Konzultace
Closed consultations
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08 Září - 07 Listopad 2011
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15 Červenec - 31 Prosinec 2011
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13 Duben - 10 Červen 2011
Public consultation on a concept paper on an amendment of Commission Regulation (EC) No 658/2007 concerning financial penalties committed by marketing authorisation holders
The European Commission is planning to put forward, a limited and targeted amendment to Commission Regulation (EC) No 658/2007 concerning financial penalties for certain obligations in connection with centrally authorised medicinal products in the human and in the veterinary sector.
The purpose of this amendment is two-fold. Firstly, to fulfil the mandate given by the legislator in the Paediatric Regulation (EC) No 1901/2006 and secondly, to adapt Commission Regulation (EC) No 658/2007 to the modifications introduced by the new pharmacovigilance legislation in the human sector. -
09 Únor - 13 Květen 2011
The European Commission is planning to put forward, in 2012, a legislative proposal to revise the Clinical Trials Directive 2001/20/EC.
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17 Červen - 10 Září 2010
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01 Červen - 30 Září 2010
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01 Červen - 30 Září 2010
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09 Říjen 2009 - 08 Leden 2010
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22 Červen - 08 Září 2009
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23 Červenec - 20 Říjen 2008