22/23 February 2024
Furthermore, the "Falsified Medicine Directive (2011/62/EU)" requires a so-called "Written Confirmation" for the import of active pharmaceutical ingredients (APIs) from third countries. This is issued by the local authorities of the individual exporting countries and shows that their GMP standard is equivalent to the Eurpoean standard.
An exception is made for APIs imported from countries that are on the so-called "White List". No written confirmation is required for imports from these countries. These include, for example, Brazil, the USA, Switzerland and Japan. On the website of the EC (European Commission) you can find a complete list of these countries and the admission procedure.
In 2018, Health Canada/Santé Canada applied to be included in the list of third countries whose quality and GMP requirements for active pharmaceutical ingredients are considered equivalent to the European requirements. Now, at the end of January, it was published on the website of the European Commission that the documents submitted by the Canadian section of the health authority as well as the preliminary audit, which was carried out by the Commission, were successfully reviewed or carried out. As a result, Canada will also be included on the "White List" in the future.