Transcription of Template for the Qualified Person’s Declaration Concerning ...
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Template for the Qualified Person’s Declaration Concerning ...
7 Westferry Circus Canary Wharf London E14 4HB United Kingdom Telephone +44 (0)20 7418 8400 Facsimile +44 (0)20 7<XXX XXXX> E-mail Website An agency of the European Union European Medicines Agency, 2010. Reproduction is authorised provided the source is acknowledged. 1 2 3 4 5 6 7 8 16 December 2010 EMA/CHMP/CVMP/QWP/696270/2010 Template for the Qualified Person s Declaration Concerning GMP compliance of the active substance used as starting material and verification of its supply chain The QP Declaration Template Draft Draft Agreed by QWP September 2010 Adoption by CVMP for release for consultation 9 December 2010 Adoption by CHMP for release for consultation 16 December 2010 End of consultation (deadline for comments) 30 Sept 2011 9 10 Comments should be
The attached QP declaration template provides, in a format considered suitable for submission, a basis for demonstrating compliance of the active substance manufacture with GMP requirements and that
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