Commission implementing decision, 2012/715/EU, of 22 November 2012 establishing a list of third countries with a regulatory framework applicable to active substances for medicinal products for human use and the respective control and enforcement activities ensuring a level of protection of public health equivalent to that in the Union, in accordance with Directive 2001/83/EC of the European Parliament and of the Council
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Incorporated into the EEA Agreement but no longer in force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)
162/2013 In force in the EEA
Yes Legal documents
Commission implementing decision, 2012/715/EU, of 22 November 2012 establishing a list of third countries with a regulatory framework applicable to active substances for medicinal products for human use and the respective control and enforcement activities ensuring a level of protection of public health equivalent to that in the Union, in accordance with Directive 2001/83/EC of the European Parliament and of the Council
Framkvæmdarákvörðun framkvæmdastjórnarinnar frá 22. nóvember 2012 um skrá yfir þriðju lönd með regluramma sem gildir um virk efni í mannalyf og tilheyrandi starfsemi á sviði eftirlits og framfylgdar sem tryggir lýðheilsuvernd sem er jafngild þeirri sem er við lýði í Sambandinu, í samræmi við tilskipun Evrópuþingsins á ráðsins 2001/83/EB (2012/715/ESB)
Durchführungsbeschluss der Kommission vom 22. November 2012 zur Festlegung einer Liste von Drittländern mit einem Rechtsrahmen für Wirkstoffe von Humanarzneimitteln und den entsprechenden Kontroll- und Durchsetzungsmaßnahmen zur Sicherstellung eines dem der EU gleichwertigen Gesundheitsschutzniveaus gemäß der Richtlinie 2001/83/EG des Europäischen Parlaments und des Rates (2012/715/EU)
Kommisjonens gjennomføringsbeslutning av 22. november 2012 om opprettelse av en liste over tredjestater med rammeregler som får anvendelse på virksomme stoffer for legemidler for mennesker, samt tilhørende virksomhet for kontroll og håndheving som sikrer et vernenivå for folkehelsen som tilsvarer Unionens, i samsvar med europaparlaments- og rådsdirektiv 2001/83/EF (2012/715/EU)
History
09.10.2013
Adopted JCD confirmed entry into force date
09.10.2013
Compliance date in the EEA
08.10.2013
Adoption of Joint Commitee Decision (JCD) incorporating the act into the EEA Agreement
17.06.2013
Draft Joint Commitee Decision (JCD) incorporating the act into the EEA Agreement sent to Commission
22.11.2012
Adoption date in the EU
11.02.2013
Compliance date in the EU
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