SRA's number for the day: 3
This article was originally published in SRA
Strict EU rules on importing active pharmaceutical ingredients (APIs) come into force today, and three countries - Brazil, Israel and Singapore - have still not been granted their request to be exempt from the burden of having to issue written confirmations to their local APIs manufacturers who wish to export their products to the EU1.
The exemption concerns a requirement of the EU Falsified Medicines Directive. Brazil, Israel and Singapore are among the seven countries that have submitted a request to the European Commission for the exemption, to date. The exemption is granted after the commission determines that the third-party country's good manufacturing practices (GMPs) are at least equivalent to those in Europe. Regulators in the countries that do not have the exemption will have to guarantee GMP standards by producing written certification for each consignment of API that the relevant local production facilities meet EU GMP standards.
The four countries that have been granted the exemption are the US, Switzerland, Australia and Japan. Brazil's GMPs are currently being assessed by the commission. The commission has previously rejected the exemption requests from Israel and Singapore, but says that contacts with both countries are "ongoing".
References
1. US becomes fourth country to get EU API waiver, Scrip Regulatory Affairs, 25 June 2013