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Rx-360 Flash Report #353
A Nonprofit Organization

Free Webinar Requirements to Import APIs into Europe as Part of the
Falsified Medicines Directive


When: Monday, February 1, 2013
10 to 11 am EST

Rx-360 is committed to ensuring all relevant companies are informed on the addition to the EU GMP Part 3 requiring Written Confirmation that APIs are made in compliance with GMP that will take effect in 2013. This addition is being made in support of a requirement in the Falsified Medicines Directive, approved in 2011. 

Rx-360 will host a free educational webinar on February 1, 2013 at 10 am ET/7:00 AM Pacific/9:00 AM Central/ 3:00 PM UK /4:00 PM CET.  

Please register via this link:

Background Information on the addition to EU GMP Part 3 requiring Written Confirmation of compliance with GMPs being implemented as part of a requirement in the Falsified Medicines Directive (2011/62/EU): 

All active substances, or active pharmaceutical ingredients (API), imported into the European Union (EU) will be required to be manufactured in compliance with good manufacturing practices (GMP) equivalent to those of the EU by 2 January 2013. Written confirmation of compliance with this requirement, which will be issued by an authority in the exporting country, will need to accompany all active substances imported into the EU as of 2 July 2013. Exporting countries may apply for an exemption to these rules; five countries have applied, but only Switzerland has been granted an exemption to date. 

An Rx-360 Memorandum with further information on the addition to EU GMP Part 3, is available at the following link:

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About Rx-360:

Rx-360 was formed in 2009 to support an industry-wide commitment to ensuring patient safety by enhancing quality and authenticity throughout the supply chain. The mission of the organization is timely in light of growing attacks and threats to an increasingly complex and global supply chain. Millions of people around the world are treated every day with the vital medicines that pharmaceutical and biotechnology companies provide. Management of the pharmaceutical supply chain has become one of the top public health concerns with respect to consumer safety. The globalization of distribution for both drug components and finished products has introduced many complications that Rx-360 is positioned to help resolve. To learn more about Rx-360, go to the website at

Rx-360 | An International Supply Chain Organization - Washington D.C.

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