HMA: Best Practice Guide on the Assessment Report for Mutual Recognition and Decentralised Procedures.

Art 28 of Dir 2001/83 EG provides for an assessment report (AR) which describes the assessment of the medicinal product and states the reasons for the conclusions. The purpose of this guideline is to describe the structure and requirements of the assessment reports used in Mutual Recognition Procedures (MRP) and Decentralised Procedures (DCP).