EU inks framework for a close collaboration with Israel, inc pharma products

The European Medicines Agency announced yesterday that s legal framework for a close collaboration between the European Union 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, recognizes 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 authorizations and of certification of conformity of each batch without rechecking at import. In addition, the official-control-authority batch release (OCABR) is also mutually recognized.