Investigational Medicinal Product Dossier (IMPD)

An Investigational Medicinal Product Dossier (IMPD) contains data on the quality, production and control of the medicinal product being researched.

This information concerns the active product, placebo and reference product (if applicable). It also contains a summary of data from all clinical and non-clinical research. The Investigator’s Brochure may be referred to for the latter. A template IMPD is available.

If the IMP is authorised in the EU or has a marketing authorisation in an ICH country, a valid Summary of Product Characteristics (SmPC) at the time of application may be submitted. The exact details of a simplified IMPD are given in table 1, section G of annex I CTR (see also document Content simplified IMPD).

If the IMP has a marketing authorisation (MA) in several Member States concerned with different SmPCs, the sponsor should justify its selection of the most appropriate SmPC.

If the investigational medicinal product is a placebo, the information requirements shall be limited to quality data. No additional documentation is required if the placebo has the same composition as the tested investigational medicinal product (with the exception of the active substance), is manufactured by the same manufacturer, and is not sterile.