Country Profile-Sudan Pharmacy

SUDAN
PHARMACEUTICAL
COUNTRY PROFILE
Copyright 2010. All rights reserved.

This report is a property of the Government of Sudan. Copyright and other intellectual
property laws protect this material. Reproduction or retransmission of the material, in
whole or in part, in any manner, without the prior written consent of the copyright holder,
is a violation of copyright law.
This report can be used as information source. This can be saved or printed a single copy
for personal use only and not to reproduce any major extract or the entire document.
Anything extracted from this report including selected passage, table diagram should
acknowledge this report and the Government of Sudan.
ii
Acknowledgement
The World Health Organization would like to thanks the FMOH, General
Directorate of Pharmacy, Central Medical Supply, the National Medicine and
Poison Boards, Sudan Medical Council and Ministry of Labor; and to express
appreciation to:
Dr. Thon Mangok.K Lukabyt; Assistant Undersecretary for Pharmacy/MOH
Dr. Gamal Khalafalla Mohamed Ali; Secretary General of National Medicine
and Poison Boards
Dr. Mohamed Elamin; General Director of Central Medical Supply
For their assistance and support for this work.
The WHO would also like to send thanks to
Dr. Amel Elamin Mohamed Elnour; National health information centre FMOH,
Dr. Wijdan Khalid Elfil; National Medicines and Poison Board
Dr. Mohamed Awad Abdalaziz Musnad; National Health Insurance
Dr. Abualbishr Osman Adam Alsharif; National Health Insurance
Dr. Nawal ElHadi; Central Medical Supply
Dr. Gadah Omar Babiker Shouna; Sudan Medical Council
Dr. Sara AbdelKareem; General Directorate of Pharmacy
For their support to provide the information needed for the country profile
iii
Foreword
This 2010 Pharmaceutical Country Profile for Sudan has been produced by the
Ministry of Health with support of the World Health Organization.
This document contains information on structures, process and outcomes of the
pharmaceutical sector in Sudan. Some of the data comes from global sources
(e.g. the World Health Statistics) or from surveys conducted in the previous
years, while other pieces of information have been collected at country level in
2010. The sources of data for each piece of information are presented in the
tables that can be found at the end of this document.
On the behalf of the Ministry of Sudan, I wish to express my appreciation
towards Dr. Nahid Salih Khalid and Dr Siham Abdoun from the World Health
Organization for their contribution to the data collection and to the
development of this profile.
It is my hope that partners, researchers and all those that are interested in the
pharmaceutical sector of Sudan will find this profile a useful tool in their
activities.
Name: H.E. Dr Abdalla Teia Juma Hammad

Federal Minister of Health
Date: December 2010
iv
Table of contents
Acknowledgement __________________________________________________ iii
Foreword ___________________________________________________________iv
Table of contents ____________________________________________________ v
Introduction ________________________________________________________ 1
Section 1 - Health and Demographic Data________________________________ 3
Section 2 - Health Services ____________________________________________ 5
Section 3 - Policy Issues_______________________________________________ 9
Section 4 - Regulation _______________________________________________ 11
Section 5 - Medicines Financing _______________________________________ 15
Section 6 - Pharmaceutical procurement and distribution in the public sector 19
Section 7 - Selection and rational use of medicines ______________________ 20
References_________________________________________________________ 22
ANNEX ___________________________________________________________ 25
Section
Section
Section
Section
Section
Section
Section
1 Health and Demographic data ________________________________ 27

2 Health Services ____________________________________________ 30
3 Policy issues _______________________________________________ 34
4 Regulation ________________________________________________ 38
5 Medicines Financing ________________________________________ 49
6 Pharm.procurement and distribution __________________________ 54
7 Selection and rational use ___________________________________ 58
Introduction
This Pharmaceutical Country Profile provides data on structures, processes and
outcomes of the pharmaceutical sector of Sudan. The aim is to put together
existing
information
and
to
make
all
relevant
information
on
the
pharmaceuticals sector available to the public in a user-friendly format. In

2010, country profiles similar to this one have been developed for 13 pilot
countries. During 2011, the World Health Organization plans to support all WHO
Member States to develop similar country profiles.
The information is categorized in 8 sections, namely: (1) Health and
Demographic data, (2) Health Services, (3) Policy Issues, (4) Regulation, (5)
Medicines Financing, (6) Supply of Pharmaceuticals, (7) Rational Use of
Medicines, and (8) Household Surveys. The indicators have been divided into
two categories, namely "core" (most important) and "supplementary" (useful if
available). The narrative profile is based only on the core indicators; while the
tables in the annexes present all indicators. For each piece of information, we
have tried to indicate the year and source of the data; these are used to build
the references in the profile and are also indicated in the tables. If key
national documents are available on-line, links are provided to the source
documents so that the user can easily access these documents.
The selection of indicators for the profiles has involved all technical units
working in the Essential Medicines Department of the World Health
Organization as well as experts from WHO Regional and Country Offices,
Harvard Medical School, Oswaldo Cruz Foundation (known as Fiocruz),
University of Utrecht, the Austrian Federal Institute for Health Care, and
representatives from the 13 pilot countries. Data collection in the pilot
countries was conducted using a user-friendly electronic questionnaire that
included a comprehensive glossary. Countries were requested not to conduct
any additional surveys, but only to enter the results from previous surveys and
to provide information available at the central level. To facilitate the work of
national counterparts, the questionnaires were pre-filled using all data
available at WHO HQ before being sent out to countries. A coordinator was
nominated for each of the 13 pilot countries. The coordinator for Sudan was
Mrs Nahid Idris Salih Khalid.
The completed questionnaires were then used to produce the country profiles.
In order to do this in a structured and efficient manner, a text template was
developed. Member states took part in the development of the profile and,
once the final product was ready, an officer from the Ministry of Health
certified the quality of the information and gave formal permission to publish
the profile on the web site of WHO.
This profile will be regularly updated by country teams. If you have any
suggestions on corrections to make please send them to Mrs Nahid Idris Salih
Khalid,
salihn@sud.emro.who.int,
Khartoum,
Osman
Digna
Street.
Section 1 - Health and Demographic Data

This section gives an overview of the demographics and health status of Sudan.
1.1 Demographics and Socioeconomic Indicators

The total population of Sudan in 2008 was 39,154,490[1] [2] with an annual
population growth rate of 2.1%. The annual GDP growth rate is 8.3% [3]. The
GNI per capita is US$ 1,511 [4].
1.2 Mortality and Causes of Death

The life expectancy at birth for men is 57 years and for women is 58 years [5].
The infant mortality rate is 81/1,000 live births. For children under the age of
5, the mortality rate is 112/1,000 live births. The maternal mortality rate is
1107/100,000 live births [6].
The 10 leading causes of mortality in hospitals in Sudan are:
1) Malaria
2) Pneumonia
3) Septicaemia
4) Other Heart Diseases
5) Malignant Neoplasm
6) Disorders of the Circulatory System
7) Heart failure
8) Acute renal failure
9) Diabetes mellitus
10) Malnutrition
The 10 leading causes of admission to hospital in Sudan are:

1) Malaria
2) Delivery case/Child birth
3) Pneumonia
4) Caes. Delivery
5) Obstetrics & gynaecology
6) Diarrhoea & Enteric Gastritis
7) Asthma
8) Cutaneous Abscess
9) Diabetes Mellitus
10) Abortion [4]
Section 2 - Health Services

This section provides information regarding health expenditures and human
resources in Sudan. The contribution of the public and private sector to overall
health expenditure is shown and the specific information on pharmaceutical
expenditure is also presented. Data on human resources for health and for the
pharmaceutical sector is provided as well.
2.1 Health and Pharmaceutical Expenditures

In Sudan, the total annual expenditure on health (THE) in 2010 was SDG (Sudan
Pounds) 7,886.5 million (US$ 3,755.5 million). The total health expenditure is
6.2% of the GDP. The total annual expenditure on health per capita is SDG 257
(US$ 122) [2].
The government annual expenditure1 on health accounts for 27.8% of the total
expenditure on health, with a total per capita public expenditure on health of
SDG 71 (US$ 33.9).The government annual expenditure on health represents 9
% of the total government budget [2]. From the total population 30 % is
covered by a public health service or public health insurance or social
insurance, or other sickness funds [7].
The total pharmaceutical expenditure (TPE) in Sudan in 2010 was SDG 2,833
million (US$ 1,349 million). The total pharmaceutical expenditure per capita
was SDG 72.3 (US$ 34.45). The pharmaceutical expenditure accounts for 2.2%
of the GDP and makes up 36 % of the total health expenditure (Figure 1).
The public expenditure on pharmaceuticals per capita in 2007 was SDG 3.5
(US$1.57). The total private expenditure on pharmaceuticals in 2007 was SDG
595.5 million (US$ 268 million). The annual growth rate of the total
pharmaceuticals market value is 52 % [8].
1
By government expenditure it is meant all expenditure from public sources, like

central government, local government, insurance funds and parastatal companies. This
follows the definition used by the WHO National Health Accounts.
FIGURE 1: Share of Total Pharmaceutical Expenditure as percentage of the Total Health

Expenditure.
36.00%
TPE
Other
64.00%
Source: Federal Ministry of Health, Sudan, 2010 [2].
2.2 Health Personnel

The health workforce is described in the table below, and in figures 2 and 3. In
Sudan, there is no strategic plan for pharmaceutical human resource
development in place.
Licensed pharmacists
1.53/10,000
Pharmacists in the public sector
0.39/10,000
Pharmaceutical technicians and
0.64/10,000 [7]
assistants (all sectors)

Physicians (all sectors)
2.8/10,000
Nursing and midwifery personnel (all
8.4/10,000 [4]
sectors)
FIGURE 2: The density of the Health Workforce 2009 in Sudan (all sectors).
Nursing and
midwifery personnel
Physicians
Pharmacists
10
/10,000 population
FIGURE 3: Distribution Pharmaceutical Personnel Sudan 2009.
Pharmacists
Pharmceutical technicians
and assistants
2.3 Health Infrastructure

The health centre and hospital statistics are described in the table below.
Hospitals
0.1/10,000
Hospital beds
7.4/10,000
Primary health care units and centres
1.5/10,000[4]
Licensed pharmacies
0.59/10,000 [7]
Section 3 - Policy Issues

This section addresses the main structure of the pharmaceutical policy in Sudan.
Information about the capacity for manufacturing medicines and regulations
regarding patents is also provided.
3.1 Policy Framework

In Sudan, a National Health Policy (NHP) exists. It was updated in 2007 [9] [10].
An official National Medicines Policy (NMP) document exists in Sudan. It was
updated in 2005.
The NMP covers:
Selection of essential medicines
Medicines pricing
Procurement
Distribution and regulation
Pharmacovigilance
Rational use of medicines
Human resource development
Research
Monitoring and evaluation
Traditional medicine [11].
There are official written guidelines on medicines donations [12]. The
pharmaceutical policy implementation is being regularly monitored/assessed.
The General Directorate of Pharmacy is responsible for this activity [13].
There is a National Good Governance Policy in Sudan, both a multisectoral one
and one specifically for the pharmaceutical sector and the Ministry of Labor
and Human Resources Development is responsible for this policy [14] [15].
A policy is in place to manage and sanction conflict of interest issues in

pharmaceutical affairs [15]. There is a formal code of conduct for public
officials. The Sudan Medical Council is by law responsible for establishing ethics
for all medical practices [16]. There is a whistle-blowing mechanism allowing
individuals to raise a concern about wrongdoing occurring in the
pharmaceutical sector of Sudan. The Sudan Medical Council is responsible for
receiving, handling and judging of all consumers complaints [15].
3.2 Intellectual Property Laws and Medicines

Sudan is not a member of the World Trade Organization; therefore information
on patenting laws is not applicable or available [17].
3.3 Manufacturing
There are 19 licensed pharmaceutical manufacturers in Sudan. Sudan does not
have the capacity for the Research & Development for discovering new active
substances and the production of pharmaceutical starting materials. On the
other hand, there is capacity for production of formulations from
pharmaceutical starting materials and for repackaging of finished dosage forms
[18]. In 2008 the percentage of market share by value of goods produced by
domestic manufacturers was 20.6 % [8].
10
Section 4 - Regulation
This section covers a broad range of pharmaceutical regulatory policy,
institutions and practices in Sudan.
4.1 Regulatory Framework

In Sudan, there are legal provisions establishing the powers and responsibilities
of the medicines regulatory authority (MRA). The MRA is a semi-autonomous
agency [19]. The MRA has its own website; the URL address is
http://www.nmpb.gov.sd. The MRA is not involved in
harmonization/collaboration initiatives [18]. An assessment of the medicines
regulatory system has been conducted in the last five year. This was done in
2006 before the separation of the MRA from the FMOH; a tool developed by
WHO was used for the evaluation [20].
4.2 Marketing Authorization

In Sudan, legal provisions require a marketing authorization (registration) for
all pharmaceutical products on the market [19]. Explicit and publicly available
criteria exist for assessing applications for marketing authorization of
pharmaceutical products [21]. In 2009, the number of pharmaceutical products
registered in Sudan is 3,702 [22]. There are no legal provisions requiring the
MRA to make the list of registered pharmaceutical products publicly available.
However, the list is available on the National Medicines and Poisons Board
website: htp://www.nmpb.gov.sd [18]. Medicines are registered by their INN
(International Non-proprietary Names) or Brand name + INN. Legal provisions
require a fee to be paid for Medicines Market Authorization (registration) based
on applications [19].
11
4.3 Regulatory Inspection

In Sudan, legal provisions exist allowing for appointment of government
pharmaceutical inspectors [19]. The Regulatory Authority has its own inspectors
[18]. Legal provisions exist permitting them to inspect premises where
pharmaceutical activities are performed. By law, inspections have to be
performed and are a pre-requisite for licensing facilities. The inspection
requirements are the same for public and private facilities [19].
4.4 Import Control

Legal provisions exist requiring authorization to import medicines. There are
laws allowing the sampling of imported products for testing. There are legal
provisions exist requiring importation of medicines through authorized ports of
entry. Legislations exist to allow for inspection of imported pharmaceutical
products at the authorized port of entry [19].
4.5 Licensing
In Sudan, legal provisions exist requiring manufacturers to be licensed. Legal
provisions exist requiring manufacturers to comply with Good Manufacturing
Practices (GMP), but these are not published by the government.
Legal provisions exist requiring importers, wholesalers and distributers to be
licensed. Good Distributing Practices have been published by the government
[18] [19]. Legal provisions exist requiring pharmacists to be registered. Legal
provisions exists requiring private and public pharmacies to be licensed.
National Good Pharmacy Practice Guidelines are published by the Medical
Council [15] [19].
12
4.6 Market Control and Quality Control

A laboratory exists in Sudan for Quality Control testing. Samples are collected
by government inspectors for post-marketing surveillance testing.
In the past 2 years, 7536 samples were taken for Quality Control testing and
816 (10.8 %) of them failed to meet the quality standards. The results of the
quality control testing are not publicly available. Only recalled medicines are
published on the MRA website [17] [18].
4.7 Medicines Advertising and Promotion

In Sudan, legal provisions exist to control the promotion and/or advertising of
all medicines. The National Medicines and Poisons Board is responsible for
regulating promotion and/or advertising of medicines. Legal provisions prohibit
direct advertising of all medicines to the public. Legal provisions require a preapproval for medicines advertisements and promotional materials. Guidelines
and regulations exist for advertising and promotion of non-prescription
medicines. There is no national code of conduct concerning advertising and
promotion of medicines by marketing authorization holders [19].
4.8 Clinical Trials

In Sudan, legal provisions exist requiring authorization for conducting Clinical
Trials by the MRA. Laws require the agreement by an ethics committee or
institutional review board of the Clinical Trials to be performed. Registration of
the clinical trials into international/national/regional registry is not required
by law [19].
13
4.9 Controlled Medicines

Sudan is signatory to the:
- Single Convention on Narcotic Drugs, 1961
- 1972 Protocol amending the Single Convention on Narcotic Drugs, 1961
- Convention on Psychotropic Substances 1971
- United Nations Convention against the Illicit Traffic in Narcotic Drugs and
Psychotropic Substances, 1988 [23].
Laws exist for the control of narcotic and psychotropic medicines and
substances, and precursors [17] , [18] by the ministry of Interior and national
medicines and poisons board. The annual consumption of Morphine is 0.029
mg/capita [24].
4.10 Pharmacovigilance
In Sudan, there are no legal provisions in the Medicines and Poisons Act that
provide for pharmacovigilance activities as part of the MRA mandate. Legal
provisions do not exist requiring the Marketing Authorization holder to
continuously monitor the safety of their products and report to the MRA. The
national medicines and poisons board emphasize the importance of
pharmacovigilance activity 11] a national pharmacovigilance centre linked to
the MRA exists in Sudan. It has 1 full-time staff member and has published at
least one analysis report in the previous two years, but it does not publish an
ADR bulletin regularly.
An official standardized form for reporting ADRs is used in Sudan [25] and a
national ADR database exists. In the past 2 years, 50 ADR reports were sent to
the WHO database in Uppsala. ADRs are monitored in at least one public health
program [18].
14
Section 5 - Medicines Financing

In this section, information is provided on the structure of user fees for
medicines and on the existence of public programmes providing free medicines.
Policies and regulations in place that affect the prices of medicines (e.g. price
control and taxes) are presented.
5.1 Medicines Coverage and Exemptions

A public programme in Sudan exists providing free medicines to children under
the age of 5. Reproductive health is supported by the UNFPA [26].
Public programmes exist providing free medicines for:
- Malaria
- Tuberculosis
- Sexually transmitted diseases
- HIV/AIDS
- Vaccines for children (Expanded Programme of Immunization).
The government also provides free medicines for treating emergency cases for
the first 24 hours; blood transfusions; renal dialyses and transplantations; and
anti cancer medicines. The Global Fund supports the medicines for Malaria, HIV
and TB. Global Alliance for Vaccines and Immunization supports the provision
of EPI vaccines [17] [27] [28].
There is a public health service, public health insurance, social insurance or
other sickness fund provides at least partial medicines coverage. It provides
coverage for medicines that are on the Essential Medicines List (EML) for
inpatients and outpatients [29]. The coverage is not full as the Health
Insurance has its own list of medicines and this does not necessarily includes all
medicines in the EML. Private health insurance schemes provide medicines
coverage. They are required to provide at least partial coverage for medicines
that are on the EML.
15
5.2 Patients Fees and Copayments

In the health system of Sudan, at the point of delivery, there are
copayments/fee requirements for both consultations and medicines. Revenue
from fees or from the sale of medicines is not used to pay the salaries or
supplement the income of public health personnel in the same facility. In the
Health Insurance Scheme, patients pay only 25% of the cost of the prescription,
but the prescribed medicines should be part of the health insurance list [13]
[17].
5.3 Pricing Regulation for the Private Sector (not including the non-profit
voluntary sector)
In Sudan, there are legal or regulatory provisions affecting pricing of medicines.
These provisions are aimed at the level of manufacturers, wholesalers and
retailers. These are based on comparisons between generics and registered
originators, and prices in other countries.
The government does not run an active national medicines price monitoring
system for retail prices. Regulations do not exist mandating that retail
medicine price information should be publicly accessible [19].
16
5.4 Prices, Availability and Affordability of Key Medicines

In 2006, WHO/HAI Pricing surveys were conducted in Sudan. The table below
contains the results of the average of the Khartoum, Kordofan, Gadarif and
Nothern State [30].
In public sector, availability of generic medicines was 51.7%. The private sector
had higher availability (77% for generics).
Prices of medicines have been compared to international reference prices2 and
expressed as a ratio of the international price (e.g. a price ratio of 2 would
mean that the price is two times the international reference price). Since
prices have been collected for a basket of medicines, the median price ratio
has been selected to represent the situation in the country.
As for patient prices, the Median Price Ratio in the public sector was 3.4 for
originators and 4.4 for generics, while the private sector had slightly higher
prices (11.5 for originators and 4.7 for generics).
Affordability of medicines is measured in terms of number of days of wage
necessary to purchase treatment for a condition. The wage is the one of the
lowest paid government worker. In the public sector of Sudan, it would take
0.275 days of wage to purchase treatment with co-trimoxazole for a child
respiratory infection using generic medicines. In the private sector, medicines
are slightly less affordable as it would take 0.3 days of wage to purchase
treatment using generic medicines and 1.4 days using originators.
The International reference price is the median of prices offered by international suppliers
(both for profit and not profit) as report by MHS International Price Indicator Guide
(http://erc.msh.org/mainpage.cfm?file=1.0.htm&module=DMP&language=English). For more
information on the methodology WHO/HAI pricing survey, you can download a free copy of the
manual at http://apps.who.int/medicinedocs/documents/s14868e/s14868e.pdf.
17
5.5 Price Components and Affordability

In 2008, a survey on medicines price components was conducted by WHO/EMRO.
The median cumulative percentage mark-up between MSP/CIF price and final
medicine price for a basket of key medicines was 66.7% in the private sector
[31].
5.6 Duties and Taxes on Pharmaceuticals (Market)

There are duties on imported raw materials, imported finished products and
there is a value-added tax on medical consumables (VAT15%) [17].
18
Section 6 - Pharmaceutical procurement and distribution in the

public sector
This section provides a short overview on the procurement and distribution of
pharmaceuticals in the public sector of Sudan.
6.1 Public Sector Procurement

The public sector procurement in Sudan is centralized and decentralized. There
is a Central Medical supplies public corporation and then there are Revolving
Drug Funds (RDF) projects at state level and regional stores.
The public sector procurement is centralized under the responsibility of a
procurement agency which is a semi-autonomous agency.
The public sector tender bids are publicly available and public sector awards
are publicly available [24]. Procurements are based on prequalification of
suppliers. Manufacturers must have been inspected and registered by the
national MRA before starting procurement of awarded items. The dossier for
each item should comply with tender technical conditions [32].
6.2 Public Sector Distribution

The government supply system department in Sudan has a Central Medical
Store at a National Level [24]. There are national guidelines on Good
Distribution Practices (GDP). There is no licensing authority that issues GDP
licenses. In Sudan distributors are also wholesalers. There is a national
guideline for them and a list of licensed distributors/wholesalers (Guideline for
Good Distribution and Transportation) [18] [33].
6.3 Private Sector Distribution

Legal provisions exist for licensing wholesalers, but not for distributors in the
private sector of Sudan. A list of GDP certified wholesalers or distributors in
the private sector does not exist [24] [33].
19
Section 7 - Selection and rational use of medicines

This section presents the structures and policies that are in place in Sudan for
selection of essential medicines and promotion of rational drug use.
7.1 National Structures

National Standard Treatment Guidelines (STGs) for the most common illnesses
have not been produced nor endorsed by the MoH in Sudan [34]. A National
Essential Medicines List (EML) exists and it is publicly available. There are 565
medicines on the EML that was lastly updated in 2007. There is a written
process for selecting medicines on the EML. [13] [17] [35].
There is no public or independently funded national medicines information
centre providing information on medicines to prescribers, dispensers and
consumers. No public education campaign on rational medicine use topics has
been conducted in the last two years. No survey on rational use of medicines
has been conducted in the previous two years. There is no national programme
or committee, involving government, civil society, and professional bodies to
monitor and promote rational use of medicines [17]. Similarly, there is no
written National Strategy to contain antimicrobial resistance [34].
7.2 Prescribing
In Sudan, there are legal provisions to govern the licensing and prescribing
practices of prescribers. Legal provisions exist to restrict dispensing by
prescribers, which is only allowed where there are no dispensaries [15]. There
are no regulations requiring hospitals to organize/develop Drug and
Therapeutics Committees (DTCs) [22].
The core medical training curriculum does not include components on the
concept of EML, use of STGs, pharmacovigilance and problem-based
pharmacotherapy.
20
The core nursing training curriculum does not include components on the
concept of EML, use of STGs and pharmacovigilance.
The core paramedical staff training curriculum does not include components on
the concept of EML, use of STGs and pharmacovigilance.
Mandatory continuing education that includes pharmaceutical issues is not
required for doctors, nurses and paramedical staff [15] [17].
Prescribing by INN name is obligatory in the public sector [19]. The average
number of medicines prescribed per patient contact in public health facilities is
2.3. Seventy three percent of medicines prescribed to outpatient in public
health care facilities are from the EML, but only 43.5% are prescribed by INN
name. Sixty five percent of patients treated in public health facilities receive
antibiotics and 28.6% receive injections. 84.4% of prescribed drugs are
dispensed to patients in the same facilities and 61.1% of dispensed drugs are
adequately labelled [13].
7.3 Dispensing
Legal provisions in Sudan exist to govern dispensing practices of pharmaceutical
personnel [19]. The core pharmacist training curriculum does not include
components on the concept of EML, use of STGs, drug information, clinical
pharmacy and medicines supply management. Yet, some universities include
some of these components.
Mandatory continuing education that includes pharmaceutical issues is not
required for pharmacists.
Substitution of generic equivalents at the point of dispensing in public and
private sector facilities is allowed [15]. Antibiotics and injectable medicines
are sold over-the-counter without a prescription [17].
21
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[11] National medicines policy. 2005.
22
[12] Guidelines for good medicines donation. Place, National Medicines and
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[19] Medicines and Poisons Act, 2009. Available at:
http://www.nmpb.gov.sd/Regulations/The%20medicines%20and%20poisns%20ac
t%202009_.pdf, 08-06-2010 (Arabic version only).
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Health Organization, 2006.
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board of pharmacy and poisons, Year 2010. Available at:
http://www.nmpb.gov.sd/Publication/volume-1.pdf, 08-06-2010.
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Medicines & Poisons Board, 2009. Available at:
http://www.nmpb.gov.sd/DisplaySearch2.php, 08-06-2010.
[23] Report of the International Narcotics Control. Vienna, International
Narcotics Control Board, 2009. Available at: www.incb.org, 08-06-2010.
[24] Central medical store. Khartoum, Central Medical Supplies Public
Corporation, 2005. Available at: http://www.cmssudan.org/, 08-06-2010.
23
[25] Adverse drug reaction reporting form. Khartoum, Federal Pharmacy and
Poisons Board; Pharmacovigilance Department, 2008. Available at:
http://www.nmpb.gov.sd/Pharmacovigilance/Form-1.pdf, 08-06-2010.
[26] Improving reproductive health. United Nations Population Fund, 2010
Available at: http://www.unfpa.org/rh/index.htm, 08-06-2010.
[27] Global EPI Program, Sudan, Federal Ministry of Health
[28] Grant portfolio Sudan. Geneva, the Global Fund to AIDS, Tuberculosis and
Malaria, 2010. Available at:
http://portfolio.theglobalfund.org/Country/Index/SUD?lang=en, 09-06-2010.
[29] List of medicines served by public health insurance, 2007. Available at:
(English versiononly)
[30] HAI Pricing survey Sudan, average of Khartoum State, Kordofan State,
Gadarif State and the Northern State. PLACE, WHO/Health Action International,
2006.
[31] Medicines prices, availability, affordability and price components report.
WHO Pricing components. Cairo, World Health Organization. Regional Office for
the Eastern Mediterranean, 2008. Available at:
http://www.emro.who.int/dsaf/dsa964.pdf, 08-06-2010.
[32] Central medical store tender. Khartoum, Central Medical Supplies Public
Corporation, 2008. Available at:
http://www.cmssudan.org/tender2008_2010/conditions.doc, 08-06-2010.
[33] Guidelines for good distribution and transportation. Sudan, National
Medicines and Poisons Board, 2008. Available at:
http://www.nmpb.gov.sd/Guidelins/Good%20Distribution%20And%20Transporta
tion%20Practice%20Of%20Medicinal%20Products.pdf, 08-06-2010.
[34] General Directorate of Pharmacy. Sudan
[35] National list of essential medicines. Khartoum, General Directorate of
Pharmacy; FMoH, 2007. Available at:
http://www.who.int/selection_medicines/country_lists/sdn_eml_2007.pdf, 0806-2010.
24
Sudan Pharmaceutical Country Profile
ANNEX
Survey Data
25
Respondents to the questionnaire:

Nahid Idris Salih Khalid (coordinator)
00249912167165
salihn@sud.emro.who.int
Siham Abdoun
abdoums@sud.emro.who.int
00249912999100
Amel Elamin Mohamed
0024121196775
Leba2000@gmail.com
Wijdan Khalid Elfil
00249912923859
Wjidan02@yahoo.com
Nawal Elhadi Elnur
00249912308355
nawal_elhadi@hotmail.com
Sara Abd Alkarim
00249912972069
srasiro@gmail.com
Dr. Mohamed Awad Abdalaziz Musnad
00249912325864
m_abdalaziz@yahoo.com
Dr. Abualbishr Osman Adam Alsharif
0912255453
Abu.alshreef@gmail.com
Gadah Omar Babiker Shouna
00249912234271
ghadashouna@hotmail.com
26
Section 1 Health and Demographic data

1.01 Demographic and Socioeconomic Indicators
Core Questions
Population, total (,000)
39,154.39
Population growth rate
(Annual %)
GDP growth (Annual %)
GNI per capita (US$ current
exchange rate)
Supplementary questions
Population < 15 years
(% of total population)
Population > 60 years
Urban population
2008
2.1
2008
National Health
Accounts
World Bank
8.3
1,511
2008
2008
World Bank
FMOH
45
2008
Sudan Census
5.1
2008
Sudan Census
38.27
2007
Annual Health
Statistical
Report
2008/FMOH
World Health
Statistics
Status of
MDG_Sudan/U
NDP
World Health
Statistics
Fertility rate, total

4.3
(Births per woman)
Population living with less than 50
$1/day (international PPP) (%)
2007
Adult literacy rate, 15+ years
2007
60.9
2008
27
1.02 Mortality and Causes of Death

Core questions
Life expectancy at birth for men 57
(Years)
Life expectancy at birth for
58
women
(Years)
Infant mortality rate, between
81
birth and age 1
(/1,000 live births)
2006
2006
2006
World Health
Statistics
World Health
Statistics
EMRO/Annual
report of the
Regional
Director, 2008
EMRO/Annual
report of the
Regional
Director, 2008
EMRO/Annual
report of the
Regional
Director, 2008
Annual Health
Statistical
Report
2009/FMOH
Under 5 mortality rate

112
2006
Maternal mortality ratio

1107
2006
Please provide a list of top 10

diseases causing mortality
Malaria
2009
Pneumonia
Septicaemia
Other Heart Diseases
Malignant Neoplasm
Disorders of the
Circulatory System
Heart failure
Acute renal failure
Diabetes mellitus
Malnutrition
Malaria
2009
Annual Health
S.S. Delivery
Statistical
Pneumonia
Report
Delivery Case
2009/FMOH
Obstetrics &
gynaecology
Asthma
Cutaneous Abscess
Abortion
Diabetes Mellitus
Diarrhoea & Enteric
Gastritis
These diseases apply to the adult mortality/morbidity
Please provide a list of top 10

diseases causing morbidity
Comments
28
Supplementary questions
Adult mortality rate for both
sexes between 15 and 60
years
(/1,000 population)
Neonatal mortality rate
Age-standardized mortality rate

by non-communicable diseases
( /100,000 population)
by cardiovascular diseases
(/100,000 population)
by cancer ( /100,000
population)
Mortality rate for tuberculosis
Mortality rate for Malaria
Comments
314
2007
World Health
Statistics
41
2006
986
2004
EMRO/Annual
report of the
Regional
Director, 2008
World Health
Statistics
543
2004
World Health
Statistics
125
2004
World Health
Statistics
19
2008
WHO/TB Data
85
2006
World Health
Statistics
No data has been calculated before for HIV/AIDS.
29
Section 2 Health Services

2.01 Health Expenditures
Core Questions
Total annual expenditure on
health (millions US$ average
exchange rate)
health (millions NCU)
Total health expenditure as %
of Gross Domestic Product
3755.5
2010
FMOH
7886.5
2010
FMOH
6.2
2008

health per capita (US$
average exchange rate)
122
2006

health per capita (NCU)
257
2006
General government annual

expenditure on health (millions
US$ average exchange rate)
1042.1
2008
General government annual

expenditure on health (millions
NCU)
2188.3
2008
Government annual
expenditure on health as
percentage of total government
budget (% of total government
budget)
Government annual
expenditure on health as % of
total expenditure on health (%
of total expenditure on health)
Annual per capita government
expenditure on health (US$
average exchange rate)
2008
Calculated from
Annual Health
Statistical
Report
2008/FMOH
Annual Health
Statistical
Report
2008/FMOH
Annual Health
Statistical
Report
2008/FMOH
Annual Health
Statistical
Report
2008/FMOH
Annual Health
Statistical
Report
2008/FMOH
Annual Health
Statistical
Report
2008/FMOH
27.8
2008
NHA
33.9
2008
Annual Health
Statistical
Report
2008/FMOH
30
Annual per capita government

expenditure on health (NCU)
71
2008
Private health expenditure as

% of total health expenditure
(% of total expenditure on
health)
Population covered by a public
health service or public health
insurance or social insurance,
or other sickness funds (% of
total population)
Total pharmaceutical
expenditure (millions US$
current exchange rate)
expenditure (millions NCU)
expenditure per capita (US$
expenditure per capita (NCU)
Pharmaceutical expenditure as
a % of GDP (% of GDP)
Pharmaceutical expenditure as
a % of Health Expenditure (%
of total health expenditure)
Total public expenditure on
pharmaceuticals (millions US$
pharmaceuticals (millions
NCU)
Share of public expenditure on
pharmaceuticals as
percentage of total expenditure
on pharmaceuticals (%)
pharmaceuticals per capita
(US$ current exchange rate)
pharmaceuticals per capita
68.5
2008
30
2009
FIP Global
Pharmacy
Workforce
Report
1,349
2010
FMOH
2,832. 9
2010
FMOH
34.45
2010
FMOH
72.3
2010
FMOH
2.2 %
2010
FMOH
2010
FMOH
61.5
2007
136.7
2007
19
2007
Pharmaceutical
Statistical
Report
Pharmaceutical
Statistical
Report
Pharmaceutical
Statistical
Report
1.57
2007
3.5
2007
35.98 %
Annual Health
Statistical
Report
2008/FMOH
NHA
Pharmaceutical
Statistical
Report
Pharmaceutical
Statistical
31
(NCU)
Total private expenditure on
pharmaceuticals (million US$
Total private expenditure on
pharmaceuticals (millions
NCU)
Annual growth rate of total
pharmaceuticals market value
(%)
Comments
Supplementary Questions
Social security expenditure as
% of government expenditure
on health (% of government
expenditure on health)
Private out-of-pocket
expenditure as % of private
health expenditure (% of
private expenditure on health)
Premiums for private prepaid
health plans as % of total
private health expenditure (%
of private expenditure on
health)
Report
268
2007
Pharmaceutical
Statistical
Report
595.5
2007
Pharmaceutical
Statistical
Report
52
2007
Pharmaceutical
Statistical
Report
Public pharmaceutical expenditure includes CMS
procurement of both free and cost recovery items. Private
pharmaceutical expenditure includes all types of medical
supplies.
11
2008
NHA
97.5
2008
NHA
2008
NHA
32
2.02 Health Personnel and Infrastructure

Core Questions
Total number of pharmacists
5,980
licensed/registered to practice
in your country
Total number of pharmacists
1,542
working in the public sector
Total number of
pharmaceutical technicians
and assistants
A strategic plan for
pharmaceutical human
resource development is in
place in your country?
Total number of physicians
Total number of nursing and
midwifery personnel
Total number of hospitals
Total number of hospitals bed
Total number of primary health
care units and centres
Total number of licensed
pharmacies
Comments
Starting annual salary for a
newly registered pharmacist in
the public sector - NCU
Are there accreditation
requirements for pharmacy
schools?
Is the Pharmacy Curriculum
regularly reviewed?
2,488
2009
FIP Global Pharmacy

Workforce Report 2009
2009
Calculated from FIP

Global Pharmacy
FIP Global Pharmacy
2009
No
11129
2009
Annual Health Statistical

Report 2009/FMOH
32,948
2009
Report 2009/FMOH
407
2009
Report 2009/FMOH
29103
2009
Report 2009/FMOH
5890
2009
Report 2009/FMOH
2,306
2009
FIP Global Pharmacy
Physicians include housemen and university staff. Nursing
and midwifery personnel include midwives, nutrition
officers and health visitors.
7,200
2007
Public Service National

Legal Provisions
Yes
2007
Sudan Medical Council

(SMC) Act
No
33
Section 3 Policy issues

3.01 Policy Framework
Core Questions
National Health Policy exists. If
yes, please write year of the
most recent document in the
"year" field and attach
document or provide URL
below*
National Medicines Policy

official document exists. If yes,
please write the year of the
below*
Group of policies addressing
pharmaceuticals exist. Please
attach document or provide
URL below *
National Medicines Policy
covers the following
components:
Selection of Essential
Medicines
Medicines Financing
Medicines Pricing
Medicines Procurement
Medicines Distribution
Medicines Regulation
Pharmacovigilance
Rational Use of Medicines
Human Resource
Development
Research
Monitoring and Evaluation
Traditional Medicine
National medicines policy
Yes
2007
Yes
2005
1- National
Health Policy
(NHP)
2- National
Health Policy
for Private
Health Sector
(NHP) 2009
National
Medicines
Policy
No
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Unknown
34
implementation plan exists. If

yes, please write year of the
below*
There are official written
guidelines on medicines
donations. Please attach
below *
Is pharmaceutical policy
implementation being regularly
monitored/assessed?
Yes
2008
Guidelines for
Good
Medicines
Yes
2007
Pharmaceutical
sector
assessment
report
Who is responsible for

pharmaceutical policy
monitoring?
Is there a national good
governance policy?
General Directorate of Pharmacy/FMOH
Yes
2007
Multisectoral
Yes
2007
For the pharmaceutical sector
Yes
2004
Which agencies are

responsible?
A policy is in place to manage
and sanction conflict of interest
issues in pharmaceutical
affairs. Please attach
below *
There is a formal code of
conduct for public officials.
Please attach document or
provide URL below *
Is there a whistle-blowing
mechanism allowing
individuals to raise a concern
about wrongdoing occurring in
the pharmaceutical sector of
your country (ombudsman)?
Ministry of Labour and Human Resources Development
Public service
national legal
provisions
Public service
national legal
provisions
Sudan Medical
Council Act
Yes
2004
Sudan Medical
Council Act
Yes
1979
Yes
2004
Medical Ethics
and Medico
Moral
Problems
Sudan Medical
Council Act
35
Please describe:
Comments
By law The Sudan Medical Council is responsible for

receiving, handling and judging of all consumers
complains.
There are multi sectoral legal provisions covering issues
related to good governance. The Sudan Medical Council
is by law responsible for establishing ethics for all medical
provisions
3.02 Intellectual Property Laws and Medicines

Core Questions
Country is a member of the
No
World Trade Organization
Legal provisions provide for
Unknown
granting of Patents on
pharmaceuticals
National Legislation has been
Unknown
modified to implement the
TRIPS Agreement
Current laws contain (TRIPS) Unknown
flexibilities and safeguards
Country is eligible for the
Unknown
transitional period to 2016
Which of the following (TRIPS)
flexibilities and safeguards are
present in the national law?
Compulsory licensing
Unknown
provisions that can be applied
for reasons of public health
Bolar exception
Unknown
Are parallel importing
Unknown
provisions present in the
national law?
The country is engaged in
Unknown
initiatives to strengthen
capacity to manage and apply
intellectual property rights to
contribute to innovation and
promote public health
Are there legal provisions for
Unknown
data exclusivity for
pharmaceuticals
Legal provisions exist for
Unknown
patent extension
2007
WHO Level I
36

linkage between patent status
and marketing authorization
3.03 Manufacturing
Core Questions
Number of licensed
pharmaceutical manufacturers
in the country
Unknown
19
Country has manufacturing

capacity for:
R&D to discover new active
substances
Production of pharmaceutical
starting materials (APIs)
Production of formulations
from pharmaceutical starting
material
Repackaging of finished
dosage forms
Percentage of market share by
value produced by domestic
manufacturers (%)
Number of multinational
pharmaceutical companies
manufacturing medicines
locally
2010
2010
National
Medicines and
Poisons Board
(NMPB)
National
Medicines and
Poisons Board
No
No (manufacturing capacity
is mainly for non sterile
medicines)
Yes
Yes
20.6
2007
Pharmaceutical
Statistical
Report
37
Section 4 Regulation
4.01 Regulatory Framework
Core Questions
Are there legal provisions
establishing the powers and
responsibilities of the
medicines regulatory
authority?
Part of MOH
Semi autonomous agency
The MRA has its own website
- If yes, please provide MRA

Web site address (URL)
The MRA is involved in
harmonization/ collaboration
initiatives
An assessment of the
medicines regulatory system
has been conducted in the last
five years.
Comments
Formal code of conduct exists
for staff involved in medicines
regulation
Medicines Regulatory Authority
gets funds from regular budget
of the government.
is funded from fees for
services provided.
receives funds/support from
other sources
- If yes, please specify
Yes
2009
Medicines and
Poisons Act
2009
No
Yes
Yes
2008
National
Medicines and
Poisons Board
2006
MRA
assessment
report
www.nmpb.gov.sd
Yes
Yes
Assessment using WHO tools conducted in 2006 before

the separation of the MRA from FMOH
Yes
2009
Yes
2010
No
2010
Yes
2010
By laws of
NMPB conduct
of work
National
Medicines and
Poisons Board
National
Medicines and
Poisons Board
WHO
WHO, EC & GF
38
Revenues derived from

regulatory activities are kept
with the regulatory authority
The Regulatory Authority is
using a computerized
information management
system to store and retrieve
information on registration,
inspections, etc.
No
Yes (national software used

for registration)
4.02 Marketing Authorization (Registration)

Core Questions
Legal provisions require a
Yes
marketing authorization
(registration) for all
pharmaceutical products on
the market
Explicit and publicly available
Yes
criteria exist for assessing
applications for marketing
authorization of
pharmaceutical products
Number of pharmaceutical
3,702
products registered in your
country
Legal provisions require the

MRA to make publicly
available the registered
pharmaceutical with defined
periodicity
- If yes, please provide
updated list or URL *
Medicines are registered by
their INN (International Nonproprietary Names) or Brand
name + INN
Legal provisions require paying
a fee for Medicines Market
Authorization (registration)
applications
2010
National
Medicines and
Poisons Board
National
Medicines and
Poisons Board
2009
Medicines and
Poisons Act
2009
Regulation of
Pharmaceutical
Products
Regulations
2009
List of
registered
medicines
(Sudan
Medicines
Index
National
Medicines and
Poisons Board
Yes
2009
Medicines and
Poisons Act
Yes
2009
Medicines and
Poisons Act
Yes
www.nmpb.gov.sd
39
Comments
Legal provisions require
holders to provide information
about variations to the existing
Legal provisions require to
publish the Summary Product
Characteristics (SPCs) of the
medicines registered
establishment of an expert
committee involved in the
process
Certificate for Pharmaceutical
Products in accordance with
the WHO Certification scheme
is required as part of the
application
Legal provision require
declaration of potential conflict
of interests for the experts
involved in the assessment
and decision-making for
registration
Legal provisions allow
applicants to appeal against
MRAs decisions
Registration fee - the amount
per application for
pharmaceutical product
containing New Chemical
Entity,NCE (US$)
Registration fee - the Amount
per application for a
multisource pharmaceutical
product (US$)
Time limit for the assessment
of a marketing authorization
List of registered medicines is regulary updated on

website
Yes
2009
Medicines and
Poisons Act
and
Regulations
Yes
2009
Medicines and
Poisons Act
and
Regulations
Yes
2009
Medicines and
Poisons Act
and
Regulations
Yes
2009
By-laws of
NMPB conduct
of work.
Yes
2009
600
2010
Medicines and
Poisons Act
and
Regulations
National
Medicines and
Poisons Board
600
2010
National
Medicines and
Poisons Board
12 (it is 9 months for

positive list)
2010
National
Medicines and
No
40
application (Months)
4.03 Regulatory Inspection
Core Questions
Legal provisions exist allowing
for appointment of government
pharmaceutical inspectors
Poisons Board
Yes
2009
Yes
2010
Legal provisions exist

Yes
permitting inspectors to inspect
premises where
pharmaceutical activities are
performed
Legal provisions exist requiring Yes
inspection to be performed
2009
Inspection is a pre-requisite for

licensing of facilities
Yes
2009
Inspection requirements are

the same for public and private
facilities
Yes
2009
Yes
2009

the sampling of imported
products for testing
No
2009
Legal provisions exist requiring

importation of medicines
through authorized ports of
entry
inspection of imported
Yes
2009
Yes
2009
Does the Regulatory Authority

have inspectors?
4.04 Import Control

Core Questions
authorization to import
medicines
2009
Medicines and
Poisons Act
and
Regulations
National
Medicines and
Poisons Board
Medicines and
Poisons Act
and
Regulations
Medicines and
Poisons Act
and
Regulations
Medicines and
Poisons Act
and
Regulations
Medicines and
Poisons Act
and
Regulations
Medicines and
Poisons Act
and
Regulations
Medicines and
Poisons Act
and
Regulations
Medicines and
Poisons Act
and
Regulations
Medicines and
Poisons Act
41
pharmaceutical products at the

authorized port of entry
4.05 Licensing
Core Questions
manufacturers to be licensed If
yes please provide documents
below. Please attach
below *
manufacturers to comply with
Good manufacturing Practices
(GMP)
GMP requirements are
published by the government.
If yes, please provide
reference or URL below *
importers to be licensed
and
Regulations
Yes
2009
Medicines and
Poisons Act
and
Regulations
Yes
2009
Medicines and
Poisons Act
and
Regulations
Yes
2009

wholesalers and distributors to
be licensed
Yes
2009
National Good Distribution

Practice requirements are
published by the government
pharmacists to be registered
Legal provisions exists
requiring private pharmacies to
be licensed
Legal provision exist requiring
public pharmacies to be
licensed
Yes
2009
Yes
2009
Yes
2009
Medicines and
Poisons Act
and
Regulations
Medicines and
Poisons Act
and
Regulations
National
Medicines and
Poisons Board
Sudan Medical
Council Law
Sudan Medical
Council Law
Yes
2009
National Good Pharmacy

Practice Guidelines are
published by the government
Comments
Yes (medical council is

2004
publishing some regulation
for pharmacy practice)
Only public pharmacies outside health facilities (belong to
public institutes).
No
Medicines and
Poisons Act
and
Regulations
Sudan Medical
Council Law
42
Yes
publication of different
categories of all
pharmaceutical facilities
licensed
4.06 Market Control and Quality Control
Core Questions
Legal Provisions for controlling Yes
the pharmaceutical market
exist
Does a laboratory exist in the
country for Quality Control
testing?
Yes
2009
2009
Medicines and
Poisons Act
and
Regulations
Medicines and
Poisons Act
and
Regulations
If not, does the regulatory

authority contract services
elsewhere?
Samples are collected by
Yes
2009
Medicines and
government inspectors for
Poisons Act
undertaking post-marketing
and
surveillance testing
Regulations
7536
How many Quality Control
2009
National
samples were taken for testing
Medicines and
in the past two years?
Poisons Board
What is the total number of
816
2009
National
samples tested in the previous
Medicines and
two years that failed to meet
Poisons Board
quality standards?
Results of quality testing in
No
past two years are publicly
available
Comments
Only recalled medicines are published in the MRA website
4.07 Medicines Advertising and Promotion
Core Questions
Legal provisions exist to
Yes
2009
Medicines and
control the promotion and/or
Poisons Ac and
advertising of prescription
Regulations
medicines
Who is responsible for
National Medicines and Poisons Board
regulating, promotion and/or
43
advertising of medicines?
Please describe:
Legal provisions prohibit direct
advertising of prescription
medicines to the public
Yes
2009
Legal provisions require a preapproval for medicines

advertisements and
promotional materials
Guidelines/Regulations exist
for advertising and promotion
of non-prescription medicines
Yes
2009
Yes
2009
A national code of conduct

exists concerning advertising
and promotion of medicines by
holders and is publicly
available
Comments
No
4.08 Clinical trials

Core Questions
authorization for conducting
Clinical Trials by the MRA
the agreement by an ethics
committee/ institutional review
board of the Clinical Trials to
be performed
registration of the clinical trials
into
international/national/regional
registry
Legal provisions exist for GMP
compliance of investigational
products
Legal provisions require
Medicines and
Poisons Act
and
Regulations
Medicines and
Poisons Act
and
Regulations
Medicines and
Poisons Act
and
Regulations
Medicines and poisons act and Regulations is prohibiting

advertisement of all to the public
Yes
2009
Yes
2009
Yes
2009
Medicines and
Poisons Act
and
Regulations
Medicines and
Poisons Act
and
Regulations
Medicines and
Poisons Act
and
Regulations
No
No
44
sponsor, investigator to comply

with Good Clinical Practices
(GCP)
National GCP regulations are
Yes
published by the Government.
Legal provisions permit
No
inspection of facilities where
clinical trials are performed
4.09 Controlled Medicines
Core Questions
The country is a signatory to
conventions
Single Convention on Narcotic Yes
Drugs, 1961
2009
International
Narcotics
Control Board
International
Narcotics
Control Board
International
Narcotics
Control Board
International
Narcotics
Control Board
The 1972 Protocol amending

the Single Convention on
Narcotic Drugs, 1961
Convention on Psychotropic
Substances 1971
Yes
2009
Yes
2009
United Nations Convention

against the Illicit Traffic in
Narcotic Drugs and
Psychotropic Substances,
1988
Laws for the control of narcotic
and psychotropic substances,
and precursors exist, If yes,
please attach below *
Annual consumption of
Morphine (mg/capita)
Comments
The laws and regulations for
the control of narcotic and
psychotropic substances, and
precursors has been reviewed
by a WHO International Expert
or Partner Organization to
assess the balance between
the prevention of abuse and
access for medical need
Yes
2009
Yes
2007
WHO Level I
0.029
2009
CMS
Data taken from CMS consumption data

No
45
Fentanyl (mg/capita)
Pethidine (mg/capita)
Oxycodone (mg/capita)
Hydrocodone (mg/capita)
Phenobarbital (mg/capita)
Methadone (mg/capita)
4.10 Pharmacovigilance
Core Questions
There are legal provision in the
Medicines Act that provides for
pharmacovigilance activities as
part of the MRA mandate
the Marketing Authorization
holder to continuously monitor
the safety of their products and
report to the MRA
A national Pharmacovigilance
centre linked to the MRA
exists in your country
If a national pharmacovigilance
centre exists in your country,
how many staff does it employ
full-time
center exists in your country,
an analysis report has been
published in the previous two
years. Please attach document
or provide URL below *
center exists in your country, it
publishes an ADR bulletin
An official standardized form
for reporting ADRs is used in
your country. If yes, please
attach document below *
0.065
2009
CMS
0.254
2009
CMS
2009
CMS
Yes
2008
2010
National
Medicines and
Poisons Board
National
Medicines and
Poisons Board
Yes
2008
National
Medicines and
Poisons Board
2008
National
Medicines and
Poisons Board
0
0
2.28
0
No
No
No
Yes
46
A national Adverse Drug

Reactions database exists in
your country.
Are ADR reports set to the
WHO database in Uppsala?
Yes
2008
Yes
2008
If yes, number of reports sent

in the past two years
50 (Is the number of reports

during the last 2 years)
2008
ADRs are monitored in at least

one public health program (for
example TB, HIV, AIDS)?
How many ADR reports are in
the database?
Yes
2008
160
2010
Feedback is provided to
reporters
Yes
2010
The ADR database is

computerized
Yes
2008
Medications errors (MEs) are

reported.
Yes
2009
How many MEs are there in

the ADRs database?
2009
There is a risk management

plan presented as part of
product dossier submitted for
Marketing Authorization?
In the past two years, who has
reported ADRs?
Yes
2010
Doctors
Yes
Nurses
Pharmacists
Consumers
Pharmaceutical Companies
Was there any regulatory
No
Yes
No
No
No
2010
National
Medicines and
Poisons Board
National
Medicines and
Poisons Board
National
Medicines and
Poisons Board
National
Medicines and
Poisons Board
National
Medicines and
Poisons Board
National
Medicines and
Poisons Board
National
Medicines and
Poisons Board
National
Medicines and
Poisons Board
National
Medicines and
Poisons Board
National
Medicines and
Poisons Board
National
Medicines and
Poisons Board
47
decision based on local PV

data in the last 2 years?
Are there training courses in
Pharmacovigilance?
If yes, how many people have
been trained in the past two
years?
Yes
1
2009
National
Medicines and
Poisons Board
48
Section 5 Medicines Financing

5.01 Medicines Coverage and Exemptions
Core Questions
If a public programme providing
free medicines exists, medicines
are available free-of-charge for:
Patients who cannot afford them No
2007
WHO Level I
Children under 5
Yes
2007
WHO Level I
Pregnant women
No
2007
WHO Level I
Elderly persons
No
2007
WHO Level I
Please describe/explain your
yes answers for questions
above
If a public programme providing
some/all medicines free exists,
the following types of medicines
are free
All medicines for all conditions
No
Any non-communicable
No
diseases
Malaria medicines
Yes
2007
WHO Level I
Tuberculosis medicines
Yes
2007
WHO Level I
Sexually transmitted diseases
Yes
2007
WHO Level I
medicines
HIV/AIDS medicines
Yes
2007
WHO Level I
EPI vaccines
Yes
2007
WHO Level I
If others, please specify
The government provides free medicines for: Treating
emergency cases for the first 24 hours; blood transfusion
services; renal dialysis and transplantation; and many
anticancer medicines.
Does a public health service,
Yes
public health insurance, social
insurance or other sickness fund
provides at least partial
medicines coverage
Does it provide coverage for
Yes
medicines that are on the EML
for inpatients
Does it provide coverage for
Yes
medicines that are on the EML
49
for outpatients
Does it provide at least partial
medicines coverage for
inpatients
Does it provide at least partial
medicines coverage for
outpatients
Please describe/explain your
answers for questions above
Do private health insurance
schemes provide any medicines
coverage?
If yes, is it required to provide at
least partial coverage for
medicines that are on the EML?
Comments
Yes
Yes
Health insurance have their own list of medicines; but

not necessary includes all medicines on EML
Yes
Yes
There are different package of services in private health

insurance, all of them provides at least partial covergae
for medicines on EML
5.02 Patients Fees and Copayments
Core Questions
In your health system, at the
Yes
2007
WHO Level I
point of delivery, are there any
copayment/fee requirements
for consultations
In your health system, at the
Yes
2007
Pharmaceutical
point of delivery, are there any
sector
copayment/fee requirements
assessment
for medicines
report
Is revenue from fees or from
No
2007
WHO Level I
the sale of medicines used to
pay the salaries or supplement
the income of public health
personnel in the same facility
Please describe the patient
In health insurance scheme, patients pay only 25% of the
fees and copayments system
cost of the prescription. The prescribed medicines should
be within the health insurance list
5.03 Pricing Regulation for the Private Sector
Core Questions
Are there legal or regulatory
Yes
2009
Medicines and
provisions affecting pricing of
Poisons Act
medicines
If yes, are the provisions aimed Yes
2009
Medicines and
50
at Manufacturers
Poisons Act
2009
Medicines and
at Wholesalers
Poisons Act
2009
Medicines and
at Retailers
Poisons Act
Please explain the positive
Compare the generic vs. registered originator and other
answers above: (explain scope registered brands and compare with prices of brand in
of provisions i.e generics vs.
other countries
originator or subsets of
medicines, EML etc.
Government runs an active
No
national medicines price
monitoring system for retail
prices
Regulations exists mandating
No
that retail medicine price
information should be publicly
accessible
5.04 Prices, Availability and Affordability
Core Questions
Please state if a medicines price
HAI Pricing Survey Sudan;
survey using the WHO/HAI
average of Khartoum, Kordofan,
methodology has been conducted
Gadarif and the Northern State,
in the past 5 years in your country.
2006
Basket of key medicines
Availability
Mean (%)
(one or both of)
Public
procurement
Public
patient
Private
patient
NA
NA
NA
NA
51.7
77.05
NA
3.41
11.5
NA
4.4
4.7
NA
1.4
0.275
0.3
Orig.
LPG
Median
(%)
Orig.
LPG
Price
Median
Price
Ratio
Orig.
LPG
Affordability Days
wages of the lowest paid
govt worker for standard
treatment
with co-trimoxazole for a
child respiratory infection
Number
of days'
wages
Orig.
LPG
51
Comments
Report on pricing survey is not received from the MoH yet.
5.05 Price Components and Affordability
Core Questions
Please state if a survey of
Yes
2008
Medicine
medicines price components
prices,
has been conducted in the
availability,
past 5 years in your country. If
affordability
yes, please indicate the year of
and price
the survey and use the results
components
to fill in the questions below
report
WHO/EMRO
Median cumulative percentage mark-up between MSP/CIF
price and final medicine price
for a basket of key medicines
in the public sector (Median %
contribution)
Median cumulative percentage 66.7
mark-up between MSP/CIF
price and final medicine price
in the private sector (Median %
contribution)
Comment
Median percentage
contribution of MSP/CIF to final
medicine price for a basket of
key medicines in the private
sector (Median % contribution)
Median manufacturer selling
price (CIF) as percent of final
key medicines (%)
Median wholesaler selling
price as percent of final
key medicines (%)
Median pharmacist mark-up or
dispensing fee as percent of
retail price for a basket of key
60
60
83.3
16.7
52
medicines (%)
Median percentage
contribution of wholesaler's
mark-up to final medicine price
(in the public and private
sectors) (%)
Median percentage
contribution of retailer's markup to final medicine price for a
basket of key medicines (in the
public and private sectors) (%)
Comment
10.8
16.7

All figures in section 5.05 are calculated from the break
down of price components
5.06 Duties and Taxes on Pharmaceuticals (Market)
Core Questions
There are duties on imported
Yes
2007
WHO Level I
active pharmaceutical
ingredients (APIs)
There are duties on imported
Yes
2007
WHO Level I
finished products
VAT (value-added tax) or any
No
other tax on pharmaceuticals
Comments
VAT (15%) is added to medical consumables.
Amount of duties on imported
11.5
2008
Medicine prices,
active pharmaceutical
availability,
ingredients, APIs (%)
affordability and
price components
report WHO/EMRO
Amount of duties on imported
11.5
2008
Medicine prices,
finished products (%)
availability,
affordability and
price components
report WHO/EMRO
53
Section 6 Pharm.procurement and distribution

6.01 Public Sector Procurement
Core Questions
Public sector procurement is
2007
CMS Legal
Provisions
Decentralized
Centralized and decentralized
Please describe
No
Yes
There is central medical stores and has RDF projects at
state level and regional stores
If public sector procurement is
2007
CMS Legal
wholly or partially centralized, it
Provisions
is under the responsibility of a
procurement agency which is:
Part of MoH
No
Semi-Autonomous
Yes
Autonomous
No
A government procurement
No
Agency which procures all
public goods
Public sector tenders bids
Yes
2008
CMS
documents are publicly
available
Public sector awards are
Yes
2008
CMS
publicly available
Procurements are based on
Yes
2008
CMS Tender
prequalification of suppliers
Conditions
If yes, please describe how it
The main criteria for manufacturer has to be inspected
works
and registered by the national MRA before starting
procurement of awarded items. Dossier for each item
should comply to tender technical conditions.
Is there a written public sector No (There is SOPs as part
2003
CMS Quality
procurement policy?. If yes,
of the QA system at CMS)
Manual
please write the year of
approval in the "year" field.
Are there provisions giving
No
2003
CMS Quality
priority in public procurement
Manual
to goods produced by local
manufacturers?
54
The key functions of the

Yes
procurement unit and those of
the tender committee are
clearly separated
A process exists to ensure the Yes
quality of products procured
If yes, the quality assurance
Yes
process includes prequalification of products and
suppliers
If yes, explicit criteria and
Yes
procedures exist for prequalification of suppliers
If yes, a list of pre-qualified
No (available only inside
suppliers and products is
CMS)
publicly available
List of samples tested during
Yes
the procurement process and
results of quality testing is
available
Which of the following tender
methods are used in public
sector procurement:
National competitive tenders
Yes
International competitive
Yes
tenders
Direct purchasing
Yes
6.02 Public Sector Distribution
Core Indicators
The government supply
Yes
system department has a
Central Medical Store at
National Level
There are national guidelines
Yes
on Good Distribution Practices
(GDP)
There is a licensing authority
No (Distributors are the
that issues GDP licenses
whole salers. There is
national guideline for
licensing wholesalers)
If a licensing authority exists, No
does it accredit public
2003
CMS Quality
Manual
2003
CMS Quality
Manual
2009
QA/CMS
2007
WHO Level I
2007
CMS Legal
Provisions
2008
National
Medicines and
Poisons Board
National
Medicines and
Poisons Board
2010
2010
National
Medicines and
55
distribution facilities?
List of GDP certified
warehouses in the public
sector exists
distributors in the public sector
exists
Which of the following
processes at the Central
Medical Store is in place
Forecasting of order quantities
Requisition/Stock orders
Preparation of picking/packing
slips
Reports of stock on hand
Reports of outstanding order
lines
Expiry dates management
Batch tracking
Reports of products out of
stock
Routine Procedure exists to
track the expiry dates of
medicines
The Public Central Medical
Store is GDP certified by a
licensing authority
The Public Central Medical

Store is ISO certified
The second tier public
warehouses are GDP certified
by a licensing authority
The second tier public
warehouses are ISO certified
Comments
No (there is a list of licensed

wholesalers who also work
as distributors)
No
2010
2010
Poisons Board
National
Medicines and
Poisons Board
National
Medicines and
Poisons Board
2003
CMS Quality
Manual
Yes
2003
CMS Quality
Manual
No (No certificate called

GDP but license to act as
wholesaler according to
medicine & poisons law and
national requirements).
Yes
2003
CMS
Yes
Yes
Yes
Yes
Yes
Yes
No
Yes
No
No
CMS acts as a procurement and supply agency by law.
56
6.03 Private Sector Distribution

Core Questions
Yes
licensing wholesalers in the
private sector
No
licensing distributors in the
private sector
No
wholesalers in the private
sector exists
No
distributors in the private
sector exists
57
Section 7 Selection and rational use

7.01 National Structures
Core Questions
National Standard Treatment
Guidelines (STGs) for most
common illnesses are
produced/endorsed by the
MoH. If yes, please insert year
of last update of STGs in the
below*
National essential medicines
list (EML) exists. If yes, please
write year of last update of
EML in the "year" field and
URL below.
If yes, number of medicines on
the EML
If yes, there is a written
process for selecting
medicines on the EML
If yes, the EML is publicly
available
No
2010
General
Directorate of
Pharmacy
Yes
2007
WHO Level I
% of public health facilities with 0.1

copy of EML (mean)- Survey
data
2007
% of public health facilities with 54.8 (only for malaria)

copy of STGs (mean)- Survey
data
2007
A public or independently
No
funded national medicines
information centre provides
information on medicines to
prescribers, dispensers and
consumers
Public education campaigns on No
rational medicine use topics
2007
Pharmaceutical
sector
assessment
report
Pharmaceutical
sector
assessment
report
WHO Level I
565 (Only number of

generics on the list)
Yes
Yes
58
have been conducted in the

previous two years
A survey on rational use of
medicines has been conducted
in the previous two years
A national programme or
committee (involving
government, civil society, and
professional bodies) exists to
monitor and promote rational
use of medicines
A written National Strategy
exists to contain antimicrobial
resistance. If yes, please write
year of last update of the
strategy in the "year" field and
URL below.
The EML includes formulations
specific for children
There are explicit documented
criteria for selection of
medicines in the EML
There is a formal committee or
other equivalent structure for
the selection of products on
the national EML
National medicines formulary
exists
Is there a funded national intersectoral task force to
coordinate the promotion of
appropriate use of
antimicrobials and prevention
of spread of infection?
A national reference
laboratory/or any other
institution has responsibility for
coordinating epidemiological
surveillance of antimicrobial
resistance
No
No
2007
WHO Level I
No
2010
General
Directorate of
Pharmacy
Yes
2007
EML 2007
2007
WHO Level I
2007
WHO Level I
No
No
No
No
No
59
7.02 Prescribing
Core Questions
govern the licensing and
prescribing practices of
prescribers, if yes please
URL below *
restrict dispensing by
prescribers, if yes please
URL below *
Regulations require hospitals
to organize/develop Drug and
Therapeutics Committees
(DTCs)
The core medical training
curriculum includes
components on:
Concept of EML
Use fo STGs
Pharmacovigilance
Problem based
pharmacotherapy
The core nursing training
curriculum includes
components on:
Concept of EML
Use of STGs
Pharmacovigilance
The core training curriculum for
paramedical staff includes
components on:
Concept of EML
Use of STGs
Pharmacovigilance
Mandatory continuing
education that includes
pharmaceutical issues is
required for Doctors
Yes
2004
Sudan Medical
Council Act
Yes
2004
Sudan Medical
Council Act
No
2007
WHO Level I
2007
WHO Level I
2010
Sudan Medical
Council
No
No
No
No
60
required for Nurses
required for Paramedical staff
Prescribing by INN name is
obligatory in:
Private sector
No
2010
Sudan Medical
Council
No
2007
WHO Level I
Public sector
Yes
2009
Medicines and
Poisons Act
Average number of medicines

prescribed per patient contact
in public health facilities
(mean)
% of medicines prescribed in
outpatient public health care
facilities that are in the national
EML (mean)
% of medicines in outpatient
public health care facilities that
are prescribed by INN name
(mean)
% of patients in outpatient
public health care facilities
receiving antibiotics (mean)
2.3
2007
% of patients in outpatient
public health care facilities
receiving injections (mean)
% of prescribed drugs
dispensed to patients (mean)
% of medicines adequately
labelled in public health
facilities (mean)
Comments
No
Pharmaceutical
sector
assessment
report
73
2007
Pharmaceutical
sector
assessment
report
43.5
2007
Pharmaceutical
sector
assessment
report
65
2007
Pharmaceutical
sector
assessment
report
28.6
2007
Pharmaceutical
sector
assessment
report
84.4
2007
Pharmaceutical
sector
assessment
report
61
2007
Pharmaceutical
sector
assessment
Dispensing by prescribers is allowed only where there are
no dispensary
61
A professional association
code of conduct exists
governing professional
behaviour of doctors
behaviour of nurses
Diarrhoea in children treated
with ORS (%)
Yes
2004
Sudan Medical
Council
2007
Pharmaceutical
sector
assessment
report
Unknown
48
62
7.03 Dispensing
Core Questions
govern dispensing practices of
pharmaceutical personnel
The basic pharmacist training
curriculum includes
components on:
Concept of EML
Use fo STGs
Drug Information
Clinical pharmacology
Medicines supply management
education tat includes rational
use of medicines is required
for pharmacists
Substitution of generic
equivalents at the point of
dispensing in public sector
facilities is allowed
Substitution of generic
equivalents at the point of
dispensing in private sector
facilities is allowed
Antibiotics are sold over-thecounter without a prescription
Injectable medicines are sold
over-the-counter without a
prescription
behaviour of pharmacists
Are the following categories of
staff prescribing prescriptiononly medicines at primary care
level in the public sector?
Doctors
Yes
2009
Medicines and
Poisons Act
Some universities have and

some do not have
2010
Sudan Medical
Council
Yes
2007
WHO Level I
Yes
2007
WHO Level I
Yes
1979
Medical Ethics
and Medico
Moral Problem
2007
WHO Level I
No
No
No
No
No
No
Yes
Yes
Yes
63
Nurses
Pharmacists
Comments
Yes
Yes
The code of conduct is included in the Medical Ethics and
Medico Moral problems.
64

Country Profile-Sudan Pharmacy

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SUDAN

Copyright 2010. All rights reserved.

Name: H.E. Dr Abdalla Teia Juma Hammad

Date: December 2010

1 Health and Demographic data ________________________________ 27

pharmaceuticals sector available to the public in a user-friendly format. In

Section 1 - Health and Demographic Data

1.1 Demographics and Socioeconomic Indicators

1.2 Mortality and Causes of Death

The 10 leading causes of admission to hospital in Sudan are:

Section 2 - Health Services

2.1 Health and Pharmaceutical Expenditures

By government expenditure it is meant all expenditure from public sources, like

FIGURE 1: Share of Total Pharmaceutical Expenditure as percentage of the Total Health

Source: Federal Ministry of Health, Sudan, 2010 [2].

2.2 Health Personnel

Pharmacists in the public sector

Pharmaceutical technicians and

assistants (all sectors)

Nursing and midwifery personnel (all

FIGURE 3: Distribution Pharmaceutical Personnel Sudan 2009.

2.3 Health Infrastructure

Primary health care units and centres

Section 3 - Policy Issues

3.1 Policy Framework

A policy is in place to manage and sanction conflict of interest issues in

3.2 Intellectual Property Laws and Medicines

4.1 Regulatory Framework

4.2 Marketing Authorization

4.3 Regulatory Inspection

4.4 Import Control

4.6 Market Control and Quality Control

4.7 Medicines Advertising and Promotion

4.8 Clinical Trials

4.9 Controlled Medicines

Section 5 - Medicines Financing

5.1 Medicines Coverage and Exemptions

5.2 Patients Fees and Copayments

5.4 Prices, Availability and Affordability of Key Medicines

5.5 Price Components and Affordability

5.6 Duties and Taxes on Pharmaceuticals (Market)

Section 6 - Pharmaceutical procurement and distribution in the

6.1 Public Sector Procurement

6.2 Public Sector Distribution

6.3 Private Sector Distribution

Section 7 - Selection and rational use of medicines

7.1 National Structures

Sudan Pharmaceutical Country Profile

Respondents to the questionnaire:

Section 1 Health and Demographic data

Fertility rate, total

Adult literacy rate, 15+ years

1.02 Mortality and Causes of Death

Under 5 mortality rate

Maternal mortality ratio

Please provide a list of top 10

Please provide a list of top 10

Age-standardized mortality rate

Section 2 Health Services

Total annual expenditure on

Total annual expenditure on

General government annual

General government annual