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Download Pricing Policy for Medicines in Saudi Arabia and UAE
Product Registration
Despite the harmonized and centralized process for drug registration in six countries, the requirements for approval of drug products in major countries like Saudi Arabia and UAE are independent. These countries have their own regulatory systems and their prosecution. Different regulations apply in each GCC country.
Check the table below for KSA registration details.
Check the table below for UAE registration details.
Marketing authorization validity period
The initial MA for consumer healthcare products is issued for 5 years.
Registration is done by a local legal entity which has acquired the necessary licenses. If you choose to register your products with us, we will act as the registration agent and hold the registration certificate (marketing authorization). If necessary and when possible, the MA can be transferred to another legal entity that owns the appropriate licenses. Fee of the marketing authorization holder to be discussed depending on the case.
Despite the harmonized and centralized process for drug registration in six countries, the requirements for approval of drug products in major countries like Saudi Arabia and UAE are independent. These countries have their own regulatory systems and their prosecution. Different regulations apply in each GCC country.
Check the table below for KSA registration details.
Service | Official SFDA approval timeframes |
Registration of a food supplement in the food sector as advanced food | 2 to 12 weeks |
Registration of cosmetic products | 3 weeks |
Check the table below for UAE registration details.
Service | Official Dubai Manicipality approval timeframes |
Registration of a food supplement or cosmetic product in Dubai Manicipality | • Cosmetic and personal care products and fragrances: up to 22 working days from the application completion date. • Health supplements: up to 12 working days from the application completion date. • Detergents: up to 5 working days from the application completion date. • Biocides: up to 3 working days from the application completion date. |
Marketing authorization validity period
The initial MA for consumer healthcare products is issued for 5 years.
Registration is done by a local legal entity which has acquired the necessary licenses. If you choose to register your products with us, we will act as the registration agent and hold the registration certificate (marketing authorization). If necessary and when possible, the MA can be transferred to another legal entity that owns the appropriate licenses. Fee of the marketing authorization holder to be discussed depending on the case.