(2003; 148 pages)
6.1 All products should be clearly identified by labels, which must remain permanently attached to the containers under all storage conditions. An area of the container should be left uncovered to allow inspection of the contents. If the final container is not suitable for labelling, the label should appear on its package. Information on batch coding must be provided to the national and/or regional authorities.
6.2 The labels of radiopharmaceuticals must comply with the relevant national regulations and international agreements. For registered radiopharmaceuticals, the national control authority should approve the labels.
6.3 The label on the container should show:
(a) the name of the drug product and/or the product identification code;
(b) the name of the radionuclide;
(c) the name of the manufacturer or the company and/or the person responsible for placing the drug on the market;
(d) the radioactivity per unit dose:
- for liquid preparations, the total radioactivity in the container, or the radioactive concentration per millilitre, at a stated date and, if necessary, hour, and the volume of liquid in the container;
- for solid preparations, such as freeze-dried preparations, the total radioactivity at a stated date and, if necessary, hour;
- for capsules, the radioactivity of each capsule at a stated date and, if necessary, hour, and the number of capsules in the container;
- where relevant, the international symbol for radioactivity.
6.4 The label on the package should state:
(a) the qualitative and quantitative composition;
(b) the radioactive isotopes and the amount of radioactivity at the time of dispatch;
(c) the route of administration;
(d) the expiry date;
(e) any special storage conditions;
(f) mandatory information related to transport regulations for radioactive materials.
6.5 The leaflet in the package should contain the specific product information and indications for use. This information is especially important for preparation kits (cold kits), and should include:
(a) the name of the product and a description of its use;
(b) the contents of the kit;
(c) the identification and quality requirements concerning the radio-labelling materials that can be used to prepare the radiopharmaceutical, namely:
- the directions for preparing the radiopharmaceutical, including the range of activity and the volume, together with a statement of the storage requirements for the prepared radiopharmaceutical;
- a statement of the shelf-life of the prepared radio-pharmaceutical;
- the indications and contraindications (pregnancy, children, drug reactions, etc.) in respect of the prepared radiopharmaceutical;
- warnings and precautions in respect of the components and the prepared radiopharmaceutical, including radiation safety aspects;
- where applicable, the pharmacology and toxicology of the prepared radiopharmaceutical, including the route of elimination and the effective half-life;
- the radiation dose that a patient will receive from the prepared radiopharmaceutical;
- the precautions to be taken by users and patients during the preparation and administration of the product and the special precautions for the disposal of the container and any unconsumed portions;
- a statement of the recommended use of the prepared radio-pharmaceutical and the recommended dosage;
- a statement of the route of administration of the prepared radiopharmaceutical;
- if appropriate for particular kits (i.e. those subject to variability beyond the recommended limits), the methods and specifications needed to check radiochemical purity.