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European Network of Centres for Pharmacoepidemiology and Pharmacovigilance
News article14 December 2023European Medicines Agency

ENCePP Resource Database and EU PAS Register downtime early next year due to migration

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Due to the migration of the ENCePP Resource Database and the EU PAS Register to the new EMA-HMA Catalogues of data sources and non-interventional studies on the EMA website, the two databases will experience a downtime from 22 January to 15 February 2024. During this period, no new entries or amendments to studies, data sources, centres and networks can be submitted. The ENCePP website will remain available for viewing and searching entries. 

In accordance with Regulation (EC) No 726/2004 and Directive 2001/83/EC, protocols and abstracts of results of non-interventional post-authorisation safety studies (PASS) imposed as an obligation of marketing authorisation by an EU competent authority should be registered in the EU PAS Register. MAHs are encouraged to publish these documents, if already available, before the downtime period, which starts on 22 January 2024. After 15 February 2024, updates to study entries, including the publication of protocols and study reports, will need to be performed in the new EMA-HMA catalogue of non-interventional studies (the replacement of the EU PAS Register).  

More information on the migration and the action points to PLIs and Administrative contact points can be found in the ENCePP website news item published on 4 December. 

Questions on the migration can be sent to metadataatema [dot] europa [dot] eu (metadata[at]ema[dot]europa[dot]eu) 

Details

Publication date
14 December 2023
Author
European Medicines Agency