The European Medicines Agency is preparing for the implementation of the electronic submission of information on medicines.
This is the first deliverable of the new pharmacovigilance legislation. It 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 or registered in the European Union 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:
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 notification of the electronic submission of medicinal product information in July 2011, which lists all of the data elements required, including the description of the characteristics of the substances contained in medicinal products. The Agency updated this information in September 2011 to include the XML Schema Definition (XSD) for the individual data elements.
The Agency has published a list of controlled vocabularies, which companies should use to fill in fields of the extended EudraVigilance product report messages (XEVPRMs). This list is updated periodically. The XSD schema files and naming conventions for substances are also available.
- All documents related to the electronic submission process are available under documents for electronic submission of information on medicines.
Phase two: Electronic submission by marketing-authorisation holders
Marketing-authorisation holders can now submit information electronically using tools developed in-house by pharmaceutical companies or software vendors. XSD-compliant product information can be submitted via the EudraVigilance Gateway.
By the end of January 2012, marketing-authorisation holders will also be able to use data-entry and submission tools provided by the Agency. These tools will be designed for small and medium-sized enterprises to use, but will be available for any pharmaceutical company to use if it wishes.
The Agency is developing a training programme in collaboration with the Drug Information Association (DIA). The Agency will announce these training courses on this website and on the EudraVigilance website.
Phase three: Processing and validation of the submitted information
The Agency will process and validate the information submitted to ensure that it is accurate and up-to-date, with the assistance of a contractor.
If information is incomplete, missing or erroneous, the contractor will liaise with the marketing-authorisation holder on behalf of the Agency, to get hold of the correct information.
Phase four: Update of the format in compliance with the ISO IDMP standards
By the end of 2014, the Agency plans 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 in the first quarter of 2012.
The Agency is making all efforts to make sure that the information on medicines submitted by 1 July 2011 can be migrated in compliance with the future ISO IDMP standards. Most data elements and detailed descriptions of substances in the format published in July 2011 are aligned with the future ISO IDMP standards.
Therefore, marketing-authorisation holders should not need to resubmit data previously provided. However, the Agency will ask them to provide updates based on additional ISO data elements not included in the July 2011 format.
Working with the pharmaceutical industry
The Agency aims to work closely with pharmaceutical industry during the implementation of these measures, including hosting workshops to allow discussion of practical questions on the implementation of the submission process.
The Agency is also planning information days during 2011 and 2012 to raise awareness about the future ISO IDMP standards and to address marketing-authorisation holders’ questions:
- Information day on the new identification of medicinal products (IDMP) international standards and International Conference on Harmonisation (ICH) M5/M2, and implementation of electronic submission of medicinal product information in the European Union (22-23/09/2011)
Details of upcoming information days are also available on the EudraVigilance website.