Pharmaceutical Standards in Israel and EU Equivalents
Recommendation
12-14 November 2024
Barcelona, Spain
Data Governance and Auditing the Analytical Process from Sampling to Reportable Value
The European Parliament accepted the so called ACAA agreement between the European Union and Israel on October 23, 2012. This agreement which had been prepared some time ago has been now finalized.
Acccording to a press release: "The ACAA agreement (Agreements on Conformity Assessment and Acceptance of industrial products) with Israel is a framework agreement that recognizes Israel industrial standards as equivalents to European standards. An appendix regarding pharmaceutical products was added to the vote. The meaning of this is that the European Union will recognize the Israeli pharmaceutical standard, and Israeli pharmaceutical products can now be marketed without delay or further inspection (in parallel to similar marketing of European drugs in Israel). Additional appendixes covering other industrial spheres will be added to the framework agreement in the near future."
Source: Press Release EurActiv
Related GMP News
02.10.2024MHRA: New Rules for Manufacturers and Wholesalers after Brexit
24.09.2024What is RCA (Root Cause Analysis)?
18.09.2024Lack of GMP Training and related Documentation: What Deviations can be found in FDA Warning Letters?
04.09.2024Switzerland: Changes for the Qualification of QPs (Responsible Person; RP in Switzerland)
04.09.2024Insufficient Root Cause Analysis leads to FDA Warning Letter
28.08.2024Switzerland to implement Measures to combat Shortages of Medicines