Quality: non-immunologicals
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.
Guidelines
- Manufacture of the finished dosage form (veterinary) - Scientific guideline
- Process validation for finished products – information and data to be provided in regulatory submissions - Scientific guideline
- Start of shelf-life of the finished dosage form (Annex to the note for guidance on the manufacture of the finished dosage form) - Scientific guideline
- Use of ionizing radiation in the manufacture of medicinal products - Scientific guideline
Guidelines
- Active substance master file procedure - Scientific guideline
- Chemistry of active substances for veterinary medicinal products - Scientific guideline
- Investigation of chiral active substances (veterinary) - Scientific guideline
- Summary of requirements for active substances in the quality part of the dossier - Scientific guideline
- Template for the qualified person's (QP) declaration concerning good manufacturing practice compliance of active substance manufacture "The QP declaration template" - Scientific guideline
- Quality Working Party questions and answers on API mix - Scientific guideline
Reflection papers
- Chemical structure and properties criteria to be considered for the evaluation of new active substance (NAS) status of chemical substances - Veterinary - Scientific guideline
- Use of cocrystals of active substances in medicinal products - Scientific guideline
Documents of interest
Guidelines
- Assessment and control of DNA reactive (mutagenic) impurities in veterinary medicinal products - Scientific guideline
- 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” - Scientific guideline
- Setting specifications for related impurities in antibiotics - Scientific guideline
- VICH GL10 Impurities in new veterinary drug substances - Scientific guideline
- VICH GL11 Impurities in new veterinary medicinal products - Scientific guideline
- VICH GL18 Residual solvents in new veterinary medicinal products, active substances and excipients - Scientific guideline
Concept papers
Questions and Answers
Guidelines
Guidelines
- Parametric release - Scientific guideline
- Specifications and control tests on the finished product - Scientific guideline
- VICH GL1 Validation of analytical procedures: definition and terminology - Scientific guideline
- VICH GL2 Validation of analytical procedures: methodology - Scientific guideline
- VICH GL39 Test procedures and acceptance criteria for new veterinary drug substances and new medicinal products: chemical substances - Scientific guideline
- VICH GL40 Test procedures and acceptance criteria for new biotechnological/biological veterinary medicinal products - Scientific guideline
- Use of near infrared spectroscopy (NIRS) by the pharmaceutical industry and the data requirements for new submissions and variations - Scientific guideline
Reflection papers
Guidelines
- Declaration of storage conditions: 1. in the product information of pharmaceutical veterinary medicinal products, 2. for active substances (Annex) - Scientific guideline
- In-use stability testing of veterinary medicinal products (excluding immunological veterinary medicinal products) - Scientific guideline
- Maximum shelf-life for sterile medicinal products after first opening or following reconstitution - Scientific guideline
- Stability testing for applications for variations to marketing authorisation - Scientific guideline
- Stability testing of existing active substances and related finished products - Scientific guideline
- VICH GL3 Stability testing of new veterinary drug substances and medicinal products - Scientific guideline
- VICH GL4 Stability testing for new veterinary dosage forms - Scientific guideline
- VICH GL5 Stability testing: photostability testing of new veterinary drug substances and medicinal products - Scientific guideline
- VICH GL8 Stability testing for medicated premixes - Scientific guideline
- VICH GL45 Bracketing and matrixing designs for stability testing of new veterinary drug substances and medicinal products - Scientific guideline
- VICH GL51 Quality: statistical evaluation of stability data - Scientific guideline
- VICH GL58 stability testing of new veterinary drug substances and medicinal products in climatic zones III and IV - Scientific guideline
Guidelines
- Declaration of herbal substances and herbal preparations in herbal medicinal products/traditional herbal medicinal products - Scientific guideline
- Quality of combination herbal medicinal products/traditional herbal medicinal products - Scientific guideline
- Quality of herbal medicinal products/traditional herbal medicinal products - Scientific guideline
- Specifications: test procedures and acceptance criteria for herbal substances, herbal preparations and herbal medicinal products/traditional herbal medicinal products - Scientific guideline
Guidelines
- Additional quality requirements for products intended for incorporation into animal feeding-stuffs (medicated premixes) - Scientific guideline
- Quality aspects of pharmaceutical veterinary medicines for administration via drinking water - Scientific guideline
- Quality aspects of single-dose veterinary spot-on products - Scientific guideline
- Quality of modified release dosage forms for veterinary use - Scientific guideline
Position papers