Transcript Kein Folientitel - Heads of Medicines Agencies

Ordinance
on 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 of
the Drug Law in the version of the Notification
of 11 December 1998 (Federal Law Gazette I
p. 3586) the Federal Ministry for Health
decrees as follows:
§1
Use of electronic storage media for
submission of documents
(1) In licensing procedures in accordance with
§ 21 of the Drug Law, in renewal procedures in
accordance with § 31 or § 105 of the Drug Law
as well as for fulfilment of notification
requirements in accordance with § 29 of the
Drug Law, documents are to be submitted to
the Federal Institute for Drugs and Medical
Devices <Bundesinstitut für Arzneimittel und
Medizinprodukte>, the Federal Institute for
Health Protection of Consumers and
Veterinary Medicine <Bundesinstitut für
gesundheitlichen
Verbraucherschutz
und
Veterinärmedizin>, and the Paul-EhrlichInstitute using electronic storage media subject
to proviso of the following regulations.
(2) A file format readable, even if encrypted, by
the competent superior federal authorities with
a justifiable effort is to be used for electronic
exchange of data.
§2
Obligation to use electronic data media for
submission of documents
(1) The following documents are to be
submitted 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 of
the Drug Law.
(2) The electronic document must bear the
qualified electronic signature of the person
responsible in accordance with the Digital
Signature Act.
§3
Exceptions
In derogation of § 2, also in conjunction with §
4 paragraph 2, the competent superior federal
authority can permit or demand exclusive
submission of paper documents, if 1. this
would present an undue hardship for the
applicant or other parties concerned or 2.
electronic submission is unsuitable for
technical reasons.
§4
Transitional provisions
(1) § 2 does not apply to documents that were
submitted prior to the effective date of this
Ordinance.
(2) In derogation of § 2 paragraph 2, the
person responsible must employ a suitable
signature system, utilisable by the competent
superior federal authority until the prerequisites
for a qualified electronic signature in
accordance with the Digital Signature Act have
been fulfilled; until that time the documents
referred to in § 2 paragraph 1 are also to be
submitted in paper.
§5
Entry into force
(1) This Ordinance enters into force on 1
January 2001 except as provided in paragraph
2.
(2) § 2 paragraph 2 will take effect, as soon as
it is ensured, that the prerequisites for a
qualified electronic signature in accordance
with the Digital Signature Act have been met
by the competentsuperior federal authority.
The Federal Ministry for Health will announce
the effective date of § 2 paragraph 2 in the
Federal Law Gazette <Bundesgesetzblatt>.
_______
Approved by the Federal Council <Bundesrat>
Bonn, 21 December 2000
The Federal Minister for Health
Andrea Fischer
Time-table
04.10.00 - No signs for a regulation concerning esubmissions 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 !
German Medicines
Technical details
• e-Mail submission of documents as attachments
• predefined Mail-bodytext (5 lines) with submissionspecific 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
German Medicines
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.
German Medicines
Projects
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 projectparticipants and the BfArM till may 2001 followed by a
submission-phase of electronically signed documents
German Medicines