More attention must be focused on the continuous improvement of the information on the primary and secondary containers of investigational products, because the label information is of primary importance to the users of the product and the successful outcome of clinical trials. What is required on the label should be the result of good common sense and a total quality management approach.
Commission of the European Communities, Brussels.“Manufacture of Investigational Medicinal Products.” Annex to the EC Guide to Good Manufacture Practice, III/3004/91-EN, Final. December 22, 1992.
2.
Commission of the European Communities, Brussels.“Good Clinical Practice for Trials on Medicinal Products in the European Community.” In: The Rules Governing Medicinal Products in the European Community, Volume III, Addendum III/9148/90:57–98. 1990.
