What Is Decentralized Procedure?

What Is Decentralized Procedure? The procedure for authorising medicines in more than one European Union Member State in parallel. It can be used for medicines that do not need to be authorised via the centralised procedure and have not already been authorised in any Member State. What is centralized procedure in EU? Marketing authorisations granted

What Is Centralised Procedure?

What Is Centralised Procedure? The European Union-wide procedure for the authorisation of medicines, where there is a single application, a single evaluation and a single authorisation throughout the European Union. Only certain medicines are eligible for the centralised procedure. What is centralized procedure in EU? Marketing authorisations granted under the “centralised procedure” allow the marketing-authorisation