MINISTRY OF HEALTHGOVERNMENT OF SOUTHERN SUDAN

Southern Sudan Pharmacy Protocol

Southern SudanPharmacy Protocal

Table of Contents

Table of Contents

Preface iii

Acknowledgements

Abbreviations & Acronyms vii

1. Introduction 1

2 Situation Analysis 3

2.1 Country Profile 32.2 Legislation 32.3 Pharmaceutical Services Administration 32.4 Financial Resources 32.5 Medicines Supply Management System 42.6 Local Manufacturing 42.7 Quality Assurance 42.8 Rational Medicine Use and Medicines Information 42.9 Veterinary Medicines and Medical Supplies 52.10 Traditional Medicines 52.11 Human Resource Development 52.12 Opportunities and Challenges 5

3 Vision 7

4 Mission Statement 7

5 The Goal And Objectives Of The Pharmacy Protocol 7

5.1 Goal 75.2 Objectives 7

6 Policy Components 8

6.1 Legislation 86.2 Institutional Framework 86.3 Financial Resources 96.4 Medicines Supply Management System 106.4.1 Procurement 106.4.2 Distribution 116.4.3 Storage 126.4.4 Inventory Control 126.4.5 Donations 126.4.6 Local Production and Self-Sufficiency 136.4.7 Pharmaceutical Regulatory System 136.4.8 Registration and Licensing of Pharmacy Professionals 136.4.9 Pharmaceutical Inspectorate 136.4.10 Marketing Authorization (Registration) of Medicines 146.4.11 Import and Export of Medicines 146.4.12 Scheduling of Medicines 156.4.13 Drug Abuse 156.4.14 Fees and Other Charges 156.5 Quality Control 156.6 Rational Medicines Use 16

6.7 Southern Sudan Pharmacy and Therapeutic Committee 16

6.8 The Essential Medicines Concept 17

6.9 Labelling , 11 Tt 17

6.10 Prescribing 17

6.11 Dispensing , 18

6.12 Standard Treatment Guidelines t t 18

6.13 Training , , 18

6.14 Medicines Information , 18

6.15 Hospital Pharmacy and Therapeutic Committees , ,. , 19

6.16 Medicines Advertisement and Promotion , 19

6.17 Veterinary Medicines and Medical Supplies „ 19

6.18 Traditional Medicines , ,,„., 20

6.19 Human Resource Development ' , ' 20

6.20 Research and Development , 21

6.21 Monitoring and Evaluation 21

6.22 Linkages 22

6.23 Inter-Sectoral Cooperation it 22

6.24 International Cooperation „ 22

6.25 The Role of the Pharmaceutical Society of Southern Sudan „ 22

6.26 Miscellaneous Issues 22

ii

Preface

The Southern Sudan Pharmacy Protocol has been developed toprovide a broad guide and reference document in the subsequent lawsand regulations or other specific guidelines with a view to ensuringsuccessful attainment of quality health care. It relates to the missionof the Ministry that strives to improve the health status of thepopulation and ensure a sector wide quality health care to all thepeople of Southern Sudan, especially the most vulnerable, women andchildren.

The protocol draws from experiences dating back to the period beforethe signing of the Comprehensive Peace Agreement (CPA), as well asthe current status of the pharmaceutical sector. It seeks to ensurethat all aspects of pharmaceutical services, including medicinessupply management that takes into account procurement, storage,distribution, as well as quality assurance and rational use, areadequately addressed. It seeks to ensure effective medicinesregulations and control to minimize entry and circulation ofsubstandard and counterfeit products, including veterinary medicinesand supplies in the Southern Sudan pharmaceutical market.Furthermore, recognizing the contribution of Traditional Medicinepractice in the overall health care delivery service of Southern Sudan,the protocol makes provision for the harnessing the benefits oftraditional medicines with due consideration to safety and efficacy.

At the moment, laws governing the practice are in the formativestages. The country does not have the requisite infrastructure andhuman resource base to move at a comparative speed withdistribution lines. This may cause an impediment in regulating thesector. However, if the attitudes are developed to harness ethicalpractices, this policy will find a solid base to cultivate the realities ofrational medicine use, quality, safety and efficacy of pharmaceuticalproducts and other medical appliances.

The Southern Sudanese people deserve to get quality health care in auniform approach that is beneficial to all. Pharmaceuticals and othermedical supplies are important in restoring good health.Pharmaceutical services are therefore vital in measuring the success,or improvement in the delivery of health services. Most other healthdelivery avenues will depend on efficient and sustainablepharmaceutical services.

It will be realised that there will be many players interested inproviding health services from all over the world, different disciplinesand beliefs, on humanitarian or commercial basis. The aim is to fully

utilize the potential of these good intentions to improve the healthstatus of the people of Southern Sudan in the most beneficial and costeffective way. It is therefore incumbent upon all stakeholders, both inthe public and private sectors to fully embrace this protocol andparticipate in its effective implementation.

This First Edition of the Southern Sudan Pharmacy Protocol is a stepforward in the delivery of health care and I wish to congratulate andsincerely thank all those who contributed to the development of thisProtocol.

Dr. Joseph Manytuil WejangMinister of HealthGovernment of Southern Sudan, Juba

iv

Acknowledgements

This Southern Sudan Pharmacy Protocol has been produced withcollective inputs of many health professionals, development partnersand individuals within and outside the Ministry of Health at variousstages of its development. The first draft of this protocol was developedprior to the Comprehensive Peace Agreement (CPA) by the formerSecretariat of Health (SOH) of the Sudan Peoples Liberation Movement(SPLM). It was then reviewed and adopted to address the currentsituation of the pharmaceutical sector in 2006 by the Ministry ofHealth, Government of Southern Sudan (MOH-GOSS), in consultationwith various development partners and individual experts andconsultants. The Ministry of Health is, therefore, indebted to a host ofcontributors to this protocol and wishes to register special thanks andappreciation to all, without whom this document would have beenincomplete, especially the following individuals who have beeninvolved at one stage or another in the development of the first editionof Southern Sudan Pharmacy Protocol.

Dr. Pius V. Subek: State Minister of Health, Central EquatoriaDr. Samuel Manyang Agoth Thon: Director General ofPharmaceutical Services, MOH-GOSSDr. Richard Igu Keri: Director of Pharmaceutical Services, MOH-GOSSDr. Olivia Lomoro: Director of Research, Planning 85 Health SystemDevelopment, MOH-GOSSDr. Eva Ombaka: Director, Pharmacist Ecumenical PharmaceuticalNetwork, Southern SudanDr. Vivian Erasmus: Director, Action Africa International, SouthernSudanDr. Jane Masiga: Chief pharmacist, Mission for Essential Medicinesand Supplies, KenyaDr John Ogotto Kanisio: Director of Animal Resources and Fisheries,Ministry of Agriculture, GOSSMs. Nadia Omer: Pharmacists Sans Frontiers (PSF), Southern SudanDr. Sebit Sindani: Specialist TB, Leprosy and Buruli Ulcer, WHO,Southern SudanMrs. Talitha Hoogebrug: Manager, International DispensaryAssociation, NetherlandsDr. Monywiir Arop: Director General of Human ResourcesDevelopment, MOH-GOSSDr. Chris Wood: Founder and Ex-Director of AMREF, East AfricaDr. Henk Buddingh: Medical Advisor, Christian EcumenicalAssociation, Southern Sudan

Dr. Pascal Verhoeven: Chief Pharmacist, International DispensaryAssociation, NetherlandsDr. Dau Aleer Abit: Executive Director Sudan Medical Care, SouthernSudanDr Carla Buddingh: Advisor, Rational Medicine Use MOH, GOSSDr. Dan Wendo: Chief of Party, Sudan Health Transformation Project,JSIDr W. 0. Wanyanga: Executive Director, PharmaQ Ltd - KenyaDr. Tim Mtana Lewa: Director, PharmaQ - KenyaDr. Besrat Hagos: Technical Officer, WHO, Southern SudanDr. Santino Tito Tipi: Chairman, Southern Sudan PharmaceuticalSociety

The continued support of the WHO, as the main technical advisor tothe Ministry of Health of the Government of Southern Sudan is highlyappreciated. I am also very grateful to all other organizations andindividuals for the moral, technical and material support provided inthe process of the development of this document.

Yak ajokUnder cretaryMinistry of Health-GOSS

vi

• yr VAN irsay LIAO

AIDS Acquired Immune Deficiency SyndromeARVs Anti-Retroviral MedicinesCMS Central Medical StoresCPA Comprehensive Peace AgreementCOA Certificate of AnalysisIEC Information, Education and CommunicationQA Quality AssuranceGMP Good Manufacturing PracticesRMS Regional Medical StoresSMS State Medical StoresHIV Human Immunodeficiency VirusINN International Non-Proprietary NameMOH Ministry of HealthGOSS Government of Southern SudanNGO Non-Governmental OrganizationsNMP National Medicine PolicyNPMP National Pharmaceutical Master PlanPHCU Primary Health Care UnitsPHCC Primary Health Care CentreSOPs Standard Operating ProceduresSSPQCL Southern Sudan Pharmaceutical Quality Control LaboratoryTRIPs Trade Related aspects of Intellectual PropertyWHO World Health Organization

vii

1 Introduction

Since the signing of the Comprehensive Peace Agreement in January2005, the Government of Southern Sudan has instituted the InterimNational Constitution, which has decentralized Government into fourlevels, i.e. Central, State, County and Community levels. TheConstitution recognizes the provision of health care services in thecountry, through promotion of public health and guarantees equalaccess to Primary Health Care Services.

The Ministry of Health developed an Interim Health Policy forSouthern Sudan 2007-2011. The Policy has a statement onPharmaceutical Medical Supplies. The statement reads:" The Ministry of Health shall ensure only products of quality, safety,and efficacy is availed to the people of Southern Sudan. Therefore, theMinistry shall establish an autonomous Southern SudanPharmaceutical Quality Control Laboratory (SSPQCL) to conductroutine quality control testing of pharmaceuticals and veterinarydrugs.

"Rational drug use is of paramount importance to the Ministry toensure that health care is evidence based and affordable. The Ministryshall also develop, promulgate and enforce a Southern SudanPharmacy and Drugs Act and related regulations/ Standard OperatingProcedures (SOPs) for the regulation of the pharmaceutical businessand other transactions and movement. This will include: registrationand regular licensure of all pharmacy professionals by the SouthernSudan Pharmacy Council; ensuring pharmacy professionals adhere tothe standards and code of ethics of practice stipulated by theSouthern Sudan Pharmacy Council; regular inspections of pharmacyoutlets/businesses and pharmaceutical manufacturers andpharmacovigilance".

"The Ministry is also exploring options to ensure the most efficientprocurement and distribution systems for Southern Sudan. Drugs orother medical supplies should not be donated to Southern Sudanwithout prior consultation with the Ministry of Health. Donated drugswith expiry date of less than 12 months will not be accepted".

This protocol document is therefore a means to expound on thiscommitment and guide health service providers and users, both in thepublic and private sectors on effective implementation of thepharmaceutical aspects of the overall health policy. The process ofdeveloping this policy started before the signing of the CPA, and drawsexperiences and expertise of a wide range of experts at various times,

1

professionals. The World Health Organization guidelines for thedevelopment of National Medicines Policies were also extensivelyreferred to in the process of the development. In this documentconsiderations have been made to the current situation of thepharmaceuticals sector, the opportunities, challenges and constraints,as well as, possible future scenarios. At times therefore, reference ismade to institutions that are yet to be established. To ensure effectiveimplementation of this Policy, a comprehensive PharmaceuticalMaster Plan will be developed shortly after its adoption. Moreover,applicable laws, regulations and guidelines, such as the SouthernSudan Pharmacy and Drugs Act and respective regulations, EssentialMedicines List for Southern Sudan and a proposal for theestablishment of autonomous Central Medical Stores are already inthe final stages of development. These documents will augment andelucidate this policy further.

2

fr 1.7.1. Lilt= ILJAIJ AIL A-14A CILLy 0%M

2.1 Country Profile

Southern Sudan is part of the Republic of Sudan, covering an area of610,175 square kilometres. The capital is Juba and consists of tenstates. Following the signing of the Comprehensive Peace Agreement(CPA) on January 2005, an autonomous Government of SouthernSudan was established that has taken into consideration one countrywith two systems.

The Ministry of Health, Government of Southern Sudan comprise oftwelve Directorates, one of which is the Directorate of Pharmaceuticalservices and supplies. It is headed by the Minister of Health, assistedby an Undersecretary and twelve Director Generals. At the State level,each Ministry of Health is headed by a State Minister of Health,assisted by one Director General and eight Directors headingdepartments. One of the newly established departments at the Statelevel is the department of Pharmaceutical Services.

2.2 Legislation

The Ministry of Health, Government of Southern Sudan has developeda Health Policy for the Government of Southern Sudan, throughextensive consultation with stakeholders. The Ministry has alsodrafted various protocols, guidelines and laws for the differentprogrammes, some of which are being used as references forimplementation.

2.3 Pharmaceutical Services Administration

Before the CPA, the Pharmaceutical Services Administration wasunder the responsibility of the Directorate of Curative andPharmaceutical Services. With the formation of the Ministry of Health,Government of Southern Sudan, it is now under the Directorate ofPharmaceutical Services and Supplies. It is important to note that aSouthern Sudan Pharmaceutical Society has been formed.

2.4 Financial Resources

Currently, the Government of Southern Sudan and its developmentpartners, through the Multi Donor Trust Fund (MDTF), have budgetedfor pharmaceutical and medical supplies. The World HealthOrganisation, other UN agencies, the European Union, other

3

outside the country or in Northern Sudan. In the private sector, theprofessionals have made an expressed need for the establishment ofregulatory mechanisms that will ensure internationally acceptablepractice standards. The main challenges are the shortage of qualifiedpharmacy professionals and inadequate regulatory mechanisms thathas left the handling of pharmaceuticals to untrained persons andunlicensed premises. The poor infrastructure and porous borders withthe neighbouring countries are also contributing to the availability ofsubstandard medicines in the country.

6

3 Vision

The vision of the Government of Southern Sudan (GOSS) is to pursuethe ideals of the right to health and access to essential medicines sothat everyone may attain full benefit of quality of life, which will resultinto the economic development and prosperity of the nation.

4 Mission Statement

The GOSS through the implementation of the Southern SudanPharmacy Protocol (SSPP) is to use available resources to develop andprovide pharmaceutical products and services on a sustainable basisto meet the requirements of Sudanese in the prevention, diagnosisand treatment of diseases using safe, quality, efficacious, and cost-effective pharmaceutical products.

5 The Goal and Objectives of the Pharmacy Protocol

5.1 Goal

The goal of the Southern Sudan Pharmacy Protocol is to ensure thatevery person in the Southern Sudan has equal opportunity and accessto quality, safe, effective pharmaceutical products and medicalsupplies, which are continuously available, affordable and put intorational use.

5.2 Objectives

The following are the main objectives of the Southern SudanPharmacy Protocol

To ensure the constant availability of quality, safe andefficacious medicines according to international standards to allsegments of the populationTo monitor and ensure equitable distribution, storageaffordability of medicines to all areas of the country whether bythe Government, private or Non-Governmental OrganizationsTo facilitate and actively promote rational use of medicinesthrough sound prescribing, good storage/dispensing practicesand appropriate training of health professionals and suitablepublic educationTo encourage self sufficiency, self reliance and capacity buildingthrough technical, economic and commercial facilitation of local

7

manufacture of pharmaceuticals which meet GMP standards fordomestic use and exportTo encourage and promote evidence-based use of traditionaland herbal medicines, with due consideration to quality andsafetyTo ensure that the provision and access of medicines forveterinary services are consistent with this policyTo ensure that sound and effective pharmaceutical regulatorymechanisms and quality assurance systems are maintained atall levels.To encourage and support scientific research and developmentin pharmaceuticals, traditional medicines or alternativemedicines and other medicinal products used in the country.

i) To ensure allocation of sufficient Government budget andmaterial and human resources to implement, monitor, evaluateand sustain this policy.

6 Policy Components

6.1 Legislation

The Government of Southern Sudan (GOSS) shall develop a soundpharmaceutical regulatory system and enact laws to ensure the timelyimplementation and enforcement.

6.2 Institutional Framework

The MOH-GOSS shall ensure effective and efficient implementation,monitoring and evaluation of the Southern Sudan Pharmacy Protocolat all levels. The following institutions shall be established andprovided with the required financial, material and human resources tocarry out their functions as appropriate:

The Southern Sudan Pharmacy Council shall be responsiblefor the development and review of standards for theeducation, registration and licensing, standards of practiceand Code of Ethics for pharmacy professionals.

The Directorate of Pharmaceutical Services shall beresponsible for: Monitoring, evaluation and periodic review ofthe Southern Sudan Pharmacy Protocol, Providing theSecretariat for the Southern Sudan Pharmacy Council,establishing a Secretariat to coordinate and document thebureaucratic activities and achievements of the committeesunder this Directorate, Ensuring access and availability of

8

medicines and medicines for human and veterinary use,Implementation and enforcement of pharmaceutical laws andregulations. This role shall be taken over by an autonomousSouthern Sudan Pharmacy Regulatory Authority in duecourse.

Management and supervision of the Central Medical Storesand Regional Medical Stores for the procurement,warehousing and distribution of pharmaceuticals for thepublic sector: This function shall be taken over by anautonomous Central Medical Stores and Regional MedicalStores in due course.

Establishment and implementation of pharmaceutical qualitycontrol system and establishment of an autonomousSouthern Sudan Pharmaceutical Quality Control Laboratory.

State Departments of Pharmaceutical Services to carry outimplementation of the Southern Sudan Pharmacy Protocoland the Pharmacy Laws and regulations, as appropriate

The Government shall support and promote theestablishment of structures for the administration,regulation and development of traditional medicines.

6.3 Financial Resources

The Government will ensure that adequate funding is made availableand efficiently managed to implement the Southern Sudan PharmacyProtocol and related laws and regulations, and in particular to providethe required quantity of essential medicines in the most cost-effectiveand sustainable way.

Bearing in mind the annual budgetary allocation, adequateallocation will be made by MOH towards the implementationthe Southern Sudan Pharmacy Policy.

The MOH will work in close collaboration with all interestedand pertinent parties, to ensure that due priority are given tothe financing and importation of essential medicines.

c. National requirements for financial resources will be basedon the careful estimation of the total quantity of medicinesand medical supplies needed in the country using data fromall available reliable sources.

9

d. In the funding of medicines supplies, MOH-GOSS shall seekand encourage inputs from different partners, includinggovernmental, non-governmental and parastatalorganizations, bilateral and multilateral agencies, the privatesector and individuals.

6.4 Medicines Supply Management System

The Government shall establish a medicines supply managementsystem that will ensure that sufficient quantities of medicines andmedical supplies of the required standards of safety, quality andefficacy are available in all public health institutions at all times.

6.4.1 Procurement

Medicines and other medical supplies for the public sector shall beprocured according to public procurement guidelines, which includedthe following key elements:

The Southern Sudan Essential Medicines List shall be thebasis for the selection of medicines for procurement

Medicines will be procured by generic name (INN), and theproducts must be registered in Southern Sudan as well ascountry of origin

Selection and Quantification of Pharmaceutical requirementswill be done annually and updated periodically throughoutthe year, based on demand by the SSNPTC.

An annual procurement plan and schedule will be madeaccording to actual resources available and realistic deliverytimes.

e. Pre-qualification of suppliers shall be open to internationalbidding. Medicines will be purchased through competitivetender from suppliers who have been pre-qualified by atechnical evaluation committee composed of members fromthe MOH, NMS.

f. The Southern Sudan Pharmaceutical Quality ControlLaboratory (SSPQCL) will regularly test the quality ofproducts procured by the NMS. In addition, other datagenerated by the SSPQCL will be used in the supplier pre-qualification process.

10

A formal supplier monitoring system will be established byNMS with objective standards for medicine quality andservices performance. Suppliers whose product quality orservice falls below standards will be notified and eventuallydeleted from the list of approved suppliers.

Supply terms will be specific to pharmaceutical products,particularly with respect to specifications, manufacturingsite, Active Pharmaceutical Ingredient (API), shelf life, andlabelling, packaging and related issues as originallysubmitted to SSPRA in the dossier for registration.

i. Medicines not listed on the SSEDL will be allowed onexceptional basis for procurement only if they fit into one ofthe following categories and provided SSPRA has given itspermission:

Medicines for emergency situations/diseases not cateredfor by the SSEDL or SSVEDL.Specifically requested medicines not catered for by theSSEDL or SSVEDL for use in institutions with specializedmedical personnel and expertise.Orphan medicines

j. A list of suppliers of pharmaceutical products and medicalequipment will be established. The list will be reviewedannually.

6.4.2 Distribution

The MOH-GOSS shall ensure that distribution of medicines andmedical supplies is done in such a way as to maintain the quality andconstant availability of the products.

The Central Medical Stores, under the MOH shall beresponsible for public medicine distribution to reach allgovernment stores and health institutions fast, efficientlyand for appropriate storage in the pharmaceutical countystores.

Medicines will be distributed according to established clinicalneeds, workload and institutional capacity to diagnose inorder to enhance rational medicine use.

c. Members of the Pharmaceutical Inspectorate will performperiodic inspections of the distribution channels, availabilityof medicines, and levels of rational medicine use.

11

U. El 1V clIG OCULU1 111NR/1V C111C111 111 iiU.1111111bU et11011, JLUldgC

transport will be encouraged with the aim to improveefficiency and enhance cost-effectiveness as well as fill gapsin the distribution line.

6.4.3 Storage

The MOH-GOSS shall ensure that medicines in storage are securedand that their quality, safety and efficacy are maintained until deliveryto the end user.

It shall facilitate and mobilize resources for the provision ofsuitably designed, equipped and well-maintained storagefacilities at all levels of the public sector medicinesdistribution system.In order to promote the correct organisation andmaintenance of medical stores throughout the country, itshall develop a Stores Procedures Manual.

6.4.4 Inventory Control

The Government will ensure that accurate and systematic recording,monitoring and reporting system is maintained at all levels.

6.4.5 Donations

The MOH-GOSS will continue to encourage and welcome donation ofmedicines and medical supplies by interested partners that canaugment government's efforts in the overall health care delivery. Inthis regard, the Government recommends the use of the World HealthOrganisation Guidelines for Donation of Medicines by all partiesintending to donate medicines and medical supplies to SouthernSudan, which includes the following, until guidelines for SouthernSudan are developed and issued:

Medicine donations should benefit the recipients to themaximum extent possible and be based on an expressedneed.Donations should be supportive, complementary, andconform to existing government health policies andprogramme, including the Essential Medicines List.

c. Medicine donations from both international and local sourcesmust comply with the provisions governing pharmacypractice and the Southern Sudan Pharmacy Policy.

12

0. 1+.0 LiOCILL rroauction illia Oell-S11111L1VilVy

The government shall encourage the establishment of localpharmaceutical industry to ensure self-sufficiency and sustainabilityin the supply of essential medicines for both human and veterinaryuse. Manufacturers will be required to adhere to internationallyaccepted standards for Quality Assurance (QA) and GoodManufacturing Practices (GMP).

6.4.7 Pharmaceutical Regulatory System

The Government shall develop, promulgate and enforce a SouthernSudan Pharmacy and Drugs Act for the regulation of thepharmaceutical business and other transactions and movement. TheMOH-GOSS shall develop regulations and Standard OperatingProcedures (SOPs) for the implementation of the Pharmacy Act toensure transparency to the public and applicants.

6.4.8 Registration and Licensing of Pharmacy Professionals

Anyone who intends to practice Pharmacy shall seek registration andlicensing from the Southern Sudan Pharmacy Council and shallpractice in accordance with the Standards and Code of Ethics ofPractice, as stipulated by the Council:

6.4.9 Pharmaceutical Inspectorate

The Pharmaceutical Inspectorate shall be responsible for the followingfunctions:

Inspection of pharmaceutical trade outlets, includingimporters, exporters, wholesalers and distribution channels,for compliance with the Pharmacy and Drugs Act andregulations thereof for the purposes of licensing.

Inspection of pharmaceutical businesses to ensurecompliance with the provisions of the Pharmacy and DrugsAct and regulations thereof, including compliance withcurrent Good Pharmacy / Distribution Practices.

c. Inspections of manufacturing premises for compliance withthe provisions of the Pharmacy and Drugs Act and currentGood Manufacturing Practices (GMP) for the purposes oflicensing.

13

u. 11101JGLUVII 111cUlUictLAU.11116 UpC1 clUULL 11/1 UULLIplliallt-U WILLI

the provisions of the Pharmacy and Drugs Act and currentGood Manufacturing Practices (GMP).

e. Routine market surveillance to monitor the quality ofmedicines and to detect and remove from the market sub-standard medicines, counterfeit products or medicines ofspurious quality.

6.4.10 Marketing Authorization (Registration) of Medicines

Pharmaceutical products intended for the Southern Sudan market aswell as products intended for export may be given marketingauthorisation based on the following requirements:

Inclusion in the Southern Sudan Essential Medicine List(SSEDL).

Pre-qualification of sources and products through a systemof scientific review of:

GMP status of existing manufacturers (site inspections orcollaboration with partner regulatory authorities).Notification of existing medicines in the market forefficacy, safety, rationality and availability.Registration of newly submitted dossiers based on quality,safety, efficacy and 'established need' criteria.

Notification of herbal medicines and existing alternativetherapies based on safety and current therapeutic value

Unique characteristic of the medicine product such as life-saving and orphan medicines.

e. New investigational medicines after scientific and ethicalconsideration by the responsible government institute forgranting approval for specific clinical trials (involving humansubjects) with that product.

6.4.11 Import and Export of Medicines

a. Import or export authorisation shall be given by SSPRA tolicensed importers/exporters and for registered productsonly with a minimum of two thirds remaining shelf life atarrival to ensure traceability and full accountability of allproducts within the Southern Sudan territory. Ports of Entrywill be defined.

14

0. enarmaceuticai imports/ exports win De mspectea Dy tneSSPRA Pharmaceutical Inspectorate or authorised officers atthese ports of entry before release to the market i.e. packinglist: product description and strength, source, presence ofrelease certificate/Certificate of Analysis (COA).

c. Unauthorized or incomplete consignments shall beconsidered as prohibited and destroyed at the port of entryhaving certified and fulfilled custom regulations and othergovernment regulations.

6.4.12 Scheduling of Medicines

The Pharmacy Council shall make medicine schedules that will enablehandling commensurate with the training of the health care provider.In general the international criteria POM, P 86 OTC will be used, butadopted to local needs as deemed necessary to ensure relevantmedicines reach the official retail and community outlets according tothe level of competence of the health care provider.

6.4.13 Drug Abuse

Legislation shall be enacted to control the manufacture anddistribution of narcotic, psychotropic and other chemical substanceswith known or potential for illicit use and abuse. Any existinglegislation shall be amended to incorporate prohibition of manufactureand distribution and trafficking for illicit use, which shall be underthe control of Narcotic Bureau (International Bureau). Chemicalslikely to be used in the manufacture of drugs of abuse shall becontrolled similarly. The medicinal use in appropriate dosage formsshall be controlled like other pharmaceutical products.

6.4.14 Fees and other Charges

The regulatory authorities may charge fees and other charges forvarious activities within their mandate. In determining the feespayable, consideration will be given for waivers for orphan medicinesand pharmaceutical products necessary and essential to managepublic health problems during emergencies and national disasters.

6.5 Quality Control

The Government shall establish an independent Southern SudanPharmaceutical Quality Control Laboratory (SSPQCL) to carry outtesting of medicines and other medical products moving through themedicines supply system.

15

Functions of the Southern Sudan Pharmaceutical QualityLaboratory shall include:To support the registration and the marketing authorizationof products.To support the pharmaceutical inspectorate in the routinesurveillance of pharmaceutical products manufactured,imported, exported or distributed in the pharmaceuticalsupply chain.To monitor and randomly verify the quality ofpharmaceuticals manufactured, imported or to be exportedand advise the Directorate of Pharmaceutical Services on thequality observed.The SSPQCL shall be of WHO Level I standard and shallgradually be upgraded to level II.A Laboratory Quality Assurance System will be instituted inthe SSPQCL that will involve collaboration withinternationally recognised laboratories.The SSPQCL shall be subject to local or internationaltechnical auditing periodically. In the interim, the SSPQCLshall have a coordinating role and shall utilize the services ofrecognized Pharmaceutical Quality Control Laboratories inthe region and Standard Mini-Labs to carry out the requiredtests.Other quality control testing facilities of internationallyrecognised standards shall be identified and used as andwhen necessary to augment the effectiveness of SSPQCL.

6.6 Rational Medicines Use

The Ministry of Health shall institute mechanisms and guidelines toensure that medicines are prescribed, dispensed and used rationallyin order to optimise the therapeutic benefit to the patient, reduce lossand/or wastage and any hazards arising from irrational practices.

6.7 Southern Sudan Pharmacy and TherapeuticCommittee

A multi-disciplinary Southern Sudan Pharmacy and TherapeuticsCommittee shall be established to formulate policies and advise thegovernment on rational use of medicines.

16

6.8 The Essential Medicines Concept

The Government shall adopt and implement the Essential MedicinesConcept that incorporates the selection of medicines that are requiredto satisfy the priority health needs of the majority and to be madeaccessible at all times in adequate quantities, at the appropriatedosage forms, and at prices that the individual and the communitycan afford.

a. The Government of Southern Sudan shall formulate andadopt the following for use in the public sector:

A Southern Sudan Essential Medicines ListA Southern Sudan Essential Veterinary Medicines List foruse in the public sector.An Essential Medical Supplies and Appliance List

b. Non-Governmental Organizations (NGOs), Faith-BasedOrganizations (FBOs) and the private sector shall beencouraged to adopt and use the above-mentioned lists.

6.9 Labelling

Labelling for both produced and imported pharmaceutical productsshall carry the generic names (INN - International Non-proprietary) inletters at least two-thirds the size of the brand name. Labelling will bein English language

6.10 Prescribing

Prescribers in the public sector shall be required to prescribe bygeneric name, based on the Essential Medicines List. Prescribers inthe private sector shall be encouraged to do the same.

17

6.11 Dispensing

The MOH-GOSS shall ensure that medicines are dispensed correctlyand efficiently in accordance with current Good Dispensing Practicesand Southern Sudan Pharmacy and Drugs Act.

6.12 Standard Treatment Guidelines

Standard Treatment Guidelines incorporating the Essential MedicinesList for use in public health facilities in Southern Sudan shall bedeveloped, adopted and widely disseminated.

Non-Governmental Organizations (NGOs), Faith-Based Organizationsand the private sector shall be encouraged to adopt and use theGuidelines.

6.13 Training

The MOH-GOSS shall ensure that all health workers involved indiagnosis, prescribing and dispensing of medicines, receive adequateand relevant theoretical and practical training to enable them performtheir functions efficiently.

The concept of rational medicines use will be incorporatedinto the training curricula of all health professionalcategories.MOH-GOSS shall develop and implement a comprehensiveContinuous Professional Development Programmeme for allhealth professionals

6.14 Medicines Information

The MOH-GOSS shall ensure the provision of correct, practical andunbiased information on the handling and rational use of medicines tohealth workers at all levels as well as community leaders, patients andthe general public.

Product inserts shall be required to accompany all productswith adequate information as to the indications,pharmacology/literature side effects, toxicology, specialprecautions, and contra-indications.The MOH-GOSS shall develop and implement acomprehensive Information, Education and Communication(IEC) programme to ensure adequate dissemination ofinformation to the public on rational medicines' use.

1$

6.15 Hospital Pharmacy and Therapeutic Committees

The MOH-GOSS shall promote and support the establishment andeffective functioning of Therapeutic Committees in all hospitals toensure correct, efficient and cost effective handling and use ofmedicines' in hospitals.

6.16 Medicines Advertisement and Promotion

The MOH-GOSS shall ensure that advertising and promotion ofmedicines is professional and of high standards to conform to rationalmedicines' use as provided in the provisions of the current Pharmacyand Drugs Act.

a. Promotion and advertising of medicines to healthprofessionals shall be ethical, factual, educational, balancedin approach and designed to impart non-exaggeratedinformation to prescribers. These principles apply equally tosymposia and other scientific meetings.

6.17 Veterinary Medicines and Medical Supplies

The Government shall ensure that veterinary pharmaceutical servicesare subject to the provisions of the Pharmacy Policy and theregulatory laws and regulations of Southern Sudan, to ensurecontinuous availability of quality veterinary medicines for the animalhusbandry and health

An Essential Veterinary Medicines List for use at all levels ofveterinary services shall be developed and regularly updatedby Southern Sudan Pharmacy and Therapeutic Committee incollaboration with the Ministry responsible for veterinaryservices.

The Ministry responsible for Veterinary services shall liaisewith the Pharmacy Regulatory Authorities for proper controland marketing authorization of Veterinary medicines.

c. The MOH-GOSS shall support the Ministry responsible forveterinary services in the implementation of the SSPP and inrespect of veterinary products.

19

6.18 Traditional Medicines

The Government shall promote the potential of traditional medicinesas an essential cultural heritage and support efforts for theinvestigation and development of indigenous traditional medicines,with due consideration for quality and safety.

The Government shall develop policy and legal framework forthe practice of traditional medicine.

The Government shall encourage the sharing of informationon efficacy and safety by the traditional healers, with dueconsideration to the protection of intellectual property rights.

The Government shall encourage and support research intraditional medicines with a view to identifying the mostuseful remedies for treatment of common diseases, bearingin mind safety and quality.

The Government shall support and facilitate efforts toprotection indigenous medicinal plants of Southern Sudan.

6.19 Human Resource Development

The MOH-GOSS shall support efforts to ensure that sufficientnumbers of suitably qualified and motivated personnel are availablefor the effective implementation of this Policy and related laws andregulations.

The Pharmacy Council shall ensure that curricula for the training andcontinuing education programmes for all health professionals involvedin prescribing and dispensing of medicines are in conformity with thisPolicy and related laws and regulations.

The Ministry shall support efforts to build the capacity forthe training of pharmacy professionals.

It shall support and facilitate the development andimplementation of continuing professional developmentprogrammes for health professionals.

c. It shall support the development of suitable career structuresfor pharmaceutical professionals, so as to attract and retainsuitably qualified personnel in the public sector.

20

It shall support and facilitate efforts to provide healthprofessionals access to current literature on medicines.

It shall continue to support and facilitate pre-service trainingof middle-cadre pharmacy personnel.

f. It shall support and facilitate efforts for the training of, andinformation sharing among, traditional healers.

6.20 Research and Development

The MOH-GOSS shall support research and developmental activities,which will facilitate the achievement of the objectives of the SouthernSudan Pharmacy Protocol.

The Ministry, in collaboration with other stakeholders, shallidentify and support priority areas of health research, whichhave a bearing on finding cost effective solutions fortreatment of neglected diseases.

It shall support and facilitate collaboration between trainingand research institutions in and outside the country inpharmaceutical research and development.

It shall register protocols for clinical trials for new medicinesand establish guidelines for clinical trials involving medicinesalready registered.

It shall implement their programmes taking intoconsideration international accords on Intellectual PropertyRights suitable to the country, and with due consideration toits sovereign right to provide health services to the people ofSouthern Sudan and in accordance with the applicableflexibilities in the Trade Related aspects of IntellectualProperty (TRIPs) agreements.

6.21 Monitoring and Evaluation

The MOH-GOSS will institute mechanisms for monitoring andevaluation to ensure the successful implementation of the SouthernSudan Pharmacy Policy.

21

The Ministry will develop a Pharmaceutical Master Plan, withindicators for monitoring progress of achievement of policyobjectives.

It shall establish and maintain a monitoring and evaluationcapability at all levels.

6.22 Linkages

The MOH-GOSS shall maximise inter-sectoral cooperation andcollaboration and actively pursue all relevant forms of technicalcooperation with other countries in order to optimise the use of limitedresources.

6.23 Inter-sectoral Cooperation

The MOH-GOSS shall spearhead the promotion of the cooperationbetween various sectors to maximize achievement of the objectives ofthe Southern Sudan Pharmacy Policy.

6.24 International Cooperation

The MOH-GOSS shall encourage technical cooperation with othercountries in the implementation of the Southern Sudan PharmacyPolicy

6.25 The Role of the Pharmaceutical Society ofSouthern Sudan

The MOH-GOSS shall encourage and facilitate the participation of thePharmaceutical Society of Southern Sudan and other healthProfessional Associations in the implementation and promotion of thisPolicy.

6.26 Miscellaneous Issues

The MOH-GOSS shall develop policies to provide for any other relevantmatter that may not be wholly covered by this policy, but may becomeurgent with the changing times

22