Can paperless submissions be accepted?

As of 01/03/2014, many regulatory letters to the Paul-Ehrlich-Institut (PEI) can be sent electronically without any signed additional paper copies.

For legal reasons, the written form continues to apply to:

  • Application for authorisation pursuant to Section 17c (1) sentence 1 no. 1 TierSG (applicant) (Section 20 (1) sentence 1 TierImpfStV),

    Please note, as of May 1, 2014, the approval will be requested pursuant to Section 11 (1) TierGesG instead of Section 17c TierSG.

  • Waiver of approval (by applicant) pursuant to Section 31 (1) no. 2 AMG
  • Consent of the previous applicant to the reference made to his authorisation documents (Section 24a sentence 1 AMG)
  • Application for a clinical trial pursuant to 7 Abs. 1 sentence 1 GCP-V
  • Protest pursuant to Section 70 (1) sentence 1 VwGO

For expert opinions pursuant to 24 AMG, a signed, scanned PDF document is considered valid instead of a signed paper document.

Can multiple applications for an authorisation from the same applicant be submitted at the same time?

Absolutely. Typically, in an eCTD or (v) NeeS structure, all dosage forms and strengths are grouped together for each product name. In MR and DC methods, eCTD or (v) NeeS submission is preferably used for a method (e.g. DE / H / 1005 / 001-002 / DC). If the Applicant chooses to create a NeeS submission for each strength or dosage form, this will also be accepted. However, the consequences for a later transition to the eCTD format should be considered, as the scope of the eCTD at the first submission has implications for the continued maintenance of the electronic dossier. If an eCTD submission is made per strength or dosage form, all other sequences must also be submitted per strength or dosage form. A change in structure is only possible in individual cases after prior approval from the RMS and assessment of the reasons.

What information must the Cover Letter contain?

The cover letter must list all medicinal products applied for at the same time, with the corresponding procedure numbers and product names to which the documentation applies. The electronic format of the submission must be indicated and the number of data carriers must be specified. It makes sense to enter an email address, as this facilitates the submission of the validation report in case of incorrect submissions.

When must an overview table of submitted sequences be submitted?

For each submission in the eCTD or (v) NeeS format, the "History of Sequences" updated as "tracking.pdf" must be submitted electronically in the same folder as the cover letter thus preventing the reader from losing track of which sequences were submitted when and where.

Which documents must be in the folder <sequence> -Working documents (human)?

In the human area, the product information texts and the Non-clinical and Clinical Overview / Summary or the Overall Summary must be made available in this folder as MS Word compatible, editable files in rtf or doc / docx format. This also applies to the product information texts in English in the decentralised procedure or in the mutual recognition procedure.

Does the AMG-EV still have to be operated?

If you have structured your submission according to eCTD or NeeS and have entered the required documents in the folder <sequence> -working documents, the separate submission according to AMG-EV can be omitted.

Apart from (v) NeeS and eCTD, can other electronic compilations be accepted?

Only if a complete paper version is presented (all modules in printed form).

Can I still submit in paper form?

Submission in paper form is still possible. In the human area, submission of the documents specified in accordance with AMG-EV must also be made by email.

How do I enter data for the Sunset Clause?

No special form is required for your reports.

Updated: 21.11.2019