Commission Directive 2005/61/EC of 30 September 2005 implementing Directive 2002/98/EC of the European Parliament and of the Council as regards traceability requirements and notification of serious adverse reactions and events.
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Incorporated into the EEA Agreement but no longer in force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)
081/2006 In force in the EEA
Yes Legal documents
Commission Directive 2005/61/EC of 30 September 2005 implementing Directive 2002/98/EC of the European Parliament and of the Council as regards traceability requirements and notification of serious adverse reactions and events.
Tilskipun framkvæmdastjórnarinnar 2005/61/EB frá 30. september 2005 um framkvæmd tilskipunar Evrópuþingsins og ráðsins 2002/98/EB að því er varðar kröfur um rekjanleika og tilkynningar um alvarlegar aukaverkanir og alvarleg meintilvik
Richtlinie 2005/61/EG der Kommission vom 30. September 2005 zur Durchführung der Richtlinie 2002/98/EG des Europäischen Parlaments und des Rates in Bezug auf die Anforderungen an die Rückverfolgbarkeit und die Meldung ernster Zwischenfälle und ernster unerwünschter Reaktionen
Kommisjonsdirektiv 2005/61/EF av 30. september 2005 om gjennomføring av europaparlaments- og rådsdirektiv 2002/98/EF med hensyn til krav til sporbarhet og melding av alvorlige bivirkninger og uønskede hendelser
History
01.02.2007
Adopted JCD confirmed entry into force date
01.02.2007
Compliance date in the EEA
21.12.2006
Constitutional requirements under Art. 103 fulfillment date (FL)
Liechtenstein
07.07.2006
Adoption of Joint Commitee Decision (JCD) incorporating the act into the EEA Agreement
11.05.2006
Draft Joint Commitee Decision (JCD) incorporating the act into the EEA Agreement sent to Commission
30.09.2005
Adoption date in the EU
31.08.2006
Compliance date in the EU
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