SFDA item 67 · III. Safety, efficacy, pharmacovigilance changes
Changes to the labeling or the package leaflet which are not connected with the summary of product characteristics.
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 67 — official PDF, p. 71 ↗
| Variant | Change | Type |
|---|---|---|
| a | Administrative information concerning the holder’s representative | Type IA(IN) |
| b | Other changes. | Type IB |
Conditions to be fulfilled and documentation to be supplied: see the official guideline, item 67.
EU European Union
Commission Guidelines C/2025/5045 — EUR-Lex ↗
Labelling or package-leaflet changes not connected with the summary of product characteristics, such as the local representative's details, follow Article 61(3) of Directive 2001/83/EC, not the variations procedures.
US FDA US Food and Drug Administration
21 CFR 314.70 and FDA guidance — 2004 Guidance §X.D · 21 CFR 314.70(d)(2)(ix),(x); (b)(2)(v)(A),(B)
| Change | Category | Reference |
|---|---|---|
| Update distributor/representative name or contact details on the labeling | Annual report | 2004 §X.D.2 |
| Re-layout of the package or container label with no change in content | Annual report | 2004 §X.D.1 |
| Change in product description or How Supplied information, not involving strength or dosage form | Annual report | 21 CFR 314.70(d)(2)(ix) |
| Other content changes to carton/container or patient labeling, including any Medication Guide change | Prior approval supplement | 21 CFR 314.70(b)(2)(v)(B) |
Note: Carton, container and patient labeling are all 'labeling' under 314.70, so any change not designated moderate or minor defaults to PAS (314.70(b)(2)(v)(A)). Medication Guide changes are PAS except the items in 21 CFR 208.20(b)(8)(iii)–(iv) (314.70(b)(2)(v)(B)).
Other items in III. Safety, efficacy, pharmacovigilance changes
- 1 · Change in the marketing authorization holder
- 2 · Remove agent name from the artwork (Mock-up)
- 3 · Change in the (invented) name of the medicinal product
- 4 · Change in name of the active substance
- 5 · Change in the name and/or address of a manufacturer or supplier of the active substance, starting material, reagent or intermediate used in the manufacture of the active substance (where specified in the product dossier) where no Certificate of Suitability is available
- 6 · Change in the name and/or address of a manufacturer of the finished product, including quality control sites
- 7 · Change in ATC Code /ATC Vet Code
- 8 · Deletion of a manufacturing sites (including for an active substance, intermediate or finished product, packaging site, manufacturer responsible for batch release, site where batch control takes place, or supplier of a starting material, reagent or excipient, when mentioned in the dossier).
- 55 · Change in the summary of product characteristics, labeling and patient information leaflet of a generic/hybrid/biosimilar medicinal product following assessment of the same change for the reference product *.
- 56 · Change(s) in the summary of product characteristics, labeling and patient information leaflet related to post authorization safety study (PASS), periodic safety update report, risk management plan or SFDA drug safety monitoring activities.
- 57 · Variations related to significant modifications of the Summary of Product Characteristics due in particular to new quality, pre-clinical, clinical or pharmacovigilance data*
- 58 · Change(s) to therapeutic indication(s)
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.