May I order the PSUR in German?

You may order the PSUR in German in return for an additional service fee. Please contact the service company concerned.

May I order a PSUR for substances before the BAH calls are published with pricing information?

You may certainly place an order for a PSUR with the BAH before the calls are published. In this case, the appropriate price will then be charged when the PSUR has been drawn up. Please consult the service company that originally contacted you.

Can cases of adverse reactions from spontaneous notification be included in the PSUR? What additional costs will be incurred?

The service company can include this data in your individual PSUR in return for an additional service fee, which is determined by the estimated time involved. Please contact the service company concerned and forward the relevant information for a cost estimate.

May we also send literature that has been found in billable literature databases and is not represented in Medline and Toxline to the service company for inclusion in the PSUR and what additional costs will be incurred?

The service company can include this literature in your individual PSUR in return for an additional service fee, which is determined by the estimated time involved. Please contact the service company concerned and forward the relevant information for a cost estimate.

Why does the service company request CIOMS forms for the cases of adverse effects identified in the course of literature research?

It is in your interest to make all CIOMS forms related to cases of adverse effects identified in the course of literature research available to the service company as this is the only way of ensuring consistency between the reported cases of adverse effects and those mentioned in the PSUR. Under certain circumstances, expedited reporting may be necessary for previously unknown adverse reactions from literature within the 15-day time limit.

The service company would be happy to prepare the CIOMS forms and/or provide an electronic ICSR on your behalf in return for an additional service fee.

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