How to submit information
Marketing-authorisation holders are required to submit information on authorised medicines to the European Medicines Agency. The information is submitted to the Extended EudraVigilance Medicinal Product Dictionary (XEVMPD) using the Extended EudraVigilance Product Report Message (XEVPRM) schema. The information can be submitted using the EudraVigilance Gateway or via the Agency's data-entry tool called EVWEB.
There are two ways to submit data on authorised medicines. For both methods, at least one member of staff of the organisation submitting the data must complete training and register before data submission can begin. For full details, see:
In-house tools (updated)
Companies can use in-house tools developed by pharmaceutical companies or software vendors. Information that complies with the updated guidance and XML schema definition (XSD) schema published by the Agency can be submitted via the EudraVigilance Gateway.
The EudraVigilance gateway supports the electronic data interchange (EDI) process, which is based on the secure electronic exchange of product messages between a sender and a receiver. The product messages contain Extended EudraVigilance Medicinal Product Reports (XEVPRMs).
An acknowledgement message confirms the receipt and outcome of the validation of a product message and completes the EDI process.
For technical details, see:
- Extended EudraVigilance product report message (XEVPRM) schema (opens in html)
- XEVMPD element acknowledgement codes (opens in Excel)
The gateway allows for:
- verification of integrity;
- non-repudiation of origin and receipt.
Companies are responsible for installing and operating software that is suitable for the successful transmission of encrypted and digitally-signed product report and acknowledgement messages. Alternatively, they can use service providers for this purpose.
Marketing-authorisation holders are also able to use the XEVMPD data-entry tool known as EVWEB to submit information. This tool was developed by the Agency for small and medium-sized enterprises, but it can be used by any company.
EVWEB is the interface to the EudraVigilance database management system (EDBMS). It allows registered users to create, send and view XEVPRMs and acknowledgement messages. EVWEB also enables users to perform queries on medicinal product information.
Registered users can access EVWEB by logging into the production or XCOMP (i.e. test) environment via the EudraVigilance web page.
XEVMPD is a database designed to support the collection, reporting, coding and evaluation of data on medicines in a standardised and structured way.
Its main objective is to assist pharmacovigilance activities in the European Economic Area (EEA), enabling the Agency to:
- create a list of all medicines authorised in the European Union (EU);
- accurately identify medicines, especially medicines included in reports of suspected adverse reactions;
- coordinate the regulation and safety monitoring of medicines across the EU.
XEVPRM is the schema that must be used to submit data on authorised medicines. It consists of a set of controlled vocabularies covering a set of codified data elements required by companies submitting information.
The Agency first published the data format in July 2011 and the XML Schema Definition (XSD) for the individual data elements in September 2011. This was followed by updated requirements in March 2012, with fewer mandatory data fields, in order to reduce the administrative burden on marketing-authorisation holders.
The latest amendment to the XSD took place on 31 January 2014. This included additional information on medicines required to fulfil new legal obligations. It comes into force on 16 June 2014. From this date, the required data elements will increase, and the following new required fields will be included in the data-submission format:
- the details of the legal basis of the marketing authorisation;
- a description of the medicinal product based on selected criteria;
- information on the authorised pharmaceutical form and, where applicable, before reconstitution into the administered pharmaceutical form;
- a description of the size of the organisation.
Full details on the data-submission requirements are available in the legal notice, detailed guidance and other documents available on Guidance documents.