The pharmaceutical company generally applies for market approval for its medicine through the central procedure in the EU. Read more on the EMA website.
About nine months after submission of the EMA, the Committee of Human Medical Products (CHMP) publishes its opinion. The formal marketing authorisation is granted by the EU commission within an additional three months, in total about 12 months after submission of an application to the EMA.
In the national process for managed introduction, a positive opinion by the CHMP is the trigger for starting the health economic evaluation and other preparations for introduction of the medicine.