Use of NDS v 6: South Africa Experience Rina Schoeman Medicines Regulatory Authority Department of Health South Africa 6-8 May 2007

Medicine Regulatory Authority South Africa

Functions of Inspectorate & Law Enforcement

Use of NDS v 6: South Africa Experience Before 2005 Manual system / local Time consuming Calculation errors Number of come backs from INCB requesting clarification

Use of NDS v 6: South Africa Experience 2005: NDS v 5.2 Load system June 2005 Pilot run for 6 months Positive feedback on system: Accuracy increased Turn around times increased Planning increased Number of permits handled increased Man-hours needed decreased

Use of NDS v 6: South Africa Experience 2006 Fully implemented NDSv5.2 Fully implemented program Little errors Work load manageable Number of come backs from INCB requesting clarification minimum

Use of NDS v 6: South Africa Experience 2006 December NDSv6.1 Fully implemented program Quarterly reports 2006/2007 submitted timeously Identified migration of data problematic Minor errors Discussion with UNODC on data migration

Use of NDS v 6: South Africa Experience WAY FORWARD Available Electronic Document Management of unendorsed permits Electronic Document Management with Applicants and other Stakeholders

Directorate: Inspectorate and Law Enforcement schoer@health.gov.za Rina Schoeman Directorate: Inspectorate and Law Enforcement schoer@health.gov.za