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 centralised and Decentralised 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 the centralized 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 products must use the centralised procedure?
- human medicines containing a new active substance to treat:
- human immunodeficiency virus (HIV) or acquired immune deficiency syndrome (AIDS);
- cancer;
- diabetes;
- neurodegenerative diseases;
- auto-immune and other immune dysfunctions;
- viral diseases.
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 an MRP procedure?
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 .
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 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 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 is decentralized money?
Decentralized currency, peer-to-peer money, and digital currency all
refer to bank-free methods of transferring wealth or ownership of any other commodity without needing a third party
. Most centralized, and some decentralized, markets use fiat currency—or physical money issued by a central bank, like U.S. dollars.
What does EMA approval mean?
The
European Medicines Agency
(EMA) is a decentralized agency of the EU responsible for the scientific evaluation, supervision, and safety monitoring of medicines. … Individual countries can choose to approve drugs that the EMA has not approved.
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’.
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 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.
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 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.
