anx_V__para

Information and particulars to be included in an application for the establishment of a maximum residue limit for a pharmacologically active substance used in veterinary medicinal products 1. Administrative particulars 1.1. Name or corporate name and permanent address of the person responsible for placing the veterinary medicinal product(s) on the market. 1.2. Name of the veterinary medicinal product(s). 1.3. Qualitative and quantitative composition in terms of active principles, with mention of the international non-proprietary name recommended by the World Health Organization, where such name exists. 1.4. Manufacturing authorization, if any. 1.5. Marketing authorizations, if any. 1.6. Summary of the characteristics of the veterinary medicinal product(s) prepared in accordance with Article 5a of Directive 81/851/EEC. 2. Identity of substance 2.1. International non-proprietary name. 2.2. International Union of Pure and Applied Chemistry (IUPAC) name. 2.3. Chemical Abstract Service (CAS) name. 2.4. Classification: Synonyms and abbreviations. 2.6. Structural formula. 2.7. Molecular formula. 2.8. Molecular weight. 2.9. Degree of impurity. 2.10. Qualitative and quantitative composition of impurities. 2.11. Description of physical properties: Toxicological studies 3.1. Short-term toxicological studies. 3.2. Long-term toxicological studies. 3.3. Studies on reproduction. 3.4. Studies on teratogenicity. 3.5. Studies on mutagenicity. 3.6. Studies for carcinogenicity. 3.7. Studies of immunological effects. 3.8. Studies of microbiological effects. 3.9. Observations in humans. 3.10. Other biological effects. 4. Metabolic and residue studies 4.1. Absorption, distribution, excretion and biotransformations. 4.2. Determination of residues, including methods of residue analysis. 4.3. Existing maximum permitted residue levels. 5. Conclusions 5.1. Level causing no toxicological effect. 5.2. Estimate of temporary acceptable daily intake for man. 5.3. Estimate of maximum residue levels in food with the specification of the residue concerned. 5.4. Methods of routine analysis that may be used by the competent authorities for the detection of residues. 5.5. Further work or information: References 7. Experts report

← ANNEX V · All articles · - →

Source: EUR-Lex (Cellar) · retrieved 2026-11-04 · Text as adopted (Official Journal); later amendments are not incorporated in this text.