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SFDA provides an electronic-Products Classification service (ePCS) in order to assist stakeholders to classify products easily with a view to achieve greater consistency, transparency and quality of classification decisions related to their products. However, there are some queries raised by applicants who wish to make variations on the classification application, in which some may affect the classification decision.
Therefore, SFDA has developed this guideline to assist applicants on the details of the various categories of variations, which affect the classification request and to provide recommendations on the preparation of the variation application.
It is important to note that the SFDA reserves the right to request any additional information and data not specifically described in this document, in order to assess adequately the classification request. Moreover, Applicants should be aware that deficient, redundant or irrelevant information documentation could lead to rejection of the application.
This document applies to change(s) made to product classification requests that are under study by the Products Classification Department (PCD) in the Saudi Food & Drug Authority (SFDA).
The variation can be categorized into two categories:
A. Type A: Minor variations
Such minor variations does not affect the classification decision, neither require reclassification; however, a notification letter for variation could be submitted to PCD either via pcs@sfda.gov.sa or through the electronic Products Classification System (ePCS).
B. Type B: Major variations:
Such major variations, which may have a significant impact on the classification decision and require a new classification request.
In order to facilitate the classification of variation, examples listed in appendix below are explicitly define the various types of changes.
Appendix 1; example of some major changes and most minor changes; which are categorized by the type of change.
Type of variation
Examples
Documentation
A
Minor
• Change in the administrative information such as:
- Name and/or address of the manufacturer
- Transfer the product to new marketing authorization holder (different legal entity)
• Change in the name of the product
• Change in the name of the active substance (if available)
• Change in the pack size or container type
An optional notification letter
B
Major
• Change in the product's label or artwork information other than those listed as type A variation
• Change in the compositions of the product (if available)
• Change in the concentration of the compositions (if available)
• Change in the mode of action of the product
• Change in the mode of action of compositions (if available)
• Change in the intended use and/or claim
• Change in pharmaceutical form and rout of administration (if available)
• Change in Instruction For Use (IFU) (if available)
A new classification request**
** Please refer to Products Classification Guidance for information on how to submit a classification request.
Last update: 02 October 2023
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