Registration of new investigational medicinal products in the EudraVigilance database (XEVMPD)
When applying for authorization to conduct a new clinical trial with medicinal products under the new EU regulation, it is a requirement that the investigational medicinal products used are registered in the CTIS portal. In order to search and register investigational medicinal products in the CTIS portal, they must be registered in the European adverse reaction database EudraVigilance (more specifically the Extended EudraVigilance Medicinal Product Dictionary (XEVMPD)). This is a requirement in order to ensure an overview of reported adverse reactions in accordance with Article 81(3) of the Regulation.
All medicinal products marketed in the EU are registered in XEVMPD and can therefore be easily searched in CTIS. Blinding, including recapsulation and repackaging, of a marketed medicinal product does not need to be registered again in XEVMPD. In CTIS, the marketed medicinal product is registered and accommodated with relevant quality documentation.
For non-approved medicinal products, including non-marketed formulations with an approved substance, it must be ensured that these are, or will be, registered by the sponsor organization's Responsible Person (RP) or the pharmaceutical manufacturer's QPPV in XEVMPD. To ensure a smooth process, it is recommended that the QPPV of the pharmaceutical manufacturer or importer is responsible for the registration in XEVMPD.
The QPPV is the qualified person responsible for pharmacovigilance at a pharmaceutical manufacturer (such as a pharmaceutical company or pharmacy). Responsible Person (RP) is the qualified person responsible for pharmacovigilance at a sponsor organization (either commercial or non-commercial). You can read more about the different roles and access to data in EudraVigilance in Annex 1 of the EudraVigilance Registration Manual.
Registration in XEVMPD first requires access and organization in the EudraVigilance database. You can read more about this registration and organization on our page about ADR reporting in EudraVigilance. Link to new page coming ASAP.
The registration of investigational medicinal products is described in the EMA guideline for electronic submission of information on investigational medicinal products for human use in the Extended EudraVigilance medicinal product dictionary (XEVMPD), chapter 1.
When the investigational medicinal product is registered in XEVMPD, it is assigned a product ID (EV product number), which together with the substance ID (EV substance number) must be used to search for the product in the CTIS portal. These numbers are only available in the XEVMPD database and must therefore be provided by the registration manager (person with access to XEVMPD) to the sponsor or delegated person responsible for the creation of the CTIS application.
For the actual application in the CTIS portal and the search for investigational medicinal products in the CTIS portal, we refer to the detailed guidance of the Danish GCP units, as well as Registration and reporting - GCP units
Available guides and support on EudraVigilance
The Danish Medicines Agency does not have access to or the ability to register sponsors in the EudraVigilance database or create new medicines in XEVMPD. Only the organization's Responsible Person or QPPV can grant user access to EudraVigilance. For technical assistance, please contact the EMA Service Desk. The EMA Service Desk requires an EMA login, which is the same login used for the actual registration in EudraVigilance.
We refer to EMA's website on safety reporting in clinical trials where you can find links that describe both legal requirements and guidelines. The entire process of organization and registration for the organization is described in section 8 of EMA's EudraVigilance Registration Manual.