SFDA item 20 · II. Quality changes · II.2 Finished product a) Description and composition
Change or addition of imprints, bossing or other markings including replacement, or addition of inks used for product marking.
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 20 — official PDF, p. 29 ↗
| Variant | Change | Type |
|---|---|---|
| a | Changes in imprints, bossing or other markings | Type IA(IN) |
| b | Changes in scoring/break lines intended to divide into equal doses | Type IB |
Conditions to be fulfilled and documentation to be supplied: see the official guideline, item 20.
EU European Union
Commission Guidelines C/2025/5045 — EUR-Lex ↗
Q.II.a.1 · Change or addition of imprints, bossing (embossing/debossing) or other markings including replacement, or addition of inks used for product marking
| Variant | Change | Type |
|---|---|---|
| a | Changes in imprints, bossing (embossing/debossing) or other markings | Type IA(IN) |
| b | Changes in scoring/break lines intended to divide into equal doses | Type IB |
US FDA US Food and Drug Administration
21 CFR 314.70 and FDA guidance — 21 CFR 314.70(d)(2)(viii) · 2004 Guidance §VII.B.1, §VII.B.6, §VII.D.2–4
| Change | Category | Reference |
|---|---|---|
| Adding or deleting an embossed, debossed or engraved code on a non-modified-release solid oral form, or a minor change to an existing imprint (e.g., numeric to alphanumeric) | Annual report | 21 CFR 314.70(d)(2)(viii); 2004 §VII.D.2, §VII.D.4 |
| Adding an ink imprint, or changing to an ink already used on CDER-approved drug products | Annual report | 2004 §VII.D.3 |
| Ink imprint using an ink not yet used on CDER-approved drug products | Prior approval supplement | 2004 §VII.B.6 |
| Adding or deleting an embossed or debossed code on a modified-release solid oral form | Prior approval supplement | 2004 §VII.B.1 |
| Adding or changing a functional score intended for dose division | Prior approval supplement | 2004 §X.B; 21 CFR 314.70(b)(2)(v)(A) |
Note: The 2004 and 2014 guidances do not address scoring. A functional score adds dose-splitting directions to the labeling and needs split-tablet data, so the safer route is a PAS (314.70(b)(2)(v)(A)); confirm with FDA. The description/How Supplied update after an imprint change is AR (314.70(d)(2)(ix)); moving ink imprinting to a new site is AR (§VI.D.6).
Other items in II.2 Finished product a) Description and composition
- 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
- 25 · Deletion of the solvent/diluent container from the pack
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.