Paul-Ehrlich-Institut

Ap­pli­ca­tion and Sub­mis­sion of Doc­u­ments

Application

The Paul-Ehrlich-Institut (PEI ) request that the electronic application form (eAF) be used for the application for a marketing authorisation of an immunological veterinary medicinal product in a national, mutual recognition, decentralised, and follow-up procedures.

Applications for authorisations in the centralised procedure must be submitted directly to the European Medicines Agency (EMA).

Labelling of Immunological Veterinary Medicinal Products

In accordance with Sections 35 and 36 Tierimpfstoff-Verordnung (Veterinary Vaccination Regulation) immunological veterinary medicinal products intended for marketing in Germany must be labelled in German, in clearly legible writing and assuring the labelling is permanent. In addition, each package must be accompanied by a package leaflet (package insert).

For the labeling of an immunological veterinary medicinal product, the PEI requests that the product information templates be used. These templates are published by the EMA.

The templates serve as guidance for applicants in creating texts for labelling. They thus facilitate the decision as to which details should be included in which order in the corresponding documents or materials.

Submission of Documents

Documents are usually submitted through the electronic submission process.

Costs

The fees payable for carrying out a procedure can be found in the Statutory Cost Regulation relating to Vaccines for Veterinary Use (TierImpfStKostV).

Updated: 21.11.2019