(1993; 36 pages)
7.1 All products shall be clearly identified by labels. The labels used must remain permanently attached to the containers under all storage conditions and an area of the container should be left uncovered to allow inspection of the contents. If the final container is not suitable for labelling (for example a capillary tube), it should be in a labelled package.
7.2 The information given on the label on the container and the label on the package shall be approved by the national control authority.
7.3 The label on the container shall show:
- the name of the drug product;
- a list of the active ingredients and the amount of each present, with a statement of the net contents, e.g. number of dosage units, weight or volume;
- the batch or final lot number assigned by the manufacturer;
- the expiry date;
- recommended storage conditions or handling precautions that may be necessary;
- directions for use, and warnings and precautions that may be necessary;
- the nature and amount of any substance used in the preparation of the biological product that is likely to give rise to an adverse reaction in some recipients;
- the name and address of the manufacturer or the company and/or the person responsible for placing the drug on the market.
7.4 The label on the package shall, in addition to the information shown on the label on the container, show at least the nature and amount of any preservative or additive in the product.
7.5 The leaflet in the package should provide instructions for the use of the product, and mention any contraindications or potential adverse reactions.