Set up a Pharmaceutical Company in the UAE

Mainland or Free Zone, which is right for you?

In the UAE there are two main jurisdictions for companies: mainland and free zone.

A mainland DED license allows your company without any limitation to trade and provide services anywhere in the UAE or internationally.

Free-trade zones are special economic areas set up with the objective of offering tax concessions and customs duty benefits to expatriate investors.

set up a Pharmaceutical Company in the UAE

Mainland

The Process:

• Trade name reservation
• Initial approval issuance
• Obtaining approval from Dubai Municipality and Ministry of Health & Prevention (MOHAP) (information on steps and requirements below)
• Final Approval issuance
• Payment voucher generating
• Obtain a DED license

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Ministry of Health & Prevention(MOHAP) License requirements:

What are the steps?

1. Initial inspection (The document for the citizen owner must be received from the Customer Happiness Center and attached to the system)

2. Initial approval (Issuing a commercial license for the facility after obtaining the initial approval)

3. Submit the final approval transaction + final inspection

4. Final approval + presence of a responsible pharmacist

Medical Warehouse Requirements:

Medical warehouse license terms

1- It should be on the ground floor and far from residential areas.

2- Construction of the warehouse, must be of concrete with the roof concrete or any other non-flammable material. The building must ensure no water leakage and is insulated against heat and humidity. The height of the ceiling is restricted to 270 cm minimum.

3- The size of the warehouse must be 50 square meters or larger and shall be proportional to the size of the stock. Admin offices are not included in the dimensions.

4- The warehouse floor must be covered with ceramic or any other non-flammable, cleanable material. The ground floor must be level (not below) the public road level. All the doors are required to be a minimum of 120 cm wide.

5- Windows for ventilation and lighting must be covered with a fabric of narrow wire to prevent the entry of flies and insects.

6- The wood intended for lifting materials must be clean, greased, and treated against insects.

7- A toilet and washbasin for workers must be available and not open to the storage site.

8- The availability of contracts with the competent authorities for the disposal of liquid and solid medical waste, and the sewage openings must be covered with new covers.

9 – If the warehouse has multiple levels, the ground floor area shall be limited to a minimum of 35 square meters. The minimum height for each floor shall be 270 cm.

10- The warehouse shall not have an outlet connected to a medical clinic, residence, pharmacy or any place of medical activity.

11- The name of the warehouse must be in Arabic on the plates and in large letters, and the name of the warehouse can be written in English with the Arabic language.

The Design:

The warehouse should be divided into:

* The receiving and delivery area

* Storage places (separate for the mentioned materials) which are:

– Chemicals

– Radioactive materials

– Narcotic drugs

– Psychotropic substances

– Expired medicines

– The products area rejected or not valid for use

– Medical devices, equipment, and supplies

* The area of the distribution and transportation process

* Must be available (pharmacist office – fixed phone – fax – computer – internet service and warehouse email)

* A place must be available for the archive to keep documents, documents, laws, scientific references, and decisions issued by the ministry

* Good and adequate lighting must be provided.

General Requirements:

Security and safety requirements. Emergency equipment, fire extinguishers, and smoke detectors must be available and in good working order.

– A backup generator must be available in every warehouse

– Fixing the license for the warehouse and the pharmacists working on the wall in a visible place.

– The warehouse must contain cabinets – wooden floors treated against insects – metal shelves for storing medicines – a cabinet for storing the controlled medicines, group A and group B in a separate place.

– The information mentioned in the order records includes (date of exchange – the name and address of the buyer – description and details of the product – batch number – storage conditions) and copies of the bills and certificates of analysis must be preserved throughout the product validity period.

– Provide a first aid box

– The electrical wires should not be exposed

– Flammable materials, chemical materials, and any hazardous materials are not discharged into the sanitation.

– The warehouse temperature shall be regulated between 15 and 20 degrees Celsius, with humidity less than 60%. An appropriate number of air conditioning units is required. The glass facades exposed to the sun must be covered with suitable curtains to protect the medicines from heat and sunlight.

– Refrigerators and freezers must be available to store pharmaceutical preparations that need to be cooled or frozen (except for warehouses of medical devices and equipment).

– Provide a digital thermometer to measure the temperature and humidity and be distributed it throughout the warehouse. For medicines stored at 25 degrees, the temperature must be checked twice a day. Medicines stored in the refrigerator must be checked three times a day.

• To combat cold air leakage, plastic or air curtains shall be at the doors where loading and unloading are needed.

– Providing devices to repel insects according to the size of the warehouse.

– Provide traps for insects and rodents at the entrances and the receiving and delivery area, and they are specially prepared for use in medical warehouses.

– Employees must wear clean and protective clothing from work hazards.

– The cabinets and shelves for storing medicines must be cleanable.

.set up a Pharmaceutical Company in the UAE

How to get approval from Dubai Municipality/Environment Department

1. You need first to register in Dubai Municipality(DM) Portal at https://www.dm.gov.ae and create an account for the company. For Registration assistance, kindly contact the DM Esupport at 800900.  

2. Use your user account (user name and password) to login in Dubai Municipality portal and select Business Services.

3. Log in as Business

4. Click on services.  

5. Choose Request for Environmental Clearance for Industrial Project and then Press on Apply for service.

6. Select the application type (Private OR Mohammed Bin Rashid Establishment for young business leaders) based on the application type.   

7. Select the proper Service request based on your type of application (Environmental Clearance (EC) for a new company).

 Fill in the requested information and attach the following documents to its designated. (S. No.) numbers!

• Dubai Economy (DE) Documents:
  • Registration & Licensing Application form
  • Details of Business Site location (duly stamped by the Dubai Municipality Planning Department)
  • Trade Name Reservation Certificate
  • Initial Approval Inquiry Receipt with Transaction Number
• EIA (summary report or full report) will be based on the production capacity, can you please send us a technical brief about the product type and capacity to advise you well.
• Initial Tenancy contract
• DE commercial register copy or Memorandum of Association for the company capital cost value.  DM fees will be 0.1% of the capital cost
• Letter appointment from the project/ Company owner to the applicant to secure the EC on their behalf

.set up a Pharmaceutical Company in the UAE

Free Zone

Dubai Healthcare City (DHCC) is the first medical-free zone in the world. The rapidly increasing population growth and economic boon in the Middle East have given Dubai Healthcare City the impetus to provide local and international patients with an extensive range of medical care. With a total number of 19,523 healthcare professionals, in the private and public sectors including 6,064 doctors, Dubai is the perfect platform for DHCC.

About the free zone setup

• 100% foreign ownership
• no custom duty
• no restrictions on capital, trade barriers, or quotas
• competitive pricing

Commercial benefits are the followings:

• Low operating costs
• State-of-the-art facilities
• Flexible real estate design to suit the industry
• Integrated healthcare community providing specialized first-class medical care
• Access to a network of regional healthcare professionals
• Attractive investment opportunity and financial return
• Increased brand exposure

 Business Convenience:

• No bureaucracy
• One-stop shop for government services
• Business support services
• Hassle-free company registration
• Hassle-free company laws and legal framework
• Quick access to knowledge workers (due to fast track immigration process)

Please find below the steps to set up a company in Dubai Healthcare City(DHCC):

Step 1: Selecting your unit:

The first step is to choose your unit in DHCC and sign a reservation agreement (10% of the annual rent, refundable in case the initial application got rejected in step 2) & Admin fee (the admin fee is non-refundable in case the initial application in step 2 got rejected).

To be able to assist you to find the best location, please advise on the space size you’re looking for.

Please note the below units’ options:

• Average unit size is: 1,000 – 1,500 sq.ft.
• Average annual rent is: 190 AED/ sq.ft.

** Please note the above units are reserved on a first come first serve basis     

Step 2: Submitting the Initial Application Form: ** Please note that all applications submitted to CPQ are subject to approval or rejection.

http://www.dhcr.gov.ae/en/E-Services/ServicesListing?DepartmentID=2

• Application Review

Step 3: Commercial License – Free Zone Authority:

http://www.dhcr.gov.ae/en/E-Services/ServicesListing?DepartmentID=2

If approved, you can proceed with signing a lease agreement with the Leasing & Tenant Relations Department on the selected location.

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