What is CP procedure?

Overview. The Centralised Procedure (CP) is commonly used to obtain a marketing authorization for medicinal products. A CP is valid for all the European Union (EU) member states.

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.

What is RMS and CMS in Europe?

The Member State that has already authorised the product is known as the Reference Member State ( RMS ). The RMS submits their evaluation of the product to other Member State/s, these are known as Concerned Member States ( CMS ). The CMS is asked to mutually recognise the MA of the RMS .

What is an Rtq in pharma?

1. RTQ. Response to questions. Health, Care, Drug. Health, Care, Drug.

What is MRP EMA?

A procedure through which an authorisation of a medicine in one European Union Member State is recognised by another Member State.

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If an application is withdrawn in one or more Concerned Member States during the Mutual recognition procedure as a consequence of a potential serious risk to public health, it is always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 is DCP approval?

The Decentralised Procedure is one of three routes available to applicants to gain multinational marketing authorisation within the European Economic Area (EEA) on the basis of a single application. It can be used only for a product which has no existing marketing authorisation in any member state.

What is MRP Pharmaceutical?

MRP. Mutual Recognition Procedures. Procedure, Recognition, Product.

What is RMS in regulatory affairs?

In both the MRP and the DCP, the applicant should request one Member State to act as Reference Member State (RMS). It is the RMS that prepares an Assessment Report on the medicinal product and sends to the other Concerned Member State(s) (CMS/s) where the applicant would like marketing authorization in.

What is full form of MHRA?

The Medicines and Healthcare products Regulatory Agency regulates medicines, medical devices and blood components for transfusion in the UK. MHRA is an executive agency, sponsored by the Department of Health and Social Care.