§ Baroness MASHAM of ILTONasked Her Majesty's Government:
Whether the skin preparation steroxin is amongst those "special pharmaceutical products" excluded from the draft EEC Directive R/2203/76 on the Classification, Packaging and Labelling of Dangerous Substances; and, if so, whether it is subject to any other EEC or United Kingdom regulation, in draft or otherwise.
§ Lord WELLS-PESTELLSubstances such as chlorquinaldol, the active ingredient of steroxin, are excluded from the requirements of the draft EEC Directive R/2203/76 on the Classification, Packaging and Labelling of Dangerous Substances since they are supplied exclusively for medicinal purposes and warnings on labels which are intended to protect workers and others handling dangerous chemicals would be inappropriate on medicinal products.
Steroxin is, however, subject to EEC Directive 65/65 on proprietary medicinal products, which includes provisions on the labelling of such products, and to the Medicines (Labelling) Regulations 1976. 1846WA It will also be subject to further regulations on the labelling of medicines, which are in preparation on the basis of proposals which were circulated to representative bodies in May 1976. I understand from Geigy Pharmaceuticals, the holders of the product licence for Steroxin, that the containers and cartons will soon show the warning "Steroxin should not be used near the eyes or mucous membranes."