NHRA Annual Report 760s Registered2017 213 14 Medicine3, LicensedAPPROVED fessionals Healthcare Pharmacies Facilities New Healthcare 110 Accredited 1 Facilities Licensed Healthcare Pro 28,031 Licensed 671 New Medical8,1Devices78 Licensed HealthcareH Facilities 3,022 Approved CPD Activities
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ContentsFrom the CEO 08NHRA Strategy 10Published Resolutions, Guidelines, Policies and Contracts 24Healthcare Facility Regulations 28Pharmacy Regulations 34Healthcare Professional Regulations 40Pharmaceutical Product Regulations 46Medical Device Regulations 52Alternative / Complementary Practice Regulations 58Continuous Professional Development &Clinical Trial Regulations 62Medical Complaints 68National Accredtation Program 76The Way Forward 84 5
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Dr. Mariam Al JalahmaCEO - NHRA 7
From the CEO The National Health Regulatory Authority (NHRA) saw many new developments in the year 2017. It was a year in which our greatest accomplishment was to achieve 84% of our planned initiatives outlined in our strategic plan. This achievement would not have been possible without the support of the Supreme Council of Health and the efforts of all our dedicated staff at NHRA. The NHRA has issued 16 policies and guidelines, highlighting our procedures and regulations, in relation to licensing facilities, professionals, medicines, advertisement, continuous professional development, accreditation, patient’s complaints, reporting incidents and inspection. These policies and guidelines primary aims are to support our clients in a way that promotes collaboration and open communication. In 2017, the total number of licensed healthcare facilities was 671, that includes 194 medical centres, 21 hospitals and 171 clinics, of which 58% are located in the Capital Governorate. In this past year, we also saw an increase in the investment of new medical centres and pharmacies. Initial approval was granted to 110 facilities, that included 20 dental centres, 15 general medical centres and 13 alternative medicine centres. The number of new pharmacies licensed in the last year was 51 bringing the total number of pharmacies registered with the Authority to 213 pharmacies. The number of registered professionals in the Authority for 2017 reached 28,031 that included 6,131 doctors, 14,395 nurses, 4,520 allied health 1,887 pharmacists and 1,098 dentists. In pursuant of the decision of the Supreme Council of Health to link continuous professional education with the renewal of licenses for healthcare professionals, the authority approved 3,022 continuing professional development training programs. These programs included conferences, workshops, scientific forums and lectures. In the area of clinical trials, the Authority has reviewed and made judgement on 12 clinical trials in the private and public sectors. The total number of registered pharmaceuticals with the Authority are 3,760 Medicines, 729 Health Products and 311 Alternative Medicine Products. Additionally, the authority reviewed 8,178 medical devices of which 6,861 were approved with a value of approximately 25 million Bahraini dinars. By far the greatest achievement for us in 2017 was the implementation of the first National Accreditation Program in the Kingdom of Bahrain. Select Healthcare facilities underwent a comprehensive assessment of all services provided by them, ranging from governance and medical care to patient and building safety, infection control, quality and other criteria that impact patient safety and quality. The accreditation team successfully completed surveying 8 private hospitals and 6 affiliated medical centres.8
Four hospitals were awarded the diamond level of accreditation, achieving more than 95% of therequired standards.Three hospitals were awarded the platinum level of accreditation, achievingbetween 90% and 94% of the standards. One hospital was awarded the gold level of accredita-tion achieving between 85% and 89% of the required standards.As for complaints and medical errors, the Authority received 237 cases last year, of which 136were direct complaints from patients and 47 were incidents reported from healthcare facilities.Fifty-two cases were referred by the prosecution and the courts, 56% against the private sectorand 42% against the government sector.The Authority completed the investigation on 118 cases of which medical error was proved inonly 44 of them.In total, the authority implemented 66 disciplinary actions on professionals, 47 against doctorsand 15 against nurses. The disciplinary proceedings included 34 suspensions, 21 warnings, and10 license cancellations. A monetary fine was issued for one facility.In spite of some of the great strides we made in 2017, we also faced our fair share of challenges,one of the biggest being the lack of a comprehensive information system for all our procedures. ThisIT development encountered numerous technical issues that have contributed to the delay of its implemen-tation. For 2018, we have once again reaffirmed our commitment to improve the IT system andenable our customers to apply for their licensing online and in turn allow us to finalize ourapprovals in an efficient and effective manner.To overcome some of our challenges we faced in 2017, the government has approved to increaseour budget and human resource capacity as requested in our budgetary report for 2018. Thisincrease in funds will help to enhance and improve our services that we offer to the Kingdom ofBahrain.This report will highlight NHRA activities and statistics for the year 2017 and will shed some lighton the most important achievements.Dr. Mariam Al Jalahma 9
NHRA Strategy10
11 NHRA Strategy
NHRA vision and goals The National Health Regulatory Authorities’ (NHRA) vision is to promote safe and high-quality care in the Kingdom of Bahrain. In 2016 the Supreme Council for Health approved the five-year strategy plan for NHRA which aims to achieve the vision through 3 strategic goals. H Regulated & Safe & Trusted Accountable Facilities Health Services Preserved Health Rights Of the thirty initiatives that were included in the strategy, NHRA was successful in implement- ing 84% of the initiatives by the end of 2017.12
Overview of NHRA StrategyThe National Health Regulatory Authorities vision is to promote safe and high quality in the deliveryof health care in the Kingdom of Bahrain. In 2016, the Supreme Council for Health had approved thefive-year strategy plan for NHRA which aimed to achieve the vision through 3 strategic goals. Intotal 30 initiatives were included in the strategy, by the end of 2017 NHRA had implemented 84%of the initiatives.The achievements are summarised below:Department 2017 Implemented InitiativesProfessionals • Establishing a licensing categorisation that unifies criteria of professional licensing • Establishing professionals code of ethics • Developing regulations to link renewal of licensing with Continuous Professional DevelopmentFacilities • Implementing the National Health Accreditation Program • Developing facility classification • Developing regulations for licensing of health care facilitiesPharmaceuticals • Developing regulatory standards for registration of medicines and pharmaceutical products.Medical Devices • Developing categorization standards for pharmaceuticalsComplaints and health productsHR & Finance • Establishing rules for the destruction or re-export of medi- cines not complying with the specifications and standards • Subjecting all drugs for laboratory testing to ensure its compliance with the technical standards • Developing regulatory standards for registration of medical supplies and devices • Establish Accountability Committee for health care facilities • Develop Disciplinary Committees for different professions • Develop internal NHRA policies & procedures • Develop a risk assessment plan • Develop training plan for all NHRA staff based on performance evaluation • Develop the financial policy for NHRA 13
Strategic Plan in Detail This Strategic Plan is the result of an inclusive authority wide planning process. The plan highlights key directions for success and accompanying goals, which support our mission and vision for the organization. The Plan, in all its parts, articulates a transformational approach to the services we provide to the people of the Kingdom and, in essence, reaffirms our commitment to work in collaboration with the clients we serve. It is our way of endorsing the authorities strongly held belief that the people of Bahrain deserve high quality, accessible and timely service from the NHRA.14
Strategic Plan in Detail Professionals Regulation Section Strategy Strategy Procedures Initiative Status KPI KPIsEnsure the Completedcompetence of 1Existence of Establishing Produce thehealth service unified criteria final documentproviders unified criteria of professional by June 2017 for professional licensing Produce the categorization categorization final document of Code of ethics by end of September 2017 2Existence of Developing Produce the Completed professional final document professional code of ethics of Code of code of ethics ethics by end of September 2017 Percentage of Developing Issue a resolution Completed regulations to for professional Completed 3renewed link renewal of licensing licensing with conditions by licensed linked CPD end of 2016 to CPD hours of total licenses Develop CPD regulations by march 2017Implement a Percentage of Setting conditions Develop a Under Processmalpractice health care and regulations proposal forinsurance workers who for insurance categories ofsystem are covered malpractice hospitals and with malpractice insurance professionals insurance to have a mandatory malpractice insurance by mid of 2018 15
Health Care Facility Section Strategy Strategy Procedures Initiative Status KPI KPIs Ensure Existence of Developing Issue a resolution Completed efficient health ruengifuieladticornitsefroiar regulations for for regulations care facilities tfohreptreocfhenssicioanl al licensing of for licensing of rceaqteugiroermizaetniotns health care health care for health facilities facilities by facilities mid of 2017 Existence of 1Establish Issue a resolution Under Process regulations for for regulating the establishment regulations for pharmaceutical of pharmaceutical licensing facilities, facilities, drug pharmaceutical factories and warehouses facilities warehouses by and the the end of establishment 2Developing 2017 of pharmaceutical factories regulations for the licensing of drug warehouses 3Developing regulations for licensing pharmaceutical factories Establishment Developing Develop CAM Completed regulations for regulations for regulations by In progress the licensing specialized the end of In progress of specialized health facilities 2016 health facilities Develop Addiction management regulations by end of 2017 Develop IVF regulations by mid of 201816
Strategy Strategy Procedures Initiative Status KPI KPIs CompletedEnsure the 1AExdiostpetninceg of 1Implementing • Issue a Completedquality of resolution Completedhealth services aucncifrieedditcartiitoenria the national regulating sfotarnpdroafredsssifoonral accreditation accreditation hcaetaelgthorfiazcaitliiotines program by end of 2016 2Adopting facility 2Developing • Issue accreditation classification facility classification policy by January 2017 •Implement accreditation by May 2017 17
Pharmacetical Products Regulation Section Strategy Strategy Procedures Initiative Status KPI KPIs Ensure the Existence of Developing Issue regulations Completed quality of by January 2017 Completed medicines 1regulatory 1regulatory Under Process Update the old Ensure the standards for standards for version by June availability of registration of registration of 2017 safe drugs medicines and medicines and pharmaceutical pharmaceutical Develop a products products. proposal for initiating a 2Percentage of 2Developing pharmacovigi- lance system categorized categorization by mid of 2018 pharmaceuticals standards for Implements and health pharmaceuticals the system by products and health end of 2018 products 1Presence of 1Developing pharmacovigi- lance system pharmacovigi- lance system 2Percentage of Establishing rules destroyed drugs annually 2for the destruction from total registered or re- export of medicines not 3Percentage of complying with the specifications drugs tested and standards annually from registered Subjecting all 3drugs for labo- ratory testing to ensure its compliance with the technical standards18
Strategy Complaint Section ResponsibilityProfessional KPI Proceduresaccountability 1Percentage of 1Initiate a CompletedSurveillance of Completedmedical errors health facilities Committee for who received a MedicalSafe clinical trials disciplinary accountability for action health care facilities 2Percentage of 2Develop professionals Disciplinary who received a committees for disciplinary different professions action Develop a Sur- Under Process Presence of an veillance system effective Surveil- for reporting lance system for medical errors medical errors reporting 1Establishing Completed Completed Presence of clinical trials guidelines regu- regulations lating clinical trials 2Establishing ethical research committeesEnsure the Existence of Develop a Completedcompetence of regulation for nationalhealth service accrediting guideline forproviders continues CPD programs professional accreditation education programs. 19
Strategy KPI Procedures Responsibility Ensure the quality Existence of Developing Completed of medical supplies In progress and devices 1regulatory standards 1regulatory standards Under Process Ensure the safety for registration of for registration of of medical supplies medical supplies medical supplies and devices and devices and devices by 2017 2Percentage of 2Establish a registered medical devices comprehensive medical device Percentage of national data medical devices recall base by end of or adverse event 2018 Develop a Surveillance system for reporting medical devices recall, alert and adverse events by end of 201920
Human Resources & Finance SectionStrategy KPI Procedures ResponsibilityDevelop the 1Internal policies 1Develop internal In processhuman resources In processof NHRA developed & NHRA policies & Publish. procedures 2The new 2Update NHRA organizational organization structure structure finalized and approved by 3Develop a risk Completed CSB. In process assessment plan Completed 3Risk assessment Completed 4Update the IT Completed plan is in place system of NHRA 4NHRA IT system 5Complete the is developed and functional employment procedures 5All NHRA jobs 6Complete are occupied performance 6All NHRA staff assessment procedures. are evaluated annually 7Develop training 7Existence of an plan for all NHRA staff annual training based on plan for all performance NHRA staff evaluation 21
Strategy KPI Procedures Responsibility Develop Finan- 1The financial 1Develop the Completed cial resources of Completed NHRA plan is adopted financial policy Completed and published for NHRA 2Adopted regula- 2Develop regulations tions for commit- for committees’ tees’ payment are financial payment published 3Develop 3Visitng Regulations for consultants’ consultant’s payment scheme payment is adopted are published22
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Published Resolutions, Guidelines, Policies and Contracts24
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Supreme Council of Health Resolutions The Supreme Council of Health issued four important resolutions in 2017 regarding drug registration and regulation, facilities licensing, and professional licensing: Published Resolutions 1. Resolution No (8) Amendments of some articles in resolution No (12) for drug registration policy. 2. Resolution No. (15) For 2017 Regarding Technical & Engineering Conditions Required in Health Care Facilities. 3. Resolution NO. (3) For 2017 Regarding Healthcare Professionals licensing requirements and standards. 4. Resolution No. (41) For 2017 regarding Issuing a Track and Trace System for the Supply Chain of Medicine within the Kingdom of Bahrain. Partnership & Contracts In an effort to ease workflow processes at NHRA and effectively collaborate with our clients NHRA signed four important agreements with international companies in relation to professional licensing, drug and medical devices registration. Agreements were signed with: • The Data Flow Group for verification of professional qualifications, work experience, licensing • Prometric for providing technology-enabled testing and assessments for licensure exams • Extedo for providing EURS (EXTEDO Universal Review System) that serves as a complete eCTD validation and reviewing solution that evaluates whether any eCTD submission conforms to the mandated standards • Dahlman Middle East to examine and ensure the safety and quality of medical and surgical equipment used in the Kingdom of Bahrain26
Published NHRA Guidelines and Policies Overview of the Year APPROVED February March Bhd AprilJanuary1. Guidelines: 1. Guidelines: 1. Guidelines: 1. Guidelines:Medicine Renewals Guide to Good Medicine Variations Pricing GuidelineGuidelines (PPR) Manufacturing Guideline (PPR) (PPR) Practices for2. Surveyors Pharmaceutical 2. Professionalshandbook (ACC) QualificationAugust July June May1. FAQ for medical 1. Dental Scope of 1. A Short Guide tocomplaints (MC) Services and Guide The Procedure for A lines Clinical Trial 2. Policy: Incident Application in The Reporting Policy Kingdom Of Bahrain (MC) (CT &CPD)September October November December1. Privileging Policy: 1. Guidelines: 1. Policy: 1. Policy: Code ofNeurology privileges Local Pharmaceutical Accreditation Policy Professional Conduct(HPR) Manufacturer (ACC) (HPR) Licensing Procedure 2. Policy: Informed (PPR) Consent Policy KeyPPR – Pharmaceutical Products Registration CT &CPD – Clinical Trials & Continuing ProfessionalHPR -Health Professionals Regulation EducationHCF – Health Care Facilities ACC – AccreditationMC – Medical Complaints MD – Medical Device 27
Healthcare Facility Regulations28
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Healthcare Facility Regulations In 2017, the total number of registered healthcare facilities in the Kingdom of Bahrain reached 671. The NHRA has seen a significant increase in the applications for new medical centers in Bahrain due to an open market strategy by the Kingdom. The majority of these applications have been for general medical centers, dental centers, complementary medicine centers, and dermatology centers. At present there are 194 medical centers in Bahrain. The greatest concentration of healthcare facilities and services in Bahrain has been within the Capital Governorate. The Capital Governorate has 76% of all hospitals, 78% of all private hospital beds, 55% of all medical centers and 68% of all clinics within Bahrain. The following infographics demonstrate facility statistics in 2017.30
Healthcare Facilities Licensing Residential Nursing Care (5) Rehabilitation Center (2) Radiology Center (2) Psychological Counseling (2) Physiotherapy (31) Optics (130) Nutrition Center (11) Laboratories (16) Health Unit (38) Dental Lab (16) Company Clinic (9) Clinics (171) Alternative Medicine Health Unit (1) Alternative Medicine Centers (13) 24Hr. Clinics (5) 24Hr. Centers (4) Medical Centers (194) Hospitals (21) Licensing ALicensing Activities: 671 Licensed Facilities ctivities Licensing Applications for New Healthcare Facilities in the Kingdom of BahrainNew (110)Renewal (656) 234Number of New 103Number of Applications Preliminary Submitted in Approvals 2017 Issued 2017 Classification of Facilities with Preliminary Approval Audiology - 4 Psychological Counseling Dental Lab - 5 Center - 2 Laboratories - 2 Company Clinic - 1 Optics - 8 Part Time Clinic - 1 Residential Nursing Care Service - 4 Full Time Clinic - 5 Nutrition Center - 2 Dental Clinic - 2 Physiotherapy - 5 Dental Center - 20 Alternative Medicine Center -14 Specialized Center - 3 Rehabilition Center - 2 General Medical Center - 15 Rehabilition Hospitals - 1 Hospital - 7 31
Healthcare Facilities Overview Hospitals: Total Number of Licensed Private Hospitals: 21 Geographic Distribution of Private Hospitals Number of Beds in the Private Sector Capital - 16 Capital - 518 Muharraq - 1 Muharraq - 50 Northern - 1 Northern - 35 Southern - 3 Southern - 62 Centers Registered Medical Centers 70 79 45 194 General Medical Dental Centers Specialized Centers Centers Distribution of Medical Centers 126 Dental Healthcare Facilities: 3366 3300 4411 General Specialized Dental Capital 12 5 11 9 5 12 13 5 1155 Dental Hospital – 2 Dental Center – 79 Muharraq Northern Southern Dental Clinic – 28 24 hr Dental Clinic - 1 Dental Lab - 16 Distribution of Specialized Medical Centers 2 15 4 2 1 3 3 5 5 1 1 1 2 Womans Wellness Clinics: Surgical Medical Center Pulmonology 171 Psychiatry Registered Private Clinics Pediatric Ophthalmology 99 Medical Obstetrics& Gynecology Clinics Orthopedic 46 Part Time Gastroenterology Clinics Fertility ENT & Sleep Disorders 26 Dental Dermatology/Aesthetic Clinics Other32
Types of Violations Identified During Inspection Visits0 60 20 143 5 132 116 242 50 146 H 10 28 9 10 862 932 105 8 9 74 87 20 451 11 3913 31 39 34No violations Unlicesned allied Patient/Human safetyContractSterilization Unlicensed nurses LaundryMedicine Expiry Previously stamped transcriptsUnregistered Medicine Previously stamped periscription Facility License ExpiryMedicine storage Operation theatre DesignWaste Storage Housing connected to facility Patient PrivacyInfection Control Fire SafetyDevice Maintainance Building Maintainance Environmentally friendly for disabledPatient Records Storage Ambulance/contractPatient Records Notes Narcotic discrepencies Sign BoardsUnlicensed Medics Supreme Council of Environment on X-ray leakage test Ensuring security of doctor stamp Practise license & advertisment discrepencies Storage of Tools 33
Pharmacy Regulations34
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Pharmacy Regulations The number of licensed pharmacies has increased from 188 in 2016 to 213 pharmacies in 2017; this increase could be attributed to amendments in the pharmacy law which has permitted the pharma- cies to open up to 5 branches and for non-pharmacists to be able to invest in opening pharmacies. The following infographics demonstrate pharmacy statistics in 2017.36
Pharmacy Licensing and Inspection Activities 213 Total Number of Licensed Pharmacies:43 Private Pharmacies 170 Public Pharmacies Private Pharmacy Public Pharmacy 25 62 43 38 27 972Capital Southern Muharraq NorthernApprovals Issued to facilities for: 64 Preparation rooms4 Change in activities from retail toimport pharmacy1 Change in activity from import toretail pharmacy 37
Geographic Distribution of Public Pharmacies 4hr Services434 ine 8 Northern very Services73 2 Capital rnative Medic Muharraq 44 3 Southern 6 3 Alte Deli 2 Inspection visits carried out in 2017 Types of Violations Identified - 118 24 Medicine Violation 791 34 Licensing Violation 15 Pharmacy Set-Up Violation 38 Temperature/Humidity/FridgeViolation 7 Price Violation Licensing Activities Licenses issued to 51 new pharmacies Northern Southern Muharraq 7 2 0 0 10 12 11 9 Capital Private Pharmacy Public Pharmacy Department Activities: Quality control assessment for 34 Laboratories in the Kingdom of Bahrain. Medical Waste Management in Private Healthcare- Regulation, Transformation and Process.38
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Healthcare Professional Regulations40
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Healthcare Professional Regulations In 2017, the NHRA saw the number of registered healthcare professionals increase to 28,031 from 23,987 in the previous year. These professionals consisted of 6,131 doctors, 1,098 dentists, 14,395 nurses, 1,887 pharmacists and 4,520 allied healthcare professionals. Pursuant to the decision of the Supreme Council of Health to link the renewal of licenses of healthcare professionals to continuing professional development (CPD), the authority approved 3,022 training programs, including conferences, workshops, scientific forums and lectures. The following infographics demonstrate Professionals statistics in 2017.42
Healthcare Professional RegulationsTotal number of Healthcare Professionals Registered in theKingdom of Bahrain:28,031Distribution of Registered Professionals in the Kingdom ofBahrainl - 6131 g - 14395 4520 acy- 1887 - 1098Medica Nursin Allied - Pharm DentalNew License Applications Processed Medical Nursing Allied Pharmacy492 946 504 82 43
NHRA Registered Physicians by Professional Category Consultant Specialist 1125 694 General Visiting 4282 30 NHRA Registered Dentists by Professional Category 839 Consultant Specialist 89 167 General Visiting 3 NHRA Registered Nurses by Professional Category Practical MMiiddwwiiffee 205 322 Specialist GGeenneerraall 262 1360544
NHRA Registered Pharmacists by Professional CategoryParmacists Pharmacy Medical Technicians Delegates1331 305 251NHRA Registered Allied Health Professionals3 Renal Dialysis Speech and Audiology5 Podiatry Cardiovascular Technology Radiation Therapy Technology Alternative Medicine7 Casting Operation Theatre Technology7 Medical Physics Dietetics and Nutrition8 Laser Hair Removal Technician Health Inspection 17 Prosthetics and Orthotics Emergency Medical Services Electro-Neurodiagnostics Allied Dental Professions 19 Occupational Therapy Optometry 19 Central Sterile Services (CSS) Radiology 26 Respiratory Therapy Physiotherapy 32 Psychology Medical Laboratory 50 1112 63 69 71 134 140 148 157 232 302 516 568 815Healthcare Professional Regulations Department Achievements in 20173 Medical Licensure Examinations 3 Nursing Licensure Examination Conducted 14(361 candidates) (374 candidates) licensure 2 Pharmacy Licensure examinations examinations3 Dental Licensure Examinations (49 candidates) for a total of(130 candidates) 930 candidates 3 Optometry Licensure Examination (16 candidates) 45
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Pharmaceutical Product Regulations The total number of drugs registered at NHRA has reached 3760 drugs, 311 Alternative and Com- plementary Medicine (CAM) products and 729 health products. In 2017, the Supreme Council of Health issued Resolution 41 for the implementation of a track and trace system for supply chain of medicines in the Kingdom of Bahrain. This resolution states that it is mandatory by December 2019, for all the medications entering Bahrain to have the Two-Di- mensional Barcode printed on the packaging of the product in accordance with the standards set by Global Standards One (GS1). The barcode shall contain the following: 1. The Global Trade Item Number (GTIN) of the Medicine. 2. The expiry date of the Medicine. 3. The batch number. The following infographics demonstrate pharmaceutical statistics in 2017.48
Pharmaceutical Products Registration Total Number of Medicines Registered in the Kingdom of Bahrain.Medicines: Medicines National PricingMedicine 1,667 329 NewVariations RegistrationApproved 141 756 License RenewalPre-Approval Applications Processed Invoices (approximately) Processed:4498 14,200ortation of No utical Products anufacturing S2,120 351 88 ites Registratio Classification n Registered ProTemporary Imp n Pharmace International Mducts 49
Alternative/Complementary MedicinesTotal Number of Alternative MedicinesApproved in the Kingdom of Bahrain: 311New Alternative Medicines ApplicationsProcessed: 77 Health Products: Number of Health Products Registeredin the Kingdom of B New Registration 729111 Total ahrain Licenses Renewal5050
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