News & insights

Saudi Arabia: Limiting the Bolar Provision

February 13, 2013

The Saudi Food and Drug Authority (SFDA) will no longer allow for generic drug companies to file for a marketing authorization (MA) before the last 24 months of the relevant patent protection term. Furthermore, the SFDA will not approve any generic drug MA unless the patent protection period has expired. It is incumbent upon the first applicant for a generic drug to provide a letter from the Saudi Patent Office as well as the GCC Patent Office stating whether or not a patent has been granted for the innovator product as well as the expiration term in case a patent exists.

The above portrays the SFDA’s commitment to conform to the regulations of Saudi Arabia, ensure better protection for patents in the country, and monitor the acceptance procedure of the generic products that follow.

Should you have any questions, or require any additional information, please do not hesitate to contact us at info@sabaip.com