• Exemption criteria
• The application for exemption
• After granting of the exemption

Exemption criteria

The BVL checks each application for exemption from the marketing authorisation requirement for compliance with the criteria specified in Section 4 (1) TAMG. To be eligible for an exemption, veterinary medicinal products must be intended for use in certain animals kept exclusively as pets and not used for food production. These may be either aquarium or pond animals, ornamental fish, ornamental birds, homing pigeons, terrarium animals, small rodents, ferrets or rabbits (i.e. pet rabbits). Veterinary medicinal products to be exempt from the marketing authorisation requirement must be intended for topical or oral use, or for water-born use in the case of aquatic species. It is also a prerequisite that the veterinary medicinal products are not classified as subject to veterinary prescription under Article 34 of Regulation (EU) 2019/6. Hence, antimicrobial veterinary medicinal products such as antibiotics, antivirals, antifungals or antiprotozoals are, among others, generally excluded from the exemption procedure. In addition, products must be made available in pack sizes appropriate for use in the indicated species according to Section 4(1) TAMG. 

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The application for exemption

The applicant shall include the information required for the Union product database (UPD) with the application for exemption from the marketing authorisation requirement. The required information is listed in Commission Implementing Regulation (EU) 2021/16. The application must also include drafts for the labelling, i.e. the information for the outer and immediate packaging of the veterinary medicinal product, and for the package leaflet. Once a complete application has been submitted, the BVL will take a decision on whether to grant or refuse the exemption within five months.

You can find further information on how to apply here.

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After granting of the exemption

All changes to the approved labelling, package leaflet or the information required for the Union product database after granting the exemption from the marketing authorisation requirement, must be notified to the BVL without delay. If these changes concern the target species, the indication, the route of administration, the active substance, the dosage or the pack size, a new application for exemption must be submitted.

Like authorised veterinary medicinal products, veterinary medicinal products for pets exempted from the marketing authorisation requirement are subject to the provisions of Chapter IV, Section 5 (“Pharmacovigilance”) of Regulation (EU) 2019/6. The holder of an exemption must thus fulfil various pharmacovigilance responsibilities. These include, for example, the collection, collation and evaluation of information on adverse events related to the veterinary medicinal product. All adverse event reports must also be recorded in the Union pharmacovigilance database in a timely manner.

As a result of pharmacovigilance findings, changes to the contents of the labelling or package leaflet might become necessary to sustain a positive benefit-risk balance of the veterinary medicinal product. The BVL can request the exemption holder to submit amended drafts in order to implement those changes within a specified time period. Revocation of the exemption is also possible under certain conditions.  

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