REGULATORY ENVIRONMENT OF PHARMACEUTICAL COMPANY IN THE UAE
The pharmaceutical industry in the UAE is strongly regulated with the view to ensure that medicines are safe, effective, and of high quality. The regulatory bodies include but are not limited to:
- MINISTRY OF HEALTH AND PREVENTION (MOHAP): Regulates pharmaceuticals and ensures compliance with international standards.
- DUBAI HEALTH AUTHORITY (DHA): Regulates healthcare in Dubai, including pharmaceutical activities.
- DEPARTMENT OF HEALTH – ABU DHABI (DOH): It works on health policy and supervision in Abu Dhabi.
IMPORTANT REGULATORY REQUIREMENTS THAT YOU SHOULD CONSIDER:
- GOOD MANUFACTURING PRACTICES (GMP): GMP compliance is a must for being consistently produced and controlled with regard to the quality standards.
- PRODUCT REGISTRATION: MOHAP needs to register all pharmaceutical products before they are marketed in the UAE.
- LICENSING: Required licenses should be obtained for manufacturing, importing, and distributing pharmaceutical products.
BUSINESS STRUCTURE AND LICENSING OF PHARMACEUTICAL COMPANY IN THE UAE
We at Creation Business Consultants will work with clients at a preliminary level in respect of guidance to understanding the model and aid in the choice of business structure. The UAE offers many alternatives, each offering distinct advantages:
FREE ZONES:
- 100% Foreign Ownership: Foreign investors may own 100% of their business without having to find a local partner.
- Tax Exemptions: Free Zones are also known to offer some tax advantages, such as annulment of corporate tax assessment.
- Simplified Import and Export Procedures: Customs procedures are simplified by Free Zones, thus easing trade.
MAINLAND COMPANIES:
- Local Market Access: Mainland companies are allowed to sell direct within the UAE market.
- Local Presence: Mainland companies can set up a physical retail or commercial unit anywhere in the country, and are not restricted to a specific area of knowledge, unlike Free Zone.
MAIN AUTHORITIES FOR REGISTERING AND SETTING UP A PHARMACEUTICAL COMPANY IN THE UAE
Establishing a pharmaceutical company in the UAE is subject to the regulations of a couple of authorities. Each authority offers different advantages and can cater best to different types of pharmaceutical companies. The main authorities subject the registration and setup of pharmaceutical companies:
1. DUBAI HEALTHCARE CITY (DHCC)
SUITABLE FOR:
Healthcare and pharmaceutical companies.
Why: Dubai Healthcare City(DHCC) free zone concentrating on healthcare services and the healthcare industry. They provide a large regulatory framework for healthcare by regulating healthcare and pharmaceutical businesses.
ADVANTAGES:
- You have 100% foreign ownership.
- You are not subject to tax on corporate and personal income.
- Access to a network of healthcare professionals and their facilities.
- Specific supports for healthcare and pharmaceutical companies.
- High quality and state-of-the-art facilities and infrastructure.
2. DUBAI HEALTH AUTHORITY (DHA)
ADVANTAGES:
- Regional Focus: DHA controls and regulates healthcare services in Dubai, and considering that a lot of the companies we are dealing with may not be looking at markets outside of the emirate, there is some advantage to working with a regionally focused government authority.
- Advanced Infrastructure: DHA allows access to healthcare in Dubai.
- Business Support: There are a number of incentives and supports for healthcare and pharmaceutical businesses.
SUITABLE FOR:
- Distribution Companies: Companies wanting to distribute pharmaceutical products in Dubai.
- Clinical Trials: Companies wanting to do clinical trials or research in the Dubai healthcare system.
- Healthcare Providers: Companies that provide pharmaceuticals directly to hospitals and clinics in Dubai.
3. DEPARTMENT OF HEALTH – ABU DHABI (DOH)
ADVANTAGES:
- Strategic Location: Abu Dhabi’s position as the capital city offers incredibly appealing business options.
- Robust Healthcare Sector: Invite innovation from a well-established healthcare environment with many hospitals & clinics.
- Innovation and Research: There is a strong focus on healthcare innovation and research that enables room for growth while allowing you to work with potential and existing collaborators.
SUITABLE FOR:
- Innovative Pharmaceuticals: Companies that have an innovative focus but also work within pharmaceuticals and biotechnology.
- Large-Scale Operations: Contributors to large-scale manufacturers or organisations that use large-scale distribution.
- Healthcare Partnerships: Partnering with Abu Dhabi healthcare actors to collaborate on research and development that is transferable.
4. DUBAI SCIENCE PARK (DSP)
ADVANTAGES:
- SPECIALISED FREE ZONE: A free zone dedicated to the life sciences (pharmaceuticals, biotechnology, and Medical Devices, etc.).
- 100% FOREIGN OWNERSHIP: Repatriation of profits while maintaining full foreign ownership of the organisation.
- TAX BENEFITS: Beneficial tax concession(s) that include exemptions from corporate and personal income tax.
SUITABLE FOR:
- BIOTECH STARTUPS: Emerging biotech companies, organisations that are looking for a supportive environment within a specialised organisation.
- R&D COMPANIES: Organisations that have a focus on research and development within pharmaceuticals and life sciences.
- MULTINATIONAL CORPORATIONS: A large multi-national company looking for a regional Middle East headquarters.
5. JEBEL ALI FREE ZONE AUTHORITY (JAFZA)
ADVANTAGES:
- LOGISTICS HUB: Jebel Ali Free Zone Authority position close to one of the busiest ports in the world provides notable logistics and distribution.
- COMPREHENSIVE FACILITIES: Facilities are available with state-of-the-art infrastructure and warehousing facilities.
- REGULATORY SUPPORT: Provides simpler customs and regulatory assurance for importing and exporting.
- WAREHOUSING: Provides bonded warehousing allowing companies to selectively import goods that will be valid for archive without having to pay customs duty tax.
SUITABLE FOR:
- GLOBAL DISTRIBUTORS: Companies with a focus on importing and selling pharmaceutical products at the global distribution level.
- LARGE-SCALE MANUFACTURERS: Companies with large-scale pharmaceutical manufacturing requirements with high logistics needs.
- EXPORT-ORIENTED BUSINESSES: Any business looking to utilise the unique location of JAFZA as a primary competing location for exporting pharmaceutical products all around the world and the MENA region.
LICENSING PROCESS FOR SETTING UP A PHARMACEUTICAL COMPANY IN THE UAE
The licensing process involves several steps:
- INITIAL APPROVAL: Initial approval from the relevant health authorities, MOHAP, DHA, DOH.
- TRADE NAME RESERVATION: Your trade name will need to be reserved with DED (Department of Economics and Development).
- BUSINESS PLAN SUBMISSION: Your business plan will need to be detailed and comprehensive, but should include the market analysis and financial projections and operational plans.
- FACILITY INSPECTION: The health authorities will complete at least one inspection of its manufacturing or distribution facility to ensure that regulatory requirements and GMP are in place.
- COMMERCIAL LICENSE: A commercial license will be issued by DED after you have provided all regulatory requirements.
- ONGOING REGULATORY AND COMPLIANCE SUPPORT: Creation Business Consultants can provide flexible and complete support in this area.
FACILITY SETUP
Building a fully-equipped state-of-the-art manufacturing or distribution facility provides for having the best product and also following the full requirements imposed on you. A few important aspects are:
- LOCATION: It is important to have a good site with easy access to transportation logistics.
- DESIGN: The facility is required to be designed with GMP law in mind; this will include cleanrooms, labs, and quality control areas.
- EQUIPMENT: Include equipment and technology that provide manufacturing efficiencies and improve product quality.
HIRING AND TRAINING STAFF
The pharmaceutical industry requires highly skilled persons to furnish the necessary work. Key considerations include:
- HIRING: Get qualified staff with pharmaceutical expertise, including pharmacists, chemists, and quality control.
- TRAINING: Provide on-going training to ensure your employees comply with regulatory requirements and best practice.
- PARTNERSHIPS: Partner with an education or training organisation to access professionally trained staff.
- IMMIGRATION & EMPLOYMENT LAW: CBC can fully assist you with all aspects of the process all of your VISA processing, employment contracts, or any local regulations regarding employment.
PRODUCT REGISTRATION PROCESS
Before you can launch your products in the UAE market, they have to be registered with the United Arab Emirates Ministry of Health and Prevention (MOHAP). The registration process includes:
- DOSSIER SUBMISSION: Prepare and submit a dossier for each product including clinical data, manufacturing details, and quality control.
- CLINICAL TRIALS: Clinical trials and studies if required to demonstrate safety and efficacy for product use.
- GMP COMPLIANCE: Evidence of GMP for the manufacturing facility.
- REGISTRATION FEES: Pay registration fees to MOHAP.
MARKETING AND DISTRIBUTION
Developing a strong marketing and distribution strategy will later determine its actualisation. Key steps include:
- LOCAL DISTRIBUTORS: Interact with reputable local distributors that have excellent connections and market knowledge within the UAE.
- LOGISTICS: Use the advanced logistics system available in the UAE for interior recirculation into the region.
- DIGITAL MARKETING: Utilise digital marketing channels including social media, online advertisements, and search engine optimisation to reach healthcare professionals and consumers.
- INDUSTRY EVENTS: Such events include medical conferences and trade exhibits. Should be used to introduce your products and meet distributors.
COMPLIANCE AND QUALITY ASSURANCE
In order to successfully operate in the UAE and provide a high level of service, organisations must adhere to and comply with local UAE rules and regulations, as well as adhere to international guidelines for the entire duration of owning and operating the business. One of the best ways to maintain compliance and follow quality standards is:
- REGULAR AUDITS: Regular internal and external audits are conducted regularly to check ongoing compliance with GMP and other requirements.
- QUALITY CHECKS: A quality control system is established to improve the safety and efficacy of products, as well as raw material and excipients.
- QUALITY ASSURANCE SYSTEM: A quality assurance system is established to monitor, review, assess, evaluate, and ensure continuous improvement of the products from a quality perspective.
CONTINUOUS INNOVATION AND EXPANSION
The pharmaceutical industry is dynamic, with continuous advancements in technology and medical research. To stay competitive:
- RESEARCH AND DEVELOPMENT (R&D): Spending money on R&D for innovation and expansion of products! You should explore new drugs, reformulation of current products, and review new treatment areas.
- GLOBAL COLLABORATIONS: Look for strategies to exchange information and/or collaborate with international pharmaceutical companies, research institutions and academic centres, to gain access to cutting-edge research and technology.
- MARKET EXPANSION: Look for opportunities in other GCC countries and potentially further afield around the World. The UAE is a strategic location to access the Middle East and Africa.
CONCLUSION
There exist a myriad of opportunities for growth and success for pharmaceutical companies in the UAE. Taking into account the regulatory environment in the UAE, selecting an appropriate business structure, and operating in compliance with local and international standards, a pharmaceutical venture can thrive in the UAE market. The UAE is thus an ideal location for pharmaceutical companies willing to further their global footprint due to its strategic location, world-class infrastructure, and business-friendly environment. If you would like further guidance on starting your pharmaceutical company in the UAE, feel free to contact the corporate consultants at Creation Business Consultants for a free consultation on how we can help your pharmaceutical company penetrate the MENA market.
Email: [email protected] | UAE: +971 4 878 6240 | Saudi Arabia: +966 56 865 2329
