Before submitting a clinical trial application in CTIS, the sponsor should ensure that all medicinal products used in the clinical trial are registered in the eXtended EudraVigilance Medicinal Product Dictionary (XEVMPD) of EMA. This dictionary includes all medicinal products that are authorised in the EU/EEA and also development products that have been used in clinical trials.
A placebo can be added manually without requiring registration in XEVMPD.
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.
More information is provided in section 1.4 of the CTIS Sponsor Handbook of EMA on the registration in XEVMPD, and in section 2.4.5 on selecting products in CTIS from XEVMPD.