With the application of Regulation (EU) 2019/6 and the entry into force of the new national Veterinary Medicinal Products Act (TAMG), there are changes for medicinal products for certain pets that were previously exempt from the obligation to obtain a marketing authorisation under Section 60 of the German Medicines Act (AMG). According to Section 4 TAMG, in accordance with Article 5 (6) of Regulation (EU) 2019/6, exemptions from the marketing authorisation requirement are still possible under certain conditions. In future, however, the exemption must be approved by the BVL.

An exemption from the marketing authorisation requirement may be granted if

1. the veterinary medicinal product

   • is intended for non-food-producing animals kept exclusively as pets, that are animals kept in aquaria or ponds, ornamental fish, ornamental birds, homing pigeons, terrarium animals, small rodents, ferrets or rabbits,
   • is intended for topical or oral administration or for aquatic administration in aquatic species,
   • is not classified as prescription-only pursuant to Article 34 of Regulation (EU) 2019/6,
   • does not come under Article 42(2) and (3) of Regulation (EU) 2019/6,
   • is to be made available in a pack size appropriate for use in pet animals, and
2. the applicant has their registered place of business in the European Union or in a Contracting Party of the Agreement on the European Economic Area.

The pack size of a veterinary medicinal product is appropriate if it is sufficient for a single curative treatment up to symptom relief or for a preventive treatment lasting up to six months

1. in the case of animals or ornamental fish kept in aquaria or ponds with a capacity of up to 25,000 litres, as part of a specific treatment plan with up to seven applications,
2. for a number of up to 50 ornamental birds or homing pigeons, or
3. for a number of up to five terrarium animals, small rodents, ferrets or domestic rabbits.

If the requirements for an exemption are met, the BVL shall grant the exemption in written or electronic form, assigning an exemption number. The BVL shall decide within a period of five months after the submission of a complete application.

Changes to exempted veterinary medicinal products

Changes to the information required for the Union product database, the labelling or the package leaflet of the veterinary medicinal product that occur after the exemption has been granted must be notified to the BVL without delay.

Note on pharmacovigilance obligations

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

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

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

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.

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.