Thursday, 13 August 2020 14.00 - 15.30 h
Submitting an application is a complex procedure which should run as smoothly as possible to avoid unnecessary delays. Now, the work of the regulatory affairs departments has been relieved in terms of numbers of applications to be submitted for a centralised authorisation. On 15 March 2013, the EMA published an updated table entitled Dossier requirements for Centrally Authorised Products (CAPs). The revision of this document was necessary in order to simplify the process of submissions through the reduction of the numbers of documents to be submitted. In addition information about the newly created Pharmacovigilance Risk Assessment Committee (PRAC) was included.
The document contains important information about the delivery of applications to the competent authority in the case of new marketing authorisations, renewals, type II variations, and further regulatory procedures. In the EMA document you can also find the updated addresses of all the EU national competent authorities. Moreover, it is indicated whether the application may be submitted via an online portal. The table also links to the list of CHMP, CAT or PRAC members (including names, addresses and contact data) with the name of the CHMP "Co-opted Members" and the PRAC's "independent scientific experts".
The EMA document refers to a fundamental document from 2011 which describes details of the electronic submission of applications. The guideline which was elaborated by the "TIGes Harmonisation Group" - a subgroup of the "Telematics Implementation Group for electronic submissions (TIGes)" is entitled Harmonised Guidance for eCTD Submissions in the EU and completes EMA's "Dossier requirements" document.