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Laura Castagno di Pharmaceutical Holding FIS ci ha inviato delle news da parte di alcune agenzie Europee che hanno dichiarato di accettare le submission elettroniche. Invitiamo tutti i nostri lettori ad imitare Laura e ad inviarci le informazioni di cui siete a conoscenza sulla situazione nelle diverse agenzie .
Partiamo dalla Germania (Bfarm) che ha il seguente annuncio:General rules for acceptance of so called electronic-only submissionsupdated: 03.05.2010 created: 26.03.2010 (From 31.03.2010 onwards the Federal Institute for Drugs and Medical Devices will accept to receive nearly paperless electronic-only submissions for new applications for authorisation or registration of medicinal product as well as for post authorisation procedures ( e.g. variations, renewals, PSURs) of those medicinal products which have already been submitted under this new rules after 31.03.2010. BfArM is currently aligning internal processes to be able to accept electronic-only submissions for post authorisation procedures for all medicinal products in near future. This preparatory work can be supported by applicants by switching their submission format to eCTD or NeeS, validating their submissions in advance and submit the validation report voluntarily. BfArM will keep applicants informed well in advance about widening the scope. For new applications BfArM is expecting preferably electronic submissions according to eCTD format (2 copies of electronic media) according to the published specifications of EU Module 1 and ICH Modules 2 to 5. Detailed information about structuring and formatting of eCTD Submissions are available at EMA website. BfArM will also accept so called „Non- eCTD electronic submissions“ (2 copies of electronic media) according to the requirements set out in the NeeS-Guideline, resulting in missing the XML backbone of the eCTD format. Detailed information about structuring and formatting of Non-eCTD electronic Submissions (NeeS) are available at EMA website. Usage of other electronic formats for electronic submissions is currently not possible due to technical reasons. Potete leggere l'intero annuncio sul sito dell'agenzia tedesca
Dalle News dell'agenzia Islandese: Announcement to Marketing Authorisation HoldersAs of 1 January 2010, the Icelandic Medicines Agency has been ready to accept electronic-only submissions, i.e. either as eCTD or NeeS.19.5.2010 Marketing Authorisation Holders interested in switching from paper submissions to electronic-only submissions are requested to fill out a request form. Switch from paper to electronic only submission is only possible at the start of a regulatory activity, e.g. submission of a variation application, renewal application, PSUR submission etc.
Dalla neonata agenzia Finlandese si ha: 07.04.2010 Fimea will accept marketing authorisation material in e-format as of 1 June 2010Fimea has prepared for accepting marketing authorisation material in e-format. The initial-stage solution will facilitate marketing authorisation for the pharmaceutical industry. Marketing authorisation applicants may submit their applications to Fimea in electronic eCTD or NeeS format as of 1 June 2010 in such a way that modules 1−3 are also delivered, on account of national archiving requirements, still in hard copy format. During the transition period in the rest of 2010 Fimea will accept marketing authorisation applications both in electronic and hard copy format. As of the beginning of 2011, applications will be accepted only in e-format. Even then, it will be necessary to provide the above-mentioned modules 1−3 in hard copy in addition to e-format. The receipt of e-submissions is part of the re-launched Säihke project aimed at e-enabling all of Fimea’s core processes. The project will progress in stages until summer 2013. It will be possible to process marketing authorisation applications entirely in e-format by the end of 2012. Fimea will publish on its website more detailed instructions for marketing authorisation holders during May, when more experience from pilot testing the reception system will have been obtained. Marketing authorisation holders are encouraged to send application documents in e-format to Fimea for pilot testing. Further information:Juha-Pekka Nenonen, Director of Information Resources, tel. +358 9 4733 4500
Jaakko Hartikka, Development Manager, tel. +358 9 4733 4445
Sul silto dell'agenzia Maltese è invece disponibile il documento "Requirements on Electronic submissions for New Applications within
National and European procedures" che per semplicità di consultazione riportiamo in allegato
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eSubmission Submission Guideline
