24.03.2017 - Adaptation of Information sheet RMP / ICH E2E – Information for submissions (available in German only) Information sheet RMP / ICH E2E – Information for submissions (MU103_10_002e_MB)
has been restructured and updated to reflect current practice. The information sheet explains the formal and regulatory aspects of submitting the RMP, RMP updates and RMP summaries. There are important modifications in the following areas:
- The obligation to submit an RMP with applications for “major variations” has been specifically delimited.
- Content and format of the RMP/RMP update specified in greater detail.
- Regulatory aspects of submitting an RMP summary specified in greater detail.
Other documents affected by the modification will be gradually updated.