Are EMA Marketing Authorisations the same as UK MHRA Marketing Authorisations?
No. EMA Marketing Authorisations are issued by the EMA under the Centralised Procedure process. Once granted this entitles the MAH to market and distribute medicines within all EU member states without an additional local UK MA.
It is recognised that many medicines were issued in the EU member states before EMA was created so there are two additional processes – De-Centralised Process (DCP) and Mutual Recognition (MR) that are also used by companies to register medicines across the EU. In these cases, the marketing authorisations issues by each NCA will be national authorisations.
Authorisations which permit marketing in the UK only will include either a PL number or a PLPI number. It should be noted that EMA also issue Parallel Distribution Notification letters to some parallel distributors as a form of marketing authorisation for that activity.