Article 1
Open ↗The Annex to Implementing Decision 2012/715/EU is replaced by the text set out in the Annex to this Decision.
Source
2013/301/EU: Commission Implementing Decision of 11 June 2013 amending Implementing Decision 2012/715/EU 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 Text with EEA relevance
2013/301/EU: Commission Implementing Decision of 11 June 2013 amending Implementing Decision 2012/715/EU 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 Text with EEA relevance
Data as of 2026-07-04 · Compiled from an official source version. Later amendments or repeals may not be reflected; the official text prevails. · Read the official text ↗
Article 2
Open ↗This Decision shall enter into force on the fifth day following that of its publication in the Official Journal of the European Union .
Supplementary provisions
ANNEXSupplementary provisions
Open ↗ANNEX ‘ANNEX Third country Remarks Australia Japan Switzerland United States of America’
Other acts of the same type
Council Decision (EU) 2019/381 of 4 March 2019 on the position to be adopted, on behalf of the European Union, within the EEA Joint Committee concerning the amendment of Annex II (Technical regulations, standards, testing and certification) and Annex XI (Electronic communication, audiovisual services and information society) to the EEA Agreement (Text with EEA relevance.)Council Decision (EU) 2019/385 of 4 March 2019 on the conclusion of the Protocol on the implementation of the Fisheries Partnership Agreement between the European Union and the Republic of Côte d'Ivoire (2018-2024)Council Decision (EU) 2019/389 of 4 March 2019 on the position to be adopted, on behalf of the European Union, within the EEA Joint Committee, concerning the amendment of Annex IX (Financial Services) to the EEA Agreement (Markets in Financial Instruments Regulation (MiFIR) and Directive MiFID II) (Text with EEA relevance.)Council Decision (EU) 2019/392 of 4 March 2019 on the conclusion, on behalf of the European Union, of the Treaty establishing the Transport CommunityCouncil Decision (EU) 2019/407 of 4 March 2019 on the conclusion, on behalf of the European Union, of the Agreement to Prevent Unregulated High Seas Fisheries in the Central Arctic OceanCouncil Decision (EU) 2019/441 of 4 March 2019 on the conclusion of the Sustainable Fisheries Partnership Agreement between the European Union and the Kingdom of Morocco, the Implementation Protocol thereto and the Exchange of Letters accompanying the AgreementCommission Decision (EU) 2019/434 of 27 February 2019 on the proposed citizens' initiative entitled ‘Europe CARES — Inclusive Quality Education for Children with Disabilities’ (notified under document C(2019) 1545)Commission Delegated Decision (EU) 2019/971 of 26 February 2019 on the definition of the requirements of the secure account service pursuant to Article 6(4) of Regulation (EU) 2018/1240 of the European Parliament and of the Council, enabling applicants to provide any additional information or documentation required (Text with EEA relevance.)Council Decision (CFSP) 2019/325 of 25 February 2019 amending Decision 2012/642/CFSP concerning restrictive measures against BelarusCommission Implementing Decision (EU) 2019/326 of 25 February 2019 laying down measures for entering the data in the Entry/Exit System (EES)Commission Implementing Decision (EU) 2019/327 of 25 February 2019 laying down measures for accessing the data in the Entry/Exit System (EES)Commission Implementing Decision (EU) 2019/328 of 25 February 2019 laying down measures for keeping and accessing the logs in the Entry/Exit System (EES)
Source: EUR-Lex (Publications Office of the EU), © European Union, reuse permitted under Commission Decision 2011/833/EU.
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