In the past years we have identified more than 60 procedural issues that we have experienced first-hand in daily operations. We have summarized them on the page below. Many of these issues are symptoms of an underlying procedural problem.

Effective procedure – documentation sharing among SAs

Article(s) involved (national, EU, or other):


It is unclear what documents the LSA and the CSA must mandatorily share with each other.

Ideal Solution

The text should specify that all CSAs should be able to access all the documents that the LSA compiles in the course of a procedure (the ‘case file’), and obligehe LSA to include every submission by the parties or piece of evidences in the ‘case file’.

Proposed Solution

Concept 7 (joint case file) addresses this issue.

National Issues

National Issues