Framework for a close collaboration with Israel in place

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21/01/2013

Framework for a close collaboration with Israel in place

A legal framework for a close collaboration between the European Union (EU) and Israel has been put in place. The agreement on conformity assessment and acceptance of industrial products (ACAA), which was signed between the European Communities and their Member States on one part, and Israel on the other part, recognises Israel’s industrial standards as equivalent to European standards.

The ACAA includes products for human and veterinary use (medicinal products, active pharmaceutical ingredients and excipients) and procedures (good-manufacturing-practice (GMP)-related). The Agency will have a coordinating role for the operational aspects of the agreement.

As part of the ACAA, Israel implemented the relevant EU legislation and aligned its GMP standards, inspection procedures and forms to those used in the EU. The agreement includes the mutual recognition of the conclusions of GMP inspections, of manufacturing and import authorisations and of certification of conformity of each batch without rechecking at import. In addition, the official-control-authority batch release (OCABR) is also mutually recognised.

Also included in the ACAA is the participation of Israel to various networks and meetings, including EudraGMP, Official Medicines Control Laboratories (OMCL) network, GMP / Good Distribution Practice Inspectors Working Group meetings, EU joint audit programme (JAP) and the European Directorate for the Quality of Medicines and Healthcare (EDQM) mutual joint audit programme.

Like other similar trade-related mutual recognition agreements, the ACAA text and other relevant documents are on the European Commission website.

Related information

Contact point:

info@ema.europa.eu