anx_I__cpt_7__cpt_2__cpt_2__table_1

Table 1: Content of the simplified IMPD (S: Data relating to the active substance; P: Data relating to the investigational medicinal product; A: Additional information on Facilities and Equipment, Adventitious Agents Safety Evaluation, Novel Excipients, and Solvents for Reconstitution and Diluents) Types of previous assessment Quality data Non-clinical data Clinical data The investigational medicinal product is authorised or has a marketing authorisation in an ICH country and is used in the clinical trial: — within the conditions of the SmPC SmPC — outside the conditions of the SmPC SmPC If appropriate If appropriate — after modification (for example blinding) P+A SmPC SmPC Another pharmaceutical form or strength of the investigational medicinal product is authorised or has a marketing authorisation in an ICH country and the investigational medicinal product is supplied by the marketing authorisation holder SmPC+P+A Yes Yes The investigational medicinal product is not authorised and has no marketing authorisation in an ICH country but the active substance is contained in an authorised medicinal product, and — is supplied by the same manufacturer SmPC+P+A Yes Yes — is supplied by another manufacturer SmPC+S+P+A Yes Yes The investigational medicinal product was subject to a previous clinical trial application and authorised in the Member State concerned and has not been modified, and — no new data are available since last amendment to the clinical trial application, Reference to previous submission — new data are available since last amendment to the clinical trial application, New data New data New data — is used under different conditions If appropriate If appropriate If appropriate

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Source: EUR-Lex (Cellar) · retrieved 2026-11-06 · Text as adopted (Official Journal); later amendments are not incorporated in this text.