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04.10.00 - No signs for a regulation concerning e-submissions in Germany (even on request).

Time-table. 04.10.00 - No signs for a regulation concerning e-submissions in Germany (even on request). 05.10.00 - 1st draft of an ordinance . Request for comments till 13.10.00 (date of paper 27.09.00; date for coming into operation 01.01.01) by the German Ministery of Health (BMG).

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04.10.00 - No signs for a regulation concerning e-submissions in Germany (even on request).

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  1. Time-table 04.10.00 - No signs for a regulation concerning e-submissions in Germany (even on request). 05.10.00 - 1st draft of an ordinance. Request for comments till 13.10.00 (date of paper 27.09.00; date for coming into operation 01.01.01) by the German Ministery of Health (BMG). 17.11.00 - Notice from the BMG about the submission of a (completly new) final draft to the Federal Council for approval in a meeting in december the 21th. 28.11.00 - Industry comment to the Federal Council and to the expert commitee of health. 06.12.00 - Approval of the ordinance by the expert committee of health. 21.12.00 - Approval by the Federal Council. 01.01.01 - Date of coming into operation without any transitional period. Not more than 87 days from the submission of the first information till the date for coming into operation. No discussions before !

  2. Technical details • e-Mail submission of documents as attachments • predefined Mail-bodytext (5 lines) with submission-specific information • text in RTF-format (PDF not allowed for text) • pictures must be converted into seperate PDF-files (link in text) • files could be "zipped" (winzip) • industry is allowed to use PGP for encoding (public key published) • electronic signatures must be used after the prerequisites for a qualified electronic signature have been met by the Federal Institute for Drugs and Medical Devices (BfArM) • automatic check of the Mailbody-content and the readability of the attachments (only formal) • automatic reply of error-messages or receipt

  3. First results • According to the german drug law, applicants had to submit for all old medicines complementary dossiers till february the 1st (2001). In this case, the ordinance demanded the e-submission of the expert reports. • 8,000 e-mails were received from 1. Jan. to 1. Feb. • containing appr. 25,000 files • largest file appr. 200 MB (via e-mail !) • largest content appr. 350 files (zipped by mistake the whole local drive) • 70 different e-mail clients were identified • appr. 25% of e-mails received had to be rejected • Parallel work on the e-submission of documents for licensing procedures , renewal procedures and variations following the submission-ordinance.

  4. Projects • Joined working group of the three german pharmaceutical associatons together with theFederal Institute for Drugs and Medical Devices (BfArM) • Pilot-project on the e-submission of whole variations via e-mail (started before the ordinance) • Development of electronic forms for variations • Definition of the technical and formal details • First phase of submission of "non-real"-variations • Second phase with "real"-variations till July • Parallel project of using electronic signatures according to the german Digital Signature Act • Implementation of signature-components at the project-participants and the BfArM till may 2001 followed by a submission-phase of electronically signed documents

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