The Paul-Ehrlich-Institut (PEI) requests you to use the possibilities of electronic submission of applications and documents such as applications for batch release or response documents. That way, you, the applicant, support modern and efficient administrative action in the context of marketing authorisations of medicinal products.
Based on the legal regulations, despite the possibility of electronic submission, some applications and documents must still be submitted as a signed paper version in addition to the electronic version, even after March 1, 2014. Alternatively, it is possible to submit these documents by De-Mail. The written form based on the laws is (still) required for
- Application for authorisation pursuant to Section 11 (1) TierGesG (Tiergesundheitsgesetz [Animal Health Act]) (Section 20 (1) sentence 1 TierImpfStV [Tierimpfstoffverordnung, Animal Vaccines Regulation])
- Waiver of approval (by applicant) pursuant to Section 31 (1) no. 2 AMG
- Consent of the pre-applicant with reference to his authorisation documents (§ 24a sentence 1 AMG)
- Protest pursuant to Section 70 (1) sentence 1 VwGO (Verwaltungsgerichtsordnung [Administrative Court Regulation])
- Transfer of pharmacovigilance obligations of the co-distributor to the authorisation holder in accordance with Section 63c (4) sentence 4 AMG (human), Section 63d (6) (PSUR) and Section 63h (6) sentence 4 AMG (AMG for veterinary products)
For expert reviews pursuant to Section 24 AMG, a signed, scanned pdf document is considered valid instead of a signed paper document.