Competent advice inVeterinary Medicines Law

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With Regulation (EU) 2019/6 (the Veterinary Medicinal Products Regulation), which entered into force on 28 January 2022, the European Union has restructured the entire veterinary medicinal products legislation. In particular, the Veterinary Medicinal Products Regulation standardises the legal framework for the authorisation of veterinary medicinal products and for the acquisition of a manufacturing or wholesale authorisation. In order to implement and concretise the Veterinary Medicinal Products Ordinance, the German Bundestag promulgated the Act on the Marketing of Veterinary Medicinal Products and on the Implementation of EU Regulations on Veterinary Medicinal Products (Veterinary Medicinal Products Act (TAMG)), which also entered into force on 28 January 2022. In addition, the TAMG will in future also regulate veterinary medicinal products excluded from the scope of application of Union law, so that the TAMG will act as a new "parent law". Regulations of the Medicinal Products Act (AMG) dealing with veterinary medicinal products were transferred to the TAMG or replaced.

For the entire veterinary medicinal products sector, the entry into force of the Veterinary Medicinal Products Ordinance and the Veterinary Medicinal Products Act was accompanied by changes and innovations, some of them serious. However, numerous regulations (such as the VET logo, which pharmacies and other distributors of veterinary medicinal products must place on their website if they wish to sell veterinary medicinal products to end customers at a distance) have also come into force at the trade level since 28 January 2022.

We will be happy to advise you on all questions relating to veterinary medicinal products law. The following areas are the main focus of our advice:

Development

• Classification of products and their demarcation (food supplements, biocides, veterinary medicinal products, medicinal feeds)
• Research and development contracts

Approval / registration

• Authorisation of veterinary medicinal products - European authorisation, mutual recognition, German authorisation
• Pharmacovigilance
• Registration of homeopathic veterinary medicinal products

Manufacturing

• Manufacturing authorisation
• Requirements for the manufacture of veterinary medicinal products
• Contract manufacturing and contract testing

Labelling

• Inspection of the labelling of the primary packaging (Art. 10 Regulation (EU) 2019/6) and the outer packaging (Art. 11 Regulation (EU) 2019/6)
• Inspection of package leaflet and SmPC (Art. 14, 35 Regulation (EU) 2019/6)

Distribution

• Good distribution practice
• Wholesale authorisation
• Distribution channels (wholesale, pharmacies, retail, mail order)
• Licensed distribution Co-promotion Co-marketing and co-distribution, cooperation with professionals
• Dispensing rights of veterinarians

Use of veterinary medicinal products

• Use by veterinarians
• Prescription by veterinarians
• Use by pet owners
• Use by veterinary practitioners

Safety of veterinary medicinal products

• Pharmacovigilance
• Liability

Advertising of veterinary medicinal products

• Advertising regulations according to Art. 119 ff. of Regulation (EU) 2019/6
• General competition law (UWG) - help with warnings and legal proceedings
• Cooperation with professional circles
• Intellectual property law - trade marks, utility models and designs