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 under the “centralised procedure”
allow the marketing-authorisation holder to market the medicine and make it available to patients and healthcare professionals
throughout the EU on the basis of a single marketing authorisation.
What EU directive defines the decentralized procedure?
The decentralised procedure was introduced by
Directive 2004/27/EC
. As the mutual recognition procedure, it is also based on recognition by national authorities of a first assessment performed by one Member State.
What is a mutual recognition procedure?
A procedure
through which an authorisation of a medicine in one European Union Member State is recognised by another Member State
.
What is a national procedure?
National Procedure (NP)
It is
useful for manufacturers who aim to obtain market authorization in specific EU member states
. In this procedure, applications are reviewed by the competent authorities of the respective EU member state. Each EU member state has a national procedure of its own.
What is EU MRP?
The
mutual recognition procedure
( MRP ) is a European authorisation route resulting in a mutually recognised product. … 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 .
Where can I find summary of product characteristics?
Summaries of product characteristics form the basis of information for healthcare professionals on how to use the medicine safely and effectively. Abbreviated as SmPC. More information can be found
under ‘Product-information requirements’ and ‘Guideline on summary of product characteristics’
.
What is the difference between centralized and decentralized?
In centralized organizations, strategic planning, goal setting, budgeting, and talent deployment are typically conducted by a single, senior leader or leadership team. In contrast, in decentralized organizations,
formal decision-making power is distributed across multiple individuals or teams
.
What are the procedures for drug approval in Europe?
- mutual-recognition procedure, whereby a marketing authorisation granted in one Member State can be recognised in other EU countries;
- decentralised procedure, whereby a medicine that has not yet been authorised in the EU can be simultaneously authorised in several EU Member States.
Is the EU decentralized?
Here again, the
EU lies at the extreme end of decentralization
. Vertical transfers, from the EU to national budgets represent about 0.5% of EU GDP. There are virtually no horizontal transfers, from state to state.
What is repeat use procedure?
What Is A Repeat Use Procedure? According to the CMDh the ‘Repeat Use Procedure'(RUP) is
the use of the Mutual Recognition Procedure (MRP) after the completion of a first MRP or Decentralised Procedure (DCP) for the recognition of a marketing authorisation by other Member States
(MS).
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. … In the United States, the equivalent process is called New Drug Application.
Marketing Authorization Holder means
a person / organization to which a legal document is issued by the competent drug regulatory authority for the purpose of marketing
or free distribution of a product after evaluation for safety, efficacy and quality.
Does EMA approve drugs?
The EMA serves the EU and three countries from the EEA—Iceland, Norway, and Liechtenstein. The EMA practices pharmacovigilance to ensure the safety and efficacy of medicines. The EMA is not involved in clinical trials or R&D.
Individual countries can choose to approve drugs that the EMA has not approved
.
How many countries are in EMA?
The Board includes one representative of each of the
27 Member States
, two representatives of the European Commission, two representatives of the European Parliament, two representatives of patients’ organisations, one representative of doctors’ organisations and one representative of veterinarians’ organisations.
What is a centrally Authorised product?
A medicine with a single marketing authorisation issued by the European Commission and valid across the European Union
. More information can be found under ‘Authorisation of medicines’.
