Contributing

What is CMDh?

Standard

What is CMDh?

The Coordination Group for Mutual Recognition and Decentralised Procedures – Human (CMDh) was set up in 2005. It replaced the informal Mutual Recognition Facilitation Group.

What is the difference between MRP and DCP?

Decentralised Procedure The main difference between the MRP and DCP lies in the fact that the Concerned Member States (CMSs) in a DCP are involved at the onset of the procedure as opposed to waiting for approval before an application is made in the CMS.

Who is market authorization holder?

Any company, firm or non-profit organization, which holds a marketing authorization granted by the European Medicines Agency (EMA), is called a Marketing Authorization Holder (MAH). An MAH is allowed to distribute and sell its medicinal products in one or more European Union (EU) member states.

What are the 4 types of procedures for approval of drug in EU?

EU establishes 4 different drug approval processes: 1) Centralized Procedure 2) Decentralized Procedure 3) National Procedure 4) Mutual Recognition Procedure.

  • The Basic Regulation.
  • Investigational New Drug Application.

What is CMDh EMA?

Coordination Group for Mutual Recognition and Decentralised Procedures – Human: the group responsible for the examination and coordination of questions relating to the marketing authorisation of human medicines in two or more Member States in accordance with the mutual recognition or decentralised procedure.

What is MAA submission?

Marketing Authorisation Application (MAA) is an application submitted by a drug manufacturer seeking marketing authorisation, that is permission to bring a medicinal product (for example, a new medicine or generic medicine) to the market.

What is a reference member state?

The Reference Member State (RMS) is the Member State, which evaluates the marketing authorisation application dossier and prepares the assessment report on behalf of the Concerned Member States in Mutual Recognition Procedure (MRP) and Decentralised Procedure (DCP).

How long is mutual recognition procedure?

60-days
If an application is withdrawn in one or more Concerned Member States during the Mutual recognition procedure as a consequence of a potential serious risk to public health, it is always discussed in the CMDh via the 60-days procedure. If there is no agreement in the CMDh, the procedure will be referred to the CHMP.

What are the responsibilities of a marketing authorisation holder?

Responsibilities of the Marketing Authorisation Holder

  • Ethical Clinical Design:
  • Oversight of Manufacturing from API to release to market:
  • Identification of the QP:
  • Control of Labelling & Packaging:
  • Supply & Distribution to the Customer:
  • Complaints, Recalls & Quality Defects:
  • Pharmacovigilance & appointment of the QPPV:

How does marketing authorization work?

What does Marketing Authorisation mean? The approval needed to place a medicinal product on the market. It sets out the medical conditions (known as indications), patient population and dosage for which the product is authorised as well as any conditions imposed on the holder of the marketing authorisation.

What is a EEA member state?

The European Economic Area ( EEA ) The EEA includes EU countries and also Iceland, Liechtenstein and Norway. It allows them to be part of the EU ‘s single market. Switzerland is not an EU or EEA member but is part of the single market.

Who approves drugs in EU?

While the majority of new, innovative medicines are evaluated by EMA and authorised by the European Commission in order to be marketed in the EU, most generic medicines and medicines available without a prescription are assessed and authorised at national level in the EU.