What is meant by marketing authorization?

Marketing authorisation is the process of reviewing and assessing the evidence to support a medicinal product, such as a drug, in relation to its marketing, finalised by granting of a licence to be sold.

What does EU approval mean?

EU Approval means (a) receipt of Regulatory Approval of a Licensed Product in the European Union by the Centralized Procedure or in at least one of the Major European Countries and (b) first receipt of Pricing Approval for such Licensed Product in at least one of the Major European Countries. Sample 2.

What is marketing 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 is global marketing authorisation?

Thus, the global marketing authorisation contains the initial authorisation and all variations and extensions thereof, as well as any additional strengths, pharmaceutical form, administration routes or presentations authorised through separate procedures, including in different Member States within the EU, and under a …

Who grants marketing authorization for a product in Europe?

The European Medicines Agency (EMA) is responsible for the scientific evaluation of centralised marketing authorisation applications (MAA). Once granted by the European Commission, the centralised marketing authorisation is valid in all European Union (EU) Member States, Iceland, Norway and Liechtenstein.

What are the marketing authorization application MAA procedures for the EU?

The procedures for application of marketing authorization are: Centralised procedure, National procedure, Mutual recognition procedure, Decentralised procedure.

How do you get marketing authorisation?

Marketing authorisation procedures. There are two ways to obtain an MA: via the Centralised Procedure (CP) or via a non-centralised procedure. The latter includes the Decentralised Procedure (DCP), the Mutual Recognition Procedure (MRP), and the National Procedure.

In which country is marketing authorization application done?

MAA is part of the official procedure before the Medicines and Healthcare products Regulatory Agency in the United Kingdom and the Committee for Medicinal Products for Human Use of the European Medicines Agency, a specialised agency of the European Commission.

What is new active substance?

NtA defines New chemical Active Substance as: • a chemical substance not previously authorised as a medicinal. product in the Union. or. • an isomer, mixture of isomers, a complex or derivative or salt of. a chemical substance previously authorised as a medicinal.

What is mutual recognition procedure?

The mutual recognition procedure is a European authorisation procedures based on the principle of recognition of the assessment by the Reference Member State (RMS). The Co-ordination Group for Mutual recognition and Decentralised procedures (CMDh) has published several Guidance documents regarding MRP and DCP.

What is a UK marketing authorisation?

by Practical Law Life Sciences. Before a medicine can be placed on the UK market it must be granted a licence, known as a marketing authorisation (MA).