In future, we will comment on medicinal product names applied for (names of human medicines applied for under the mutual recognition (MRP) and decentralised procedures (DCP)) on Day 50 for MRP and on Day 100 for DCP with Denmark as concerned member state, and on Day 70 with Denmark as reference member state. This takes place at request from the pharmaceutical industry.
Subject to approval of name
However, this procedure is subject to the final approval of a name, because in the period until a marketing authorisation has been granted for a medicinal product, other medicinal product names may have been approved that can be confused with the medicinal product name applied for. Consequently, companies should note that the longer the clock stop period for an application, the greater the probability that the medicinal product name applied for has already been approved for another medicinal product, since it is not possible to reserve a name during the procedure.
In addition, other circumstances may also arise, such as changed naming practice, with the result that the name cannot be approved.
Regarding medicinal product names applied for under the purely national procedure, we will continue to comment on the name applied for both on Day 0 and when we send our Day 110 letter.
As regards veterinary medicines, we will also comment on the name applied for on Day 54 (MRP) as well as on Day 100 (DCP).
We only evaluate proposals for medicinal product names based on an actual application.
You can read more about the practice for the naming of medicines on our website.