Medicinal products for certain pets might be exempt from the obligation to obtain a marketing authorisation according to Section 4 of the German Veterinary Medicinal Products Act (TAMG). The exemption must be approved by the BVL.

According to Article 2 (4) of Regulation (EU) 2019/6, all provisions of Chapter IV Section 5 (Pharmacovigilance) of Regulation (EU) 2019/6 apply to veterinary medicinal products for pets exempted from the marketing authorisation requirement.

The exemption holder shall record in the pharmacovigilance database all suspected adverse events of their veterinary medicinal products. It shall continuously evaluate by appropriate means the benefit-risk balance of the veterinary medicinal products, carry out a signal management process for its veterinary medicinal products, if necessary, and take appropriate measures to sustain a positive benefit-risk balance. Exemption holders should report the outcomes of their signal management activities on an annual basis to the European Medicines Agency’s online platform IRIS.

The BVL sets due dates for the submission of these annual statements for exempted VMPs. The following due dates are recommended: 30th of June and 31st of December. Exemption holders are kindly requested to select a due date from the above and use the same date for the following years.

Further Information:

Information on pharmacovigilance for exemption holders and their representatives are provided by the BVL here.

Guidance documents and information on veterinary good pharmacovigilance practices (VGVP) are available on the European Medicines Agency’s (EMA) website.

Year of issue 2024
Date 03.09.2024

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