SFDA item 1 · I. Administrative changes
Change in the marketing authorization holder
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 1 — official PDF, p. 12 ↗
| Variant | Change | Type |
|---|---|---|
| a | Change in the name and/or address of the marketing authorization holder | Type IA(IN) |
| b | Transfer the product to new marketing authorization holder (different legal entity) | Type IB |
Conditions to be fulfilled and documentation to be supplied: see the official guideline, item 1.
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(a) covers a change of the holder's name or address within the same legal entity. A transfer to a different legal entity is not an EU variation; it follows a separate transfer procedure (Regulation (EC) No 2141/96 for centrally authorised products).
US FDA US Food and Drug Administration
21 CFR 314.70 and FDA guidance — MAPP 5242.1 (name/address) · 21 CFR 314.72 (transfer) · 2004 Guidance §X.D.2 (labeling)
| Change | Category | Reference |
|---|---|---|
| Applicant name and/or address changes, same legal entity: administrative correspondence to the application, no supplement | Administrative correspondence | MAPP 5242.1 |
| Transfer of the NDA/ANDA to a different legal entity: letters from former and new owner under 314.72, no supplement | Administrative correspondence | 21 CFR 314.72 |
| Update the company name printed on carton/container labeling to the new name (editorial) | Annual report | 2004 §X.D.2 |
Note: MAPP 5242.1 (name or address) and 21 CFR 314.72 (transfer of ownership) govern these changes. Under 314.72(b), a new owner may report a labeling change to the brand name or to the manufacturer, packer or distributor name in the next annual report; any other change in approval conditions still follows 314.70.
Other items in I. Administrative changes
- 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)
- 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.