SFDA item 65 · III. Safety, efficacy, pharmacovigilance changes
Variations concerning the replacement or addition of a serotype, strain, antigen or combination of serotypes, strains or antigens for a veterinary vaccine against avian influenza, foot-and-mouth disease or bluetongue.
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 65 — official PDF, p. 70 ↗
| Variant | Change | Type |
|---|---|---|
| - | Variations concerning the replacement or addition of a serotype, strain, antigen or combination of serotypes, strains or antigens for a veterinary vaccine against avian influenza, foot-and-mouth disease or bluetongue. | Type II |
EU European Union
Commission Guidelines C/2025/5045 — EUR-Lex ↗
Veterinary vaccine strains are outside C/2025/5045. EU veterinary variations follow Regulation (EU) 2019/6 and Implementing Regulation (EU) 2021/17.
US FDA US Food and Drug Administration
21 CFR 314.70 and FDA guidance — Not covered by 21 CFR 314.70 (veterinary vaccine; USDA APHIS Center for Veterinary Biologics)
| Change | Category | Reference |
|---|---|---|
| Veterinary vaccine change | No US equivalent |
Note: Not covered by 21 CFR 314.70. US veterinary vaccines are licensed by the USDA APHIS Center for Veterinary Biologics under the Virus-Serum-Toxin Act (9 CFR Subchapter E), not by FDA.
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.