Commission Implementing Decision (EU) 2019/769 of 14 May 2019 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.)
Date: 2019-05-14
Institutions: Directorate-General for Health and Food Safety, European Commission
Subjects: drug surveillance, import (EU), medicinal product, public health, third country








L_2019126EN.01007001.xml










15.5.2019   


EN


Official Journal of the European Union


L 126/70








            COMMISSION IMPLEMENTING DECISION (EU) 2019/769
of 14 May 2019
         
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)


THE EUROPEAN COMMISSION,

Having regard to the Treaty on the Functioning of the European Union,


Having regard to Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community Code relating to medicinal products for human use (1), and in particular Article 111b(1) thereof,

Whereas:







(1)


In accordance with Article 111b(1) of Directive 2001/83/EC a third country may request the Commission to assess whether its regulatory framework applicable to active substances exported to the Union and the respective control and enforcement activities ensure a level of protection of public health equivalent to that of the Union in order to be included in a list of third countries ensuring an equivalent level of protection of public health.












(2)


The Republic of Korea requested, by letter dated 22 January 2015, to be listed in accordance with Article 111b(1) of Directive 2001/83/EC. On the basis of a review of relevant documentation and two on-site reviews, and taking due account of the action plan proposed by the Korean competent authorities, the Ministry of Food and Drug Safety, on 12 February 2019, the equivalence assessment by the Commission concluded that the requirements of that Article were fulfilled.












(3)


Commission Implementing Decision 2012/715/EU (2) should be amended accordingly,





HAS ADOPTED THIS DECISION:



Article 1
The Annex to Implementing Decision 2012/715/EU is replaced by the text set out in the Annex to this Decision.


Article 2
This Decision shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.




Done at Brussels, 14 May 2019.


For the Commission


The President

Jean-Claude JUNCKER
            





(1)  
            OJ L 311, 28.11.2001, p. 67.

(2)  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 (OJ L 325, 23.11.2012, p. 15).




ANNEX



‘ANNEX

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







Third country


Remarks




Australia


 




Brazil


 




Israel (1)



 




Japan


 




Republic of Korea


 




Switzerland


 




United States of America


 






            ’
         


(1)  Hereafter understood as the State of Israel, excluding the territories under Israeli administration since June 1967, namely the Golan Heights, the Gaza Strip, East Jerusalem and the rest of the West Bank.