The GCC Guidance for Presenting the SPC, PIL and Labeling ...

6.6 Special precautions for disposal − Include practical instructions for preparation and handling of the product, whereapplicable, including disposal of the medicinal product, and waste materials derivedfrom the used medicinal product.− If applicable, e.g. for cytotoxics, the following standard statement should be included,‘Any unused product or waste material should be disposed of in accordance with localrequirements.’− If there are no special use or handling instructions for the pharmacist or other healthcareprofessionals, the following standard statement should be included:7. Marketing authorisation holder{Name and address}8. Marketing authorisation number(s)9. Date of first Authorisation/ renewal of the authorisation 10. Date of revision of the text{MM/YYYY}Page 28 of 52