Commission Delegated Regulation (EU) 2016/161 of 2 October 2015 supplementing Directive 2001/83/EC of the European Parliament and of the Council by laying down detailed rules for the safety features appearing on the packaging of medicinal products for human use
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Incorporated into the EEA Agreement but no longer in force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)
116/2019 In force in the EEA
Yes Legal documents
Commission Delegated Regulation (EU) 2016/161 of 2 October 2015 supplementing Directive 2001/83/EC of the European Parliament and of the Council by laying down detailed rules for the safety features appearing on the packaging of medicinal products for human use
Framseld reglugerð framkvæmdastjórnarinnar (ESB) 2016/161 frá 2. október 2015 um viðbætur við tilskipun Evrópuþingsins og ráðsins 2001/83/EB að því er varðar ítarlegar reglur um öryggisþætti á umbúðum mannalyfja
Delegierte Verordnung (EU) 2016/161 der Kommission vom 2. Oktober 2015 zur Ergänzung der Richtlinie 2001/83/EG des Europäischen Parlaments und des Rates durch die Festlegung genauer Bestimmungen über die Sicherheitsmerkmale auf der Verpackung von Humanarzneimitteln
Delegert kommisjonsforordning (EU) 2016/161 av 2. oktober 2015 om utfylling av europaparlaments- og rådsdirektiv 2001/83/EF gjennom fastsettelse av nærmere regler for sikkerhetselementer på emballasjen til legemidler for mennesker
History
01.06.2019
Adopted JCD confirmed entry into force date
01.06.2019
Compliance date in the EEA
08.05.2019
Adoption of Joint Commitee Decision (JCD) incorporating the act into the EEA Agreement
01.02.2018
Draft Joint Commitee Decision (JCD) incorporating the act into the EEA Agreement sent to Commission
02.10.2015
Adoption date in the EU
09.02.2019
Compliance date in the EU
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