SFDA item 60 · III. Safety, efficacy, pharmacovigilance changes
Change in legal status of a medicinal product or distribution site
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 60 — official PDF, p. 69 ↗
| Variant | Change | Type |
|---|---|---|
| a | For generic/biosimilar medicinal products following an approved legal status or distribution site changes of the reference medicinal product | Type IB |
| b | Legal status changes of reference medicinal products that require further substantiation by new additional data to be submitted by the MAH. | Type II |
| c | Change the distribution site of the reference medicinal product | Type IB |
Conditions to be fulfilled and documentation to be supplied: see the official guideline, item 60.
EU European Union
Commission Guidelines C/2025/5045 — EUR-Lex ↗
C.5 · Change in the legal status of a medicinal product for centrally authorised medicinal products
| Variant | Change | Type |
|---|---|---|
| a | For generic/hybrid/biosimilar medicinal products following an approved legal status change of the reference medicinal product | Type IB |
| b | All other legal status changes | Type II |
Note: C.5 applies only to centrally authorised products; for nationally authorised products, including MRP/DCP, legal-status changes are handled at national level.
US FDA US Food and Drug Administration
21 CFR 314.70 and FDA guidance — 21 CFR 314.70(b)(2)(v)(A) · 2004 Guidance §X.B
| Change | Category | Reference |
|---|---|---|
| Generic (ANDA) follows the RLD's switch and adopts OTC Drug Facts labeling | Prior approval supplement | 2004 §X.B; 21 CFR 314.70(b)(2)(v)(A) |
| Innovator Rx-to-OTC switch supported by new data (e.g., actual-use and label-comprehension studies): efficacy supplement | Prior approval supplement | 2004 §X.B; 21 CFR 314.70(b)(2)(v)(A) |
| Change of distribution channel (e.g., hospital-only supply) | No US equivalent |
Note: The 2004 guidance does not address OTC switches. A switch replaces the whole labeling, so PAS applies (supplement under 21 CFR 310.200(b)); a generic needs a new ANDA if the OTC version was approved as a separate NDA. FDA has no separate category for distribution-channel status; REMS dispensing restrictions (FDCA 505-1) change through the REMS process, not 314.70.
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.