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.)

• CELEX: Implementing Decision (EU) 2019/769
• Articles: 3

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 .

Schedules & Appendices

ANNEX

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.