The designation by the EC effectively means that API manufacturers from both countries will not have to receive written confirmation from local regulators that their GMP standards are equivalent to those in the EU.
Israel and Brazil join Australia, the US, Japan and Switzerland as the only countries that have been declared exempt from the Commission’s written confirmation rules. Switzerland was the first country to be declared exempt under the current system.
The Falsified Medicines Directive says that countries outside the EU may request the Commission to assess whether its regulatory framework applicable to APIs exported to the EU, and the respective control and enforcement activities, ensure a level of protection of public health equivalent to that in the EU.
If an exemption is not obtained, companies operating in countries outside the EU must obtain written confirmations containing a reference to the date of an API manufacturer’s audit and a declaration that the outcome of the audit confirms that the manufacturing complies with the principles and guidelines of EU GMPs (good manufacturing practices).
Brazil and Israel both requested to be included as an exempt country back in 2012. Israel was initially rejected from the exemption as the Commission said that relevant Israeli legislation covers only active substances used for the manufacture of finished products manufactured in Israel.
Singapore is the only other country to be rejected from the exemption as the Commission said relevant Singapore legislation provides for a non-mandatory GMP certification scheme, though “contacts are ongoing,” and in the meantime, Singapore is issuing written confirmations. New Zealand and South Korea have also requested exemptions from the rules.