Centralised procedure

One dossier goes to the European Medicines Agency, its Committee for Medicinal Products for Human Use reviews it and issues a scientific opinion, and the European Commission then takes the legally binding decision. The output is a single marketing authorisation covering every member state, extended to the EEA states.

The distinction between opinion and decision is not pedantry. The EMA does not approve anything, and a candidate who says it does has revealed that they learned the sector from an American source and swapped the acronym.

The route is compulsory for medicines produced by biotechnology processes, for advanced therapy medicines, for orphan medicines and for several named therapeutic areas including cancer, diabetes, HIV and neurodegenerative disease. Products outside that scope may still use national or mutual recognition routes, which is why an older or minor product can hold a patchwork of national authorisations rather than one European one.

The United Kingdom sits outside the procedure. The MHRA grants its own authorisations and operates recognition routes that can shorten its review, but it is a separate decision on a separate timetable. Modelling one European approval event where there are two misphases revenue in a way nobody spots until launch.