Commission Regulation (EC) No 668/2009 of 24 July 2009 implementing Regulation (EC) No 1394/2007 of the European Parliament and of the Council with regard to the evaluation and certification of quality and non-clinical data relating to advanced therapy medicinal products developed by micro, small and medium-sized enterprises
Proposed act with possible EEA relevance
Act under scrutiny by EEA EFTA
Draft Joint Committee Decision (JCD) under consideration
Entry into force of Joint Committee Decision (JCD) pending
Incorporated into the EEA Agreement and in force
Incorporated into the EEA Agreement but no longer in force
Legal status
EU legal act incorporated into the EEA Agreement by a Joint Committee Decision (JCD) Area (EEA Agreement)
II Technical Regulations, Standards, Testing and Certification
II.XIII Medicinal Products
Joint committee decision (JCD)
047/2012 In force in the EEA
Yes Legal documents
Commission Regulation (EC) No 668/2009 of 24 July 2009 implementing Regulation (EC) No 1394/2007 of the European Parliament and of the Council with regard to the evaluation and certification of quality and non-clinical data relating to advanced therapy medicinal products developed by micro, small and medium-sized enterprises
Reglugerð framkvæmdastjórnarinnar (EB) nr. 668/2009 frá 24. júlí 2009 um framkvæmd reglugerðar Evrópuþingsins og ráðsins (EB) nr. 1394/2007 að því er varðar mat og vottun gæðagagna og óklínískra gagna um hátæknimeðferðarlyf sem örfyrirtæki og lítil og meðalstór fyrirtæki framleiða
Verordnung (EG) Nr. 668/2009 der Kommission vom 24. Juli 2009 zur Umsetzung der Verordnung (EG) Nr. 1394/2007 des Europäischen Parlaments und des Rates im Hinblick auf die Beurteilung und Zertifizierung von qualitätsbezogenen und nichtklinischen Daten zu von Kleinstunternehmen und kleinen und mittleren Unternehmen entwickelten Arzneimitteln für neuartige Therapien
Kommisjonsforordning (EF) nr. 668/2009 av 24. juli 2009 om gjennomføring av europaparlaments- og rådsforordning (EF) nr. 1394/2007 med omsyn til vurdering og sertifisering av kvalitetsdata og prekliniske data om lækjemiddel for avansert terapi som er utvikla av svært små, små og mellomstore føretak
History
31.03.2012
Adopted JCD confirmed entry into force date
31.03.2012
Compliance date in the EEA
30.03.2012
Adoption of Joint Commitee Decision (JCD) incorporating the act into the EEA Agreement
08.03.2011
Draft Joint Commitee Decision (JCD) incorporating the act into the EEA Agreement sent to Commission
24.07.2009
Adoption date in the EU
14.08.2009
Compliance date in the EU
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