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SFDA Guidance: Registration Rules of Pharmaceutical Product Manufacturers & their Products

Saudi Food & Drug Authority on 17th November 2022, released an updated guidance on "The Registration Rules of Pharmaceutical, Herbal and Health Product Manufacturers and their Products".

This guidnce contains definitions, chapters, and articles that are related to the Registration of Pharmaceutical, Herbal, and Health Product Manufacturers.

Companies without a commercial investment license must appoint one or more agents for each pharmaceutical or herbal product they intend to market in Saudi Arabia. As per the guideline, the companies interested in manufacturer registration submit the following data and documents:

  1. A certificate issued by the regulatory authorities in the country of origin confirming its compliance with good manufacturing practices (GMP) or the equivalent requirement related to the herbal and health products, including proof of periodic inspections by the mentioned authorities.

  2. A list of the manufactured products, whether owned by the company or for its account or by contract manufacturing or for other companies and the dates of their registration and marketing in the country of origin and countries where such products are marketed.

  3. A list signed by the company including names of the countries where such products are registered accompanied with a copy of the registration certificates.

  4. Provide the site master file.

  5. The production lines that the company wants to register.

  6. Paying the inspection fees.

  7. Signing the acknowledgment of publishing the Committee's decisions

Click this LINK to know more about the registration requirements that a company needs to follow to market in the Saudi kingdom.


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