The BAH/WiDi's PSUR project offers a cost-effective means of outsourcing the preparation of a PSUR that complies with the pharmacovigilance requirements of EudraLex Volume 9a and contains the stipulated up-to-date critical evaluation of the benefit to risk balance for your active substance or product.

We can offer this service in the form of a jointly usable PSUR as the heads of Medicines Agencies have adopted a consolidated list of  EU-Harmonised “virtual” Bith Dates (HBDS) and accompanying Data Lock Points for the forthcoming PSURs, dated February 2007.

You will find important information concerning the BAH/WiDi PSUR project here, including the aim of the project, detailed information about the offered service spectrum, the current list of PSUR submission dates and the necessary forms. These are supplemented by the most important regulatory guidance documents and a compilation of FAQs.

Our service aims to help you deal with the increasingly demanding pharmacovigilance requirements in an efficient, cost-effective manner.

If you have any queries or would like more detailed information, please do not hesitate to contact us. The BAH and the two contract service organisations (Dr. Ebeling & Assoc. GmbH for chemically defined substances and PhytoLab GmbH & Co. for herbal medicinal products; PV Group) would be happy to be of service.

BAH/WiDi