Electronic submission of information on medicines

The European Medicines Agency is progressing with the implementation of the electronic submission of information on medicines.

This is a deliverable of the 2010 pharmacovigilance legislation. Article 57(2) of the Regulation requires:

• the Agency to publish the format for the electronic submission of information on medicinal products for human use by 2 July 2011;
• marketing-authorisation holders to submit information to the Agency electronically on all medicinal products for human use authorised in the European Union (EU) by 2 July 2012, using this format;
• marketing-authorisation holders to inform the Agency of any new or varied marketing authorisations granted in the EU as of 2 July 2012, using this format.

Details on the legal provisions and requirements can be found in:

• Legal notice
• Regulation (EU) No 1235/2010

Phases of implementation

The Agency is applying a phased approach to support the pharmaceutical industry with the implementation of the electronic submission.

Phase one: Notification of the electronic submission format

The Agency published the format for the electronic submission of medicinal product information in July 2011. The XML Schema Definition (XSD) for the individual data elements was published in September 2011.

Based on feedback from industry stakeholders, the Agency published an update of the format on 5 March 2012, with considerably reduced mandatory data fields. This was intended to reduce administrative burden and help marketing-authorisation holders to meet their legal deadline of 2 July 2012 for submitting information on authorised medicines.

The updated format includes detailed guidance, Extended EudraVigilance Medicinal Product Dictionary (XEVMPD) messaging schemas, controlled vocabularies and frequently asked questions, as well as working examples:

• Documents for electronic submission of information on medicines

Phase two: Electronic submission by marketing-authorisation holders - initial submission and maintenance of information

Marketing-authorisation holders are required to submit information on all human medicines authorised in the EU by 2 July 2012.

Marketing-authorisation holders now also need to submit information on new marketing authorisations granted after 2 July 2012. They should supply information on new marketing authorisations to the Agency within 15 calendar days from the date of notification of the granting of the marketing authorisation by the competent authority, including the availability of the approved summary of product characteristics.

Marketing-authorisation holders will also need to inform the Agency about changes to marketing authorisations using a two-speed system. The details of the process for this system will be agreed in September 2012 at a workshop with pharmaceutical industry associations.

The Agency will provide further guidance on these issues in the near future.

Marketing-authorisation holders can submit information electronically using tools developed in-house by pharmaceutical companies or software vendors. Information that complies with the updated guidance and XSD schema published by the Agency can be submitted via the EudraVigilance Gateway.

Marketing-authorisation holders are also able to use the XEVMPD data-entry tool also known as EVWEB provided by the Agency to submit information. This tool was developed for small and medium-sized enterprises specifically but can be used by any pharmaceutical company following a process of training and registration.

Information on registration and training offered by the Agency and instructions on how to perform testing is available.

Phase three: Processing and validation of the submitted information

The Agency, with the assistance of a contractor, will process the information submitted by marketing authorisation holders and perform an overall review of the quality and integrity to ensure that it is accurate and up-to-date. If information is incomplete, missing or erroneous, the Agency will liaise with the marketing-authorisation holder in order to obtain the correct information.

Phase four: Update of the format in compliance with the ISO IDMP standards

The Agency maintains its plan to update the initial format published in July 2011 in line with the International Organization for Standardization (ISO) Identification of Medicinal Products (IDMP) standards. The IDMP standards are scheduled for finalisation during the second half of 2012.

A roadmap towards the implementation of the ISO IDMP standards will be developed in consultation with the EU regulatory network and the European pharmaceutical industry associations. 

Working with the pharmaceutical industry

The Agency is working closely with the European pharmaceutical industry associations on the implementation of these measures, including hosting workshops where practical questions on the implementation or the submission process can be discussed.

Work with the EU regulatory network and European pharmaceutical industry associations will continue throughout 2012 on further defining requirements for data maintenance and data submission. This will include defining requirements for structured substance information.

The Agency will be hosting a workshop with European pharmaceutical industry associations in September 2012 to discuss:

• the scope and process of post-authorisation maintenance activities for variations, extensions of marketing authorisations and transfers of marketing authorisations;
• maintaining information on the qualified person for pharmacovigilance, pharmacovigilance enquiry details and the location of the pharmacovigilance system master file;
• handling suspensions, revocations and withdrawals.

The Agency is also setting up a joint implementation group together with industry representatives. This group will address:

• technical and operational questions related to the implementation of the requirement for submission of information on medicines;
• the development of a roadmap on the implementation of the ISO IDMP standards;
• definition of the requirements for structured substance information.