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EDQM - What is the CEP 2.0 and what will change?

The CEP 2.0 (new name of the CEP of the future) is a “new-look” CEP that will better meet the current needs of stakeholders and offer both enhanced user-friendliness and greater transparency of the information conveyed without, however, increasing the regulatory burden related to revisions of CEPs.

In the context of the project of the CEP of the future, the EDQM organised in late 2020 a wide public consultation with its stakeholders. This was followed in 2022 by targeted consultations in order to define the design of the CEP and discuss specific questions. 

Based on the feedback received during these discussions the Certification Steering Committee decided on the future design of CEPs for which the deployment is expected for 2023. This will have impacts on CEP applicants, CEP holders and users of CEPs. 

The changes linked to its implementation cover the following 9 areas and will be further detailed within the next months... [EDQM]



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La guida descrive le varie parti interessate nella catena di approvvigionamento dei medicinali, le loro...



Report Egualia: Generici, mercato fermo al palo, si rischia che questi farmaci spariscano

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Carenze farmaci: una proposta per tornare al “Made in Europe” e ridurre la dipendenza dai fornitori (come Cina e India)

After the European Commission proposed a massive overhaul to the EU’s drug legislation,...