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introduction



The Department is responsible for overseeing the pre-marketing phase of pharmaceuticals and installations, including issuing and renewing the necessary licenses to allow them to operate and market in Saudi Arabia.



Vission:



To be a leader in the field of medical licensing practices and to provide services with great speed and accuracy that contribute to the development of management and the sector.



Mission :



Ensure the safety and effectiveness of the licensed product through the application of technical specifications.



Management functions:

  • Preparation and updating of regulations, codes and regulations for the licensing of pharmaceutical preparations.
  • Receiving and reviewing applications for registering pharmaceuticals and updating their files.
  • Licensing of pharmaceutical establishments.
  • Issuing licenses for licensing of human, veterinary, herbal and health medicines.
  • Setting controls and requirements for advertising, promotion and advertising of preparations.
  • Pricing of drugs according to pricing rules and regulations.
  • Setting the controls and conditions for approving clinical studies.
  • Studying the applications for clinical studies and issuing their approval.
  • Control of narcotic drugs, psychotropic substances, controlled drugs and precursor chemicals.