Active ways to establish the need for educational materials and redistribution

The MA holder must, particularly with a view to their own data on the consumption of the concerned medicinal product, estimate the adequate need for each doctor and their future need, in particular with regard to the EM for patients, and must continue to actively assess this need, either via their specialised representatives or by directly asking the doctors (by phone, e-mail). Doctors must not be required to print the EM for patients and other target groups themselves. It is not possible to transfer the entire responsibility for notification of the need for additional EM to the doctors, either. Such responsibility may be taken over by a doctor only after a signature of a written contract with the MA holder.

A specialised representative’s question on the need to provide more EM for doctors and their patients is not considered an act of promotion. Alternatively, mass distribution repeated in adequate time intervals and scheduled in advance may be employed. Such repeated mass distribution must form part of an approved Distribution Plan.