Ordinanceon the Submission of Documents within Licensing and Renewal Procedures

for Medicinal Products(AMG-Submission-Ordinance, AMG-Einreichungsverordnung, AMG-EV)

of 21 December 2000

On the basis of § 35 paragraph 1 number 1 ofthe Drug Law in the version of the Notificationof 11 December 1998 (Federal Law Gazette Ip. 3586) the Federal Ministry for Healthdecrees as follows:

§ 1Use of electronic storage media for

submission of documents

(1) In licensing procedures in accordance with§ 21 of the Drug Law, in renewal procedures inaccordance with § 31 or § 105 of the Drug Lawas well as for fulfilment of notificationrequirements in accordance with § 29 of theDrug Law, documents are to be submitted tothe Federal Institute for Drugs and MedicalDevices <Bundesinstitut für Arzneimittel undMedizinprodukte>, the Federal Institute forHealth Protection of Consumers andVeterinary Medicine <Bundesinstitut fürgesundheitlichen Verbraucherschutz undVeterinärmedizin>, and the Paul-Ehrlich-Institute using electronic storage media subjectto proviso of the following regulations.

(2) A file format readable, even if encrypted, bythe competent superior federal authorities witha justifiable effort is to be used for electronicexchange of data.

§ 2Obligation to use electronic data media forsubmission of documents

(1) The following documents are to besubmitted via electronic storage media:

1. drafts for labelling in accordance with § 10,for package leaflets in accordance with §11, and for expert information(Fachinformation) in accordance with §11a of the Drug Law and

2. Expert reports in accordance with § 24 ofthe Drug Law.

(2) The electronic document must bear thequalified electronic signature of the personresponsible in accordance with the DigitalSignature Act.

§ 3Exceptions

In derogation of § 2, also in conjunction with §4 paragraph 2, the competent superior federal

authority can permit or demand exclusivesubmission of paper documents, if 1. thiswould present an undue hardship for theapplicant or other parties concerned or 2.electronic submission is unsuitable fortechnical reasons.

§ 4Transitional provisions

(1) § 2 does not apply to documents that weresubmitted prior to the effective date of thisOrdinance.

(2) In derogation of § 2 paragraph 2, theperson responsible must employ a suitablesignature system, utilisable by the competentsuperior federal authority until the prerequisitesfor a qualified electronic signature inaccordance with the Digital Signature Act havebeen fulfilled; until that time the documentsreferred to in § 2 paragraph 1 are also to besubmitted in paper.

§ 5Entry into force

(1) This Ordinance enters into force on 1January 2001 except as provided in paragraph2.(2) § 2 paragraph 2 will take effect, as soon asit is ensured, that the prerequisites for aqualified electronic signature in accordancewith the Digital Signature Act have been metby the competentsuperior federal authority.The Federal Ministry for Health will announcethe effective date of § 2 paragraph 2 in theFederal Law Gazette <Bundesgesetzblatt>.

_______Approved by the Federal Council <Bundesrat>

Bonn, 21 December 2000The Federal Minister for Health

Andrea Fischer

German Medicines Manufacturers‘ Association

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.

Time-table

Not more than 87 days from the submission of the first information till the date for coming into operation.

No discussions before !

German Medicines Manufacturers‘ Association

• 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

Technical details

German Medicines Manufacturers‘ Association

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.

First results

German Medicines Manufacturers‘ Association

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 documents

Projects