Belgium/Luxembourg
On Thursday 1st of June, the Luxembourg authority DPM published the “Guideline on BE/LU packages”.
This guideline assists applicants/MAH in creating or updating a common BE/LU pack and Product information (PI) for medicinal products for human use.
The guidance is applicable for common BE/LU PI, in the frame of national procedures (NP) when Belgium is the country of origin, mutual recognition procedure (MRP) and decentralised procedure (DCP) when LU and BE are both part of the same procedure.