SFDA item 46 · II. Quality changes · II.2 Finished product e) Container closure system
Change in the packaging design of the primary and/or Secondary packaging not in contact with the finished product formulation
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 46 — official PDF, p. 55 ↗
| Variant | Change | Type |
|---|---|---|
| - | Change in the packaging design of the primary and/or Secondary packaging not in contact with the finished product formulation | Type IB |
Conditions to be fulfilled and documentation to be supplied: see the official guideline, item 46.
EU European Union
Commission Guidelines C/2025/5045 — EUR-Lex ↗
A change to the packaging design (mock-up) not connected with the summary of product characteristics is not an EU variation; it follows Article 61(3) of Directive 2001/83/EC.
US FDA US Food and Drug Administration
21 CFR 314.70 and FDA guidance — 2004 Guidance §X.B, §X.D.1, §IX.B.5 · 21 CFR 314.70(b)(2)(v)(A), (d)(2)(x)
| Change | Category | Reference |
|---|---|---|
| Layout/design change of carton or container label with no change in labeling content | Annual report | 2004 §X.D.1 |
| Design change that also alters labeling content (not otherwise designated CBE-0 or AR) | Prior approval supplement | 2004 §X.B; 21 CFR 314.70(b)(2)(v)(A) |
| Removal of a protective secondary component (light-protective carton, moisture overwrap) or a secondary-component change that may affect the impurity profile | Prior approval supplement | 2004 §IX.B.5 |
Note: A pure layout change is AR (§X.D.1); content changes follow the labeling categories (most PAS; safety strengthening CBE-0 under 314.70(c)(6)(iii); editorial AR under 314.70(d)(2)(x)). Physical changes to protective secondary packaging are CMC changes (§IX.B.5).
Other items in II.2 Finished product e) Container closure system
- 39 · Change in immediate packaging of the finished product
- 40 · Change in the specification parameters and/or limits of the immediate packaging of the finished product
- 41 · Change in test procedure for the immediate packaging of the finished product
- 42 · Change in shape or dimensions of the container or closure (immediate packaging)
- 43 · Change in pack size of the finished product
- 44 · Change in any part of the (primary) packaging material not in contact with the finished product formulation (such as color of flip-off caps, color code rings on ampoules, change of needle shield (different plastic used)
- 45 · Change in supplier of packaging components or devices (when mentioned in the dossier)
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.