Group 31: Authorisation of Veterinary Medicines (Head: Dr Norbert Möller)

Unit 311: General Steering Unit for the authorisation of Veterinary Medicines

Unit 311 "General Steering Unit for the authorisation of Veterinary Medicines" is responsible for the cross-unit steering and administrative support of the procedures for the authorisation of veterinary medicinal products. This includes both national and European authorisation procedures as well as their follow-up procedures. In addition, Unit 311 supervises the registration of homeopathic medicinal products for animals. Internal and external enquirers are competently advised on regulatory issues.

Dr Angelika Schadewinkel-Scherkl

• Member of the ATCvet Working Group of the WHO Collaborating Centre for Drug Statistics Methodology.

Unit 312: Pharmacy of biological substances and antibiotics

Units 312 "Pharmacy of biological substances and antibiotics" and 313 "Pharmacy of chemically defined substances" monitor compliance with relevant rules of pharmaceutical quality in the marketing authorisation and registration of veterinary medicinal products. The work of Unit 312 focuses on veterinary medicinal products containing biological substances or antibiotics as active ingredients. Ensuring pharmaceutical quality essentially involves monitoring of the development, manufacture, testing and stability of a medicinal product as well as compliance with formal pharmaceutical requirements, for example for product texts or package inserts.

Dr. Lukasz Japtok

• Member of the NtA of the Directorate General SANCO

Unit 313: Pharmcy of chemically defined substances

The units 312 "Pharmacy of Biological Substances and Antibiotics" and 313 "Pharmacy of chemically defined substances" control compliance with relevant rules of pharmaceutical quality in the marketing authorisation and registration of veterinary medicinal products. The work of Unit 313 focuses on veterinary medicinal products containing chemically defined active substances. Ensuring pharmaceutical quality essentially involves monitoring of the development, manufacture, testing and stability of a medicinal product as well as compliance with formal pharmaceutical requirements, for example for product texts or package inserts.

Dr. Luela Fröhlich

• Member of the Working Group of Enforcement Officers of HMA
• Member of the EDQM Group of Experts No.12 (Dosage Forms and Methods)

Unit 314: Efficacy and target animal safety

Unit 314 "Efficacy and Target Animal Safety" evaluates whether the documents submitted with the marketing authorisation application demonstrate efficacy and target animal safety of the veterinary medicinal product for the respective indication in the target species. All information and instructions that are important for safe and effective use in the target animals are included in the product literature (summary of product characteristic, package leaflet).

In addition, unit 314 is responsible for the assessment of clinical trial applications in accordance with §10 of the Veterinary Drugs Act (TAMG).

Dr Nadine Matzmohr

Unit 315: Toxicology and user safety

Unit 315 "Toxicology and User Safety" evaluates health risks of veterinary medicinal products with focus on human health. Within the framework of the establishment of maximum residue limits in animal foodstuffs (MRL procedure), a toxicological assessment of pharmacologically active substances is carried out. In addition, the unit assesses the user safety of veterinary medicinal products on the basis of the toxicological evaluation of active substances and excipients and is involved in the approval of applications to conduct clinical trials in accordance with §10 of the Veterinary Medicinal Products Act (TAMG).

Dr Uta Herbst

Unit 316: Residues

Unit 316 "Residues" is involved in procedures for setting maximum residue limits for pharmacologically active substances in foodstuffs of animal origin (MRL procedures). Based on these legally established limits, withdrawal periods for the treatment of animals used for food production are derived in authorisation procedures. Unit 316 is responsible for the approval of residue studies and determines withdrawal periods according to §10 TAMG for substances to be tested in clinical studies if foodstuffs for human consumption (meat, milk, eggs, honey) are to be obtained from animals in such studies.

Dr Anke Finnah

• Member of the CVMP Safety Working Party
• Member of the CVMP Scientific Advice Working Party
• Member of the Joint FAO/WHO Expert Committee on Food Additives (JECFA)
• Member of the German delegation at the Codex Committee on Residues of Veterinary Drugs in Foods (CCRVDF)

Group 32: Post-Marketing (Head: Prof. Dr Thomas Heberer)

Crisis Management and Communication

The BVL's crisis management encompasses all measures for the detection, prevention, management and follow-up of crises.
The national crisis management of department 3 for veterinary medicinal products acts as an interface to the European partner authorities as well as national and international stakeholders: In the event of a crisis, adequate measures are taken immediately to manage the crisis, these are coordinated and the public is informed.

Dr Alina Hoskins

Unit 321: Variations

Unit 321 "Variations" is responsible for the interdepartmental control and administrative support of the variation procedures for veterinary medicinal products. This includes both national and European variation procedures. Internal and external enquirers are advised on regulatory issues related to variation procedures.

Wiebke Godow

• Vice-Chair of the CMDh-CMDv Variation Regulation Working Party

Unit 322: Pharmacovigilance

Unit 322 "Pharmacovigilance" is responsible for all procedures and questions concerning pharmacovigilance, i.e. for monitoring the safety of authorised veterinary medicinal products. If adverse events occur in animals, humans or in the environment following the use of a veterinary medicinal product, veterinarians are asked to and pharmaceutical companies are obliged to report them. Adverse events in animals treated with human medicinal products should also be reported. The adverse event reports are recorded and evaluated in a database in Unit 322. Furthermore, Unit 322 is responsible for all questions regarding the legal status of supply (prescription status) of veterinary medicinal products, for the exemption of veterinary medicinal products for certain pets from the need to obtain a marketing authorisation and for risk communication.

Dr Constance McDaniel

• Member of the Veterinary Strategic Focus Group (VSFG) of EMA and HMA
• Member of the Pharmacovigilance Working Party of the CVMP (PhVWP)
• Member of the VICH Pharmacovigilance Expert Working Group

Unit 323: Drug Resistance

The unit "Drug Resistance" is concerned with monitoring the use of antimicrobial drugs in veterinary medicine and develops preventive measures and concepts to minimise the development and spread of drug resistance. The focus is particularly on resistance to antimicrobials (subject area 323.I) and antiparasitics (subject area 323 II).

Within the framework of its statutory tasks, the Unit evaluates the quantities of antimicrobial veterinary medicinal products dispensed by the pharmaceutical industry reports these dispensed quantities to EMA and to WOAH. In addition, Unit 323 carries out the annual calculation and publication of the "Nationwide key figures on therapy frequency in certain livestocks". Since 2023, the collection antimicrobials used in certain farm animals has also been mandatory throughout the EU. Unit 323 is responsible for the national implementation and reporting of the data to the EMA. Together with Unit 505, Unit 323 is the publisher and co-author of the GERMAP reports on antibiotic resistance and consumption.

PD. Dr. Svenja E. Sander

• Member of the Interministerial Working Group on Antimicrobial Resistance (IMAG AMR) of the German Antibiotic Resistance Strategy (DART)

• Member of the BMEL-BVL-BfR working group on antibiotic resistance

Unit 324: Inspections and Post-Marketing

Unit 324 "Inspections and Post-Marketing" carries out inspections of the pharmacovigilance system and the pharmacovigilance system master file (PSMF) at pharmaceutical companies and is responsible for all procedures after the authorisation of veterinary medicinal products (post-marketing). This includes, among other things, the veterinary assessment of variations, the processing of applications for the extension of certain marketing authorisations and the withdrawal/revocation of veterinary medicinal products, as well as responsibility for the rapid alert system for quality defects in veterinary medicinal products. Furthermore, Unit 324 is engaged in the implementation of referrals and in questions regarding counterfeits, internet trade and availability of veterinary medicinal products and coordinates SPC harmonisation.

Dr Andrea Winchenbach

• Member of the Pharmacovigilance Inspectors Working Group
• Member of the Working Group of Quality Managers of the HMA

Group 33: Strategy & Management (Head: Prof. Dr Thomas Heberer)

Unit 331: Internal Process Management, Departmental Office

Unit 331 "Internal Process Management, Departmental Office" is responsible for the area of quality management of Department 3 and performs tasks of the office for the head of the department.

Dirk Jochim

Unit 332: General Affairs and Strategic Advancement

Unit 332 "General Affairs and Strategic Advancement" is responsible for strategic organisational and personnel development, taking into account current and future technological, social and legal developments in the field of marketing authorisation of veterinary medicinal products. Furthermore subject area 332.I Electronic File Management is integrated in the unit.

Daniel Freudl

Unit 333: Digitalization and IT- Application Development

Unit 333 "Digitalisation and Development of IT Applications" is responsible for the databases, applications and interfaces that are necessary for the tasks of the department Veterinary Medicines in both the national and EU context. The unit has to determine the requirements of the technical units and to plan, introduce, adapt and further develop the systems in close cooperation with the IT. The systems include the electronic application (eSubmission) containing application forms, electronic file management and case processing in the BVL's own case procedural processing and document management system as well as the national medicinal products database and participation in the development of the EU product database with its depending and supporting systems (e.g. substance database).

Dr Miriam Alexander-Katz

• Change liaison in the EU SPOR programme
• Member (Business Representative) of the EMA Telematics Forum
• Member of the Vet Experts Group for Veterinary Product Data Systems

Unit 334: Biostatistics, Data Management and Big Data

Unit 334 "Biostatistics" provides mathematical-statistical support to the specialised units of Department 3 regarding the evaluation of efficacy, target animal safety as well as user and consumer safety, i.e., in the scope of marketing authorisation procedures for veterinary medicinal products, in the drafting and revision of corresponding scientific guidelines and in giving scientific advice to pharmaceutical companies related to marketing authorisation procedures for veterinary medicinal products. The tasks also include conducting and evaluating complex database searches to answer internal and external enquiries. In addition, the department represents the interests of the BVL in European working groups regarding data management and the use of big data as well as advanced analytics in the context of veterinary medicinal product regulation. Moreover, it contributes to the implementation of the European Veterinary Big Data Strategy in working routines within the BVL.

Dr Dr habil. Werner Terhalle

Unit 335: Legal and Fees Affairs

Unit 335 "Legal and Fee Matters" deals with legal issues and fee matters. This includes providing legal advice to the specialised units of Department 3 as well as legal information to external stakeholders such as companies, ministries, state authorities, veterinarians and interested consumers. Furthermore, the unit is in charge of appeals and lawsuits against decisions of Department 3. In addition, opinions on national and European legislative procedures are drafted.

Manuel Wedemeyer

• Contact point for the European Data Gathering Initiative veterinary of HMA/EMA/NCAs

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