SFDA item 25 · II. Quality changes · II.2 Finished product a) Description and composition
Deletion of the solvent/diluent container from the pack
Variation category under SFDA, EU and US FDA rules for this change, with the variant wording as published.
SFDA Saudi Food and Drug Authority
Guidelines for Variation Requirements v6.3 (DS-G-006), item 25 — official PDF, p. 33 ↗
| Variant | Change | Type |
|---|---|---|
| - | Deletion of the solvent/diluent container from the pack | Type IB |
Conditions to be fulfilled and documentation to be supplied: see the official guideline, item 25.
EU European Union
Commission Guidelines C/2025/5045 — EUR-Lex ↗
Q.II.a.6 · Deletion of the solvent/diluent container from the pack
| Variant | Change | Type |
|---|---|---|
| - | Deletion of the solvent/diluent container from the pack | Type IB |
US FDA US Food and Drug Administration
21 CFR 314.70 and FDA guidance — 21 CFR 314.70(d)(2)(ix), (b)(2)(v)(A) · 2004 Guidance §X.B, §X.D
| Change | Category | Reference |
|---|---|---|
| How Supplied/package-description change only; the diluent stays available as an approved product and reconstitution directions are unchanged | Annual report | 21 CFR 314.70(d)(2)(ix) |
| Diluent is part of the approved product or kit, or the Dosage and Administration reconstitution directions must change | Prior approval supplement | 2004 §X.B; 21 CFR 314.70(b)(2)(v)(A) |
Note: The 2004 and 2014 guidances do not address deleting a co-packaged diluent. Removing it has minimal potential for adverse effect on product quality, so the labeling decides the category: How Supplied-only edits are AR (314.70(d)(2)(ix)); any change to reconstitution or administration directions is PAS (314.70(b)(2)(v)(A)). Confirm with the review division whether the diluent is a separately approved product.
Other items in II.2 Finished product a) Description and composition
- 20 · Change or addition of imprints, bossing or other markings including replacement, or addition of inks used for product marking.
- 21 · Change in the shape or dimensions of the pharmaceutical form*
- 22 · Changes in the composition (excipients) of the finished product
- 23 · Change in coating weight of oral dosage forms or change in weight of capsule shells
- 24 · Change in concentration of a single-dose, total use parenteral product, where the amount of active substance per unit dose (i.e. the strength) remains the same
Not regulatory advice. The binding text is each regulator's current official document; confirm the category with the authority before filing. FDA publishes no classification table: the US category follows FDA guidance or, where the guidance does not name the change, the closest example under 21 CFR 314.70.