Written Confirmations: Questions & Answers Document Version 4.1 published!

The requirements on the importation of APIs in the EU have grown drastically because of the relevant provisions laid down in Directive 2011/62/EU, article 46b(2)(b). As of 2 July 2013, each API import in a EU member state will have to be accompanied by a "Written Confirmation". This situation causes somewhat of a headache for the European pharmaceutical industry. Over and over again, considerable clarification is needed regarding specific issues of the regulation.

The EU Commission has already released 3 Versions of a Questions & Answers document on "Written Confirmation" at short intervals. The 3rd update dates back to 28 January 2013 (see our GMP News from 20 February 2013). On 5 April 2013 Version 4.0 was published but it was only 1 week available on the Commission's website. In this document the atypical active substances topic was addressed (atypical active substances are materials which primary use is not in a medicinal product but e.g. in products of the food industry). Due to the need of further discussions of this topic the Commission decided to replace Version 4.0 by Version 4.1 which appeared on 12 April 2103. In this once again updated document the question and answer whether atypical active substances also need a written confirmation has been deleted.

Compared to Version 3.0 the Version 4.1 document now contains 2 new questions as well as their answers about the following topics:

  • Written Confirmation for blood plasma and APIs manufactured with them (Question 2A)
  • Written Confirmation for Starting Materials for the manufacture of APIs (Question 10A)

Please find furter information in the actual Q&A document Version 4.1 on Written Confirmations.

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