EMA Guidance: XEVPRM – Electronic Submission of Medicinal Product Information
Accurate and structured medicinal product information is an important part of the regulatory and pharmacovigilance framework. Chapter 3.II: XEVPRM Detailed User Guidance provides detailed instructions for marketing authorisation holders (MAHs) on the electronic submission of information on medicinal products for human use to the European Medicines Agency through the XEVMPD.
What is XEVPRM?
XEVPRM stands for eXtended EudraVigilance Medicinal Product Report Message. It is the message used by marketing authorisation holders to submit medicinal product information to the eXtended EudraVigilance Medicinal Product Dictionary (XEVMPD).
The guidance describes how MAHs can submit and maintain medicinal product information using XEVPRMs and the applicable data elements, operation types, and business and technical rules.
Where is XEVPRM Used?
XEVPRM is used to electronically submit information on medicinal products for human use to the EMA in accordance with Article 57(2) of Regulation (EC) No. 726/2004. XEVPRMs can be generated and submitted using an in-house gateway submission tool and/or the XEVMPD user interface (XEVMPDweb). Registered users can access XEVMPDweb after setting up multi-factor authentication and requesting access to the XEVMPD production environment through the EMA Account Management portal.
Why is XEVPRM Important?
XEVPRM provides a structured method for MAHs to submit medicinal product information to XEVMPD and to maintain information that has already been submitted.
The guidance covers the electronic submission and maintenance of medicinal product information, including information associated with authorised medicinal products and relevant data elements held within XEVMPD.
Initial Submission of Medicinal Product Information
MAHs use the Insert operation to submit new medicinal product information to XEVMPD.
The guidance covers submission requirements for medicinal products falling within the relevant Article 57(2) obligations. It also describes information that needs to be provided for medicinal products and the processes for submitting the required data electronically.
XEVPRM Operation Types
XEVPRM provides different operation types for submitting and maintaining medicinal product information.
Insert
The Insert operation allows the sender organisation to insert medicinal product information into XEVMPD. For XEVMPDweb users, the Reinsert function is also available. This allows users to reinsert an existing medicinal product while retaining the previous information and creating a new medicinal product using the Insert operation.
Update
The Update operation allows the sender organisation to correct erroneous information previously submitted, in accordance with the applicable business and technical rules. This operation is also used to maintain specified medicinal product information according to the maintenance requirements described in the guidance.
Nullification
The Nullification operation allows users to identify incorrectly submitted information, including duplicate information, as non-current in accordance with the applicable business and technical rules.
Invalidate MA.
The Invalidate MA operation allows the sender organisation to submit notification of the withdrawal of an authorised medicinal product from the market through an XEVPRM.
This operation also covers certain scenarios involving the transfer of an authorised medicinal product to another MAH and renewal of a marketing authorisation where the marketing authorisation number changes.
XEVPRM Acknowledgements
Following successful submission of new medicinal product data to XEVMPD, an EV Code is assigned to each XEVMPD entity or data element.
The EV Code is provided to the MAH sender organisation through an XEVPRM Acknowledgement (XEVPRM ACK).
MAH organisations registered as Web Trader organisations that submit XEVPRMs through XEVMPDweb or the relevant posting functionality can retrieve the XEVPRM acknowledgement through their Web Trader Inbox.
Maintaining Medicinal Product Data
XEVPRM is also used to maintain medicinal product information already submitted to XEVMPD.
The guidance provides detailed information on the maintenance of medicinal product data and covers different data elements associated with medicinal products. These include information relating to the medicinal product, marketing authorisation, pharmaceutical form, route of administration, substances, indications, ATC information, and other relevant product information.
The document also addresses maintenance activities associated with changes to medicinal product information and specific regulatory scenarios.
XEVPRM and PSMF Information
The guidance also describes the submission of information relating to the Pharmacovigilance System Master File (PSMF).
PSMF location information is submitted through the relevant section of an XEVPRM using the Insert operation. Following processing, the PSMF receives a unique reference number, and the PSMF is linked to the relevant medicinal product information in the Article 57 database.
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