Possibility of referring to the SmPC

The applicant may submit the version of the SmPC valid at the time of application, as the IMPD if the investigational medicinal product is authorised. The exact requirements are detailed in Table 1. Where new data are provided, it should be clearly identified. 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 If the investigational medicinal product is defined in the protocol in terms of active substance or ATC code (see above, paragraph 18), the applicant may replace the IMPD by one representative SmPC for each active substance/active substance pertaining to that ATC group. Alternatively, the applicant may provide a collated document containing information equivalent to that in the representative SmPCs for each active substance that could be used as an investigational medicinal product in the clinical trial.

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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.