SFDA item 43 · II. Quality changes · II.2 Finished product e) Container closure system
Change in pack size of the finished product
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 43 — official PDF, p. 53 ↗
| Variant | Change | Type |
|---|---|---|
| a.1 | Change in the number of units (e.g. tablets, ampoules, etc.) in a pack — Change within the range of the currently approved pack sizes | Type IA(IN) |
| a.2 | Change in the number of units (e.g. tablets, ampoules, etc.) in a pack — Change outside the range of the currently approved pack sizes | Type IB |
| b | Deletion of a pack size(s) * | Type IA |
| c | Change in the fill weight/fill volume of sterile multi-dose (or single-dose, partial use) medicinal products, and biological/ immunological multi-dose medicinal products. | Type II |
| d | Change in the fill weight/fill volume of non-parenteral multi-dose (or single-dose, partial use) products | Type IB |
| e | Change in the presentations of units (Tablets, Capsule) without changing the number of units | Type IA(IN) |
Conditions to be fulfilled and documentation to be supplied: see the official guideline, item 43.
EU European Union
Commission Guidelines C/2025/5045 — EUR-Lex ↗
Q.II.e.6 · Change in pack size of the finished product
| Variant | Change | Type |
|---|---|---|
| a.1 | Introduction of a new pack size or change in the number of units (e.g. tablets, ampoules, etc.) in a pack — Change within the range of the currently approved pack sizes | Type IA(IN) |
| a.2 | Introduction of a new pack size or change in the number of units (e.g. tablets, ampoules, etc.) in a pack — Change outside the range of the currently approved pack sizes | Type IB |
| b | Deletion of pack size(s) | Type IA |
| c | Change in the fill weight/fill volume of sterile multidose (or single-dose, partial use) parenteral finished products | Type II |
| d | Change in the fill weight/fill volume of non-parenteral multi-dose (or single-dose, partial use) products | Type IB |
| e | Addition of or change to a calendar package for a pack size already registered in the dossier | Type IA(IN) |
US FDA US Food and Drug Administration
21 CFR 314.70 and FDA guidance — 2004 Guidance §IX.B.4, §IX.C.1.c, §IX.C.2.b, §IX.D.3, §IX.D.6 · 21 CFR 314.70(d)(2)(ix)
| Change | Category | Reference |
|---|---|---|
| Nonsterile solid: number of units or labeled amount in a multiple-unit (bulk) container | Annual report | 2004 §IX.D.3 |
| Deletion of a pack size while others remain (How Supplied labeling update) | Annual report | 21 CFR 314.70(d)(2)(ix) |
| Nonsterile solid: blister/unit-dose configuration change with the same count and same-or-better protection | Annual report | 2004 §IX.D.6 |
| Nonsterile non-solid: labeled amount (fill) in a multiple-unit container | CBE-0 supplement | 2004 §IX.C.2.b |
| Any nonsterile product: number of units or labeled amount in a unit-of-use (patient-ready) container | CBE-30 supplement | 2004 §IX.C.1.c |
| Sterile product: new container size or single-dose to multiple-dose presentation | Prior approval supplement | 2004 §IX.B.4 |
Note: The category depends on container type: count changes in multiple-unit (bulk) containers of nonsterile solids are AR (§IX.D.3), but in unit-of-use patient packs they are CBE-30 (§IX.C.1.c). The 2004 and 2014 guidances have no example of a fill-volume change alone for a sterile product in the same container; the safer route is a PAS; confirm with FDA.
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)
- 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)
- 46 · Change in the packaging design of the primary and/or Secondary packaging not in contact with the finished product formulation
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.