide, and patient medical reports have their own page.
Tell us when a file contains unpublished formulations, stability data or launch artwork, and we will discuss your confidentiality requirements, including any NDA you need, before you send it.
No. SWLT translates and certifies. Dossier preparation, submission and regulatory strategy belong to your regulatory team, local agent or a regulatory consultancy.
You May Also Need
Consent forms, protocols, IFUs and common submission errors.
Certified translation of patient reports and records.
Right-to-left layout for leaflets, cartons and manuals.
Operating manuals, SDS and technical specifications.
Get an instant estimate — final quote via WhatsApp
Send your leaflet, label text, dossier section or certificates on WhatsApp and tell us which product it covers. We confirm the price per page, build the product glossary, and return editable files plus certified copies of the certificates and agreements.