API Importation Flashcards
What are the white list countries, mhra list of countries with equivalent regulatory standards for the manufacture of active substances
Australia
Brazil
Israel
Japan
Republic of Korea
Switzerland
United States of America
EU
Canada and Taiwan added to European Commission website but not yet mhra
What are the rules around importation of API
The Falsified Medicines Directive introduces EU-wide rules for the importation of active substances.
These can only be imported if they are accompanied by written confirmation from the competent authority of the exporting country that attests that the standards of good manufacturing practice and control of the manufacturing site are equivalent to those in the EU.
This requirement is waived for certain third countries and territories listed by the Commission. The mhra have an equivalent list of authorised countries but has not had the additions the EU has had to their list
