Veterinary medicinal products legislation 2022: changes and effects under the microscope

Veterinary medicinal products legislation is a complex and multi-layered set of rules that regulates the manufacture, authorization, distribution and use of veterinary medicinal products and veterinary products. With the introduction of the European Veterinary Medicinal Products Regulation (Regulation (EU) 2019/6) and the German Veterinary Medicinal Products Act (TAMG) on January 28, 2022, the regulatory landscape for veterinary medicinal products has changed fundamentally. These new regulations offer numerous opportunities, including the harmonization of the European single market and the increased fight against antimicrobial resistance. At the same time, they pose considerable challenges for the stakeholders concerned - in particular due to the stricter requirements for good manufacturing practice (GMP) and good distribution practice (GDP). Particularly relevant are the separate manufacturing licenses required for GMP testing laboratories, the revised requirements for the Qualified Person and stricter standards for the storage, transport and documentation of veterinary medicinal products. This blog article highlights key aspects and the most important provisions of the European Veterinary Medicinal Products Regulation, the TAMG and the supplementary regulations.

Maintaining and promoting animal health is a top priority - not only for those who keep or treat animals, but also for society and the environment as a whole. Healthy livestock is the foundation of sustainable and productive agriculture and ensures global food security. The use of high-quality, safe and effective veterinary medicines and veterinary products plays a crucial role in this.

In order to standardize the quality, safety and availability of veterinary medicinal products across Europe, the legal framework has been fundamentally revised. The EU Regulation (EU) 2019/6 and the German Veterinary Medicinal Products Act (TAMG) and its implementing and delegated regulations have been in force since January 28, 2022.

Introduction to veterinary medicinal products legislation: Improved standards for veterinary medicinal products!

The EU Regulation (EU) 2019/6 is the centerpiece of the new veterinary medicinal products legislation and replaces the former Directive 2001/82/EC. It contains directly applicable, harmonised provisions for veterinary medicinal products in all EU member states and regulates their authorisation, manufacture, import, export, dispensing, use, restrictions and sanctions.

One of the main aims of the regulation is to harmonize the European internal market. Uniform regulations are intended to reduce the administrative burden and facilitate trade in veterinary medicinal products. This is supported, among other things, by a central EU database that records all authorized veterinary medicinal products and pharmacovigilance data (Articles 55 and 73). This database provides veterinarians with better access to important information and facilitates the import of medicinal products from other Member States and third countries (Article 90).Another focus is the fight against antimicrobial resistance. Key measures include:

• Restriction of the use of certain antibiotics: Antibiotics that are of critical importance for human medicine may only be used in veterinary medicine to a limited extent (Article 37)
• Preventive use of antibiotics: The preventive use of antibiotics is now only permitted in exceptional cases (Article 107)
• Recording and reporting of antibiotic quantities: The quantities of antibiotics used must be recorded and reported electronically to the EU (Article 58).

Another important element of Regulation (EU) 2019/6 is the introduction of a new system for the categorization of veterinary medicinal products. Article 34 of the Regulation and Section 40 of the German Veterinary Medicinal Products Act (TAMG) make clear distinctions between products that are available only in pharmacies and those that are available over the counter.

• Rtx medicinal products may only be dispensed by pharmacies and veterinary in-house pharmacies. This regulation ensures that access to these products is strictly controlled and that only qualified specialist personnel are involved.
• OTC medicinal products, on the other hand, may also be sold outside pharmacies, for example in drugstores or via the Internet. This category includes products with lower associated risk that can be used to treat minor ailments or for general health care.

TAMG: Important changes to German veterinary medicinal products legislation!

The Veterinary Medicinal Products Act (TAMG) was introduced in Germany at the same time as EU Regulation 2019/6 came into force on January 28, 2022. It replaces the previous regulations of the German Medicinal Products Act (AMG) for veterinary medicinal products and creates an independent set of rules for their manufacture, authorization, dispensing, use, record-keeping and pharmacovigilance. The TAMG supplements EU Regulation 2019/6 with special national features and goes beyond the EU requirements in some areas:

• 7/31-day rule: According to Section 44 (3) TAMG, veterinary medicinal products for food-producing animals may be dispensed for up to 31 days, while systemically acting antibiotics may only be dispensed for seven days. This regulation is specific to Germany and extends the EU requirements, which do not specify precise time limits.
• Reporting obligations for antibiotic consumption quantities: According to Section 56 TAMG, veterinarians must report the consumption of antibiotics in animals electronically, regardless of the size of the herd and also for hobby farms. This supplements the EU regulation with a specific national reporting obligation. Since the beginning of the year, veterinarians have had to report prescriptions, applications or dispensing of antibiotics to the HI-Tier-TAM database as part of the antibiotic minimization concept and now for the recording of antibiotic consumption quantities for all farm sizes. From the reporting half of the year 2023, notifications can only be made electronically in the HI-Tier database. It is possible to commission third parties with the reporting for all notifications.
• Documentation requirements: The TAMG sets out additional record-keeping requirements for veterinarians. According to Section 52 TAMG, veterinarians must keep detailed records of veterinary prescriptions issued, which goes beyond the general requirements of the EU Regulation.
• National databases: Several databases have been introduced to improve the traceability of veterinary medicinal products. These include the Union Product Database, the pharmacovigilance database and the manufacturing and wholesale distribution database.Since 2023, only the type of use, initial stock and changes in stock have to be reported, as well as the fact that no antibiotically active medicinal products have been used. The submission of the notification via the livestock owner insurance is no longer required.
• Stricter regulations for the use of antibiotics: The TAMG contains specific regulations to minimize the use of antibiotics and prevent resistance. For example, systemically active antibiotics for food-producing animals may only be dispensed for a limited period of time. In addition, a benchmark system has been introduced to monitor and reduce the use of antibiotics on farms, which goes beyond the EU requirements.
• Rededication of medicinal products: Under certain conditions, the TAMG allows the reclassification of medicinal products if no authorized veterinary medicinal product is available for the animal species and area of application in question. This regulation is anchored in Articles 112 to 114 of EU Regulation 2019/6 and is supplemented by national provisions that define specific requirements and exceptions.

Implementing regulations and delegated acts: an overview of the supplementary regulations!

The new EU Regulation (EU) 2019/6 on veterinary medicinal products and the German Veterinary Medicinal Products Act (TAMG) have far-reaching implications for the manufacture, distribution and use of veterinary medicinal products. In addition to the main regulations, several supplementary legal acts and implementing regulations have been issued that set out specific requirements and exemptions in detail. These include:

Delegated Regulation (EU) 2021/578 on antimicrobial active substances lays down criteria for antimicrobial active substances that are exclusively reserved for human medicine. The aim is to limit the spread of antimicrobial resistance by banning the use of certain antibiotics in veterinary medicine. This helps to preserve the effectiveness of these drugs for human medicine and prevent the development of resistant germs.

Implementing Regulation (EU) 2021/1248 on Good Distribution Practice (GDP), on the other hand, defines standards for the Good Distribution Practice of veterinary medicinal products. It ensures that medicinal products are handled under optimal conditions during storage and transportation in order to guarantee the integrity and quality of veterinary medicinal products throughout the supply chain.

GMP compliance: Important changes to good manufacturing practice!

The new veterinary medicinal products legislation, including supplementary implementing regulations, has far-reaching effects on good manufacturing practice (GMP).

The authorization for the manufacture of veterinary medicinal products and veterinary technical products requiring approval is now anchored in German law in accordance with Section 28 (1) TAMG. Whereas previously a single manufacturing authorization was held for human and veterinary medicinal products, these must now be separated and, if necessary, applied for separately.

External testing laboratories also require a manufacturing authorization: The manufacturing authorization is not only required for the actual production, but also for participation in a phase of the manufacturing process. This means that external testing laboratories involved in the testing of veterinary medicinal products also require a specific manufacturing authorization for veterinary medicinal products - and a Qualified Person.

For the latter, there are a few deviations in terms of expertise from the requirements traditionally established in the human sector: according to Article 97 of the Regulation, the qualified person may now have a university degree in pharmacy, human medicine, veterinary medicine, chemistry, pharmaceutical chemistry and technology or biology and at least two years' experience in companies with a manufacturing authorization in quality assurance, the qualitative analysis of medicinal products, the quantitative analysis of active substances and tests and trials to demonstrate the quality of veterinary medicinal products. The duration of the activity can be reduced by one year if the course of study comprises at least five years, and by one and a half years if the course of study comprises at least six years.

Conclusion: Your partner for TAMG compliance!

The new regulatory requirements of EU Regulation (EU) 2019/6 and the German Veterinary Medicinal Products Act (TAMG) ensure that veterinary medicinal products meet the highest standards throughout the EU. These regulations not only improve the quality and safety of medicinal products, but also make a significant contribution to combating antibiotic resistance and promoting animal health. However, the stricter requirements and the continuous adaptation of the regulations require manufacturers and veterinarians to have a deep understanding of the legal requirements and their precise implementation.

This is where our experts at Tentaconsult Pharma & Med come into play: we offer you comprehensive support by providing advice, applying for relevant manufacturing and trade licenses, preparing approval dossiers or taking on legal functions such as the Wholesale Representative or Qualified Person.

Please do not hesitate to contact us!