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U.S. Department of Health and Human Services

Drugs

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FDA seeks listing under EU's Falsified Medicines Directive

STATEMENT DATE:  JANUARY 24, 2013

The European Union (EU) has strengthened its oversight of active pharmaceutical ingredients (APIs) imported into the EU for use in human medicines. Under the EU Directive, countries outside of the EU must give written confirmation that API(s) exported from their country adhere to EU good manufacturing practices (GMPs) or request listing if the country’s rules for GMP are equivalent to those in the EU before the EU will grant entry of the API.  On January 17, 2013, FDA submitted a formal request to be listed as a third country (“Listing Request”) pursuant to EU Directive 2011/62/EU. The European Commission (EC) is assessing countries that have submitted listing requests to determine which countries have equivalent rules for GMPs.
 
The FDA’s Listing Request sends a clear and strong message that recognition of equivalent scientifically-based standards better protects the public and provides a greater level of protection for more people. Working with the EU under this Directive is evidence of the FDA’s commitment: (1) to meet the challenges of globalization, (2) to rely on our trusted partners in other countries, and (3) to better use our resources where there is greatest risk. In addition, United States exporters of APIs benefit greatly from FDA’s Listing Request. If the FDA’s listing request is approved, exporters will avoid duplicative administrative efforts, which could impede trade and delay the manufacture of needed medicines. 
 
More information about the Falsified Medicines Directive and FDA’s request can be found below. 
 
Link to a list of third countries which have so far requested to be listed, as well as the status of the request: http://ec.europa.eu/health/human-use/quality/index_en.htm
 
EC New rules on importing active pharmaceutical ingredients into the EU: http://ec.europa.eu/health/files/documents/active_pharmaceutical_ingredients_leaflet_en.pdf   

EU Falsified Medicines Directive (EU Directive 2011/62/EU):  http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2011:174:0074:0087:EN:PDF