European Commission Publishes Extended Question/Answer Document on Written Confirmation

As from 2 July 2013, APIs from countries outside the EU shall only be imported if they are accompanied by a "Written Confirmation" (see our News from 11 July 2012). The EU Commission has published a question and answer document to explain the details of this regulation and its exemption clauses. After having already released two versions of the Q&A document (Version 1.0 on 10 July 2012 and Version 2.0 on 26 October 2012 - see our News from 31 October 2012), the EU Commission has now published Version 3.0.

In total, two new questions and answers have been added to the document. In addition, the answer to question 18 A has been amended. One of the two new questions (No 11 A) is:

"Is the written confirmation also required where the finished dosage form manufactured in the EU is destined for exportation only?" The answer to this question is concisely and clearly yes.

The second new question in the document (No 19 A) refers to "unannounced inspections" mentioned in the "Written Confirmation" template: "Does that mean that an unannounced inspection has to have been conducted?" The answer here is: no. "Rather, the system of supervision as a whole (including different types of inspections, such as unannounced inspections) has to ensure a protection of public health at least equivalent to that in the EU." Unannounced inspections may be a part of the measures but must not.

The template for the "Written Confirmation" has also been extended in the course of the new revision by the EU Commission. The current Version 2.0 now contains the following complements:

  • Clarification that EU-GMP are those of WHO/ICH Q7
  • E-mail address in case of GMP deviations to report
  • Name of the inspecting authority if different from the issuing regulatory authority
  • Indication of the date of validity
  • The "Written Confirmation" is without prejudice to the responsibilities of the manufacturer to ensure the quality of the medicinal product

Here you can find the current "Written Confirmation" form. Read more about the regulation on "Written Confirmation" in the latest Q&A document.

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