EU GMP · Part III

Written Confirmation Template: Template for the "written confirmation" for active substances exported to the European Union for medicinal products for human use

Version 2, January 2013 2 paragraphs Official PDF (European Commission)

Independent edition, not an official version. The text is extracted from the official PDF and split into paragraphs by Compliome; tables and figures may be incomplete, so check the official PDF before relying on it. Source: European Commission, EudraLex Volume 4 (health.ec.europa.eu), © European Union, reused under CC BY 4.0. The European Commission does not endorse Compliome. Not legal advice.

Document status Document history:

Template for the "written confirmation" for active substances exported to the European Union for medicinal products for human use Date of submission of draft to the Pharmaceutical Committee:1 16 January 2013 e o b a e e S :n oita cilb u p f o eta D Date of entry into force: N/A2 2 ylu J f o 0.1 n oisre :s e d e sre p u S Changes compared to superseded version 1.0: - Clarification that EU-GMP are those of WHO/ICH Q7 - Indication of inspection authority if different from that issuing the written confirmation - Reminder of general principle of manufacturer's responsibility http://ec.europa.eu/health/documents/pharmaceutical-committee/index_en.htm Written confirmations based on the previous version of the template remain valid.