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Isis Pharmaceuticals, Inc. Message Board

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  • dinepat203 dinepat203 Nov 15, 2012 10:25 AM Flag

    ISIS edge over AEGR it might secure EMA approval today

    go to URL ema dot europa dot eu and check for latest news on 15th November schedule

    Sentiment: Strong Buy

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    • The CHMP plays a vital role in the marketing procedures for medicines in the European Union:

      In the ‘centralised’ or ‘Community’ procedure, the CHMP is responsible for conducting the initial assessment of medicines for which an EU-wide marketing authorisation is sought. The CHMP is also responsible for several post-authorisation and maintenance activities, including the assessment of any modifications or extensions (‘variations’) to an existing marketing authorisation.
      In the ‘mutual-recognition’ and ‘decentralised’ procedures, the CHMP arbitrates in cases where there is a disagreement between Member States concerning the marketing authorisation of a particular medicine (‘arbitration procedure’). The CHMP also acts in referral cases, initiated when there are concerns relating to the protection of public health or where other Community interests are at stake (‘Community referral procedure’).

    • The CHMP plays a vital role in the marketing procedures for medicines in the European Union:

      In the ‘centralised’ or ‘Community’ procedure, the CHMP is responsible for conducting the initial assessment of medicines for which an EU-wide marketing authorisation is sought. The CHMP is also responsible for several post-authorisation and maintenance activities, including the assessment of any modifications or extensions (‘variations’) to an existing marketing authorisation.
      In the ‘mutual-recognition’ and ‘decentralised’ procedures, the CHMP arbitrates in cases where there is a disagreement between Member States concerning the marketing authorisation of a particular medicine (‘arbitration procedure’). The CHMP also acts in referral cases, initiated when there are concerns relating to the protection of public health or where other Community interests are at stake (‘Community referral procedure’).

 
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