From: )@aefi.org> HI Ares(20i 5)5462899 •• 30/11/201 Sent: 24 November 2015 15:18 To: SANTE-D6-DA-GM P-l M P Subject: CONSULTATION ON Commission Delegated Act on Principles and Guidelines on GMP for investigational medicinal products {AEFI) Dear Sirs, The Spanish Association of Pharmacists in Industry (AEFI), as a representative organism of pharmacists and other professionals that serve in Industry, would like to send you the following comment on the Consultation Document, Commission Delegated Act on Principles and Guidelines on good manufacturing practice for investigational medicinal products for human use and inspection procedures, pursuant to the first subparagraph of Article 63 (1) of Regulation (EU) N 536/2014 Question la: Would a requirement for a product specification file (a reference file containing, or referring to files containing, all the information necessary to draft the detailed written instructions on processing, packaging, quality control testing, batch release and shipping of an investigational medicinal product) be useful to be introduced? It would be very useful. Yours faithfully, blog AEFI: www.aefi.org.es Este mensaje se dirige exclusivamente a su destinatario y puede contener informaci livilegiada o confidenciai. Sì no es Vd, ei destinatario indicado, íe notificamos que su utilizaci divulgaci /o copia sin autorizaci Prohibida en virtud de la Iegislsci igente. Si ha recibido este mensaje por error, le rogamos que lo comunique inmediatamente a! remitente por esta misma vüy proceda a su destrueei Antes de imprimir este mensaje, asegrese de que es necesario Proteger el medio ambiente est--ambiflten su mano.