ACAA with Israel: what the QP needs to know

The ACAA agreement (Agreements on Conformity Assessment and Acceptance of Industrial Products) with Israel is a framework agreement that recognises Israeli industrial standards as equivalent to European standards and is similar to a Mutual Recognition Agreement (MRAs). The ACAA between the EU and Israel entered into force on 19 January 2013. The products covered by the ACAA include medicinal products, active pharmaceutical ingredients, pharmaceutical excipients or mixtures thereof, for human or veterinary use.

One of the most important regulations is the recognition of the conclusion of inspections. Similar to an MRA, GMP Certificates issued by either party are mutually recognised.

Very important for Qualified Persons (QP) are the regulations regarding batch certification, re-testing and release:
Each batch of medicinal product transferred from Israel to the EU must be accompanied by a batch certificate. In this case, no re-testing has to be performed by the importer, if the quality control site is located in Israel. But the QP still has to certify the batch. Certificates issued before the entry into force of the Agreement are covered as well. The internationally harmonised requirements for the content of the batch certificate are provided in Part 3 of the EU GMP Guide.

Note:
The following products are not covered by the ACAA:

• medicinal products derived from human blood or human plasma,
• advanced therapy medicinal products,
• investigational medicinal products (IMPs),
• homeopathic medicinal products,
• medical gases and
• veterinary immunologicals

Source:

• Agreement between Israel and the EU on conformity assessment and acceptance of industrial products
• Questions and Answers Document