Companies required to update information on drugs

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Companies required to update information on drugs

INICIO/Políticas y legislación | Posted 04/07/2014 0 Post your comment

The European Medicines Agency (EMA) announced that as of 16 June 2014 marketing authorization holders would be required to update the information on medicines authorized in the European Union.

The requirement comes as part of the 2010 pharmacovigilance legislation [1] and will require companies to update ‘old’ information for drugs, as well as providing more comprehensive information on ‘new’ drugs. The requirement covers nationally authorized, centrally authorized, mutually recognized and decentrally authorized medicinal products.

The additional information that companies are now required to submit includes:

details of the legal basis of the marketing authorization
description of the medicinal product type based on controlled vocabularies
information on the authorized pharmaceutical form before reconstitution into the ‘administered’ pharmaceutical form
description of the size of the marketing-authorization-holder company.

EMA has released several guidance documents to help companies in providing this information. Companies need to complete the update process for all medicines for which they hold a marketing authorization in both the EU and in European Economic Area (EEA) countries (which are also covered by the pharmacovigilance legislation) by the end of 2014.

As well as updating ‘old’ information for drugs already authorized in the EU, companies will also be required to submit information for new marketing authorizations within 15 calendar days from the date of notification of the granting of the marketing authorization by a regulatory authority.

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Reference
1. GaBI Online - Generics and Biosimilars Initiative. EMA finalises pharmacovigilance guidance [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2014 Jul 4]. Available from: www.gabionline.net/Guidelines/EMA-finalises-pharmacovigilance-guidance

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Source: EMA