AVANTCORE – Your Specialists for Approval, Sales, and Advertising of Veterinary Medicinal Products
The Veterinary medicinal products law was developed January 28, 2022 comprehensively reformed.
Since then, the following has applied directly in all EU member states: Regulation (EU) 2019/6 on veterinary medicinal products (Veterinary Medicinal Products Regulation)It centrally regulates on a European level Admission, Manufacturing, Placing on the market, Application, Pharmacovigilance and advertising of veterinary medicinal products.
In Germany, the Animal Medicinal Products Act the European regulations. It includes, in particular, national regulations on Responsibilities, market surveillance, Antibiotic minimization and Veterinary prescription.
AVANTCORE Lawyers has been advising companies, wholesalers, pharmacies, and other market participants on all legal matters relating to veterinary medicinal products for many years – from Product Development about the Market access until legally compliant marketingWe represent you towards Authorities, Registration offices and Dishes – nationally and Europe-wide.
Our Services in Animal Drug Law
1. Approvals and Permits according to the Veterinary Medicinal Products Regulation and the TAMG
- Legal support centralized, decentralized and national approval process
- Support for Extensions, Variational method and Registrations
- Consultation on special procedures such as "Limited MarketsorExceptional Circumstances"
- Review of legal requirements for Reallocations
2. Manufacturing, Import & Wholesale
- Application and Defense of Manufacturing permits and Wholesale permits according to the Animal Medicinal Products Regulation and the Animal Medicines Act
- Creation and testing of Quality Assurance Agreements (QAA), Contract manufacturing agreements and Delivery agreements
- Accompanying on official inspections, Audits and Certification processes
3. Pharmacovigilance & Antibiotic Minimization
- Consulting on the setup and implementation of Pharmacovigilance systems according to the Animal Medicinal Products Regulation
- Support for Reporting obligations to adverse events, resistance development, and environmental risks
- Consultation on Antibiotic consumption reports and to restrictions on use Reserve antibiotics
- Representation in regulatory complaints and risk assessments
4. Prescription, Dispensing & Veterinary Practice Pharmacy
- Legal advice on veterinary prescription requirement according to Art. 105 ff. of the Animal Medicinal Products Regulation
- Implementation of Reclassification regulations for veterinary medicines
- Compliance Audit Veterinary dispensary (Dispensing Law), including storage, documentation, and dispensing rules
- Support for Practice inspections and procedures of the competent authorities
5. Advertising & Marketing Communications
- Legal review of Advertising measures for veterinary medicinal products according to the requirements of the Veterinary Medicinal Products Regulation (including the distinction between professional circles/laypersons)
- Prevention of unauthorized health claims, Deceptive practices or Violations of application restrictions
- Defense against Warnings and Injunctions by competitors or associations
- Submission precautionary protective filingsto prevent injunctions
6. Administrative Procedures & Legal Representation
- Objection proceedings against decisions of licensing and supervisory authorities
- Representation in administrative and civil court proceedings
- Legal support for Market surveillance measuresProduct recalls and sales stops
Your Benefits with AVANTCORE Lawyers
- SpecializationLong-standing experience in veterinary medicinal product law – current, precise, and practical
- Legal framework competence: Advice based on Regulation (EU) 2019/6 (Animal Medicines Regulation) and Veterinary Medicines Act
- Interdisciplinary approachGear engagement with Product Liability Law, Food Safety and Compliance Law, Data Protection Law and Competition Law
- Efficient representationEnforcing your interests at national and European level
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