SFDA item 50 · II. Quality changes · II.4 PMF/VAMF
Inclusion of a new, updated or amended Plasma Master File in the marketing authorization dossier of a medicinal product.
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 50 — official PDF, p. 62 ↗
| Variant | Change | Type |
|---|---|---|
| a | First-time inclusion Plasma Master File affecting the properties of the finished product | Type II |
| b | First-time inclusion of a new Plasma Master File not affecting the properties of the finished product | Type IB |
| c | Inclusion of an updated/amended Plasma Master File when changes affect the properties of the finished product | Type IB |
| d | Inclusion of an updated/amended Plasma Master File when changes do not affect the properties of the finished product | Type IA |
Conditions to be fulfilled and documentation to be supplied: see the official guideline, item 50.
EU European Union
Commission Guidelines C/2025/5045 — EUR-Lex ↗
Q.V.a.1 · Inclusion of a new, updated or amended Plasma Master File in the marketing authorisation dossier of a medicinal product. (PMF 2nd step procedure)
| Variant | Change | Type |
|---|---|---|
| a | First-time inclusion of a new Plasma Master File affecting the properties of the finished product | Type II |
| b | First-time inclusion of a new Plasma Master File not affecting the properties of the finished product | Type IB |
| c | Inclusion of an updated/amended Plasma Master File when changes affect the properties of the finished product | Type IB |
| d | Inclusion of an updated/amended Plasma Master File when changes do not affect the properties of the finished product | Type IA |
US FDA US Food and Drug Administration
21 CFR 314.70 and FDA guidance — Outside 21 CFR 314.70 — plasma-derived products are CBER-licensed BLAs, 21 CFR 601.12
| Change | Category | Reference |
|---|---|---|
| First-time inclusion or update of a certified Plasma Master File | No US equivalent |
Note: FDA has no Plasma Master File certification. Plasma-derived products are licensed by CBER under BLAs, and their changes follow 21 CFR 601.12, not 21 CFR 314.70.
Other items in II.4 PMF/VAMF
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.