Health Product Regulatory Support
MOHAP Product Registration in UAE
Professional support for classifying, preparing, submitting, renewing, and amending health product registration files for UAE market access.
Health Product Regulatory Support
Professional support for classifying, preparing, submitting, renewing, and amending health product registration files for UAE market access.
MOHAP product registration has historically covered regulated healthcare product categories such as conventional pharmaceutical products, biological products, medical products, medical devices, and general sale pharmaceutical products. MOHAP's official conventional pharmaceutical product service allows eligible clients to submit applications to register conventional, biological, or other human pharmaceutical products for importation and trading within the UAE.
The UAE regulatory landscape is evolving, and MOHAP has announced the transfer of selected product-related services to the Emirates Drug Establishment. PROXPAT helps companies confirm the correct current route, prepare compliant documents, and coordinate the submission pathway with MOHAP, EDE, or the relevant UAE authority.
Medicine registration files for approved importation, trading, and UAE market access.
Biological and specialty product route review, technical file preparation, and authority coordination.
Health-related general sale product classification, label checks, and registration guidance.
Medical product and device route review, manufacturer documents, and submission readiness support.
Manufacturing site and MAH readiness checks where registration of company or manufacturer is required.
Registration renewal, variation, label update, certificate update, and amendment support.
Product classification and authority route review
MOHAP / EDE pathway confirmation
Applicant company and warehouse readiness review
Manufacturer and marketing authorization holder document checks
Technical file checklist and document organisation
Label, leaflet, claim, and pack artwork review
Certificate, GMP, CPP, FSC, and authorization letter coordination
Online submission guidance and authority follow-up
Remarks, corrections, renewals, and amendments
Import, distribution, and post-registration support coordination
Review ingredients, formula, intended use, label claims, dosage form, and product category.
Confirm whether the product falls under MOHAP, EDE, Dubai Municipality, or another authority.
Check applicant, warehouse, manufacturer, MAH, agency, and authorization requirements.
Collect certificates, technical files, product specifications, labels, artwork, GMP, CPP/FSC, and supporting documents.
Review file consistency, translations, country-of-origin records, product composition, and authority-specific formatting.
Guide portal steps, document upload, payment readiness, and communication with the relevant authority.
Respond to remarks, corrections, additional requirements, committee review, and final approval steps.
Support renewals, amendments, import documentation, distribution approvals, and regulatory updates.
Document requirements vary by product type, authority route, manufacturer location, registration status, and intended claims.
Valid applicant company or licensed warehouse details
Manufacturer and marketing authorization holder documents
Product formula and ingredient list
Certificate of Pharmaceutical Product or Free Sale Certificate, if applicable
Good Manufacturing Practice certificate
Product specifications, method of analysis, and stability data where required
Label, leaflet, pack artwork, and Arabic/English text where required
Authorization letter, agency agreement, or appointment letter
Country-of-origin registration or approval documents
Any authority-specific laboratory, sample, or technical file requirements
UAE regulated product registration experience
MOHAP, EDE, and Dubai Municipality route awareness
Clear classification and document gap review
Label, claim, certificate, and technical file support
Authority follow-up for remarks and corrections
Support beyond registration for renewals and amendments
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PROXPAT helps health product companies prepare compliant files, confirm the correct UAE authority route, and move through registration, renewal, and amendment steps with clear documentation support.