Greetings from
Freyr UAE
Clear-cut Regulatory guidelines coupled with constantly growing economy makes the United Arab Emirates (UAE) a favorable destination for foreign medicinal products & medical device manufacturers who are willing to enter the region. The Ministry of Health regulates the importation of medical devices and medicinal products. It can sometimes be difficult for foreign manufacturers to navigate through various Regulatory approvals required for importation which results in lengthy and complex procedural challenges.
To address the manufacturer’s unique challenges for UAE market access, Freyr provides knowledge-based Regulatory affairs in the region. Freyr, as a preferred global Regulatory partner, provides end-to-end Regulatory Affairs services to assist foreign manufacturers to minimize the compliance related risks in effective timelines to enter the UAE market. Freyr is capable to expedite the registrations and market approval processes for:
Industries We Serve in UAE
United Arab Emirates (UAE), a prominent GCC member Nation, has an advanced healthcare system. Its market potential is proven and consistently on a rise, governed by the Drug Control Department of the Ministry of Health (DCD MOH). Centralized governance and linguistic barriers are major hinderances for medical device registration in UAE, along with linguistic complexities and lack of efficient communication channels with the Health Authorities.
With a stable economy and a high disposable income, the cosmetic market in the UAE flourishes despite global economic fluctuations. With the presence of numerous cosmetic companies in the UAE, the average consumer in the country has access to major global cosmetic brands. Entering this competitive and attractive market poses complex Regulatory challenges for cosmetic manufacturers. The Dubai Municipality (DM) and the Emirates Authority for Standardization and Metrology (ESMA) are responsible for regulating cosmetics in the United Arab Emirates (UAE).
The prime focus of a national Health Authority (HA) is consumer safety. All food and food supplements that are introduced or imported to the United Arab Emirates (UAE) should be compliant with the food regulations. The Food Safety Department of the Dubai Municipality (DM) and the Ministry of Health and Prevention (MOHAP) aim at guaranteeing and enforcing proper food control procedures. To enable food product registration or food supplement registration in the UAE, the manufacturer should file the product under the DM food registration system, and before any food item can be imported to Dubai, the food item and its label must be registered in the Food Import Re-Export System (FIRS) of the DM, as per Local Order No. 11/2003.
Cleaning and disinfectant products are called/identified and regulated differently across countries and regions, making it very challenging for the industry to place these products in different markets. In the UAE, Dubai Municipality (DM)/Health & Safety Department regulates the manufacture, sale, and importation of chemical disinfectant and detergent household cleaning products. These products are to be registered prior to their placement in the Dubai market, and the individuals running the activities related to these products are required to be licensed in Dubai.
Freyr Offerings
- Strategic Regulatory Consulting
- Registrations and licensing
- Dossier management
- Pharmacovigilance
- Regulatory roadmap for market access
Freyr Advantages
- Strategic and well-versed local regulatory knowledgebase - with the Ministry of Health & Muncipality
- Expert Regulatory team with proven global RA expertise
- Proactive and Collaborative approach
- Quick turnarounds and faster time-to-market
- Keeping abreast with region-specific legislation and Regulatory guidelines
