Medicinal Product Registration

Before completing the clinical trial application in CTIS, the sponsors of clinical trials should ensure that the details of the medicinal products used in the clinical trial are already registered in the eXtended EudraVigilance Medicinal Product Dictionary (XEVMPD). The dictionary includes all medicinal products that are authorised in the EU/EEA and also development products that are associated with clinical trials.

A placebo can be added manually without resorting to a registration in XEVMPD necessarily.

For each trial in CTIS, the sponsor has to associate at least one test product. Other product types that can be associated in CTIS are: comparator, placebo and auxiliary medicinal product.

In CTIS, the product information is retrieved from XEVMPD and this is enabled by a search and selection process for an authorised product (product with a marketing authorisation from the EU/EEA), development product, an active substance or an ATC code.

For more information, see CTIS training module 10 including video: CTIS – M10 How to submit an initial CTA in the CTIS – Fill in the Product details of Part I section. See also chapter 5 of the CTIS Sponsor handbook on "Product management in CTIS”.

Further guidance by EMA to be developed.