Article 13

The following particulars shall appear on containers and outer packages of proprietary medicinal products: 1. Name of the proprietary product which may be a brand name, or a common name together with a trade mark or name of the manufacturer, or a scientific name together with a trade mark or name of the manufacturer. 2. Next to the name of the proprietary product, a statement of the active constituents expressed qualitatively and quantitatively per dose-unit or as a percentage, according to the pharmaceutical form. The international non-proprietary names recommended by the World Health Organisation shall be used wherever they exist. 3. Reference number for production identification (manufacturer's batch number). 4. Number of the authorisation to place the proprietary product on the market. 5. 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. 6. Method of administration. 7. Expiry date for proprietary products with a shelf life of less than three years. 8. Special storage precautions, if any. The pharmaceutical form and the contents by weight, by volume or by number of dose-units need only be shown on the outer packages.

← art_12__para · All articles · art_13__para →

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