IIIa.3A2.1.
Pharmacodynamics
IIIa.3A2.2.
Pharmacokinetics
IIIa.3A3.
Toxicology
IIIa.3A3.1.
Single-dose toxicity
IIIa.3A3.2.
Repeat-dose toxicity
IIIa.3A3.3.
Tolerance in the target species
IIIa.3A3.4.
Reproductive toxicity including developmental toxicity
IIIa.3A3.5.
Genotoxicity
IIIa.3A3.6.
Carcinogenicity
IIIa.3A3.7.
Exceptions
IIIa.3A4.
Other requirements
IIIa.3A4.1.
Special studies
IIIa.3A4.2.
Observations in humans
IIIa.3A4.3.
Development of resistance and related risk in humans
IIIa.3A5.
User safety
IIIa.3A6.
Environmental risk assessment
IIIa.3A6.1.
Environmental risk assessment of veterinary medicinal products not containing or consisting of genetically modified organisms
IIIa.3A6.2.
Environmental risk assessment for veterinary medicinal products containing or consisting of genetically modified organisms
IIIa.3B.
Residue tests
IIIa.3B1.
Identification of the product
IIIa.3B2.
Depletion of residues
IIIa.3B3.
Residue analytical method
IIIa.4.
Part 4: Efficacy documentation (pre-clinical studies and clinical trial(s))
IIIa.4A.
Pre-clinical studies
IIIa.4A1.
Pharmacology
IIIa.4A1.1.
Pharmacodynamics
IIIa.4A1.2.
Pharmacokinetics
IIIa.4A2.
Development of resistance and related risk in animals
IIIa.4A3.
Dose determination and confirmation
IIIa.4A4.
Tolerance in the target animal species
IIIa.4B.
Clinical trials
IIIa.4B1.
General principles
IIIa.4B2.
Documentation
IIIa.4B2.1.
Clinical trials
IIIa.4B2.2.
Clinical trials
SECTION IIIb
REQUIREMENTS FOR IMMUNOLOGICAL VETERINARY MEDICINAL PRODUCTS
IIIb.1.
Part 1: Summary of the dossier
IIIb.2.
Part 2: Quality documentation (physicochemical, biological and microbiological information)
IIIb.2.A.
Product description
IIIb.2A1.
Qualitative and quantitative composition
IIIb.2A2.
Product development
IIIb.2B.
Description of the manufacturing method
IIIb.2C.
Production and control of starting materials
IIIb.2C1.
Starting materials listed in pharmacopoeias
IIIb.2C2.
Starting materials not listed in a pharmacopoeia
IIIb.2C2.1.
Starting materials of biological origin
IIIb.2C2.2.
Starting materials of non-biological origin
IIIb.2D.
Control tests during the manufacturing process
IIIb.2E.
Control tests on the finished product
IIIb.2F.
Batch-to-batch consistency
IIIb.2G.
Stability tests
IIIb.2H.
Other information
IIIb.3.
Part 3: Safety documentation (safety and residues tests)
IIIb.3A.
General requirements
IIIb.3B.
Pre-clinical studies
IIIb.3C.
Clinical trials
IIIb.3D.
Environmental risk assessment
IIIb.3E.
Assessment required for veterinary medicinal products containing or consisting of genetically modified organisms
IIIb.3F.
Residue tests to be included in the laboratory studies
IIIb.4.
Part 4: Efficacy documentation (pre-clinical studies and clinical trial(s))
IIIb.4A.
General requirements
IIIb.4B.
Pre-clinical studies
IIIb.4C.
Clinical trials
SECTION IV
REQUIREMENTS FOR SPECIFIC MARKETING AUTHORISATION APPLICATIONS
IV.1.
Applications for generic veterinary medicinal products
IV.2.
Applications for hybrid veterinary medicinal products
IV.3.
Applications for combination veterinary medicinal products
IV.4.
Applications based on informed consent
IV.5.
Applications based on bibliographic data
IV.6.
Applications for limited markets
IV.7.
Applications in exceptional circumstances
SECTION V
REQUIREMENTS FOR MARKETING AUTHORISATION APPLICATIONS FOR PARTICULAR VETERINARY MEDICINAL PRODUCTS
V.1.
Novel therapies veterinary medicinal products
V.1.1
General requirements
V.1.2.
Quality requirements
V.1.3.
Safety requirements
V.1.4.
Efficacy requirements
V.1.5.
Specific data requirements for particular types of novel therapy products
V.1.5.1.
Principles
V.1.5.2.
Gene therapy veterinary medicinal products
V.1.5.3.
Regenerative medicine, tissue engineering and cell therapy veterinary medicinal products
V.1.5.4.
Veterinary medicinal product specifically designed for phage therapy
V.1.5.5.
Veterinary medicinal product issued from nanotechnologies
V.1.5.6.
RNA antisense therapy and RNA interference therapy products
V.2.
Vaccine antigen master file
V.3.
Multi-strain dossier
V.4.
Vaccine platform technology
V.5.
Authorised homeopathic veterinary medicinal products
SECTION I
GENERAL PRINCIPLES AND REQUIREMENTS
I.1. General principles
I.1.1.
The documentation accompanying an application for a marketing authorisation pursuant to Articles 8, and 18 to