Required Documents For Registering A (Conventional/GSL/Herbal) Manufacturer:

• 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 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.

Required Documents For Registering A medical device manufacturing site:

• A Notarized 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 files on their behalf, to the Drug Department of ministry of health and prevention.

• Valid legalized ISO 13485 certificate issued by the competent authority in country of origin.

• Require Legalized valid Business licenses / Manufacturing License issued by the competent authority in country of origin (Attested true by the UAE Embassy In country of origin).

• List of the products manufactured and/or assembled by the site.

• Detailed Company profile.

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

Renewal of registration must be done every 5 years.

Renewal of registration will be in the same fees and procedures.

Manufacturing Site Should have a Marketing Authorization Holder (Legal Manufacturer) & it should be registered on Ministry Of Health & Prevention.

Required documents for MAH registration:

• The application form (part 1) duly filled, signed and stamped by the responsible person in the company.

• 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 Department.

• Legalized company license issued by the competent authority in its country origin, showing all its licensed activities there. (attested true by UAE Embassy).

• Company Profile.

• List of associated manufacturing facilities, if any.

• List of all products dealing with, in the country of origin.

• Evidence of the company's presence in other countries, if available.

For registration of marketing authorization holder (MAH) in UAE MOHAP, applicant can submit the documents with the site registration application OR by submitting the required documents through the courier to drug department of ministry of health & prevention.