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EMA gives December deadline for information updates

Pharma companies must revise their medicines information by year-end

European Medicines Agency (EMA)Regulatory workloads are set to substantially increase across the industry between now and the end of December after the European Medicines Agency (EMA) confirmed new information requirements.  

The regulator wants companies to update, complete and improve the quality of information on all products submitted to it, a hefty task that must be completed before the end of the year.  

The expanded information will support pharmacovigilance data analysis and help streamline procedures so that adverse reaction reporting is simpler for companies and the EMA can ensure fees are calculated accurately.

Part of the task will involve adding four new elements to previously submitted information:  

• The details of the legal basis of the marketing authorisation
• A description of the medicinal product type based on controlled vocabularies 
• Information on the authorised pharmaceutical form and before reconstitution into the 'administered' pharmaceutical form  
• A description of the size of the marketing-authorisation-holder company.  

Furthermore, the EMA's data submission system will now only accept submissions that are in line with its updated data-submission format. Then, from next month, the regulator will begin a systematic review of the quality and integrity of the information submitted, to ensure that it is accurate and up-to-date.  

The changes have industry buy-in according to the EMA, which has been working with European industry associations through the  Joint Implementation Working Group (IWG).  

To assist companies the EMA has been releasing a series of guidance documents and this week put out two new documents covering the splitting of the full presentation names and substance names best practice.  

The need to revise information on authorised medicines applies to all holders of marketing authorisations for all medicines in the European Union.  

As such it covers nationally and centrally authorised products as well as those approved under the mutual recognition or decentralised procedures. It also covers Iceland, Liechtenstein and Norway, which are within the European Economic Area (EEA) but outside the EU.  

The changes are a requirement of wide-ranging pharmacovigilance changes that came into effect in 2012 introducing, among other things, new rules for the monitoring, identification and assessment of adverse events.

Article by
Dominic Tyer

19th June 2014

From: Regulatory

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