Data submission on authorised medicines (Article 57)
HumanData on medicinesRegulatory and procedural guidance
All holders of marketing authorisations for medicines in the European Union (EU) and the European Economic Area (EEA) must submit information to the European Medicines Agency (EMA) on authorised medicines and keep this information up-to-date. This is a legally binding requirement from the EU pharmaceutical legislation. The Agency uses this information to support the analysis of data, regulatory activities and communication.
The aim of the submission of data is to establish a complete inventory of all medicines authorised for use in the EU and EEA, including medicines authorised centrally via the EMA and those authorised at national level.
The Agency uses this information for a range of purposes. These include:
- performing data analysis, including:
- analysis of data in EudraVigilance and signal management;
- reporting and coding of individual case safety reports;
- data analytics and business intelligence;
- facilitating medicines regulation and fulfilling regulatory actions and legal obligations, such as:
- coordination of regulatory actions to safeguard public health, including referral procedures, establishment of a repository of periodic safety update reports (PSURs) and literature monitoring;
- supporting the calculation of fees for pharmacovigilance;
- strengthening communication with stakeholders by:
- establishing the European medicines web portal;
- publishing a complete list of all medicines authorised in the EEA with contact details for pharmacovigilance enquiries;
- granting proactive and reactive access to EudraVigilance data;
- exchanging data within the EU and internationally;
- supporting communication between the Pharmacovigilance Risk Assessment Committee (PRAC) and marketing-authorisation holders.
Legal background
The submission of data on medicines by marketing-authorisation holders is a legal requirement from the 2010 pharmacovigilance legislation.
Marketing-authorisation holders were initially required to submit information on medicinal products for human use to the European Medicines Agency (EMA) using the electronic format referred to as Article 57 format or eXtended EudraVigilance Product Report Message (XEVPRM) format by 2 July 2012.
Since July 2012, marketing-authorisation holders are required to submit information on new marketing authorisations granted after 2 July 2012 within 15 calendar days from the date of notification of the granting of the marketing authorisation by the national competent authority.
By 31 December 2014 marketing-authorisation holders were also required to improve quality of information on authorised medicines submitted to the EMA, bring their medicinal product entries up-to-date and submit additionally required information.
Information on amendments to the terms of marketing authorisations following variation, transfer, renewal, suspension, revocation or withdrawal shall be notified to the EMA no later than 30 calendar days from the date on which the amendments have been authorised.
Full details on the legal provisions and requirements for marketing-authorisation holders are available in the Legal notice on the implementation of Article 57(2), second subparagraph of Regulation (EC) No. 726/2004.
Working with the pharmaceutical industry
The Agency is working closely with the European pharmaceutical-industry associations on the implementation of these measures.
The Agency hosts meetings of the Joint Implementation Working Group (IWG) with representatives from EU industry associations to address practical questions on data-submission requirements. These meetings cover aspects related to planning and the submission process.
Topics endorsed at the IWG include:
- definition of the processes and timeline for post-authorisation maintenance submission due to variations, extensions of the terms of marketing authorisations and transfers of marketing authorisations;
- definition of the processes and timeline for maintenance of pharmacovigilance information on the qualified person for pharmacovigilance, pharmacovigilance enquiry details and the location of the pharmacovigilance system master file;
- definition of processes and timeline for handling suspensions, lifting of suspensions, revocations and withdrawals of marketing authorisations;
- definition of technical aspects related to the implementation of additional information on medicines required to be submitted during the 'transition maintenance phase' for the Agency to support new legal obligations;
- definitions of business requirements to develop a new functionality to enable the export of medicinal product data from the Extended EudraVigilance Medicinal Product Dictionary (XEVMPD) by industry to facilitate the data-quality revision and improvement.