SFDA item 87 · IV. PMF/VAMF
Replacement or addition of blood containers (e.g. bags, bottles)
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 87 — official PDF, p. 77 ↗
| Variant | Change | Type |
|---|---|---|
| a | The new blood containers had MDMA. | Type IA |
| b | The new blood containers do not have MDMA | Type II |
Conditions to be fulfilled and documentation to be supplied: see the official guideline, item 87.
EU European Union
Commission Guidelines C/2025/5045 — EUR-Lex ↗
M.12 · Addition or replacement of blood containers (e.g. bags, bottles)
| Variant | Change | Type |
|---|---|---|
| a | The new blood containers are CE-marked | Type IA |
| b | The new blood containers are not CE-marked and there is no impact on the quality criteria of the blood in the container | Type IB |
| c | The new blood containers are not CE-marked and there is potentially an impact on the quality criteria of the blood in the container | Type II |
Note: CE-marked containers are M.12(a); containers that are not CE-marked are M.12(b) or (c), depending on the impact on blood quality.
US FDA US Food and Drug Administration
21 CFR 314.70 and FDA guidance — Outside 21 CFR 314.70 — CBER-regulated containers; 21 CFR 601.12
| Change | Category | Reference |
|---|---|---|
| Container change is a collection-establishment license matter | No US equivalent |
Note: Blood and plasma containers are FDA (CBER)-regulated products in their own right, and switching them is a collection-establishment license matter (21 CFR 601.12), not a PMF or NDA/ANDA variation.
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.