National procedure, Mutual recognition procedure, Decentralised and centralised procedure are the four marketing authorisation routes are granted in the European Union.
You will get the details about European medicine Agency in European Union and how these marketing authorisations are granted in the Europe.
You will also know about the:
Marketing authorisation (MA), marketing authorisation application (MAA) and marketing authorisation holder (MAH)
Who approves drugs in Europe?
Detail about European regulatory system, 28 EU Member States, European economic areas, European Commission, European medicine agency and national competent authorities.
Concept of "Reference Member State" RMS and ‘concerned member states” or CMS
Various choices of Choice of marketing authorisation routes which includes Mandatory CP Scope, Optional CP Scope and Outside of any CP Scope to decide about Products included and excluded from the Centralized procedure.
What are the Benefits of the centralized procedure for EU CITIZENS?
How generic medicines and OTC medicines authorised in the EU.
