Article 5

For the purpose of obtaining the marketing authorization provided for in Article 4, the person responsible for marketing shall lodge an application with the competent authority of the Member State. The following particulars and documents shall be appended to the application: 1. name or corporate name and permanent address or registered place of business of the person responsible for marketing and of the manufacturer, if different; 2. name of the veterinary medicinal product (brand name, non-proprietary name, with or without a trade-mark or name of the manufacturer ; scientific name of formula, with or without a trade-mark or name of the manufacturer); 3. qualitative and quantitative particulars of all the constituents of the veterinary medicinal product, using the usual terminology but not empirical chemical formulae and giving the international non-proprietary name recommended by the World Health Organization, if such a name exists; 4. brief description of the method of preparation; 5. therapeutic indications, contra-indications and side-effects; 6. dosage for the various species of animal for which the veterinary medicinal product is intended, its pharmaceutical form, method and route of administration and proposed shelf life if less than three years; 7. reasons for the precautionary and safety measures to be taken when using the veterinary medicinal product, if applicable; 8. indication of the withdrawal period necessary between the last administration of the veterinary medicinal product to animals under normal conditions of use and the production of foodstuffs from such animals in order to ensure that such foodstuffs do not contain any residues which might constitute a health hazard to the consumer; 9. description of the control testing methods employed by the manufacturer (qualitative and quantitative analysis of the constituents and the finished product, specific tests, e.g. sterility tests, tests for the presence of pyrogens, for the presence of heavy metals, stability tests, biological and toxicity tests, tests on intermediate products); 10. results of: - physico-chemical, biological or microbiological tests, toxicological and pharmacological tests, clinical trials. The results of the toxicological and pharmacological tests must relate more particularly to the metabolism of the active ingredients in the animal and as far as possible to the mode and duration of their elimination, if such data are important for the purpose of checking the indicated withdrawal period. However, (a) a copy of the published references relating to the toxicological and pharmacological tests and clinical trials and the data concerning the withdrawal period may be substituted for the relevant test results in the case of: (i) a veterinary medicinal product with an established use, which has been adequately tested on animals so that its effects, including side-effects, are already known and are included in the published references; a new veterinary medicinal product, in which the active ingredients are identical to those of a known medicinal product with an established use; a new veterinary medicinal product containing only known constituents that have already been used together in comparable proportions in adequately tested medicinal products with an established use; in the case of a new veterinary medicinal product containing known constituents not hitherto used together for therapeutic purposes, references to published data may be substituted for the tests on such constituents; 11. one or more specimens or mock-ups of the sales presentation of the veterinary medicinal product together with a package insert where a package insert is required; 12. a document showing that the manufacturer is authorized in his own country to produce veterinary medicinal products; 13. any marketing authorization for the relevant veterinary medicinal product which may have been obtained in another Member State or in a third country.

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Source: EUR-Lex (Cellar) · retrieved 2026-11-06 · Text as adopted (Official Journal); later amendments are not incorporated in this text.