INCB PERMITS & REQUIREMENTS FOR ESTIMATES. This presentation will probably involve audience discussion, which will create action items. Use PowerPoint to keep track of these action items during your presentation In Slide Show, click on the right mouse button Select “Meeting Minder” Select the “Action Items” tab Type in action items as they come up Click OK to dismiss this box This will automatically create an Action Item slide at the end of your presentation with your points entered. INCB PERMITS & REQUIREMENTS FOR ESTIMATES. 2/25/2019

Overview of INCB International Narcotics Control Board (INCB) is an independent and quasi-judicial control organ monitoring the implementation of United Nation Drug Control Conventions 2/25/2019

Duties of INCB Single Convention on Narcotic Drugs 1961 Convention on Psychotropic Substances of 1971 UN Convention against illicit traffic in Narcotic Drugs and Psychotropic substances of 1988 2/25/2019

INCB Role Ensures that drugs are available for medical and scientific use Diversion of drugs from licit sources to illicit channels does not occur Identifies and correct weaknesses on national and international control systems seen in illicit manufacturing of, or trafficking in and use of drugs Assesses chemicals used in the illicit manufacturing of drugs and then places those chemicals under international controls. 2/25/2019

Functions Administers a system of estimates for narcotic drugs and psychotropic substances (art 12) Monitoring licit activities through statistical returns (art 13) Monitors and promotes measures taken by governments to prevent diversion of substances Analyses information supplied by governments and other UN bodies with a view to ensuring that provisions of international drug control treaties are carried out by relevant bodies. 2/25/2019

Department of Health Requirements 22A Control of medicines and Scheduled substances (11) (a) No person shall import or export any specified Schedule 5, Schedule 6, Schedule 7 or Schedule 8 substance or other substance or medicine prescribed for that purpose unless a permit has been issued to him or her by the Director-General in the prescribed manner and subject to such conditions as may be determined by the Director-General 2/25/2019

11 (c) The issue of a permit referred to in paragraph (a) may be refused if- (i) the Director-General is not convinced that the applicant is capable of keeping or storing the substance or medicine in a satisfactory manner in order to prevent the loss thereof; (ii) the use of such substance or medicine has not been authorised in terms of this Act; (iii) the Director-General is of the opinion that the annual importation quota for such substance has been exceeded or will be exceeded; (iv) the Director-General is of the opinion that such substance or medicine, of an acceptable quality, is already available in the Republic; or (v) the applicant did not comply with the conditions under which a previous permit was issued to him or her. 2/25/2019

(12) (a) The control on the importation of Scheduled substances shall relate to- (i) any specified Schedule 5, Schedule 6, Schedule 7 or Schedule 8 substance; (ii) such substances irrespective of the scheduling status allocated thereto, as the Minister may prescribe; (iii) any other substance which becomes subject to international control in terms of the 1961 Single Convention on Narcotic Drugs or the 1971 Convention on Psychotropic Substances entered into by the Republic. (b) The obtaining of import or export permits as required in terms of subsection (11) shall not apply to any preparation which contains a substance as prescribed which is specifically exempted from all control measures for the obtaining of such import or export permits by the 1961 Single Convention on Narcotic Drugs referred to in paragraph (a). (c) Notwithstanding paragraph (b), no such importation or exportation shall take place unless authorised by the Director-General. 2/25/2019

(13) Any permit issued under subsection (11) shall be subject- (a) to the applicant's furnishing the registrar annually with the prescribed information; (b) to the requirement that there shall be no deviation from the particulars reflected on the permit: Provided that if the quantity of such substance or medicine to be imported is less than that provided for in the permit, the Director-General shall be informed in writing thereof within 10 days after the importation of such substance or medicine; and (c) to the conditions, as detailed on the permit, having been complied with, the triplicate copy of the permit having been certified by a customs officer or an employee of the S.A. Post Office Limited. 2/25/2019

Case Study ZOLPIDEM Year Estimate (kg) Actual (kg) Last Issued 2005 300 261.3 Oct 2006 360 332.5 2007 432 428.5 Sept 2008 356.6 June 2008   450  440.0 DEC  2/25/2019

Case Study Calculation Of Estimates Omissions Consumption of previous years Figures supplied by industry Omissions Product extension Inaccurate forecasting 2/25/2019

Case Study Consequences Remedy Additional information Country denied Sales Economy Remedy Supplementary estimates Additional information www.incb.com 2/25/2019

Thank you G. Molewa – Deputy Director Law Enforcement Medicines Regulatory Affairs Department of Health Tel +27 12 312 3300 Fax +27 12 312 0914 Email: molewg@health.gov.za 2/25/2019