Article 4

In order to obtain an authorisation to place a proprietary medicinal product on the market as provided for in Article 3, the person responsible for placing that product on the market shall make application to the competent authority of the Member State concerned. The application shall be accompanied by the following particulars and documents: 1. Name or corporate name and permanent address of the person responsible for placing the proprietary product on the market and, where applicable, of the manufacturer. 2. Name of the proprietary product (brand name, or common name together with a trade mark or name of the manufacturer, or scientific name together with a trade mark or name of the manufacturer). 3. Qualitative and quantitative particulars of all the constituents of the proprietary product in usual terminology, but excluding empirical chemical formulae, with mention of the international non-proprietary name recommended by the World Health Organisation where such name exists. 4. Brief description of the method of preparation. 5. Therapeutic indications, contra-indications and side-effects. 6. Posology, pharmaceutical form, method and route of administration and expected shelf life if less than three years. 7. Control methods employed by the manufacturer (analysis and assay of the constituents and of the finished product, special tests, e.g. sterility tests, tests for the presence of pyrogenic substances, the presence of heavy metals, stability tests, biological and toxicity tests). 8. Results of: - physico-chemical, biological or microbiological tests; pharmacological and toxicological tests; clinical trials. However: (a) a List of published references relating to the pharmacological tests, toxicological tests and clinical trials may be substituted for the relevant test results in the case of: (i) a proprietary product with an established use, which has been adequately tested on human beings so that its effects, including side-effects, are already known and are included in the published references; a new proprietary product, in which the combination of active constituents is identical with that of a known proprietary product with an established use; a new proprietary product consisting solely of known constituents that have been used in combination in comparable proportions in adequately tested medicinal products with an established use; In the case of a new proprietary product containing known constituents not hitherto used in combination for therapeutic purposes, references to published data may be substituted for the tests of such constituents. 9. One or more specimens or mock-ups of the sales presentation of the proprietary product, together with a package leaflet where one is to be enclosed. 10. A document showing that the manufacturer is authorised in his own country to produce proprietary products. 11. Any authorisation obtained in another Member State or in a third country to place the relevant proprietary product on the market.

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Source: EUR-Lex (Cellar) · retrieved 2026-11-05 · Text as adopted (Official Journal); later amendments are not incorporated in this text.