Thursday, 28 October 2021 14.00 - 15.30 h
The EU Commission has announced on 22 November 2012 that Switzerland has been listed as the first country with equivalent standards in the manufacture of active pharmaceutical ingedients (APIs) to those of the EU.
The European Commission performed an assessment of the regulatory system for the GMP control and supervision of APIs. The assessment was made after Switzerland decided to apply for the "listing of third countries". This listing refers to Article 46b(2) of Directive 2001/83/EC. According to this article, "active substances shall only be imported if, inter alia, the active substances are accompanied by a written confirmation from the competent authority of the exporting third country which, as regards the plant manufacturing the exported active substance, confirms that the standards of good manufacturing practice and control of the plant are equivalent to those in the Union." (see also our GMP News about API Importation)
Based on the decision to ad Switzerland to the listing of third countries, 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 2 July 2013. Currently the following countries requested an accessment: Israel, Australia, Singapore and Brazil. The recently signed ACAA agreement with Israel does not have an impact on the accessment for the written confirmation. The accessment for all 4 countries is still ongoing. Large exporting countries like China and India have not yet applied for the listing of third countries.
Source: EU Commission