INCB PERMITS

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INCB PERMITS REQUIREMENTS FOR ESTIMATES.

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

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Case Study

• Calculation Of Estimates
• Consumption of previous years
• Figures supplied by industry
• Omissions
• Product extension
• Inaccurate forecasting

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Case Study

• Consequences
• Country denied
• Sales
• Economy
• Remedy
• Supplementary estimates
• Additional information
• www.incb.com

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Thank you

• G. Molewa Deputy Director Law Enforcement
• Medicines Regulatory Affairs
• Department of Health
• Tel [phone]
• Fax [phone]
• Email molewg_at_health.gov.za