Rx-360 Summary: Israel and Brazil API Standards Are Equivalent to EU

The EU Falsified Medicines Directive (FMD) states that countries outside the European Union (EU) may request that the Commission assess “whether its regulatory framework applicable to active substances exported to the Union and the respective control and enforcement activities ensure a level of public health protection equivalent to that of the Union”. If an exemption is not obtained by these countries, companies operating in countries outside the EU must obtain written confirmation from the competent authority of the exporting country confirming that the standards of good manufacturing practice (GMP) and control of the manufacturing plant are equivalent to those in the EU.

On 2 July 2015, the EU officially announced that both Israel and Brazil have been added to the list of countries outside the EU that have standards of manufacture and supervision of APIs deemed equivalent to those of the EU. As a result, API manufacturers from both countries will no longer have to receive written confirmation from local regulators that their GMP standards are equivalent to the EU. This decision becomes effective on the twentieth day following publication in the Official Journal of the EU.

To view or download the EU Commission Implementation Decision, click here