The European Union (EU) has an agreement on conformity assessment and acceptance of industrial products in place with Israel.
This agreement recognises Israel’s industrial standards as being equivalent to European standards. It covers products for human and veterinary use (medicinal products, active pharmaceutical ingredients and excipients) and procedures related to good manufacturing practice (GMP).
The agreement means that Israel and the EU recognise each other's:
- GMP inspection conclusions;
- manufacturing and import authorisations;
- certification of conformity of batches, without the need for re-testing at import;
- official-control-authority batch release (OCABR).
Under the terms of the agreement, Israel can participate in networks and meetings, including:
- the Official Medicines Control Laboratories network;
- GMP and Good Distribution Practice (GDP) Inspectors Working Group meetings;
- the EU joint audit programme (JAP);
- the mutual JAP of the European Directorate for the Quality of Medicines and Healthcare (EDQM).
The agreement came into force in January 2013, after Israel had implemented the relevant EU legislation and aligned its GMP standards, inspection procedures and forms to those used in the EU.
The European Medicines Agency has a coordinating role for the operational aspects of this agreement.
Full details on the agreement, including its scope, contact points and conformity assessment bodies are available on the European Commission's website:
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