Division Possibility of referring to the SmPC
United Kingdom
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 |