Industry news

EU-Israel ACAA

An ‘Agreement on Conformity Assessment and Acceptance of Industrial Products’ (ACCA) between the European Union and Israel came into effect on 4 January 2013.

The ACAA applies to medicinal products for human and veterinary use including chemical, biological, immunological, radio-pharmaceuticals and herbal medicinal products, active pharmaceutical ingredients and excipients. It does not apply to investigational medicinal products (IMPs), homeopathic products, medicinal gases and veterinary immunologicals, advanced therapy products or products based on human tissues, blood and cells. There is provision to extend the ACAA to cover IMPs, veterinary immunologicals or products based on human tissues, blood and cells at a later date.

The EU and Israel also will share information on the regulatory status of manufacturers and importers, with the EMA managing a GMP database to facilitate the exchanges. Inspection reports are to be forwarded to the other party in 30 days or less, with an additional 30-day extension allowed in cases where a new inspection or product re-evaluation is carried out.

The ACAA brings Israel into the EU’s rapid alert system for product quality defects and recalls. It also grants Israel access to EU training sessions and GMP-related working groups.

As far as the need for re-testing on importation and QP certification, the same interpretation applies as for other Mutual Recognition Agreements (MRAs); ie that there can be an exemption from the need for re-testing on importation but that certification by the QP is still required.

There are two cases in which provisions of the ACAA apply to finished or intermediate medicinal products imported from a third country and exported to the other party:

• If each batch of the medicinal product has been subject to re-analysis by either the importer from a third country or a manufacturer located in one of the parties; or
• If the manufacturer in the third country has been subjected to an inspection by the competent authority of either party, with an outcome demonstrating GMP compliance.