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The European Medicines Agency (EMEA) is to start publishing reports in language the general public can understand.
The agency’s European public assessment reports (EPARs) will now also be published in shorter, non-technical language as ‘EPAR summaries for the public’.
EMEA’s summaries will provide information about how a particular medicine works, its indications, how it was studied, its benefits and risks, and the reasons why it received a positive recommendation for authorisation.
The reports, in all European languages, will only be published for newly authorised medicines, but eventually the agency will work back and cover all centrally authorised products on the market.
An EMEA spokesman said: “The publication of EPAR summaries is one of the new provisions introduced in the revised EU pharmaceutical legislation concerning the availability of better information about medicines.
“Implementation of this new initiative has already begun, with the publication today of EPAR summaries for the newly authorised products Ionsys and Yttriga.”
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