Prime Minister’s Order n° 014/03 determining the organisational structure of Rwanda Food and Drugs Authority

Official Gazette n° Special of 30/08/2023 Umwaka wa 62 Year 62 62ème Année Igazeti ya Leta n° Idasanzwe Official Gazette n° Special of Journal Officiel n° Spécial du yo ku wa 30/08/2023 30/08/2023 30/08/2023 Ibirimo/Summary/Sommaire page/urup. Iteka rya Minisitiri w’Intebe /Prime Minister’s Order/Arrêté du Premier Ministre Iteka rya Minisitiri w’Intebe n° 014/03 ryo ku wa 29/08/2023 rigena imbonerahamwe y’imyanya y’imirimo y’Ikigo gishinzwe Kugenzura Ibiribwa n’Imiti mu Rwanda……………2 Prime Minister’s Order n° 014/03 of 29/08/2023 determining the organisational structure of Rwanda Food and Drugs Authority …………………………………………………………....2 Arrêté du Premier Ministre n° 014/03 du 29/08/2023 déterminant la structure organisationnelle de l’Office Rwandais des Produits Alimentaires et Pharmaceutiques……….2 1 Official Gazette n° Special of 30/08/2023 ITEKA RYA MINISITIRI W’INTEBE N° PRIME MINISTER’S ORDER N° 014/03 ARRÊTÉ DU PREMIER MINISTRE N° 014/03 RYO KU WA 29/08/2023 RIGENA OF 29/08/2023 DETERMINING THE 014/03 DU 29/08/2023 DÉTERMINANT IMBONERAHAMWE Y’IMYANYA ORGANISATIONAL STRUCTURE OF LA STRUCTURE Y’IMIRIMO Y’IKIGO GISHINZWE RWANDA FOOD AND DRUGS ORGANISATIONNELLE DE L’OFFICE KUGENZURA IBIRIBWA N’IMITI MU AUTHORITY RWANDAIS DES PRODUITS RWANDA ALIMENTAIRES ET PHARMACEUTIQUES ISHAKIRO TABLE OF CONTENTS TABLE DE MATIÈRES Ingingo ya mbere: Imbonerahamwe Article One: Organisational structure Article premier : Structure y’imyanya y’imirimo organisationnelle Ingingo ya 2: Imishahara n’ibindi Article 2: Salaries and fringe benefits Article 2 : Salaires et avantages liés à la bigenerwa abakozi bijyanye related to the organisational structure structure organisationnelle n’imbonerahamwe y’imyanya y’imirimo Ingingo ya 3: Abayobozi bashinzwe Article 3: Authorities responsible for the Article 3 : Autorités chargées de gushyira mu bikorwa iri teka implementation of this Order l’exécution du présent arrêté Ingingo ya 4: Ingingo y’ururimi Article 4: Language provision Article 4 : Disposition linguistique Ingingo ya 5: Ingingo ivanaho Article 5: Repealing provision Article 5 : Disposition abrogatoire Ingingo ya 6: Gutangira gukurikizwa Article 6: Entry into force Article 6 : Entrée en vigueur 2 Official Gazette n° Special of 30/08/2023 ITEKA RYA MINISITIRI W’INTEBE N° PRIME MINISTER’S ORDER N° 014/03 ARRÊTÉ DU PREMIER MINISTRE N° 014/03 RYO KU WA 29/08/2023 RIGENA OF 29/08/2023 DETERMINING THE 014/03 DU 29/08/2023 DÉTERMINANT IMBONERAHAMWE Y’IMYANYA ORGANISATIONAL STRUCTURE OF LA STRUCTURE Y’IMIRIMO Y’IKIGO GISHINZWE RWANDA FOOD AND DRUGS ORGANISATIONNELLE DE L’OFFICE KUGENZURA IBIRIBWA N’IMITI MU AUTHORITY RWANDAIS DES PRODUITS RWANDA ALIMENTAIRES ET PHARMACEUTIQUES

Minisitiri w’Intebe; The Prime Minister; Le Premier Ministre ; Ashingiye ku Itegeko Nshinga rya Repubulika Pursuant to the Constitution of the Republic Vu la Constitution de la République du y’u Rwanda, cyane cyane mu ngingo yaryo ya of Rwanda, especially in Article 119; Rwanda, spécialement en son article 119 ; 119; Ashingiye ku Itegeko Ngenga n° 001/2020.OL Pursuant to Organic Law n° 001/2020.OL of Vu la Loi Organique n° 001/2020.OL du ryo ku wa 08/06/2020 rishyiraho amategeko 08/06/2020 establishing general provisions 08/06/2020 portant dispositions générales rusange agenga ibigo bya Leta, cyane cyane governing public institutions, especially in régissant les établissements publics, mu ngingo yaryo ya 18; Article 18; spécialement en son article 18 ; Asubiye ku iteka rya Minisitiri w’Intebe no Having reviewed Prime Minister’s Order no Revu l’Arrêté du Premier Ministre no 162/03 162/03 ryo ku wa 21/12/2020 rigena 162/03 of 21/12/2020 determining du 21/12/2020 déterminant la structure imbonerahamwe y’imyanya y’imirimo y’Ikigo organisational structure of Rwanda Food and organisationnelle de l’Office Rwandais des gishinzwe Kugenzura Ibiribwa n’Imiti mu Drugs Authority; Produits Alimentaires et Pharmaceutiques ; Rwanda; Bisabwe na Minisitiri w’Abakozi ba Leta On proposal by the Minister of Public Service Sur proposition du Ministre de la Fonction n’Umurimo; and Labour; Publique et du Travail ; Inama y’Abaminisitiri yateranye ku wa After consideration and approval by the Après examen et adoption par le Conseil des 01/08/2023 imaze kubisuzuma no kubyemeza; Cabinet, in its meeting of 01/08/2023; Ministres, en sa séance du 01/08/2023 ; 3 Official Gazette n° Special of 30/08/2023 ATEGETSE: ORDERS: ARRÊTE : Ingingo ya mbere: Imbonerahamwe Article One: Organisational structure Article premier : Structure y’imyanya y’imirimo organisationnelle Imbonerahamwe y’imyanya y’imirimo y’Ikigo The organisational structure of Rwanda Food La structure organisationnelle de l’Office gishinzwe Kugenzura Ibiribwa n’Imiti mu and Drugs Authority is in annex of this Rwandais des Produits Alimentaires et Rwanda iri ku mugereka w’iri teka. Order. Pharmaceutiques est en annexe du présent arrêté. Ingingo ya 2: Imishahara n’ibindi Article 2: Salaries and fringe benefits Article 2 : Salaires et avantages liés à la bigenerwa abakozi bijyanye related to the organisational structure structure organisationnelle n’imbonerahamwe y’imyanya y’imirimo Imishahara n’ibindi bigenerwa abakozi b’Ikigo Salaries and fringe benefits for employees of Les salaires et les avantages alloués au gishinzwe Kugenzura Ibiribwa n’Imiti mu Rwanda Food and Drugs Authority are personnel de l’Office Rwandais des Produits Rwanda biri mu mbonerahamwe y’imishahara contained in the Salary structure approved by Alimentaires et Pharmaceutiques sont yemejwe n’Inama y’Abaminisitiri yateranye the Cabinet, in its meeting of 01/08/2023 and indiqués dans la structure salariale approuvée ku wa 01/08/2023 kandi iboneka muri available in the Ministry in charge of public par le Conseil des Ministres, en sa séance du Minisiteri ifite abakozi ba Leta mu nshingano. service. 01/08/2023 et disponible au Ministère ayant la fonction publique dans ses attributions.

Ingingo ya 3: Abayobozi bashinzwe Article 3: Authorities responsible for the Article 3 : Autorités chargées de gushyira mu bikorwa iri teka implementation of this Order l’exécution du présent arrêté Minisitiri w’Abakozi ba Leta n’Umurimo, The Minister of Public Service and Labour, Le Ministre de la Fonction Publique et du Minisitiri w’Ubuzima na Minisitiri w’Imari the Minister of Health and the Minister of Travail, le Ministre de la Santé et le Ministre n’Igenamigambi bashinzwe gushyira mu Finance and Economic Planning are entrusted des Finances et de la Planification bikorwa iri teka. with the implementation of this Order. Économique sont chargés de l’exécution du présent arrêté. 4 Official Gazette n° Special of 30/08/2023 Ingingo ya 4: Ingingo y’ururimi Article 4: Language provision Article 4 : Disposition linguistique Iri teka ryateguwe mu rurimi This Order was drafted in Ikinyarwanda. Le présent arrêté a été rédigé, en rw’Ikinyarwanda. Ikinyarwanda. Ingingo ya 5: Ingingo ivanaho Article 5: Repealing provision Article 5 : Disposition abrogatoire Iteka rya Minisitiri w’Intebe no 162/03 ryo ku Prime Minister’s Order no 162/03 of L’Arrêté du Premier Ministre no 162/03 du wa 21/12/2020 rigena imbonerahamwe 21/12/2020 determining organisational 21/12/2020 déterminant la structure y’imyanya y’imirimo y’Ikigo gishinzwe structure of Rwanda Food and Drugs organisationnelle de l’Office Rwandais des Kugenzura Ibiribwa n’Imiti mu Rwanda Authority is repealed. Produits Alimentaires et Pharmaceutiques est rivanyweho. abrogé. Ingingo ya 6: Gutangira gukurikizwa Article 6: Entry into force Article 6 : Entrée en vigueur Iri teka ritangira gukurikizwa ku munsi This Order comes into force on the date of its Le présent arrêté entre en vigueur le jour de sa ritangarijweho mu Igazeti ya Leta ya publication in the Official Gazette of the publication au Journal Officiel de la Repubulika y’u Rwanda. Agaciro karyo gahera Republic of Rwanda. It takes effect as of République du Rwanda. Il sort ses effets à ku wa 01/08/2023. 01/08/2023. partir du 01/08/2023. 5 Official Gazette n° Special of 30/08/2023 Kigali, 29/08/2023 (sé) Dr NGIRENTE Edouard Minisitiri w’Intebe Prime Minister Premier Ministre (sé) Prof. BAYISENGE Jeannette Minisitiri w’Abakozi ba Leta n’Umurimo Minister of Public Service and Labour Ministre de la Fonction Publique et du Travail Bibonywe kandi bishyizweho Ikirango cya Repubulika : Seen and sealed with the Seal of the Republic: Vu et scellé du Sceau de la République :

(sé) Dr UGIRASHEBUJA Emmanuel Minisitiri w’Ubutabera akaba n’Intumwa Nkuru ya Leta Minister of Justice and Attorney General Ministre de la Justice et Garde des Sceaux 6 Official Gazette n° Special of 30/08/2023 UMUGEREKA W’ITEKA RYA ANNEX TO PRIME MINISTER’S ANNEXE À L’ARRÊTÉ DU PREMIER MINISITIRI W’INTEBE N° 014/03 RYO ORDER N° 014/03 OF 29/08/2023 MINISTRE N° 014/03 DU 29/08/2023 KU WA 29/08/2023 RIGENA DETERMINING THE DÉTERMINANT LA STRUCTURE IMBONERAHAMWE Y’IMYANYA ORGANISATIONAL STRUCTURE OF ORGANISATIONNELLE DE L’OFFICE Y’IMIRIMO Y’IKIGO GISHINZWE RWANDA FOOD AND DRUGS RWANDAIS DES PRODUITS KUGENZURA IBIRIBWA N’IMITI MU AUTHORITY ALIMENTAIRES ET RWANDA PHARMACEUTIQUES IMBONERAHAMWE Y’IMYANYA ORGANISATIONAL STRUCTURE OF STRUCTURE ORGANISATIONNELLE Y’IMIRIMO Y’IKIGO GISHINZWE RWANDA FOOD AND DRUGS DE L’OFFICE RWANDAIS DES KUGENZURA IBIRIBWA N’IMITI MU AUTHORITY PRODUITS ALIMENTAIRES ET RWANDA PHARMACEUTIQUES 7 ORGANISATIONAL STRUCTURE OF RWANDA FOOD AND DRUGS AUTHORITY Ministry of Health Internal Audit Team (2) -Internal Audit Specialist (1) Board of Directors -Internal Auditor (1) Office of Director General (7) - Director General (1) - Advisor to DG (1) Quality Management System (QMS) - Legal Affairs Analyst (1) Division (7) - Legal Affairs Officer (1) - Division Manager (1) - Public Relations Specialist (1) - Quality Assurance Analyst (1) - Communication Specialist (1) - Quality Compliance Specialist (1) - Administrative Assistant to DG (1) - QMS Certification and Maintenance Specialist (1) - Customer Satisfaction Specialist (1) - Talent and Competency Deputy Director General (2) Development Specialist (1) Office of the CFO (32) - Deputy Director General (1) - Environmental, Occupational Health - Administrative Assistant (1) and Safety (EHS) Specialist (1) - Chief Finance Officer (1) - Administrative Assistant (1) - Procurement Specialist (2) - Software Developer (1) - System Administration Specialist (1) - IT Security Specialist (1) - IT Help Desk Officer (1)

Regulatory Ecosystem Drugs Department (131) Laboratory Services Department (48) Planning Unit (4) Strategy Division (11) Food Department (72) - Director (1) - Division Manager (1) - Head of Department (1) - Head of Department (1) - Head of Department (1) - Planning Officer (1) - Regulatory Affairs and - Laboratory Logistics Officer (1) - Sample Repository and Archiving Officer (1) - Sample Repository and Archiving Officer (1) - Quality Management System - M&E Officer (1) Partnerships Analyst - Food Registration Management and Monitoring Specialist (1) - Drugs Registration Management and Monitoring Specialist (1) - Research and Statistics Officer (1) (2) Specialist (1) - Pharmaceutical - Sample Reception and Archiving Production & Supply Officer (1) Chain Specialist (1) - Maintenance Specialist (1) - Health Emergency Medicines and Human Resource Strategy Specialist (1) & Administration Unit (14) - Market, Pricing, and -Director (1) Industrial Support Food Registration and Food Safety Monitoring, Food Imports & Exports Control -Human Resources Officer (1) Analyst (1) Information Control Division Inspections and Licensing Division (20) -Logistics Officer (1) (16) Division (33) Microbiology Unit (5) - Industrial Market and - Head of Central Secretariat (1) Support Specialist (5) - Division Manager (1) Human Medicines and Devices Veterinary Medicines and Devices Cosmetics & Household Pharmacovigilance and Clinical Trial Drugs Imports & Exports -Secretaries in the CS (2) - Division Manager (1) - Division Manager (1) Pharmaceutical Inspections and - Director (1) Registration Division (22) Registration Division (10) Chemicals Registration Division Division (22) Control Division (27) -Documentation and Archives Officers (2) - Food Products - Food Establishment Licensing Division (35) - Microbiology Testing (12) -Drivers (6) Information, Promotion Licensing Specialist (3) - Division Manager (1) Specialist (1) - Division Manager (1) - Division Manager (1) - Division Manager (1) Division Manager (1) and Advertising Specialist - - Microbiology Testing Food Imports & Exports - Division Manager (1) - Pharmaceutical Establishment (1) Officer (2) Licensing Team (3) Licensing Specialist (3) - Food Imports and - Laboratory Technician (1) Finance Unit (6) Fortified Food and Dairy Food Technology and Exports Licensing Engineering Team (13) Veterinary Medicines Registration Products Team (4) Analyst Team Leader -Director (1) Team (5) Pharmacovigilance and Drug (1) Medicated Cosmetics Team (5) Drugs Imports and Exports Licensing -Accountant (2) Finished and Active Information Team (6) GMP and Engineering Team (12) - Food Supplement, - Food Plant Principal - Food and Beverages Team (8) Drugs Testing Division (10) -Revenue Accountants (2) Pharmaceutical Products - Veterinary Medicines Fortified Food Engineer (1) Import & Export - Secretary to DF Unit (1) team (7) Registration Analyst Team - Cosmetics Registration - Pharmacovigilance Analyst - Pharmaceutical Plant Senior Registration Analyst - Food Plant Senior Licensing Specialist - Drugs Import and Export Leader (1) Analyst Team Leader (1) Team Leader (1) Engineer (1) - Division Manager (1) Team Leader (1) Engineer (4) (2) Analyst Team Leader (1) - Pharmaceutical - Veterinary Medicines - Cosmetics Registration - Pharmacovigilance Data Entry - Good Engineering and - Human Medicines - Food additives - Food Technology - Human Medicines Import & Products Registration Registration Specialist (3) Specialist (4) Specialist (1) Manufacturing Practices Testing Specialist (3) Registration Specialist Inspection Analyst Team Food Imports & Exports Export Licensing Specialist (3) Analyst Team Leader - Veterinary Pesticides - Human Pharmacovigilance (GEMP) Inspection Analyst (1) - Veterinary Medicines (1) Leader (1) Control Team (16) - Veterinary Medicines Import & (1) Registration Specialist (1) Public Health Chemicals Team (6) Specialist (1) - GEMP Inspection Specialist (1) Testing Specialist (2) - Food Supplement and - Food Technology - Food Imports & Export Licensing Specialist (1) - Pharmaceutical - Veterinary Pharmacovigilance - Good Manufacturing Practices - Cosmetics Testing Fortified Food Inspection Specialist (6) Exports Control - Tobacco Products and Products Registration Veterinary Vaccines, Biologicals, - Public Health Chemicals Specialist (1) (GMP) Inspection Analyst Team Specialist (2) Registration Specialist - Animal Feed Processing Analyst Team Leader Registration Analyst Team Leader (1) Controlled Substances Import Diagnostics and Devices Team (4) - Cosmetovigilance Specialist (1) - Herbal Medicine Testing (1) Inspection Specialist (1) (1) Analyst (1) &Export control Specialist (1) Leader (1) - Drugs Information, Promotion - GMP Inspection Specialist (2) Specialist (1) - Dairy Products - Food Imports & - Pharmaceutical - Public Health Chemicals - Vaccine Manufacturing Facility - Cosmetics Import & Export - Veterinary Vaccines, and Advertising Specialist (1) - Drugs Laboratory Registration Specialist Food Safety, and Food Stores Exports Control Products Registration Control Specialist (1) Biologicals, Diagnostics & Registration Specialist (1) Inspection Analyst (1) Technician Officer (1) (1) & Outlets Inspection Team Specialist (15) Specialist (5) - Household Chemicals Import & Devices Registration Analyst - Household Pesticides Post Market Surveillance Team (9) - Vaccine GEMP Inspection Beverages Team ( 5) (16) Export Control Specialist (1) Team Leader (1) Registration Specialist (1) Analyst (1) Radiotherapy, Diagnostics - Veterinary Vaccines and - Household Cleaning - Post Marketing Surveillance - Vaccine GMP Inspection - Beverages Registration - Food Stores and Outlets Medical Devices & Diagnostic Vaccines & Biologics Testing and Medical Devices Team Biosimilar Registration Chemicals Registration Analyst Team Leader (1) Analyst (1) Analyst Team Leader (1) Inspection Analyst Team Licensing Team (2) Division (11) (4) Specialist (1) Specialist (1) - Post Marketing Surveillance - Biologics and Blood Products - Beverages Registration Leader (1) - Antiseptic and Disinfectants GMP Inspection Analyst (1) - Radiotherapy, - Veterinary Biological Specialist (Human Medicines) Specialist (4) - Food Stores and Outlets - Medical Devices & Diagnostics - Division Manager (1) Diagnostics and Products Registration Registration Specialist (1) (4) - Biologicals and Blood Products Inspection Specialist Import & Export Licensing - Vaccines & Biologics Medical Devices Specialist (1) - Laboratory Chemicals - Veterinary Medicines Post GMP Specialist (2) Cereal and Other Packaged (6) Analyst Team Leader (1) Testing Analyst (1) Registration Analyst - Veterinary in vitro Registration Specialist (1) Marketing Surveillance Food Products Team (5) - Food Post Marketing - Medical Devices & Diagnostics - Vaccines & Biologics Team Leader (1) Diagnostics & Medical Specialist (1) GDP/GSP and GCP Team (19) Surveillance Analyst Import & Export Licensing Testing Specialist (8) - Diagnostics and Devices Registration - Cosmetics Post Marketing - Other Packaged Food Team Leader (1) Specialist (1) - Vaccines Laboratory Medical Devices Specialist (1) Surveillance Specialist (2) - Retail and Wholesale Products Registration - Food Safety and Technician Officer (1) Registration Specialist - Medical Device Surveillance Pharmacies Inspection Analyst Analyst Team Leader (1) Surveillance Specialist Drugs and Devices Imports & Exports (2) Specialist (1) Team Leader (1) - Cereal Products (8) Control Team (16) - Radiopharmaceuticals - Retail and Wholesale Registration Specialist Food Testing Unit (8) & Radiotherapy Clinical Trial Team (6) Pharmacies Inspection (1) Specialist (10) - Drugs Point of Entry Products Registration - Director (1) - Other Packaged Food - Clinical Trial Analyst Team - Veterinary Pharmacies Coordination Analyst Team Specialist (1) - Food Products Testing Products Registration Leader (1) Inspection Specialist (3) Leader (1) Specialist (2) - Drugs Point of Entry Inspection Specialist (1) Vaccines, Biosimilar and - Clinical Trial Analyst (1) - Cosmetics Establishment - Animal Feeds Specialist (15) - Food Products Testing Biologics Team (6) - Clinical Trial Specialist (4) Inspection Specialist (1) Registration Specialist Officer (4) - Household Chemicals (1) - Food Laboratory Technician - Vaccines and Biosimilar Establishment Inspection (2) Registration Analyst Specialist (1) Team Leader (1) - Good Clinical Practices (GCP) - Vaccines and Biosimilar Analyst Team Leader (1) Registration Specialist - Good Clinical Practices (GCP) (3) Specialist (2) Devices & Instrumentation - Biological Products Testing Unit (4) Registration Specialist (1) - Director (1) - Blood and Blood - Medical Devices Testing Products Registration Officer (3) Specialist (1)

Herbal Medicines and Controlled Substances Team (4) - Herbal Medicines Pesticides & Poisonous Registration Specialist Substances & Chemical Testing Team Leader (1) Unit (5) - Herbal Medicines Registration Specialist - Director (1) (1) - Pesticides Testing Officer (2) - Tobacco Products and - Poisonous Testing Officer (1) Substances of abuse - Chemicals Testing Officer (1) Registration Specialist (1) - Controlled Substances Specialist (1)

Official Gazette n° Special of 30/08/2023 Bibonywe kugira ngo bishyirwe ku Seen to be annexed to Prime Minister’s Vu pour être annexé à l’Arrêté du Premier mugereka w’Iteka rya Minisitiri w’Intebe Order no 014/03 of 29/08/2023 determining Ministre no 014/03 du 29/08/2023 no 014/03 ryo ku wa 29/08/2023 rigena the organisational structure of Rwanda déterminant la structure organisationnelle imbonerahamwe y’imyanya y’imirimo Food and Drugs Authority de l’Office Rwandais des Produits y’Ikigo gishinzwe Kugenzura Ibiribwa Alimentaires et Pharmaceutiques n’Imiti mu Rwanda 9 Official Gazette n° Special of 30/08/2023 Kigali, 29/08/2023 (sé) Dr NGIRENTE Edouard Minisitiri w’Intebe Prime Minister Premier Ministre (sé) Prof. BAYISENGE Jeannette Minisitiri w’Abakozi ba Leta n’Umurimo Minister of Public Service and Labour Ministre de la Fonction Publique et du Travail Bibonywe kandi bishyizweho Ikirango cya Repubulika : Seen and sealed with the Seal of the Republic: Vu et scellé du Sceau de la République : (sé) Dr UGIRASHEBUJA Emmanuel Minisitiri w’Ubutabera akaba n’Intumwa Nkuru ya Leta Minister of Justice and Attorney General Ministre de la Justice et Garde des Sceaux 10