January 28, 2025

The regulation of veterinary medicinal products is a complex framework that governs their manufacture, authorization, distribution, and use. On January 28, 2022, the introduction of the European Veterinary Medicinal Products Regulation (EU) 2019/6 and the German Veterinary Medicinal Products Act (TAMG) transformed this regulatory landscape. These new regulations bring both challenges and opportunities for manufacturers, veterinarians, and other stakeholders.

While harmonizing the European single market and intensifying measures to combat antimicrobial resistance (AMR) represent major advancements, stricter requirements for Good Manufacturing Practice (GMP), Good Distribution Practice (GDP), and compliance have added complexities that require expert navigation.

Harmonizing Standards to Promote Animal Health

The EU Regulation (EU) 2019/6 and TAMG emphasize ensuring high-quality, safe, and effective veterinary medicinal products to promote animal health. Healthy livestock is vital for sustainable agriculture, global food security, and societal well-being.

Goals of the Regulations:

  • Standardization: Ensuring the quality, safety, and availability of veterinary medicinal products across Europe.
  • Combatting AMR: Restricting certain antibiotics and limiting their preventive use.
  • Facilitating Trade: Establishing a central EU database for veterinary medicinal products and pharmacovigilance data.

With expertise in dossier preparation, pharmacovigilance, chemical risk assessments, and toxicological evaluations, Maven helps clients meet these evolving standards while keeping animal health and safety as top priorities.

Key Provisions of EU Regulation (EU) 2019/6

1. Harmonization of the European Market:

  • Uniform Regulations: Reducing administrative burdens and simplifying cross-border trade.
  • Central Database: Articles 55 and 73 establish a unified platform, giving veterinarians access to product and pharmacovigilance data.

2. Measures to Combat AMR:

  • Restricted Use of Critical Antibiotics: Reserved for human medicine (Article 37).
  • Preventive Antibiotic Use: Allowed only in exceptional circumstances (Article 107).
  • Mandatory Reporting: Article 58 requires electronic reporting of antibiotic use.

3. Categorization of Veterinary Products:

  • Prescription-Only (Rx) Products: Strictly controlled by pharmacies.
  • Over the Counter (OTC) Products: Available outside pharmacies for low-risk applications.

Maven’s regulatory intelligence services help businesses comply with these requirements while contributing to global AMR reduction efforts.

Unique Provisions of the German Veterinary Medicinal Products Act (TAMG)

Germany’s TAMG introduces national features that go beyond the EU regulation, including:

  • 7/31-Day Rule: Antibiotics for food-producing animals are capped at 7 days, while other medicinal products can be dispensed for up to 31 days.
  • Mandatory Reporting: Veterinarians must electronically report antibiotic use, even for hobby farms, through databases like HI-Tier-TAM.
  • Stricter Documentation: Detailed records of all prescriptions are mandatory.
  • National Databases: Enable better traceability and transparency of veterinary medicinal products.

Maven provides tailored support for German-specific requirements, including electronic reporting, record-keeping, and database submissions.

Good Manufacturing Practice (GMP) and Qualified Person (QP) Updates

The revised regulations significantly impact GMP, requiring:

  • Separate Manufacturing Licenses: Mandatory for human and veterinary products.
  • Testing Laboratory Requirements: External labs now need manufacturing authorization and a Qualified Person (QP).
  • Updated QP Qualifications: QPs must have expertise in pharmacy, veterinary medicine, or related fields with industry-specific experience.

Maven assists stakeholders in:

  • Securing manufacturing and testing licenses.
  • Ensuring GMP compliance for veterinary laboratories.
  • Supporting QP qualification and training.

Maven: Your Partner for Regulatory Compliance

At Maven, we specialize in providing comprehensive solutions for veterinary product registration and regulatory compliance, including:

  • Dossier Preparation: Tailored for compliance with EU and TAMG standards.
  • Pharmacovigilance: Electronic reporting and database submissions.
  • GMP/GDP Compliance: Supporting manufacturing licenses and QP services.
  • Toxicological Risk Assessments: Ensuring safety and efficacy of veterinary products.
  • Regulatory Intelligence: Keeping clients ahead of evolving requirements.

Our global team of regulatory experts and toxicologists ensures that your products meet the highest standards while facilitating smooth market access.

Conclusion

The introduction of EU Regulation (EU) 2019/6 and Germany’s TAMG has set new benchmarks for quality and safety in veterinary medicinal products. While these regulations demand significant adaptation, they also open opportunities to innovate and lead in promoting animal health.

With extensive expertise, Maven is your trusted partner in navigating this complex regulatory landscape. Whether you need help with manufacturing licenses, dossier preparation, or GMP/GDP compliance, we are here to support your success.

Contact Maven today to ensure your veterinary medicinal products meet the highest standards of quality, safety, and compliance.