Drug labeling and package leaflets play an important role for both patients and healthcare professionals in the safe and efficient use of the medication. Hence, the approval of the labeling content, Patient Information Leaflet (PIL), and Summary of Product Characteristics (SPC) are integral components of the marketing authorization process.
On 12th August 2021, the Saudi Food and Drug Authority (SFDA) released an updated version of “Guidance for Presenting the Labeling Information, SPC and PIL” for drafting labeling information, SPC, and PIL to the applicants of herbal and health products for human use to ensure standardization of the product information.
The new section contains an update to the section on particulars to appear on the outer packaging and immediate packaging in labeling and the section on minimum particulars to appear on small immediate packaging units.
The new guidance is interconnected and should be read in combination with the guidance on templates for labeling information, SPC, and PIL. The templates for Labeling Information, SPC, and PIL are designed to give applicants practical advice on how to create Labeling information, SPC, and PIL in order to ensure that product information submitted to the SFDA is streamlined and consistent.
In addition, applicants are recommended to transfer all points related to the guidelines on presenting the information in the SPC, PIL, and labeling to the “Templates for SPC, PIL, and Labeling information.”
Some of the key requirements/guidelines of the Gulf Cooperation Council (GCC) with respect to the content and format of the SFDA templates are:
- Data displayed in the label should follow the given template, regardless of the actual labeling sequence, location, and potential duplication on the individual sides/flaps.
- A separate text should be completed for outer and inner packaging labeling.
- Applicants should submit an Arabic version of these specifications.
Patient Information Leaflet (PIL):
- A separate PIL should be given per strength and per pharmaceutical form in instances with varying indications for different strengths and/or medication types.
- Applicants can submit patient information leaflets with different strengths in one document, clearly indicating the strength or presentation of alternative text elements.
So as to ensure the implementation of these guidelines, marketing authorization holders will have to acquire sound Regulatory knowledge and realign with these new requirements of product information guidelines and templates to avoid non-compliance. Consulting a specialized Regulatory labeling services provider will enable companies to effectively contain costs and focus on core business operations.