Regulatory information – EMA introduces product numbers to track medicines through pre-authorisation procedures

News 11/02/2014

The European Medicines Agency has introduced unique product identifiers (UPIs) to track medicines through pre-authorisation procedures.

From now on, companies that approach the Agency for the first time with a new medicine, whether this is for an orphan designation, a procedure related to paediatric development or a scientific advice procedure, will need to fill in a registration form to provide simple information on the medicine and send it to in order to receive their UPI. Companies will then need to use this UPI every time they contact the Agency for any matter related to this specific medicine.

The Agency will assign UPIs to all new medicines; this does not apply to medicines for which procedures are already ongoing.

The assignment of UPIs contributes to the Agency's initiatives to improve the efficiency of its processes as part of the ongoing reorganisation. It will also help create a unique platform for all pre-authorisation activities.

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