# Regulation (EU) No 536/2014 of the European Parliament and of the Council of 16 April 2014 on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC (Text with EEA relevance), Division: Possibility of referring to the SmPC

Extent: E+W+S+N.I.

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

---
Source: https://www.legislation.gov.uk/eur/2014/536/annex/I/division/G/division/1.2/division/3 (the official version)
Page: https://openlegislation.uk/eu-regulation-2014-536/annex-I/division-G/division-1.2/division-3
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.