mandatory scope of the centralised procedure
optional scope of the centralised procedure
Medicinal products authorised by the Community through Centralised procedure
Centralised, Mutual Recognition and Decentralised Procedure or National Licenses.
The EMA (the ‘Agency’) is responsible for the ‘centralised procedure’.
Search for medicines authorised through the centralised authorisation procedure.
The EU does not have a centralised authorisation procedure for the use of botanicals and derived preparations in food.
Under the centralised authorisation procedure, pharmaceutical companies submit a single marketing-authorisation application to EMA.
centralised marketing authorisation application
application for a centralised marketing authorisation
human medicinal products through the centralized procedure
National, Mutual Recognition, Centralized and Decentralized Procedures
Crisis Management Plan for Centrally Authorised Products
The EU system for the authorisation of medicinal products
Article 40 Procedure for centralised marketing authorization
Article 40 Procedure for centralised marketing authorisation
In the centralised procedure, the CHMP is responsible for:
· a centralised procedure, in which the Commission grants an authorisation;
In some cases in Europe, the centralised procedure is mandatory.
The Marketing Authorization Application is being reviewed under the EMEA’s centralized procedure.
Since 2008, all ATMPs are required to use the Centralised Procedure (CP).
Since 2008, all the advanced therapy medicines require the use of the centralised procedure.
Since 1995, medicinal products can be evaluated via the Centralised procedure.
Requêtes fréquentes français :1-200, -1k, -2k, -3k, -4k, -5k, -7k, -10k, -20k, -40k, -100k, -200k, -500k, -1000k,
Requêtes fréquentes anglais :1-200, -1k, -2k, -3k, -4k, -5k, -7k, -10k, -20k, -40k, -100k, -200k, -500k, -1000k,
Traduction Translation Traducción Übersetzung Tradução Traduzione Traducere Vertaling Tłumaczenie Mετάφραση Oversættelse Översättning Käännös Aistriúchán Traduzzjoni Prevajanje Vertimas Tõlge Preklad Fordítás Tulkojumi Превод Překlad Prijevod 翻訳 번역 翻译 Перевод