Commission Directive 2005/28/EC of 8 April 2005 laying down principles and detailed guidelines for good clinical practice as regards investigational medicinal products for human use, as well as the requirements for authorisation of the manufacturing or importation of such products
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Incorporated into the EEA Agreement but no longer in force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EU legal act incorporated into the EEA Agreement, but no longer in force in the Agreement Area (EEA Agreement)
II Technical Regulations, Standards, Testing and Certification
II.XIII Medicinal Products
Joint committee decision (JCD)
062/2009 In force in the EEA
No Legal documents
Commission Directive 2005/28/EC of 8 April 2005 laying down principles and detailed guidelines for good clinical practice as regards investigational medicinal products for human use, as well as the requirements for authorisation of the manufacturing or importation of such products
Tilskipun framkvæmdastjórnarinnar 2005/28/EB frá 8. apríl 2005 um meginreglur og ítarlegar viðmiðunarreglur um góðar klínískar starfsvenjur að því er varðar rannsóknarlyf í flokki mannalyfja og einnig um kröfur varðandi leyfi til framleiðslu eða innflutnings á slíkum lyfjum
Richtlinie 2005/28/EG der Kommission vom 8. April 2005 zur Festlegung von Grundsätzen und ausführlichen Leitlinien der guten klinischen Praxis für zur Anwendung beim Menschen bestimmte Prüfpräparate sowie von Anforderungen für die Erteilung einer Genehmigung zur Herstellung oder Einfuhr solcher Produkte
Kommisjonsdirektiv 2005/28/EF av 8. april 2005 om fastsetjing av prinsipp og detaljerte retningslinjer for god klinisk praksis med omsyn til prøvingspreparat for menneske, og om krav i samband med løyve til framstilling eller import av slike preparat
History
01.03.2010
Adopted JCD confirmed entry into force date
01.03.2010
Compliance date in the EEA
22.12.2009
Constitutional requirements under Art. 103 fulfillment date (NO)
Norway
11.01.2010
Constitutional requirements under Art. 103 fulfillment date (FL)
Liechtenstein
29.05.2009
Adoption of Joint Commitee Decision (JCD) incorporating the act into the EEA Agreement
29.06.2006
Draft Joint Commitee Decision (JCD) incorporating the act into the EEA Agreement sent to Commission
09.04.2005
Adoption date in the EU
29.01.2006
Compliance date in the EU
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