Regulation (EU) No 536/2014 of the European Parliament and of the Council of 16 April 2014 on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC
Proposed act with possible EEA relevance
Adopted 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Incorporated into the EEA Agreement but no longer in force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)
213/2015 In force in the EEA
Yes Legal documents
Regulation (EU) No 536/2014 of the European Parliament and of the Council of 16 April 2014 on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC
Reglugerð Evrópuþingsins og ráðsins (ESB) nr. 536/2014 frá 16. apríl 2014 um klínískar prófanir á mannalyfjum og niðurfellingu á tilskipun 2001/20/EB
Verordnung (EU) Nr. 536/2014 des Europäischen Parlaments und des Rates vom 16. April 2014 über klinische Prüfungen mit Humanarzneimitteln und zur Aufhebung der Richtlinie 2001/20/EG
Europaparlaments- og rådsforordning (EU) nr. 536/2014 av 16. april 2014 om kliniske utprøvinger av legemidler for mennesker og om oppheving av direktiv 2001/20/EF
History
01.08.2016
Adopted JCD confirmed entry into force date
01.08.2016
Compliance date in the EEA
13.06.2016
Constitutional requirements under Art. 103 fulfillment date (NO)
Norway
18.04.2016
Constitutional requirements under Art. 103 fulfillment date (FL)
Liechtenstein
25.09.2015
Adoption of Joint Commitee Decision (JCD) incorporating the act into the EEA Agreement
02.07.2015
Draft Joint Commitee Decision (JCD) incorporating the act into the EEA Agreement sent to Commission
16.04.2014
Adoption date in the EU
16.06.2014
Compliance date in the EU
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