Electronic submission of documents
Submission of applications and documents in the regulatory field such as applications for batch releases or response documents is already possible in many cases. To reduce bureaucratic hurdles, we have simplified submission methods even further as per 1 March 2014. Submissions in paper form bearing so-called "wet signatures", which have up to now been required, have been abolished for many applications.
In using the electronic methods offered, you as the applicant can encourage modern and efficient administrative processes. The Paul-Ehrlich-Institut is requesting you to make use of the methods described in this section as much as possible.
- Overview of existing format requirements
- Information in the Federal Gazette (Bundesanzeiger)
Overview of existing format requirements
Extensive correspondence takes place between pharmaceutical companies and the Paul-Ehrlich-Institut (PEI). In the section below you will find a listing as to which formats are required for applications and documents sent to the PEI. This listing shows for which procedures a purely electronic submission is possible (text form), and which ones still require paper copies (written form).
Übersicht Formerfordernisse für Dokumente und Anträge / Overview formal requirements for documents and applications
Based on statutory regulations, some applications and documents still require additional submission of paper copies with wet signatures after 1 March 2014, even though electronic submission is possible.
Application for authorisation pursuant to Section 17c (1) sentence 1 No 1 TierSG (Tierseuchengesetz, Animal Diseases Act) (applicant) (Section 20 (1) sentence 1 TierImpfStV (Tierimpfstoffverordnung, German Animal Vaccines Regulation)),
Please note: As from 1 May 2014 the application for this submission must be carried out based on Section 11 (1) TierGesG (Tiergesundheitsgesetz, Animal Health Law) instead of Section 17c TierSG.
- Renouncement of authorisation (by the applicant) pursuant to Section 31 (1) No 2 AMG (Arzneimittelgesetz, German Medicinal Products Act)
- Previous applicant's written agreement that reference is made to his authorisation documents (Section 24a sentence 1 AMG)
- Application for authorisation of clinical trials pursuant to Section 7 (1) sentence 1 GCP-V (Ordinance on the Implementation of Good Clinical Practice in the conduct of clinical trials on medicinal products for human use)
- Objection pursuant to Section 70 (1) sentence 1 VwGO (Verwaltungsgerichtsordnung, Code of Administrative Court Procedure)
- Transmission of pharmacovigilance duties of the co-distributor to the marketing authorisation holder pursuant to 63c (4) sentence 4 AMG (human), Section 63d (6) (PSUR) and Section 63h (6) sentence 4 AMG (AMG veterinary products)
For an expertise pursuant to Section 24 AMG a signed and scanned pdf document instead of a signed paper copy is considered as valid.
In the area of clinical studies a purely electronic submission of applications and variation notifications is currently not possible for technical reasons. Please also refer to the notes concerning this, which you will find under Clinical Trials.
Information in the Federal Gazette (Bundesanzeiger)
|17.03.2014||Bekanntmachung über die Änderung der Möglichkeiten zur elektronischen Einreichung von Anträgen im regulatorischen Bereich des Paul-Ehrlich-Instituts für Human- und Veterinärarzneimittel nach dem Arzneimittelgesetz (AMG), der Tierimpfstoffverordnung (TierImpfStV), dem Tierseuchengesetz (TierSG) (bzw. dem Tiergesundheitsgesetz (TierGesG)) sowie nach der GCP-Verordnung (GCP-V) - Vom 14. Februar 2014||to the article|
|29.04.2010||Bekanntmachung über die Möglichkeit zur elektronischen Einreichung von Zulassungsunterlagen für Humanarzneimittel nach §§ 21 ff. des Arzneimittelgesetzes (AMG) beim Bundesinstitut für Arzneimittel und Medizinprodukte und beim Paul-Ehrlich-Institut vom 26.03.2010||to the article|
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Please contact us if you have any questions on electronic submission of documents at the Paul-Ehrlich-Institut.