1. INCB PERMITS & REQUIREMENTS FOR ESTIMATES.
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INCB PERMITS & REQUIREMENTS FOR ESTIMATES.
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2. 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
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3. 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
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4. 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.
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5. 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.
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6. 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
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7. 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.
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8. (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.
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9. (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.
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10. 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 
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11. Case Study Calculation Of Estimates Omissions
Consumption of previous years
Figures supplied by industry
Omissions
Product extension
Inaccurate forecasting
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12. Case Study Consequences Remedy Additional information Country denied
Sales
Economy
Remedy
Supplementary estimates
Additional information
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13. Thank you G. Molewa – Deputy Director Law Enforcement
Medicines Regulatory Affairs
Department of Health
Tel
Fax
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