i Marketing Authorization of Pharmaceutical Products with Special Reference to Multisource (Generic) Products. A Manual for a Drug Regulatory Authority. Regulatory Support Series, No.5 (WHO/DMP/RGS/98.5). Geneva, World Health Organization, 1999.
ii Quality assurance of pharmaceuticals. A compendium of guidelines and related materials. Volume 2. Good manufacturing practices and inspection. Geneva, World Health Organization, 1999.