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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.V  2w           & 5HH88 0 0c`P  L Time-table&   0 0tc@D GNot more than 87 days from the submission of the first information till the date for coming into operation. No discussions before !,  2tH 0 0޽h ? ̙33, @4l(  4_ 4 0ԞcX 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  2. #  ) >     x,, 4 0c`P  mTechnical details&H 4 0޽h ? ̙33J P8( < 8y 8 0c@z 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.< 2( 2 2.   3     "    "#  8 0Tc`P  q First results& H 8 0޽h ? ̙33 `D8( &B D4 D 0cpm Joined working group of the three german pharmaceutical associatons together with the Federal 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 documentsv 200202A9 4        &          D 0ԡc`P  dProjects& H D 0޽h ? ̙33Wnx xU9I:DGPDT>}JTPtWNuщ :.:mGYOdb${Ut:wwԻ_]:= hniq\p;---- ﴡs@&z! 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