Common Contracts
1 similar Import Agreement contracts
Import of Investigational Medicinal Products into IsraelImport Agreement • March 19th, 2022
Emphasising Israel’s growing links with Europe is the Agreement on Conformity Assessment and Acceptance of Industrial Products (ACAA) between the European Union and Israel which came into effect on 19 January 2013. This is very similar to the mutual recognition agreement (MRA) the EU already has with Switzerland, Canada, Australia, New Zealand and Japan, whereby standards of good manufacturing practice for pharmaceuticals have been assessed as equivalent. For pharmaceuticals, this means that inspections for compliance of manufacturers and importers to EU GMP and equivalent Israeli GMP guidelines and GMP certificates issued by either party will be recognised. This can also apply to inspections carried out outside the parties’ territories. Therefore, audits of facilities within the global supply chain performed by a European qualified person (QP) will be recognised by the Israeli responsible pharmacist (RP) and vice versa. Manufacturing and import authorisations confirming compliance wit
