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About this service

This service enables medical companies and manufacturers to submit their applications to amend their registration data.

Service process

  • Login to the MoHAP website or smart app using the UAE PASS

  • Submit the request online, meet all conditions and pay the required fees

  • The competent technical committees will examine the file and refer it to the competent ministerial committee

  • Letters are to be addressed to the concerned companies stating the committee's decisions

  • The customer will follow up with the Pharmacological Analysis Section of at the Drug Control Department

  • The company should complete the requirements and submit them via electronic service

  • The relevant technical and ministerial committees will re-deliberate the registration of products that have been deferred in advance as soon as companies complete the requirements

  • The certificates of minor changes will be issued after fulfilling all conditions and requirements approved by MOHAP

Required documents

  • A legalized letter issued by the company on its original letterhead, signed and stamped by the responsible person in the company, authorizing a person or a local establishment to submit the registration file on its behalf, to the Drug Control Department. Attested true by UAE Embassy. This person / the local establishment will be responsible to receive the registration certificate from the Drug Control Department

  • Legalized Current GMP Certificate Issued By The Competent Authority In Country Of origin. (Attested True By The UAE Embassy In country of origin).

  • Legalized Valid Manufacturing License Issued By The Competent Authority In Country Of Origin. (Attested True By the UAE Embassy In country of origin).

  • List of medicines manufactured at the manufacturing site.

  • Site Master File

  • Certified copies of certificates of registration/ certificates of good manufacturing practice of the manufacturing site in other countries.

  • A Declaration Letter Issued By The Company On Its Original Letterhead, Signed And Stamped By The Responsible Person In The Company , Showing The Details Of Minor Change With Existing Details & Proposed Minor Changes.

  • Current Registration Certificate Issued By MOHAP UAE.

Conditions and requirements

  • The applicant must be a medical warehouse licensed by MOHAP and must hold a valid license.

  • The Company must provide the valid approval of the competent authorities in the country of origin regarding such submitted changes.

Service completion duration

10 working days

Service fees

  • Certificate of amendment to any registration data of a medical company or a manufacturer with marketing rights: 2000 AED

SDGs Goals

Service locations

Support

Payment channels

  • E-payment

Target audience

  • Medical warehouses

  • Local Pharmaceutical manufacturers

  • Marketing offices

Resources

Service category

Business services

Main service

Medical, Pharmaceutical and Drug Licencing and Registration

Service code

110-04-009-000

Service classification

  • Government to business

Service type

Transactional

Sub service type

Variation

Number of transactions

0

Notes

This service accepts documents authenticated with the UAE PASS Digital Seal.

Start service

Service completion duration

10 working days

Service fees

  • Certificate of amendment to any registration data of a medical company or a manufacturer with marketing rights: 2000 AED

Average rating

0 From 0 Users

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