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.
The IMPD consists of 2 parts:
- The Quality section with information on the active medicinal product, placebo and reference medicine (if applicable).
- The Safety and Efficacy section with a summary of data from all clinical and non-clinical studies, with an overall assessment of the risks and benefits. For this part, reference can also be made to the Investigator's Brochure (IB).
Templates for these two parts of the IMPD are 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. Table 1, paragraph G, of Annex I to the CTR gives an overview of which data should be included in a 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.