SFDA item 59 · III. Safety, efficacy, pharmacovigilance changes
Deletion of
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 59 — official PDF, p. 68 ↗
| Variant | Change | Type |
|---|---|---|
| a | a pharmaceutical form | Type IB |
| b | a strength | Type IB |
Conditions to be fulfilled and documentation to be supplied: see the official guideline, item 59.
EU European Union
Commission Guidelines C/2025/5045 — EUR-Lex ↗
C.7 · Deletion of:
| Variant | Change | Type |
|---|---|---|
| a | a pharmaceutical form | Type IB |
| b | a strength | Type IB |
US FDA US Food and Drug Administration
21 CFR 314.70 and FDA guidance — 21 CFR 314.70(d)(2)(ix) (exclusion), (b)(2)(v)(A),(C)
| Change | Category | Reference |
|---|---|---|
| Remove a discontinued strength or dosage form from the labeling (Highlights, Dosage Forms and Strengths, How Supplied) | Prior approval supplement | 21 CFR 314.70(d)(2)(ix) (exclusion); 314.70(b)(2)(v)(A) |
Note: The 2004 and 2014 guidances have no example. The annual-report route for description/How Supplied changes excludes changes involving dosage strength or form (314.70(d)(2)(ix)), and strengths appear in PLR Highlights, so the default is a labeling PAS; confirm with the review division. Stopping marketing is notified to FDA separately (FDCA 506I).
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.