European Medicines Agency publishes format for submission of information on medicines

1 July 2011

Today the European Medicines Agency reached the first milestone in the implementation of the new pharmacovigilance legislation, by publishing the format in which pharmaceutical companies need to submit information on all of the medicines authorised or registered in the European Union (EU).

The format shows the types of information that companies will need to submit to the Agency by the legal deadline of 2 July 2012. This information will help the Agency to:

• create a list of all medicines authorised and registered in the EU, including medicines authorised centrally via the Agency and medicines authorised by regulatory authorities in EU Member States;
• identify medicines accurately, especially medicines included in reports of suspected adverse reactions;
• co-ordinate the regulation and safety-monitoring of medicines across the EU.

Today's publication includes a Legal notice on the implementation of Article 57(2), second subparagraph of Regulation (EC) No. 726/2004 summarising the main requirements of pharmaceutical companies, supported by a detailed Detailed guidance on the electronic submission of information on medicinal products for human use by marketing authorisation holders to the European Medicines Agency in accordance with Article 57(2), second subparagraph ....

The Agency encourages pharmaceutical companies to familiarise themselves with these documents, so that they are prepared for the electronic submission of the information, starting later in the year. The Agency will be providing instructions for how companies should submit this information, along with a data-entry tool designed to help small and medium-sized enterprises.

The Agency is committed to working with the pharmaceutical industry in implementing the requirement to submit information on its medicines. As part of this, the Agency is organising face-to-face and online training sessions, starting in the autumn.

The pharmacovigilance legislation was adopted in the EU in December 2010 and aims to save lives by strengthening the European-wide system for monitoring the safety of medicines. It is the biggest change to the legal framework for human medicines since the Agency was established in 1995 and will be a major focus for the Agency, the EU regulatory network and its stakeholders in the coming years.