I forgot to order a PSUR in time for the scheduled deadline. Can I order the PSUR anyway?

Please contact the BAH. If an order has been placed for the substance in question, it may be possible to place an order for the PSUR even though the deadline has elapsed.

When does a participating company receive the PSUR for review?

The service company will send you the PSUR for review no later than 20 days prior to the submission date.

I am having problems with the list of required documents. Who can help me?

Please address your queries to the service company that originally contacted you. The responsible member of staff will be able to give you detailed answers to all of your questions.

What happens if the PSUR has to be amended?

Please address any change requests to the service company that sent the PSUR to you. The responsible member of staff will take all aspects of the matter into consideration before implementing the necessary changes in consultation with you.

Your company would like to implement more extensive changes or supplements:

You may implement such extensive changes/supplements yourself if you wish. The service company can also make these changes/supplements on your behalf, of course, in return for an additional service fee. In this case, please contact the respective service company.


May I change the final evaluation of the benefit to risk balance of the preparation?

You may certainly change the final evaluation of the benefit to risk balance to the same extent as you can alter any other parts of the PSUR. An update may be necessary if you add cases of adverse reactions from spontaneous notifications. The service company would be happy to implement such changes in return for a service fee.

How is information gathered between Data Lock Point and the submission date?

Information that becomes available during this period and is relevant in terms of pharmacovigilance will be included in the "late-breaking information" in section 8.2 of the PSUR.

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