Marketing Authorisation in EU| European Medicines Agency (EMA)| MRP, DCP, CP & National Procedure
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- Опубликовано: 19 апр 2020
- National procedure, Mutual recognition procedure, Decentralised and centralised procedure are the four marketing authorisation routes are granted in the European Union.
You will get the details about European medicine Agency in European Union and how these marketing authorisations are granted in the Europe.
You will also know about the:
Marketing authorisation (MA), marketing authorisation application (MAA) and marketing authorisation holder (MAH)
Who approves drugs in Europe?
Detail about European regulatory system, 28 EU Member States, European economic areas, European Commission, European medicine agency and national competent authorities.
Concept of "Reference Member State" RMS and ‘concerned member states” or CMS
Various choices of Choice of marketing authorisation routes which includes Mandatory CP Scope, Optional CP Scope and Outside of any CP Scope to decide about Products included and excluded from the Centralized procedure.
What are the Benefits of the centralized procedure for EU CITIZENS?
How generic medicines and OTC medicines authorised in the EU.
Informative 😊
Thanks for useful information
Thank u so much sir
Good job!
Please upload all videos related to dossier, CTD ICH, modules, and all topics of international licensing
Thanks for clear Information
Ans is Iceland..lichenstein...norway
Sir please do make more videos of topic based on regularity affairs
Well done.well explained
Please explain variations and review of artworks
Iceland, Liechtenstein, Norway
Liechtenstein, Norge und Island
Answer is Iceland ,Norway, Liechtenstein
useful, but audio quality could be better
How can i Register my Pharmaceutical Products in EU
I appreciate your afford, but I like your more videos if it make with more enthusiastic voice
Yes voice is not clear atleast he go for captions
nil: norway,iceland,lithistein
Ans. : Iceland leitchstein and Norway
Very i informative but too fast .I watched 2 times
Liechtenstein Norway Iceland
Sir,
can we get your contact details.
UK left the EU?
Yes.. the first country to leave EU.. referred as brexit..i.e british exit
Painful accent. Music background totally unrelated to the topic
It wasn't an accent test or video, this chap put lots efforts in presentation. So appreciate the efforts or simply move on.