Transcription of QRD general principles regarding the SmPC …
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QRD general principles regarding the SmPC …
30 Churchill Place Canary Wharf London E14 5EU United Kingdom An agency of the European Union Telephone +44 (0)20 3660 6000 Facsimile +44 (0)20 3660 5555 Send a question via our website European Medicines Agency, 2018. Reproduction is authorised provided the source is acknowledged. 18 June 2018 EMA/627621/2011 Human Medicines Evaluation Division QRD general principles regarding the SmPC information for a generic/hybrid/biosimilar product Background information This document outlines the general principles to follow for the preparation of the summary of productcharacteristics (SmPC) for a generic, hybrid or biosimilar medicinal product to be authorised via thecentralised procedure using a reference medicinal product authorised either at national level orcentrally. The following types of applications are discussed in this document: generic applications (as per (1) of Directive 2001/83/EC), hybrid applications (as per Art.)
Qrd general principles regarding the smpc information for a generic/hybrid/biosimilar product EMA/627621/2011 Page 2/2 and the SmPC guideline should be applied to the generic, hybrid or biosimilar SmPC as far as
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