National requirements on the product information can be found here.

Name of the medicinal product

According to the Veterinary Medicinal Products Adjustment Regulation 2024, Article 2 §3, the name must include the target species or the addition “für Tiere”.

Prescription status

The prescription status is subject to national regulations. Detailed information can be found at Rezeptpflicht - BASG.

High-quality national translations

All submitted texts must provide a high-quality translation in accordance with the BEST PRACTICE GUIDE for the submission of high quality national translations for veterinary medicines (EMA/CMDv/5098/2022) or will otherwise be rejected by the BASG.

Electronic package leaflet

Please find detailed information here.

Implementation date

In principle, for VRAs, the date of approval by the BASG (“Approval Date”) is adopted as the date of the amendment to the dossier (“Implementation Date”).

However, an extension of the implementation date to 12 months over the course of the QRD adaptation is possible and can be initiated in two ways:

• in the Cover letter or
• in the eAF.

Renewal

According to Article 152 Paragraph 1 of Regulation (EU) 2019/6 as amended in conjunction with Section 93 Paragraph 2 of the Veterinary Medicines Act as amended (TAMG), veterinary medicinal specialties that were approved before 28 January, 2022 on the basis of the provisions of the Medicinal Products Act (AMG) are considered to be unlimited authorised.

It is therefore neither necessary to submit an application for a renewal nor to have the marketing authorisation updated.

MAH transfer / Change of Ownership

Please find detailed information here.

Withdrawal of the marketing authorisation / registration

A veterinary withdrawal acc. to TAMG §15 is carried out in practice analogously to the human withdrawal acc. to AMG §23. Please find further information here.