Quality guidelines: non-immunologicals
VeterinaryRegulatory and procedural guidanceQuality of medicinesResearch and developmentScientific guidelines
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The European Medicines Agency's scientific guidelines on the non-immunologicals help medicine developers prepare marketing authorisation applications for veterinary medicines.
For a complete list of scientific guidelines currently open for consultation, see Public consultations.
Development pharmaceuticals
Manufacture of medicinal product
- Manufacture of the finished dosage form (veterinary)
- Process validation for finished products – information and data to be provided in regulatory submissions
- Start of shelf-life of the finished dosage form (Annex to the note for guidance on the manufacture of the finished dosage form)
- Use of ionizing radiation in the manufacture of medicinal products
Active substance
Guidelines
- Active substance master file procedure
- Chemistry of active substances for veterinary medicinal products
- Investigation of chiral active substances (veterinary)
- Summary of requirements for active substances in the quality part of the dossier
- Template for the qualified person's (QP) declaration concerning good manufacturing practice compliance of active substance manufacture "The QP declaration template"
Reflection papers
- Chemical structure and properties criteria to be considered for the evaluation of new active substance (NAS) status of chemical substances - Veterinary
- Use of cocrystals of active substances in medicinal products
Questions and answers
- Questions and Answers on how to use a CEP in the context of a Marketing Authorisation Application or a Marketing Authorisation Variation
- Quality Working Party questions and answers on API mix
Documents of interest
Impurities
- Assessment and control of DNA reactive (mutagenic) impurities in veterinary medicinal products
- Control of impurities of pharmacopoeial substances: compliance with the European Pharmacopoeia general monograph “Substances for Pharmaceutical Use” and general chapter “Control of Impurities in Substances for Pharmaceutical Use”
- Setting specifications for related impurities in antibiotics
- VICH GL10 Impurities in new veterinary drug substances
- VICH GL11 Impurities in new veterinary medicinal products
- VICH GL18 Residual solvents in new veterinary medicinal products, active substances and excipients
- Risk management requirements for elemental impurities in veterinary medicinal products, including immunological veterinary medicinal products
- Question and answer document on the Guideline on assessment and control of DNA reactive (mutagenic) impurities in veterinary medicinal products (EMA/CVMP/SWP/377245/2016)
Packaging
Specifications, analytical procedures and analytical validation
- Parametric release
- Specifications and control tests on the finished product
- VICH GL1 Validation of analytical procedures: definition and terminology
- VICH GL2 Validation of analytical procedures: methodology
- VICH GL39 Test procedures and acceptance criteria for new veterinary drug substances and new medicinal products: chemical substances
- VICH GL40 Test procedures and acceptance criteria for new biotechnological/biological veterinary medicinal products
- Use of near infrared spectroscopy (NIRS) by the pharmaceutical industry and the data requirements for new submissions and variations
- Dissolution specification for generic oral immediate release products
Transmissible spongiform encephalopathies (TSEs)
Stability
- Declaration of storage conditions: 1. in the product information of pharmaceutical veterinary medicinal products, 2. for active substances (Annex)
- In-use stability testing of veterinary medicinal products products
- Stability testing of existing active substances and related finished products
- VICH GL3 Stability testing of new veterinary drug substances and medicinal products
- VICH GL4 Stability testing for new veterinary dosage forms
- VICH GL5 Stability testing: photostability testing of new veterinary drug substances and medicinal products
- VICH GL8 Stability testing for medicated premixes
- VICH GL45 Bracketing and matrixing designs for stability testing of new veterinary drug substances and medicinal products
- VICH GL51 Quality: statistical evaluation of stability data
- VICH GL58 stability testing of new veterinary drug substances and medicinal products in climatic zones III and IV
- Stability testing for applications for variations to a marketing authorisation for veterinary medicinal products
Herbal medicinal products
- Declaration of herbal substances and herbal preparations in herbal medicinal products/traditional herbal medicinal products
- Quality of combination herbal medicinal products/traditional herbal medicinal products
- Quality of herbal medicinal products/traditional herbal medicinal products
- Specifications: test procedures and acceptance criteria for herbal substances, herbal preparations and herbal medicinal products/traditional herbal medicinal products
Specific veterinary dosage forms
- Additional quality requirements for products intended for incorporation into animal feeding-stuffs (medicated premixes)
- Quality aspects of pharmaceutical veterinary medicines for administration via drinking water
- Quality aspects of single-dose veterinary spot-on products
- Quality of modified release dosage forms for veterinary use
- Maximum in-use shelf-life for medicated drinking water
- Premixes for medicated feeding stuffs for veterinary use versus powders/granules for oral use or use in drinking water