Switzerland became the first country to be listed as a ‘third country’ with standards in the manufacture of active pharmaceutical ingredients (APIs) equivalent to those of the EU, according to a release form the European Commission (EC).
This means in practice that Switzerland will not have to issue a ‘written confirmation’ for each consignment of active substance for medicinal product for human use imported into the EU as of July 2, 2013, as mandated by the Falsified Medicines Directive (2011/62/EU).
After a successful assessment, the EC concluded that the regulatory framework applicable to active substances exported to the Union from Switzerland, the respective controls and the enforcement activities are equivalent to those of the EU.
The ‘written confirmation’ aims at verifying that the active substance is manufactured in compliance with standards of good manufacturing practices. Being listed by the EC or issuing a ‘written confirmation’ are two possible options introduced by the Falsified Medicines Directive to ascertain the quality of imported active substances.
Switzerland had applied for ‘third country’ status in April while Israel applied a month later. Australia and Singapore followed in September and Brazil in October. There is no update on the status of these requests.
EP News Bureau – Mumbai