SFDA item 5 · I. Administrative changes
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
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 5 — official PDF, p. 13 ↗
| Variant | Change | Type |
|---|---|---|
| - | 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 | Type IA |
Conditions to be fulfilled and documentation to be supplied: see the official guideline, item 5.
EU European Union
Commission Guidelines C/2025/5045 — EUR-Lex ↗
E.4 · Change in the name and/or address of the marketing authorisation holder, ASMF holder, storage site of the master and/or working cell bank, manufacturing site for an active substance, intermediate or finished product, primary and/or secondary packaging site, manufacturer responsible for batch release, site where quality control takes place, and/or supplier of a packaging component, medical device (part), starting material, reagent and/or excipient (when mentioned in the dossier)
| Variant | Change | Type |
|---|---|---|
| a | The change in the name and/or address concerns the marketing authorisation holder | Type IA(IN) |
| b | The change in the name and/or address concerns a manufacturer(s)whose activities include batch release of the finished product | Type IA(IN) |
| c | The change in the name and/or address does not concern a manufacturer(s) whose activities include batch release of the finished product nor the marketing authorisation holder | Type IA |
Note: E.4(c): name or address change of a manufacturer or supplier of the active substance, starting material, reagent or intermediate, with the physical site and operations unchanged.
US FDA US Food and Drug Administration
21 CFR 314.70 and FDA guidance — 21 CFR 314.70(a)(1),(d)(1) · 2004 Guidance §III, §VI, Att. A
| Change | Category | Reference |
|---|---|---|
| Administrative name/address update for the same physical drug substance site, operations unchanged | Annual report | 21 CFR 314.70(d)(1) |
| The 'new address' is in fact a move of drug substance manufacture to a different site | CBE-30 supplement | 2004 §VI.C.1.a |
Note: The 2004 and 2014 guidances give no example. A named site is a condition of approval (314.70(a)(1)); a name/address change with the same site and operations has minimal potential for adverse effect (annual report, 314.70(d)(1)). A DMF holder also amends the DMF. A physical move is a different site (Att. A) under §VI: final intermediate CBE-0, other intermediates AR.
Other items in I. Administrative 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
- 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)
- 59 · Deletion of
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.