Non-clinical local tolerance testing of medicinal products. CPMP Working Party on Safety of Medicinal Products.

Guideline Title Non-clinical Local Tolerance Testing of Medicinal Products Legislative basis Directive 75/318/EEC as amended Date of first adoption December 1990 Date of entry into force June 1991 Status Last revised 1990 Previous titles/other references Local Tolerance Testing of Medicinal Products III/3979/88 Additional Notes This note for guidance concerns the application of part 3, section II. H of the Annex to Directive 75/318/EEC as amended with a view to the granting of a marketing authorisation for a medicinal product.