Saudi Food and Drug Administration (SFDA) issued a draft guidelines in October, 2018 related to the Drug Exclusivity Marketing so as to encourage the availability of the essential and important drugs in the Kingdom of Saudi Arabia by granting company an exclusive rights of marketing of these drugs in the Saudi market for a certain period of time.

The scope of the drugs under this decree are :

   1-   The essential list of drugs that is not available in the market (exempted from Fees ).

   2-   The list of products recommended by the Companies and Manufacturing site registration committee, which is needed due to  the importance of its availability in the market.

The duration proposed for the marketing exclusivity rights:

1-   New products:  The SFDA will issue the registration certificate for five years based on which these products will be granted the first three years of exclusive rights to market the products.

2-   Registered Products:  The SFDA will issue  the approval on the marketing exclusivity rights based on the company request for three years from the date of the SFDA approval.

I have attached the SFDA drafted guidelines and the SFDA essential lists ( The SFDA updates these lists on regular basis, they are available on the official website). It is an opportunity to assess the company’s pipelines against the published lists highlighting that these products get approval on the priority assessment for the regulatory registration phase.

Regarding the process for the execution of this decree, it is written in Arabic- thus if you are interested in the details, please text me so as to do the translation-