Germany has implemented Regulation (EU) 2019/6 on veterinary medicines. Companies entering the market need to comply with these standards. Being compliant will make them eligible to sell a veterinary product in the country.
This guide provides you with an overview of Veterinary Drug Regulations in Germany and the Veterinary Drug Registration in Germany procedure. It explains the approval process, necessary paperwork, production criteria, labelling regulations, and post-approval duties. It will assist you in understanding what’s required to get veterinary medicine into the German market.
Regulatory Authority for Veterinary Pharmaceuticals in Germany
There are several authorities that regulate the Animal Health Products Regulation in Germany. They are responsible for the type of application, based on the approval route.
Key authorities include:
- Federal Office of Consumer Protection and Food Safety (BVL)
- European Medicines Agency (EMA)
- European Commission (EC)
- Committee for Veterinary Medicinal Products (CVMP)
- Coordination Group for Mutual Recognition and Decentralised Procedures – Veterinary (CMDv)
Role and Responsibilities of the Federal Office of Consumer Protection and Food Safety (BVL) Veterinary Drug Regulations
BVL administers the Federal Office of Consumer Protection and Food Safety (BVL) Veterinary Drug Regulations. It is the principal Veterinary Pharmaceutical Regulatory Authority in Germany for veterinary medicines. It has the following main duties:
- Evaluates national marketing applications.
- Compares the quality, safety, and effectiveness of products.
- Obtains or holds national veterinary marketing authorisations.
- Engages in decentralised and mutual recognition processes.
- Represents Germany in EMA committees such as the CVMP.
- Supervises compliance post product approval.
- Ensures pharmacovigilance and regulatory enforcement.
Veterinary Pharmaceuticals Regulations in Germany
The Regulation (EU) 2019/6 and the Veterinary Medicinal Products Act (TAMG) of Germany cover:
- Product approval and registration
- Clinical studies
- The manufacturing and GMP process
- Import and distribution
- Product labeling
- Pharmacovigilance
- Post-market surveillance
Veterinary Pharmaceuticals Registration Process in Germany
The Veterinary Drug Registration in Germany depends on the type of product and the path of registration. The overall process, however, is as follows:
Step 1: Select the Approval Route
Choose the appropriate authorisation procedure based on your product and target markets.
- National procedure
- Decentralised procedure (DCP)
- Mutual Recognition Procedure (MRP)
- Centralised procedure via the EMA
Step 2: Prepare the Registration Dossier
Prepare necessary technical and administrative paperwork. The dossier should contain information on quality, safety, efficacy, and product information.
Step 3: Submit the Application
If the procedure is chosen to be BVL or EMA, submit the application to the same. EMA applications must be submitted electronically.
Step 4: Regulatory Review
The authority reviews the data submitted in the application and validates the application. Applicants are subject to questions and will be asked for further information if necessary.
Step 5: Receive Marketing Authorisation
The authority issues a marketing authorisation if the product fulfils all regulations. The product can then be sold in Germany under the conditions approved.
Documents Required for Veterinary Pharmaceuticals Registration
Veterinary Drug Registration Requirements in Germany differ depending on the product and the approval process. Most applications will, however, need the following documents:
- Administrative application forms
- Data related to product quality (CMC)
- Information on safety and efficacy
- Clinical or field study reports (if applicable)
- Risk-benefit assessment
- Label and packaging details
- Summary of Product Characteristics (SmPC)
- GMP compliance documents
- Manufacturing site information
EMA procedures must be submitted electronically. The format and technical requirements of the dossier should be adhered to.
Environmental Risk Assessment (ERA) Requirements for Veterinary Medicines in Germany
All veterinary medicinal product applications per Regulation (EU) 2019/6 shall be accompanied by an Environmental Risk Assessment (ERA). The ERA assesses the likely environmental effects of a product in accordance with its use. It is assessed during the marketing-authorisation procedure.
This assessment is done in two phases:
- Phase I: Evaluates the potential environmental exposure from the targeted species, route of administration, and use pattern. It will be a requirement for all applications.
- Phase II: If there is a potential environmental risk found in Phase I, it is required. Further ecotoxicity tests and environmental fate data are required to make a more detailed assessment of risk.
The Federal Environment Agency (UBA) assesses the ERA that is submitted with the application and makes this assessment available to the BVL in Germany.
Veterinary Clinical Trial Requirements for Pharma Products in Germany
The Veterinary Clinical Trial Requirements for Germany will vary based on product and approval route.
Prior to the start of a study, sponsors should:
- Develop a comprehensive study plan.
- Produce quality, safety, and efficacy information.
- Respect animal welfare and ethical considerations.
- Maintain complete study documentation.
- The study results should be included in the marketing authorisation dossier.
Veterinary GMP Requirements for Pharma Manufacturing in Germany
To be able to manufacture veterinary medicines for the German market, manufacturers are required to meet the Veterinary GMP Requirements in Germany. They must:
- Possess a valid Veterinary Drug Manufacturing License in Germany.
- Run a good manufacturing process (GMP).
- Accredit manufacturing, cleaning, and testing activities.
- Have a Qualified Person (QP) certify each batch before release.
- Use GMP-qualified source materials.
- Prepare batch records, deviations, CAPAs, and change controls.
- Beware of GMP inspections carried out by the competent authority.
Veterinary Drug Import Requirements in Germany
Veterinary Drug Import Requirements in Germany are necessary for companies that want to place veterinary medicines in Germany that cannot be produced within the EU. They must:
- Have an import or manufacturing licence.
- Purchase products from factories that are qualified to GMP standards.
- Complete batch certification or testing prior to release, as required.
- Qualify and monitor overseas manufacturers.
- Maintain complete import and distribution records.
- Fulfil EU customs and traceability requirements.
Veterinary Pharmaceuticals Labelling Requirements
Under the Veterinary Drug Labelling Requirements in Germany, labels and package leaflets must match the approved marketing authorisation. Any changes require regulatory approval.
The approved label must include:
- Product name and strength.
- Active ingredient(s).
- Target animal species.
- Indications and dosage instructions.
- Route of administration.
- Withdrawal period, where applicable.
- Storage conditions.
- Batch number and expiry date.
- Marketing authorisation holder details.
- Required warnings and precautions.
Timeline for Veterinary Drug Approval in Germany
The German Veterinary Drug Approval Process timeline depends on the approval route and the quality of the submission. Below is the typical timeline.
| Approval Route | Typical Timeline* |
| National procedure |
~210 active review days
|
| Decentralised procedure (DCP) | ~210 days |
| Mutual Recognition Procedure (MRP) | ~90 days |
| Centralised procedure (EMA) |
~210 active review days
|
Fees for Veterinary Pharmaceuticals Registration in Germany
The fees for Veterinary Medicinal Product Approval in Germany depend on the application type and the approval procedure. National applications submitted to the BVL follow Germany’s AMGKostV fee schedule, while centralised applications are subject to EMA fees.
National Procedure (BVL)
| Application Type | Fee (EUR) |
| New substance (no reference) | €57,800 |
| New substance (partial reference) | €40,400 |
| New substance (complete reference) | €30,600 |
| Known substance (no reference) | €28,200 |
| Known substance (partial reference) | €25,800 |
| Known substance (complete reference) | €22,300 |
| Duplicate application/reference application | €2,200 |
If an environmental risk assessment by the Federal Environment Agency is not required, lower fees apply for several application types.
Centralised Procedure (EMA)
For products submitted through the EMA, fees are charged under Regulation (EU) 2024/568. The applicable fee depends on the legal basis of the application (new active substance, known active substance, generic, hybrid, etc.) and any eligible fee reductions.
You can always refer to the following AMG Fee Regulation – AMGKostV and REGULATION (EU) 2024/568 OF THE EUROPEAN PARLIAMENT to verify the cost based on your product type.
PMS & Pharmacovigilance Requirements for Veterinary Products
After approval, marketing authorisation holders must comply with:
- Veterinary Pharmacovigilance Requirements in Germany and
- Veterinary Drug Post-Marketing Surveillance in Germany
throughout the product’s lifecycle.
These activities help identify and manage safety risks after commercialisation.
Marketing authorisation holders must:
- Maintain a pharmacovigilance system.
- Record and investigate suspected adverse events.
- Report serious adverse events within the required timelines.
- Submit periodic safety reports when required.
- Monitor the product’s benefit-risk profile.
- Update product information if new safety data becomes available.
- Conduct post-marketing surveillance studies when requested by the authorities.
Conclusion
Germany has a well-developed regulatory system for veterinary medicines. A timely knowledge of these needs can minimise delays and facilitate a smoother market entry.
Artixio’s regulatory experts can guide you through the regulatory approval process if you are planning to register a veterinary medicinal product in Germany or expand across the EU. Contact our team at info@artixio.com to discuss Veterinary Regulatory Compliance Support Services.
FAQs
1. Can foreign companies register veterinary medicines in Germany?
Yes. Foreign manufacturers can register veterinary medicines in Germany. However, they must appoint an EU-established marketing authorisation holder or legal representative where required and comply with all applicable EU and German regulatory requirements.
2. Is a veterinary medicine approved in one EU country automatically approved in Germany?
No. A national approval from another EU country is not automatically valid in Germany. Companies can use the Mutual Recognition Procedure (MRP) or the Decentralised Procedure (DCP) to extend approvals across EU Member States.
3. How long is a veterinary marketing authorisation valid in Germany?
A marketing authorisation generally remains valid for an unlimited period unless it is suspended, revoked, or specific conditions are attached by the competent authority. Marketing authorisation holders must continue to meet all post-approval obligations.
4. Can changes be made to an approved veterinary medicine after registration?
Yes. Changes such as manufacturing site updates, formulation changes, labelling revisions, or new indications require regulatory approval through the appropriate variation procedure before implementation.
5. What are the most common reasons for delays in veterinary drug approval?
Common reasons include incomplete dossiers, deficiencies in quality or clinical data, GMP compliance issues, labelling inconsistencies, and delayed responses to authority questions during the review process.
