June 2020: Update from BfArM and PEI on Publication of Test Centers

An update was posted on the BfArM website on June 19, 2020:
Publication of the test centers in results reports in accordance with Section 42b of the Medicines Act (AMG) – Updated joint information from the Federal Institute for Drugs and Medical Devices (BfArM) and the Paul Ehrlich Institute, Federal Institute for Vaccines and Biomedical Drugs (PEI) from June 19, 2020.

Section 42b(3) AMG requires to report the names and addresses of all the investigators involved in the clinical trial. However, a previous joint document published by BfArM, PEI and the German Institute for Medical Documentation and Information (DIMDI) on June 17, 2014, had reported that the investigator’s personal information should be published only if the consent has been given.

Now, with the amended joint document published on June 19, 2020, it is declared that, for all reports submitted after August 16, 2019, according to Section 42b AMG, the name of all investigators with their name and address is required. The procedure described in the publication by BfArM, DIMDI and PEI of June 17, 2014, is therefore irrelevant; the original publication is hereby invalid. Additionally, one of the FAQ’s has also been updated to include the updated joint information.

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