Joint recommendations from the Federal Institute for Drugs and Medical Devices and the Paul-Ehrlich-Institut on observational studies in accordance with section 67 subsection 6 of the Medicinal Products Act and on submitting notifications regarding non-interventional post-authorisation safety studies in accordance with section 63f of the Medicinal Products Act (15 December 2022; German only)

date of issue 20.12.2019

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• file "Joint recommendations from the Federal Institute for Drugs and Medical Devices and the Paul-Ehrlich-Institut on observational studies in accordance with section 67 subsection 6 of the Medicinal Products Act and on submitting notifications regarding non-interventional post-authorisation safety studies in accordance with section 63f of the Medicinal Products Act (15 December 2022; German only)"download(PDF, 841KB, File does not meet accessibility standards.)