Company Registration
- Manufacturer Site Registration - MOHAP
- Scientific Office Registration & Licensing - MOHAP
- Medical warehouse/Drug Store/ Pharmacy Registration & Licensing -MOHAP/DHA
- Company Registration - Chamber of commerce
- Company Registration - FTA (VAT Certificate)
- Company Registration - Dubai Municipality & Montaji
- Custom Code (Import/Export)
Manufacturer Site Registration - MOHAP (UAE)
The Ministry of Health and Prevention registered products, the Company and Manufacturing Sites must be registered by the Ministry of Health and Prevention.
The structures are part 1 (for Marketing Authorization Holder MAH) and part 2 (for manufacturing site), toward the end of each structure there is a list of documents that are required to be attached alongside the structure, the applications must be filled as well as stamped. Submit the application through the electronic service.
Documents Required
The applicant must be a medical warehouse licensed by MOHAP.
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 the 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.
Service completion duration: 2 to 4 weeks
Service fees:
Application: AED 100
Registration of a medical products manufacturer: AED 10,000
Validity: 5 years.
Renewal of registration will be in the same fees and procedures.
Scientific Office Registration & Licensing - MOHAP (UAE)
A ‘Scientific Office’ is essentially a representative office of an overseas pharmaceutical company which manufactures pharmaceutical drugs. A Scientific Office, whether established in onshore Dubai or in a free zone must be licensed by the UAE Ministry of Health.
Service completion duration: 5 working days
Service fees:
Application fee: AED 100
Initial inspection Fee: 1,000 AED per inspection
- Initial approval will be valid for six months only,
Final inspection Fee: AED 10,000
Medical staff (pharmacists) :
Application Fee: AED 100
License Fee: AED 1,000
Validity: One Year, Renewal must before expiry.
Medical warehouse/Drug Store/ Pharmacy Registration & Licensing -MOHAP/DHA
Medical warehouses, Drug stores, pharmacies must be licensed by the UAE Ministry of Health. Dubai Health Authority (DHA) licensed must open the pharmacy in Dubai Emirates.
MOHAP-Registration & Licensing
Service completion duration: 5 working days
Service fees:
Application fee: AED 100
Initial inspection Fee: 1,000 AED per inspection
- Initial approval will be valid for six months only,
Final inspection Fee: AED 7,500
Medical staff (pharmacists) :
Application Fee: AED 100
License Fee: AED 1,000
Validity: One Year, Renewal must before expiry.
DHA-Registration & Licensing
Processing Time: 10 Working days
Service Fee:
New Facility License: AED 1000
Activate Facility License: AED 5000
Inspection fee:AED 2000
Re-inspection fee– AED 1000
Add-on Yearly fees: Telehealth: AED 14,000
Validity: One Year, Renewal must before expiry.
Company Registration - Chamber of commerce
All commercial and industrial businesses in Dubai must be registered with the Dubai Chamber of Commerce & Industry (DCCI) unless you are a very small trading outfit or professional. Once your company has been formerly recorded in the DCCI register, it is entitled to import and export goods in Dubai.
Processing Time: 1 day
Validity: 1 Year
Company Registration - FTA (VAT Certificate)
Value Added Tax (VAT) was introduced in the UAE on 1 January 2018. The rate of VAT is 5 percent. Criteria for registering for VAT: A business must register for VAT if its taxable supplies and imports exceed AED 375,000 per annum.
It is optional for businesses whose supplies and imports exceed AED 187,500 per annum.
Service completion duration: 20 working days
Service Fee: Free
Company Registration - Dubai Municipality & Montaji
Before starting the product registration, your company must have a valid license with related activity to a consumer product category, and you need to create an account on the Dubai Municipality portal and Montaji.
Once you have a valid license in place, it’s time to start the product registration.
Service completion duration: 24 Hours
Custom Code (Import/Export)- ICE
An Import-Export Code (IEC) issued by the relevant customs department in UAE is required to import goods from a foreign country into UAE or to export goods produced in UAE or to re-export goods earlier imported into UAE.
Service Fee: AED 100
Validity: 1 Year
Renewal existing code fee: AED 25