For the application for a marketing authorisation of a veterinary medicinal product within the area of responsibility of the Paul-Ehrlich-Institut (PEI) in a national, mutual recognition, and decentralised procedure, and for follow-up procedures, the electronic application form (eAF) must be used.
Applications for authorisations and follow-up procedures in the centralised procedure must be submitted directly to the European Medicines Agency (EMA) using the eSubmission Gateway and the eSubmission Web Client.
EMA eSubmission - Gateway and eSubmission Web Client
The provisions and information on the labelling are regulated in Regulation (EU) 2019/6. As defined in Sections 35 and 36 Veterinary Vaccines Regulation (Tierimpfstoff-Verordnung, TierImpfStV) and pursuant to Sections 7 and 8 Veterinary Medicinal Products Act (Tierarzneimittelgesetz, TAMG), veterinary medicinal products within the area of responsibility of the Paul-Ehrlich-Institut intended for marketing in Germany must be labelled in German, in easily legible writing and assuring the labelling is permanent. In addition, each product must be accompanied by a package leaflet (package insert).
For the product information of a veterinary medicinal product, the product information templates published by the EMA must be used. These templates serve as guidance for applicants in creating texts for labelling and package leaflets. They thus facilitate the decision as to which details should be included in which order in the corresponding documents or materials.
The Paul-Ehrlich-Institut only accepts electronic submissions of documents for authorisation procedures for veterinary medicinal products under its responsibility and their follow-up procedures. Electronic submissions must be made via the Common European Submission Platform (CESP).
CESP - Common European Submission Platform
The fees payable for carrying out a procedure can be found in the Special Fees Ordinance of the Federal Ministry of Food and Agriculture for Individually Attributable Public Services in its Area of Responsibility (Besondere Gebührenverordnung BMEL, BMELBGebV) and the Special Fees Ordinance of the Federal Ministry of Health for Individually Attributable Services in its Area of Responsibility (Besondere Gebührenverordnung BMG, BMGBGebV)
Updated: 26.09.2024
