Commission Delegated Regulation (EU) 2017/1569 of 23 May 2017 supplementing Regulation (EU) No 536/2014 of the European Parliament and of the Council by specifying principles of and guidelines for good manufacturing practice for investigational medicinal products for human use and arrangements for inspections
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Incorporated into the EEA Agreement but no longer in force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)
088/2018 In force in the EEA
Yes Legal documents
Commission Delegated Regulation (EU) 2017/1569 of 23 May 2017 supplementing Regulation (EU) No 536/2014 of the European Parliament and of the Council by specifying principles of and guidelines for good manufacturing practice for investigational medicinal products for human use and arrangements for inspections
Framseld reglugerð framkvæmdastjórnarinnar (ESB) 2017/1569 frá 23. maí 2017 um viðbætur við reglugerð Evrópuþingsins og ráðsins (ESB) nr. 536/2014 með því að tilgreina meginreglur og viðmiðunarreglur um góða framleiðsluhætti við gerð rannsóknarlyfja sem ætluð eru mönnum og fyrirkomulag við eftirlitsúttektir
Delegierte Verordnung (EU) 2017/1569 der Kommission vom 23. Mai 2017 zur Ergänzung der Verordnung (EU) Nr. 536/2014 des Europäischen Parlaments und des Rates durch die Festlegung von Grundsätzen und Leitlinien für die Gute Herstellungspraxis bei Prüfpräparaten, die zur Anwendung beim Menschen bestimmt sind, und der Einzelheiten von Inspektionen
Delegert kommisjonsforordning (EU) 2017/1569 av 23. mai 2017 om utfylling av europaparlaments- og rådsforordning (EU) nr. 536/2014 ved nærmere fastsettelse av prinsipper og retningslinjer for god framstillingspraksis for utprøvingspreparater for mennesker samt inspeksjonsordninger
History
28.04.2018
Adopted JCD confirmed entry into force date
28.04.2018
Compliance date in the EEA
27.04.2018
Adoption of Joint Commitee Decision (JCD) incorporating the act into the EEA Agreement
02.03.2018
Draft Joint Commitee Decision (JCD) incorporating the act into the EEA Agreement sent to Commission
23.05.2017
Adoption date in the EU
01.04.2018
Compliance date in the EU
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