The Agreement on Conformity Assessment and Acceptance of Industrial Products (ACCA) between the European Union and Israel came into effect on 19 January 2012. Further information is available using the links to the European Medicines Agency (EMA) and the European Commission (EC) websites below:

 

 

 

In addition, we would like to clarify regarding the batch certification by European Qualified Persons (QPs), that it is the MHRA and EMA’s understanding that the same interpretation applies as for other Mutual Recognition Agreements (MRAs). This is derived from the following text extracted from the GMP Annex Section IV of the ACAA:

 

“Certification of the conformity of each batch to its specifications by either the manufacturer established in one of the Parties, or the importer, shall be recognised by the other Party without re-control at import from one Party to the other. However, the additional responsibilities of the qualified person or the responsible pharmacist of the importer in each Party, with respect to the certification of each batch as set out in Section I above, remain in accordance with the provisions of the EU and Israeli national laws set out in Section I.”