Variation application form and FAQ Variation document updated

News

15 December, 2022 - 02:00 (CET)

Announcement

WHO Prequalification Team – Medicines (PQT/MED) updated the variation application form and FAQ variation document:

Variation application form – updated to include a separate section for Annual notifications
FAQ: variation document – updated to provide additional guidance on variation applications regarding nitrosamine impurities, and other updates

In addition, an update regarding nitrosamine contamination policy for FPPs issued.

For further information please contact PQT/MED directly at prequalvariation@who.int for variations or FPPassessment@who.int for policy on nitrosamines.

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