April 2020 .CMDh/418/2020

Practical guidance of the CMDh for facilitating the handling of processes during the COVID-19 crisis This document is prepared by CMDh in line with and in addition to the EC/EMA/HMA “Notice to stakeholders: Questions and answers on regulatory expectations during a pandemic”.

It is intended to give further explanations and practical guidance how to address, apply and implement the provisions given by this notice for MR/DCP products.

 

Practical guidance of the CMDh for facilitating the handling of processes during the COVID-19 crisis