SFDA item 83 · IV. PMF/VAMF
Addition of non-MDMA test kit to test individual donations as a new test kit or as a replacement of an existing test kit
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 83 — official PDF, p. 76 ↗
| Variant | Change | Type |
|---|---|---|
| a | The new test kit has not previously been approved in the PMF for any blood centre for testing of donations | Type II |
| b | The new test kit has been approved in the PMF for other blood centre(s) for testing of donations | Type IA |
Conditions to be fulfilled and documentation to be supplied: see the official guideline, item 83.
EU European Union
Commission Guidelines C/2025/5045 — EUR-Lex ↗
M.10 · Addition or replacement of blood and plasma tests
| Variant | Change | Type |
|---|---|---|
| a.1 | Test kit for individual donations (serology markers and NAT) — CE-marked | Type IA |
| a.2 | Test kit for individual donations (serology markers and NAT) — Non-CE-marked, not previously been approved in the PMF for any blood centre for testing of donations | Type II |
| a.3 | Test kit for individual donations (serology markers and NAT) — Non-CE-marked, previously approved in the PMF for other blood centre(s) for testing of donations | Type IB |
| b.1 | Test for mini-pools NAT — CE-marked | Type IA |
| b.2 | Test for mini-pools NAT — Non-CE-marked | Type II |
| c | Test for plasma pools (antibody, antigen or NAT test) | Type II |
Note: M.10(a.2) where the kit is not yet approved in the PMF for any testing centre; M.10(a.3) where it is already approved for another centre.
US FDA US Food and Drug Administration
21 CFR 314.70 and FDA guidance — Outside 21 CFR 314.70 — 21 CFR 610.40
| Change | Category | Reference |
|---|---|---|
| Unauthorized donor-screening kits cannot be used in the US | No US equivalent |
Note: A donor-screening test not licensed, approved or cleared by FDA cannot be used in the US at all (21 CFR 610.40); changes between authorized kits sit with the establishment's CBER license.
Other items in IV. PMF/VAMF
- 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.