Type R variations must be reported and reviewed annually as part of the vaccines prequalification annual reporting obligations. Type R variations may be submitted by the manufacturer up to 12 months after implementation (taking into account the date of the prequalification of the vaccine, as part of the subsequent prequalified vaccine annual report). WHO may request complementary information during the course of reviewing the annual report submission. This information has to be provided within 30 days. In the event that WHO considers the complementary information to be incomplete, not sufficient and/or not satisfactory, the variation may be rejected.

The annual reporting requirements for prequalified vaccines are defined in Section 8 of the Procedure for assessing the acceptability, in principle, of vaccines for purchase by UN agencies.

Documents to be submitted

The following documents should be included in the annual report, where applicable, with each application for a Type R variation:

• a listing of all Type R variations for each vaccine that has been prequalified and that have occurred in the preceding 12 months, using the notification Type R form
• a copy of the most recent revised label(s) (inner and outer) if a Type R label variation has been made.

Supporting data for Type R changes, as recommended in the associated guidance documents, must be submitted with the prequalified vaccine annual report.

Where to submit a Type R variation application

The changes included in this reporting category should be submitted by the vaccine manufacturer to the Vaccines Prequalification Team as part of the Prequalification Annual Report (PQVAR).