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GCC Guidance on Labeling Information, SPC and PIL - Gulf Cooperation Council & SFDA

The Gulf Health Council released a new updated version of the guidance on 12th August 2021 on “Guidance for Presenting the Labeling Information, SPC and PIL”.

This guide is intended to applicants on the information required by the Gulf Cooperation Council (GCC) States for:

  • Labeling information

  • Summary of Product Characteristics (SPC); and

  • Patient Information Leaflet (PIL);

This guidance is applicable to medicinal products intended for human use and what's new from the existing guide is the updates on Particulars to appear on the outer packaging and the immediate packaging in Labeling and Minimum particulars to appear on small immediate packaging units.


For more detailed information and to check the guide, click here.


The above guidance is interlinked and should be read in conjunction with the guidance on “Templates for Labeling information, SPC and PIL” which was also released on 12th August 2021.


The Templates for Labeling information, SPC, and PIL document which is intended to provide the applicant practical advice on how to draw up Labeling information, SPC, and PIL in order to ensure standardization of product information submitted to the SFDA.


For more in details insights on Labeling refer to the following guidelines:

  • Guidance for Graphic Design of Medication Packaging

  • Drug Barcoding Specifications

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