Good information saves time and increases the quality of your actions.
The European Medicines Agency (EMA) obliges marketing authorisation holders in Europe and the European Economic Area to make information on medicinal products available to the EMA and to maintain it.
This abbreviation stands for eXtended EudraVigilance Medicinal Product Dictionary. It is a database for all authorised medicines in the European Union (EU) and the European Economic Area (EEA).
What is the aim of the database?
The database shall be a complete inventory of all medicines authorised for human use in the EEA, including medicines authorised centrally via the EMA and those authorised at national level via the National Competent Authorities (NCAs).
The information entered will be used e.g. to
- support regulatory business activities
- process and evaluate Individual Case Safety Reports
- support Pharmacovigilance signal management activities
- perform data analysis and business analysis at the European Medicines Agency
- facilitate the coordination of regulatory decisions and actions to safeguard public health, e.g. to support referral procedures, the establishment of a repository oaf Periodic Safety Update Reports (PSURs) and literature monitoring
- calculate the Pharmacovigilance Fees payable by MAHs
- strengthen transparency and communication with the European Medicines Agency
Who must submit data- and when?
- Sponsors of clinical trials must provide information on investigational medicinal products (IMPs) to the xEVMPD before submission of a clinical trial application in the European Union.
- Marketing Authorisation Holders (MAHs) are legally required to submit information on new marketing authorisations and to keep all information up to date. Within 15 calendar days from the date of notification of the granting of the marketing authorisation by the national competent authority or the EMA, MAHs have to enter the information into the xEVMPD database.
Who is allowed to submit data?
- At least one user from each organisation should follow the special xEVMPD training and obtain a ‘Notification of successful completion of the XEVMPD knowledge evaluation’. This is to ensure the quality of data submitted to the database. Also, this ‘Notification’ is required for at least one user from each organisation during the EudraVigilance registration process before the data submission can begin.
- The task can be delegated to a 3rd party service provider. If you have made arrangements with a service provider to fulfil the task of entering and maintaining the information in the xEVMP database on your behalf, it is sufficient, that a member of staff of this service provider organisation has successfully completed the xEVMPD training.
Our xEVMPD solution for you
We would like to offer you a software solution as well as the necessary staff to take care of the submission of extensive production information as required by the EU.
We use the validated software gxpd from software provider Arivis AG.Together with other Dr. Haney customers, you simply share the monthly fee for the database. This saves enormous costs. Each company gets an individual account.
We will take care of your duties regarding your medicinal product authorisations:
Your advantages at a glance:
If you are interested or have any questions, please contact our xEVMPD team here.
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