WHO will review variations Type N (immediate notification) within 30 days of receipt of the notification and will update the prequalification documentation and information that it holds. If WHO has not sent the manufacturer a written opinion on the notification within 30 days following its acknowledgement of receipt of a valid notification, the notification shall be deemed acceptable.

Documents to be submitted

The following documents should be provided with each application for a variation Type N:

• a covering letter
• a completed variation form
• listing of all Type N changes that have occurred in the preceding six months, compiled using the notification Type N form
• a copy of the most recent revised label(s) (inner and outer).

Supporting data for the Type N changes cited and/or referred to in the associated guidance document should not be submitted. However, the data should be made available to WHO if requested at any time. Type N variations pertaining to the administrative scetion, and needed in order to keep the product information up-to-date and to facilitate documentation management should be reported, as described in the Guidance on variations to a prequalified vaccine.

Where to submit a Type N variation application

The changes included in this reporting category should be submitted by the Manufacturer of the prequalified vaccine to the Vaccines Prequalification Team by email to vaccprequalification@who.int