The main risk-minimisation activities to reduce the risk of medication errors between the 100 units/ml and 200 units/ml strengths are that the 200 units/ml strength is only presented in a pre-filled pen, that both strengths are dialled-in units, that the pack design of the two strengths has been clearly differentiated and that an educational programme, including a Direct Healthcare Professional Communication, has been agreed.

There was consensus among patients, healthcare professionals, experts and the CHMP that the introduction of a new insulin strength is a significant change and will require careful preparation to introduce it safely on the market. The Agency will use its network of EU organisations representing patients and healthcare professionals to encourage national diabetes patient associations and learned societies to prepare their members for the market introduction of the new strength.