SFDA item 68 · III. Safety, efficacy, pharmacovigilance changes
Introduction of a new Pharmacovigilance system
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 68 — official PDF, p. 71 ↗
| Variant | Change | Type |
|---|---|---|
| a | Which has not been assessed by the relevant national competent authority for another product of the same MAH | Type II |
| b | Which has been assessed by the relevant national competent authority for another product of the same MAH | Type IB |
Conditions to be fulfilled and documentation to be supplied: see the official guideline, item 68.
EU European Union
Commission Guidelines C/2025/5045 — EUR-Lex ↗
C.8 · Introduction of a summary of pharmacovigilance system for medicinal products
| Variant | Change | Type |
|---|---|---|
| a | Introduction of a summary of pharmacovigilance system after a change of the holder | Type IA(IN) |
Note: C.8(a) applies only to nationally authorised products after a change of holder; otherwise QPPV or PSMF-location changes are recorded in the Article 57 database, not by variation.
US FDA US Food and Drug Administration
21 CFR 314.70 and FDA guidance — No US equivalent (21 CFR 314.80)
| Change | Category | Reference |
|---|---|---|
| No US equivalent: no PV-system filing to vary | No US equivalent |
Note: The US has no PSMF, QPPV or PV-system description in the application; postmarketing safety reporting under 21 CFR 314.80 (NDA) and 314.98 (ANDA) applies regardless, so a new PV system needs no submission.
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.