EU Commission publishes Version 2.0 of the Question and Answer Document on API Importation

The European Commission has published a Version 2.0 of the Q&A document "Importation of Active Substances for Medicinal Products for human use" on 26 October. Version 1.0 was published on 10 July 2012  (see our GMP News EU GMP Part 3: New Final Document on Written Confirmation)

The revised document contains four new Q&As. In the Q&As the EU commission explains additional scenarios about how to obtain a written (GMP) confirmation for APIs. Starting from July 2, 2013 any API imported to the EU is subject to the rules on the written confirmation. Many stakeholders (industry and regulatory authority) have addressed concerns about the implementation process. Some Non-EU authorities like China and India may not provide written confirmations until July 2, 2013.

The revised document provides some additional clarification. According to the document the issuing authority of the non-EU country can refer to inspection results from EU authorities or other authorities applying equivalent standards for GMP such as the US FDA. That means that for example the Chinese or Indian authority may issue a written (GMP) confirmation based on an inspection by EU or FDA.  It would also be possible for Non EU countries to refer to past inspections. Therefore it is not necessary for the Non-EU authority to perform an inspection specifically for the purpose of issuing a written (GMP) confirmation.

Source: EU Commission: Importation of Active Substances for Medicinal Products for human use - Question and Answers - Version 2.0

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