News 
Market Data 
Discover
Replies to post #322726 on Amarin Corp Plc (AMRN)
02/01/21 10:40 AM
The review process
Companies wishing to market a medicinal product that is eligible for the centralised authorisation procedure, submit their application directly to the European Medicines Agency (EMA). The EMA is responsible for the validation and scientific evaluation of the application.
The EMA's Committee for Medicinal products for Human Use (CHMP) carries out a scientific assessment of the application and give a recommendation on whether the medicine should be authorised or not. A favourable opinion is accompanied by a draft summary of the product's characteristics, the package leaflet, and the proposed text for the packaging.
The time limit for the evaluation procedure is 210 days, subject to extensions if additional questions need to be addressed. Within 15 days of the adoption, the EMA will forward its opinion to the European Commission to start the decision-making phase.
Authorisation
Within 15 days a draft implementing decision is sent by the Commission to the Standing Committee on Medicinal Products for Human Use, allowing for its scrutiny by EU countries. These have fifteen days to return their linguistic comments, and 22 days for substantial ones. Once a favourable opinion is reached, the draft decision is adopted via an empowerment procedure. The adoption of the decision should take place within 67 days of the opinion of the EMA.
The Commission's Secretariat-General then notifies the decision to the marketing authorisation holder. The decision is subsequently published in the Union Register.
Marketing authorisations are initially valid for five years. Applications for renewal must be made to the EMA at least six months before this five-year period expires.
02/01/21 11:01 AM
