The European Medicines Agency has published an updated set of mandatory
requirements for marketing authorisation holders to comply with Article 57(2),
one of the key measures of the new pharmacovigilance legislation. The Agency
has considerably reduced the number of data fields initially required in
the format published on 2 July 2011, thus significantly reducing the
administrative burden and helping marketing authorisation holders to meet their
legal deadline of 2 July 2012.
The Agency will continue to support marketing authorisation holders on the
data submission process through online and face-to-face training and a
dedicated helpdesk. An online data entry tool (EVWEB) hosted by the Agency to
facilitate data submission by small and medium-sized enterprises was also
released into production today.
Article 57(2) of the new pharmacovigilance legislation requires the Agency
to establish lists of all human medicines authorised in the European Union
(EU), based on structured data submitted by the marketing authorisation holders
of these medicines. These lists will assist the Agency in the coordination of
pharmacovigilance activities and the protection of public health by
facilitating clear identification of medicines in reports on adverse reactions
and of medicines affected by a safety review.
Since the initial publication of the requirements in July 2011, the Agency
has listened carefully to all stakeholders and looked at how the mandatory data
set could be reduced while ensuring that the public-health goals of the
legislation and patient safety are not compromised. These goals have been successfully
achieved and have resulted in a reduction in the number of data fields which
are mandatory.
In January 2012, the Agency held a workshop with EU pharmaceutical industry
associations for human medicines. During this workshop, stakeholders were
supportive of the Agency’s proposal for an updated set of mandatory data for
submission by 2 July 2012. A summary of the workshop is available on the
Agency's website.
The Agency will work with stakeholders throughout 2012 on further defining
requirements for data maintenance, submission of structured substance
information and the implementation of ISO IDMP standards, a set of
internationally harmonised specifications for the unique identification of
medicines.
Notes
- More information on the revised Article 57 requirements is available in the summary note: Article 57(2) requirements: information to marketing authorisation holders on the revised format for electronic submission of information on medicines.
- The revised legal notice on the implementation of Article 57(2), second subparagraph of Regulation (EC) No 726/2004, together with the format (detailed guidance and XEVMPD messaging schemas) of the electronic submission of information on medicinal products for human use by marketing authorisation holders to the European Medicines Agency and a frequently asked questions document are available: Documents for electronic submission of information on medicines. Working examples are included in the detailed guidance.
- For any questions on the implementation of Article 57(2), marketing authorisation holders are advised to use the Agency’s dedicated mail box: art57@ema.europa.eu and dedicated helpline +44 (0)20 7523 7010.
- Information on training and how to register to submit data to the Agency are available: Registration and training.
- The summary of the workshop held on 30 January 2012 is available: European Medicines Agency workshop with European Union pharmaceutical industry associations on the implementation of Article 57(2), second subparagraph of Regulation (EC) No. 726/2004.