Commission Delegated Regulation (EU) No 357/2014 of 3 February 2014 supplementing Directive 2001/83/EC of the European Parliament and of the Council and Regulation (EC) No 726/2004 of the European Parliament and of the Council as regards situations in which post-authorisation efficacy studies may be required
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Incorporated into the EEA Agreement but no longer in force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)
263/2014 In force in the EEA
Yes Legal documents
Commission Delegated Regulation (EU) No 357/2014 of 3 February 2014 supplementing Directive 2001/83/EC of the European Parliament and of the Council and Regulation (EC) No 726/2004 of the European Parliament and of the Council as regards situations in which post-authorisation efficacy studies may be required
Framseld reglugerð framkvæmdastjórnarinnar (ESB) nr. 357/2014 frá 3. febrúar 2014 um viðbætur við tilskipun Evrópuþingsins og ráðsins 2001/83/EB og reglugerð Evrópuþingsins og ráðsins (EB) nr. 726/2004 að því er varðar kringumstæður sem gætu kallað á verkunarrannsóknir eftir veitingu markaðsleyfis
Delegierte Verordnung (EU) Nr. 357/2014 der Kommission vom 3. Februar 2014 zur Ergänzung der Richtlinie 2001/83/EG des Europäischen Parlaments und des Rates und der Verordnung (EG) Nr. 726/2004 des Europäischen Parlaments und des Rates im Hinblick auf Situationen, in denen Wirksamkeitsstudien nach der Zulassung verlangt werden können
Delegert kommisjonsforordning (EU) nr. 357/2014 av 3. februar 2014 om utfylling av europaparlaments- og rådsdirektiv 2001/83/EF og europaparlaments- og rådsforordning (EF) nr. 726/2004 med hensyn til situasjoner der det kan være nødvendig å utføre studier av virkning etter at markedsføringstillatelse er gitt
History
13.12.2014
Adopted JCD confirmed entry into force date
13.12.2014
Compliance date in the EEA
12.12.2014
Adoption of Joint Commitee Decision (JCD) incorporating the act into the EEA Agreement
03.11.2014
Draft Joint Commitee Decision (JCD) incorporating the act into the EEA Agreement sent to Commission
03.02.2014
Adoption date in the EU
30.04.2014
Compliance date in the EU
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