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 | | 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.
|