Rwanda FDA Guidelines for Food Premises Registration and Licensing PDF
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Uploaded by Faustin
INES Ruhengeri
2022
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Summary
This document provides guidelines for the registration and licensing of food premises in Rwanda. It details the requirements for different types of food premises and the associated application processes.
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Guideline for Registration and Licensing of Food Premises GUIDELINES FOR REGISTRATION AND LICENSING OF FOOD PREMISES FEBRUARY, 2022 Guideline for Registration and Licensing of Food Premises GUIDELINE DEVELOPMENT HISTORY DRAFT ZERO...
Guideline for Registration and Licensing of Food Premises GUIDELINES FOR REGISTRATION AND LICENSING OF FOOD PREMISES FEBRUARY, 2022 Guideline for Registration and Licensing of Food Premises GUIDELINE DEVELOPMENT HISTORY DRAFT ZERO 07/05/2019 ADOPTION BY RWANDA FDA 13/05/2019 STAKEHOLDERS CONSULTATION 13/05/2019 ADOPTION OF STAKEHOLDERS`COMMENTS 13/05/2019 REVISION No: 0 13/05/2019 REVISION No:1 29/09/2021 STAKEHOLDERS CONSULTATION 08/11/2021 ADOPTION OF STAKEHOLDERS`COMMENTS 12/11/2021 EFFECTIVE DATE 20/ 02/2022 DOCUMENT REVISION HISTORY Date of revision Revision Changes made and/or reasons for number revision 07/05/2019 0 Guideline for registration and licensing of food premises. 14/09/2021 1 1. Chapter I was amended by adding the scope, the classification of food premises and the products regulated by Rwanda FDA. 2. Chapter II is renamed APPLICATION LICENSING & INSPECTIONS instead of Licensing Requirements 3. Chapter 5. The administrative sanctions and fines were added. 4. Formats of operational license as well as updated requirements for premises licensing are added. Doc. No.: DIS/GDL/005 Revision Date: 29/9/2021 Review Due Date: 20/02/2025 Revision No.: 1 Effective Date: 20/02/2022 Page 1 of 46 Guideline for Registration and Licensing of Food Premises TABLE OF CONTENTS GUIDELINE DEVELOPMENT HISTORY..................................................................................1 TABLE OF CONTENTS.................................................................................................................3 ABBREVIATIONS AND ACCRONYMS......................................................................................5 DEFINITION OF TERMS...............................................................................................................6 CHAPTER 1. INTRODUCTION....................................................................................................8 1.1. SCOPE........................................................................................................................................8 1.2. CLASSIFICATION OF FOOD PREMISES...........................................................................8 1.2.1. FOOD MANUFACTURING FACILITIES.........................................................................8 1.2.2. FOOD OUTLETS...................................................................................................................8 1.2.2.1. WHOLESALERS OF FOOD PRODUCTS......................................................................8 1.2.2.2. RETAILERS OF FOOD PRODUCTS..............................................................................8 1.3. FOOD PRODUCTS REGULATED BY RWANDA FDA.....................................................9 CHAPTER 2. APPLICATION REQUIREMENTS FOR PREMISE REGISTRATION AND OPERATIONAL LICENSE................................................................................................10 2.1. GENERAL APPLICATION REQUIREMENTS.................................................................10 2.2. TYPES OF APPLICATIONS.................................................................................................10 2.2.1. NEW APPLICATION FOR PREMISE REGISTRATION.............................................10 2.2.2. RENEWAL FOR PREMISE REGISTRATION...............................................................10 2.2.3. VARIATION OF REGISTERED PREMISE....................................................................11 2.2.4. RE- INSPECTION OF FOOD PREMISE.........................................................................11 2.3. REQUIREMENTS FOR NEW PREMISE LICENSING....................................................11 2.3.1. PREREQUISITE TO APPLY FOR REGISTRATION AND LICENSING OF FOOD MANUFACTURING PREMISES......................................................................................11 2.3.2. REQUIREMENTS TO APPLY FOR REGISTRATION AND LICENSING OF FOOD MANUFACTURING PREMISES......................................................................................12 2.3.3. LICENSE TO OPERATE A WHOLESALE OF FOOD PRODUCTS...........................13 2.3.4. LICENSE TO OPERATE A RETAIL OF FOOD PRODUCTS......................................13 2.3.5. LICENSE TO OPERATE A RESTAURANT AND RELATED FOOD BUSINESSES..13 2.3.6. LICENSE TO OPERATE A WHOLESALE OR RETAIL OF FOOD SUPPLENMENTS AND/OR INFANT FORMULA SHOP BUSINESSES....................14 2. 4. RENEWAL OF PREMISE LICENSE.................................................................................15 2.5. VARIATION OF REGISTERED PREMISE.......................................................................15 2.6. REJECTION OF APPLICATION.........................................................................................16 Doc. No.: DIS/GDL/005 Revision Date: 29/9/2021 Review Due Date: 20/02/2025 Revision No.: 1 Effective Date: 20/02/2022 Page 3 of 46 Guideline for Registration and Licensing of Food Premises CHAPTER 3. INSPECTION OF PREMISES FOR SUITABILITY........................................17 3.1. LOCATION OF PREMISES FOR FOOD PREMISES......................................................17 3.2. BUILDING DESIGN OF PRODUCTION AREAS..............................................................17 3.3. FOOD EQUIPMENT, UTENSILS AND FOOD CONTACT SURFACE.........................18 3.4. PERSONNEL...........................................................................................................................18 3.5. STORAGE FACILITIES........................................................................................................18 3.6. SANITATION AND HYGIENE.............................................................................................19 3.7. DOCUMENTATION AND RECORD KEEPING...............................................................19 3.8. REGULAR WATER SUPPLY...............................................................................................19 3.9. CONTAINERS TO BE CLEANED.......................................................................................20 3.10. DESCRIPTIVE MATERIALS TO BE KEPT SECURE...................................................20 3.11. FIRE-FIGHTING EQUIPMENT.........................................................................................20 3.12. WEIGHING, MEASURING, TESTING AND RECORDING EQUIPMENT TO BE CHECKED............................................................................................................................20 3.13. QUALITY CONTROL AREAS...........................................................................................20 3.14. RECALLS, REJECT AND WITHDRAWAL OF PRODUCTS.......................................20 3.15. REGULATORY ACTIONS..................................................................................................21 CHAPTER 4. ADMINISTRATIVE SANCTIONS AND FINES...............................................22 REFERENCES................................................................................................................................23 ANNEXES.......................................................................................................................................24 ANNEX 1. LIST OF REQUIREMENTS FOR PREMISE REGISTRATION AND LICENSING OF FOOD PREMISES.................................................................................25 ANNEX 2. APPLICATION LETTER FORMAT AND APPLICATION FORM FOR PREMISE REGISTRATION AND LICENSING OF FOOD PREMISES....................33 ANNEX 3. FORMAT OF PREMISE INSPECTION REPORT................................................36 ANNEX 4. NARRATIVE REPORT FORMAT...........................................................................38 ANNEX 5. FORMATS OF LICENSES........................................................................................41 END OF THE DOCUMENT.........................................................................................................46 Doc. No.: DIS/GDL/005 Revision Date: 29/9/2021 Review Due Date: 20/02/2025 Revision No.: 1 Effective Date: 20/02/2022 Page 4 of 46 Guideline for Registration and Licensing of Food Premises ABBREVIATIONS AND ACCRONYMS Rwanda FDA: Rwanda Food and Drugs Authority RDB: Rwanda Development Board RCA: Rwanda Cooperative Agency Doc. No.: DIS/GDL/005 Revision Date: 29/9/2021 Review Due Date: 20/02/2025 Revision No.: 1 Effective Date: 20/02/2022 Page 5 of 46 Guideline for Registration and Licensing of Food Premises DEFINITION OF TERMS The following definitions are given for the purpose of these guidelines: “Authority” means RWANDA FOOD AND DRUGS AUTHORITY, or the acronyms Rwanda FDA established under the Law NO 003/2018 of 09/02/2018. “Business” includes professional practices and any activity carried on by a person of a body of persons in relation to products regulated under this Law N O 47/2012 of 14/01/2 “Director General” means the Chief Executive of the RWANDA FOOD AND DRUGS AUTHORITY appointed under Article 7 of the Law NO 003/2018 of 09/02/2018 “Equipment” mean machines, instrument, apparatus, utensil, or appliance, other than a single use item, used or intended to be used in or in connection with food handling and include any equipment used to or intended to be used to clean food. “Food” means any item other than pharmaceutical, cosmetic and tobacco used as food or drink for human beings and includes any substance used in manufacture or treatment of food. “Food manufacturing facilities” means premises where operations involve production, preparation, and processing, formulating, filling, refining, transformation packing, packaging, or re-packaging of food. “Food outlets” means premises where food is stored, sold, distributed, displayed for sale, or exhibited “Handling” includes the making, processing, producing, collecting, extracting, processing, storing, transporting, delivering, preparing, treating, preserving, packing, cooking, thawing, serving, or displaying of food. “Inspector” means any officer appointed, authorized or recognized under the Law Nº 003/2018 of 09/02/2018. Doc. No.: DIS/GDL/005 Revision Date: 29/9/2021 Review Due Date: 20/02/2025 Revision No.: 1 Effective Date: 20/02/2022 Page 6 of 46 Guideline for Registration and Licensing of Food Premises “Premises” includes building structures, basements, and vessels and in relation to any building including part of a building and any cartilage, forecourt, yard or places of storage used in connection with the building or part of that building and in relation to a vessel means ship, boat, aircraft and includes a carriage or receptacle of any kind. “Sell” means sell by wholesale or retail and include import, offer, exhibit, keep, expose, display, transmit, consign, convey or deliver for sale or authorize, direct or allow a sale, or prepare or possess for the purpose of sale and batter or exchange supply or dispose of to any person whether for a consideration or otherwise. Doc. No.: DIS/GDL/005 Revision Date: 29/9/2021 Review Due Date: 20/02/2025 Revision No.: 1 Effective Date: 20/02/2022 Page 7 of 46 Guideline for Registration and Licensing of Food Premises CHAPTER 1. INTRODUCTION 1.1. SCOPE This guideline shall be used for submission of documentation for registration and licensing of food premises. It describes the types of applications of food premises and food products regulated by Rwanda FDA, the minimum licensing requirements for registration, the procedures for approval and refusal of application, renewal of registration and variation of registered food premises, general requirements of any premise and administrative sanctions and penalties. 1.2. CLASSIFICATION OF FOOD PREMISES Food premises are classified in two major categories namely facilities for food manufacturers premises, and food outlets which includes wholesalers and retailers of food products. 1.2.1. FOOD MANUFACTURING FACILITIES Rwanda FDA classifies food manufacturing facilities based on production capacity. The criteria of classifying large scale and small-scale food manufacturing facilities are determined by national food value chain actors. 1.2.2. FOOD OUTLETS Rwanda FDA classifies food outlets according to their plant size, the source of goods, the quantity of food products and their role in the supply chain of food products. 1.2.2.1. WHOLESALERS OF FOOD PRODUCTS These are food businessmen conducting business ideally in bulks of food products from manufacturers and/or distributors; store them in warehouses prior to reselling to other businesses especially retailers. Wholesalers include food importers, food distributors and food warehouses. Any wholesaler involved in manufacturing/restaurant activities will be considered as a manufacturer/ restaurant. 1.2.2.2. RETAILERS OF FOOD PRODUCTS These are food dealers that sell processed food products from wholesalers and resell directly to consumers as the end-user for consumption and not for resale. They encompass supermarkets, canteens, boutiques, kiosk, food catering, drop shipping and any other of the kind. In this category, we also find food processing facilities that process food preserved for short-term /or cooked food with a short shelf life and sell directly to consumers. Doc. No.: DIS/GDL/005 Revision Date: 29/9/2021 Review Due Date: 20/02/2025 Revision No.: 1 Effective Date: 20/02/2022 Page 8 of 46 Guideline for Registration and Licensing of Food Premises These include hotels kitchen, restaurants, snack bars, cafeteria, smoothies, milk shop, drinking water shop, public barbeques, food truck/van, street food vendors and any of the kind. Any retailer involved in wholesale/manufacturing activities will be considered as a wholesaler or a manufacturer. 1.3. FOOD PRODUCTS REGULATED BY RWANDA FDA In reference to Law Nº 003/2018 of 09/02/2018, Rwanda FDA has been mandated to regulate processed foods, fortified foods, food supplements and animal feeds. Processed foods are defined as food products transformed from their original state to extend/prolong their shelf life, packaged, labeled complying to all specified standards, and ready for consumption. In other words, any food other than a raw agricultural commodity that has been subjected to processing including but not limited to canning, cooking, freezing, dehydration, and milling or changed in nutritional composition with fortifying, preserving or preparing in a different way. A list of main processed foods includes but not limited to: a) Cereals and cereal products (maize flour, rice, wheat flour, …) b) Alcoholic beverages (beer, wine, liquors etc.…) c) Non-alcoholic beverages (soft drinks, juice etc. …) d) Drinking water e) Coffee and tea products f) Milk and milk products (fermented milk, yogurt,...) g) Bakery products and pastries (bread, donuts, …) h) Processed meat products and fish products i) Animals feeds j) Edible salt, sweeteners, honey, and confectionaries k) Fats and oils l) Spices, soups, sauces, salads and proteins, processed vegetables, processed fruits m) Infant formulae, complementary foods for infants n) Food supplements o) Cooked food Any organization or company intended to manufacture/process, store, distribute and retail any food falling into these categories or any food product which will be defined by Rwanda FDA shall request authorization. Doc. No.: DIS/GDL/005 Revision Date: 29/9/2021 Review Due Date: 20/02/2025 Revision No.: 1 Effective Date: 20/02/2022 Page 9 of 46 Guideline for Registration and Licensing of Food Premises CHAPTER 2. APPLICATION REQUIREMENTS FOR PREMISE REGISTRATION AND OPERATIONAL LICENSE 2.1. GENERAL APPLICATION REQUIREMENTS 2.1.1. Any organization, a company or individual, who intends to do business related to processed food for human and animal consumption either production, packaging/re-packaging and labeling, storage, and distribution shall apply for registration of premise and license of carrying out such a food business. 2.1.2. In order to adhere to the legal requirements, the applicant has to follow the instructions prescribed in these guidelines. These guidelines are available from RWANDA FDA headquarter office or via the official website of Rwanda FDA. 2.1.3. All applications should be sent to Rwanda FDA via the electronic system. 2.1.4. An application for premise registration either processing facility or food outlet shall be made according to the details provided below; 2.2. TYPES OF APPLICATIONS For the purposes of submission of premises registration dossier to Rwanda FDA, applications are classified into four categories as follows: 2.2.1. New application for premise registration New application is any application requesting for registration in Rwanda FDA for the first time with intention to open a food premise. Such license has a validity of one year. The premise license grants the authorization to manufacture food products but does not translate into authorization to sell the products. Therefore, after approval for premise license, the applicant should obtain product license before release products on market. The duration for processing applications for manufacturing facilities and food outlets should not exceed 30 working days from the application date unless they don’t comply. 2.2.2. Renewal for premise registration Any application for renewal of a registered premise is considered as license renewal. This application shall be made at least one (1) month before the expiry of existing registration. Doc. No.: DIS/GDL/005 Revision Date: 29/9/2021 Review Due Date: 20/02/2025 Revision No.: 1 Effective Date: 20/02/2022 Page 10 of 46 Guideline for Registration and Licensing of Food Premises 2.2.3. Variation of registered premise Application for any change made in the registered premise is considered as variation of the license. Any change shall be communicated to Rwanda FDA. These changes may be change of ownership, change of responsible technician, change of location, additional line of production, opening a new branch or any other change different from the previously submitted application. 2.2.4. Re- inspection of food premise Re-inspection shall be carried out after unsuccessful initial premise licensing inspection(s), and will attract an inspection fee in addition to the application fee paid. Applicants shall notify Rwanda FDA of changes made to comply with the set recommendations, by submitting the following requirements; 1) Re-inspection application letter addressed to the Director General of Rwanda FDA, mentioning the proposed dates. 2) The proof of payment of prescribed re-inspection fees 3) A Corrective and Preventive Actions (CAPA) report, detailing what has been implemented with respective visual proof and timelines for non-implemented recommendations. 2.3. REQUIREMENTS FOR NEW PREMISE LICENSING 2.3.1. PREREQUISITE TO APPLY FOR REGISTRATION AND LICENSING OF FOOD MANUFACTURING PREMISES Applicants should fulfill the prerequisites as detailed below prior to new application for premise licensing. Applicants should apply for: A. Site location approval The Authority shall approve the site location for food product manufacturers after satisfactory review of the following preliminary documents: 1) Letter of intent 2) Site master plan (indicating the location /plan of the premise and the surroundings activities) 3) Environmental impact assessment B. Architectural Plan Approval; The applicant shall submit the following documents: 1) Approval letter for site location from the Authority 2) Architecture plan showing but not limited to the following: Doc. No.: DIS/GDL/005 Revision Date: 29/9/2021 Review Due Date: 20/02/2025 Revision No.: 1 Effective Date: 20/02/2022 Page 11 of 46 Guideline for Registration and Licensing of Food Premises i) Production process flow chart. ii) Sanitation facilities (Clean water and waste water treatment system) iii) Mechanical ventilation /Air handling unit /Heat, Ventilation and Air Conditioning (HVAC). iv) Construction and process materials (food grade material) v) Finishing materials (food production floor, ceiling and walls should be seamless, easy to clean). 2.3.2. REQUIREMENTS TO APPLY FOR REGISTRATION AND LICENSING OF FOOD MANUFACTURING PREMISES A complete application for opening and/or operating a food manufacturing premise shall include the following documents: 1. Application letter addressed to Director General (See format, annex 2, p.34) 2. A duly filled application form for premises registration of food premise. (See annex 2, p.35) 3. Certificate of Rwanda Development Board (RDB) or Certificate of Rwanda Cooperative Agency (if applicable) showing the owner or representative of the company, the exact current physical location and scope. 4. Identity card or Passport of the representative (Owner, Managing Director, or any legal representative of the premise). 5. Recent passport photo of the representative (owner, managing director or any legal representative). 6. Proof of Payment of prescribed fees to Rwanda FDA Accounts 7. Most recent Plant layout / architectural site plan. 8. Process flowchart(s) of the products. 9. Lease contract of the premise of at least one year (if applicable) 10. Notarized degree of qualified responsible technician or notarized equivalence of degree if the degree was issued abroad. 11. Curriculum vitae of the responsible technician. 12. Contract of the technician with the company (of at least one year). 13. Commitment letter of the technician attesting the assurance of food safety addressed to Director General of Rwanda FDA. 14. Identity card or passport of the responsible technician 15. Recent passport photo of the responsible technician. Note: 1. The qualified technician should have at least a bachelor’s degree in Food sciences, Food Microbiology or Biotechnology. However, other qualifications, or other educational levels of study may be accepted after analysis and approval by the Authority. 2. The above requirements shall also apply to applicants engaged in reprocessing, partial processing including but not limited to food fortification, packaging and re-packaging. Doc. No.: DIS/GDL/005 Revision Date: 29/9/2021 Review Due Date: 20/02/2025 Revision No.: 1 Effective Date: 20/02/2022 Page 12 of 46 Guideline for Registration and Licensing of Food Premises 2.3.3. LICENSE TO OPERATE A WHOLESALE OF FOOD PRODUCTS A complete application for opening and/or operate a wholesale of food products shall include the following documents: 1. Application letter addressed to Director General (See format, annex 2, p.34) 2. A duly filled application form for premises registration of food premise (See annex 2, p.35) 3. Certificate of Rwanda Development Board (RDB) or Certificate of Rwanda Cooperative Agency (if applicable) showing the owner or representative of the company. 4. Identity card or Passport of the representative (Owner, Managing Director or any legal representative of the premise). 5. Recent passport photo of the representative (owner, managing director or any legal representative) 6. Proof of payment of the prescribed fees to Rwanda FDA Accounts 7. Lease contract of the premise of at least one year (If applicable) Note: The space should be suitable and exclusively reserved for food products. 2.3.4. LICENSE TO OPERATE A RETAIL OF FOOD PRODUCTS A complete application for opening and/or operating a retail of food shall include the following documents: 1. Application letter addressed to Director General ( See format, annex 2, p. 34) 2. A duly filled application form for premises registration of food premise (See annex 2, p. 35) 3. Certificate of Rwanda Development Board (RDB) or Certificate of Rwanda Cooperative Agency (if applicable) showing the owner or representative of the company. 4. Identity card or Passport of the representative (Owner, Managing Director or any legal representative of the premise). 5. Recent passport photo of the representative (owner, managing director or any legal representative) 6. Proof of Payment of the prescribed fees to Rwanda FDA accounts. Note: The space should be suitable and exclusively reserved for food products. 2.3.5. LICENSE TO OPERATE A RESTAURANT AND RELATED FOOD BUSINESSES A complete application for opening and/or operate a Restaurant or related businesses shall include the following documents: 1. Application letter addressed to Director General ( See format annex 2, p. 34) 2. A duly filled application form for premises registration of food premise (See annex 2, p.35) 3. Certificate of Rwanda Development Board (RDB) or Certificate of Rwanda Cooperative Agency (if applicable) showing the owner or representative of the company. Doc. No.: DIS/GDL/005 Revision Date: 29/9/2021 Review Due Date: 20/02/2025 Revision No.: 1 Effective Date: 20/02/2022 Page 13 of 46 Guideline for Registration and Licensing of Food Premises 4. Identity card or Passport of the representative (Owner, Managing Director or any legal representative of the premise). 5. Recent passport photo of the representative (owner, managing director or any legal representative) 6. Proof of Payment of the prescribed fees to Rwanda FDA Accounts 7. Lease contract of the premise of at least one year (if applicable) 8. Qualification of the Specialized personnel 7. Curriculum Vitae of responsible specialized personnel 8. Contract of specialized personnel 9. Identity card or Passport of specialized personnel 10. Recent passport photo of specialized personnel Note: The specialized personnel should have at least a diploma of food processing or culinary arts. However, other qualifications, or other educational levels of study may be accepted after analysis and approval by the Authority. 2.3.6. LICENSE TO OPERATE A WHOLESALE OR RETAIL OF FOOD SUPPLENMENTS AND/OR INFANT FORMULA SHOP BUSINESSES A complete application for opening and/or operate a wholesale or retail of food supplements/ infant formula shall include the following documents: 1. Application letter addressed to Director General (See format, annex 2, p. 30) 2. A duly filled application form for premises registration of food premise (See annex 2, p. 31) 3. Certificate of Rwanda Development Board (RDB) or Certificate of Rwanda Cooperative Agency (if applicable) showing the owner or representative of the company 4. Identity card or Passport of the representative (Owner, Managing Director or any legal representative of the premise). 5. Recent passport photo of the representative (owner, managing director or any legal representative) 6. Proof of Payment of the prescribed fees to Rwanda FDA Accounts 7. Lease contract of the premise with at least one year (if applicable) 8. A Degree of the Responsible Technician (notarized) 9. A Valid License to Practice Profession of the Responsible Technician (notarized) 10. Curriculum Vitae of Responsible Technician 11. Professional agreement or Contract of Responsible Technician 12. Written commitment of the Responsible Technician. 13. Identity card or Passport of Responsible Technician 14. Recent photo passport of Responsible Technician Note: Doc. No.: DIS/GDL/005 Revision Date: 29/9/2021 Review Due Date: 20/02/2025 Revision No.: 1 Effective Date: 20/02/2022 Page 14 of 46 Guideline for Registration and Licensing of Food Premises 1. For establishments dealing with retail of food supplements, the premise shall have a minimum space of 40m2 as a which can be separated into a minimum sales area of 30m2 and 10m2 for storage in Kigali and secondary cities; For the rest of the country, for retail of food supplements, the premise shall have a minimum space of 30m2 which that can be separated into a minimum sales area of 20m2 and 10m2 for storage. 2. For wholesale of food supplements, the premise shall have a minimum space of 70m2 which that can be separated into a minimum sales area of 20m2 and 50m2 for storage. 3. The premise of food supplements should a standard alone premise or the products may be sold in pharmacy. 4. The qualified technician should have at least a bachelor’s degree in Nutrition with a valid license to Practice the Profession. However, other qualifications, or other educational levels of study may be accepted after analysis and approval by the Authority. 2. 4. RENEWAL OF PREMISE LICENSE 2.4.1. An authorization shall be renewed after one year from the date it was issued. 2.4.2. The applicant must apply for renewal of license at least one (1) month before the expiration date. 2.4.3. Renewal of premise license shall be done through Rwanda FDA official email or electronic system by submitting the updated version of the documents required for new application with the original license of the previous year. (See annex 3) 2.3.4. Dealers who shall delay to renew their licenses beyond the expiration date shall be required to pay the prescribed fee together with administrative fines described in the regulation related to the regulatory service, tariff/fees and fines. Failing to do so, the premises shall be closed down. 2.5. VARIATION OF REGISTERED PREMISE 2.5.1. Application for change of location (shift of premises), change of type of business, trade name of the premises, ownership, change of responsible technician, additional line of production, additional branch, suspension or termination of premise operations or any other change of registered premises shall be addressed to the Director General. 2.5.2. Change of location or type of business shall be treated as a new application. Therefore, the application procedure for new premise as prescribed in these guidelines shall apply. Doc. No.: DIS/GDL/005 Revision Date: 29/9/2021 Review Due Date: 20/02/2025 Revision No.: 1 Effective Date: 20/02/2022 Page 15 of 46 Guideline for Registration and Licensing of Food Premises 2.5.3. The rest of variations of the operational license shall be done by submitting the updated version of the documents required for specific variation with the original license, specifying the current variation made. 2.5.4. Before receipt of notification for any changes made, the applicant shall be required to pay the respective service fees. 2.5.5. The Authority shall process and effect the necessary changes for any variations and the previous license shall cease to have effect from the date of issuance of the amended license. 2.5.6. Whenever a premise registration holder wishes to terminate the registration, he/she shall notify the Authority in writing at least thirty (30) days prior to date of termination, giving reasons thereof. 2.6. REJECTION OF APPLICATION 2.6.1. Incomplete application that will dormant for a period exceeding 3 months shall be rejected and the applicant shall be required to apply again, with prescribed fees applicable. 2.6.2. Applicants whose applications have been withheld for any reason shall be required to carry out rectification or give a clarification within 3 months before they are eligible for consideration. After the elapse of this period, the application shall be withdrawn automatically. Doc. No.: DIS/GDL/005 Revision Date: 29/9/2021 Review Due Date: 20/02/2025 Revision No.: 1 Effective Date: 20/02/2022 Page 16 of 46 Guideline for Registration and Licensing of Food Premises CHAPTER 3. INSPECTION OF PREMISES FOR SUITABILITY The Authority shall inspect the premises to determine suitability of the food premises. The premises that do not comply with the requirements for suitability shall not be eligible for premises licensing. Food premises requirements include, but not limited to the following; 3.1. LOCATION OF PREMISES FOR FOOD PREMISES 3.1.1 The food premise shall be a permanent nature, located away from sites or activities that emit obnoxious material like fumes, dust, smoke, offensive trade or breeding sites for vermin. 3.1.2. The food premise should have sufficient space for the carrying out and supervision of the necessary operations. 3.1.2 Physical address of the premise where the business is to be carried out shall be clearly indicated in the application form to include plot and house numbers, street, district, province and coordinates as this will facilitate easy reach during supervision and inspection. 3.1.4. The food premise should be located within commercial or industrial area. 3.2. BUILDING DESIGN OF PRODUCTION AREAS 3.2.1. The food premises shall be designed for the intended purpose and shall have no direct link with any business or occupation that may lead to contamination of food. 3.2.2. The premises shall be of suitable layout, constructed to facilitate easy maintenance and sanitation and good flow of operations. 3.2.3. The food premises and facilities installed shall have: a) Sufficient space for placement and storage of materials, which are necessary for sanitary operations. b) Adequate space, either by partition, location or other effective means for those operations, which may cause contamination of food; c) Sufficient lighting and ventilation to enable all operations to be carried out satisfactorily and safely. d) Maximum protection against rodents, birds, vermin etc. e) The floor, walls and ceiling of food premises shall be adequately seamless cleanable and maintained in a clean and good state of repair. f) The fixtures, ducts and pipes shall not be suspended over areas where drips or condensate may contaminate food and raw materials or food contact surfaces. g) Aisles or working spaces between equipment and walls shall be unobstructed and of sufficient width to allow employees to perform their duties without contaminating the food or food contact surface with their clothing or personal contact. Doc. No.: DIS/GDL/005 Revision Date: 29/9/2021 Review Due Date: 20/02/2025 Revision No.: 1 Effective Date: 20/02/2022 Page 17 of 46 Guideline for Registration and Licensing of Food Premises 3.3. FOOD EQUIPMENT, UTENSILS AND FOOD CONTACT SURFACE 3.3.1. Every utensil and equipment used in food premises shall be suitable for their intended use and food grade; well designed and adequately cleanable and proper maintenance of cold chain for frozen products. 3.3.2. Every food contact surface shall be smooth and impervious, free from pits, crevices and loose scale, non-toxic, and capable of withstanding repeated cleaning disinfection and sanitization. 3.3.3. Utensils, crockery, cutlery, and other equipment coming in contact with food shall be sufficient in number to enable adequate sanitization before reuse. Single service articles shall be stored in appropriate containers and handled, dispensed, used and disposed to prevent contamination of food or food contact surfaces. 3.3.4. There shall be transportation/ channeling means for food products that limits human interaction and/ or cross-contamination risk, and they shall be made in food grade materials. 3.4. PERSONNEL 3.4.1. Every food premise should present the Managing Director and Responsible technician (if applicable). 3.4.2. The responsible technician should present the degree or certificate with required qualification. 3.4.3. The premise shall have trained personnel from a recognized institution. 3.4.4. Any person who owns a food business shall ensure that persons suffering from communicable diseases shall not be involved in handling of food or food contact surfaces. 3.4.5. Thorough medical examination for food handlers shall be carried out prior to employment and after every six months. 3.4.6. Medical examination records for each worker shall be kept properly and accessible for inspection. The records shall be kept and maintained for not less than two years. 3.4.7 Any responsible technician wishing to resign from his/her responsibilities shall inform the authority with a resignation letter signed by both the employer and the employee. This shall result into suspension of production until a new responsible technician is hired. 3.5. STORAGE FACILITIES 3.5.1. Storage facilities shall protect products from deterioration and the specified storage conditions shall be monitored and maintained accordingly. 3.5.2. Controlled storage environment/facilities e.g. air conditions, refrigeration for cold chain products shall be made available and monitored using suitable temperature recording devices and records reviewed and filed. 3.5.3. All food products shall be stored off the floor in well-fitted shelves or pallets. Doc. No.: DIS/GDL/005 Revision Date: 29/9/2021 Review Due Date: 20/02/2025 Revision No.: 1 Effective Date: 20/02/2022 Page 18 of 46 Guideline for Registration and Licensing of Food Premises 3.5.4. Storage facilities for grains should be monitored for humidity, temperature and pests and records should be kept properly. 3.6. SANITATION AND HYGIENE All food premises shall be provided with adequate and easily accessible sanitary conveniences to cater separately for both genders, for employees and/or customers. 3.6.1. There shall be adequate and readily available potable water supply; hot and cold running water to be used for the intended operation or use. 3.6.2. There shall be a proper system of waste disposal. 3.6.3. There shall be provision of protective gears and occupation health facilities. 3.6.4. Food handlers shall be clean in person and shall avoid unhygienic practices such as smoking, sneezing and coughing over food, nose picking, finger licking, talking over food etc. 3.6.5. There shall be adequate provision for hand washing facilities with hot and cold running water, nail brushes and disinfectant liquid soap. To avoid recontamination of hands there shall be automatic or elbow or foot operated water taps. 3.6.6. Doors may be designed to open by pushing from all sides or self-operating doors to avoid contaminating the food handler's hands. 3.7. DOCUMENTATION AND RECORD KEEPING Any person who owns a food business shall make available the following documents/records: a) Food import licenses and/or purchasing documents b) Sanitation and fumigation documents c) Ledger book or an appropriate inventor control system d) Visitors' book e) Sales receipts (wholesalers) f) Inspection log book g) Medical examination records where applicable h) Complaints handling book i) Register for expired/ recalled / rejected/ withdrawn food products j) Food Hygiene Regulation k) Standard of the product being manufactured 3.8. REGULAR WATER SUPPLY 1) The premises shall have a regular and sufficient supply of water. 2) Water treatment plants and distribution systems should be designed, constructed and maintained so as to ensure a reliable source of water of an appropriate quality. Doc. No.: DIS/GDL/005 Revision Date: 29/9/2021 Review Due Date: 20/02/2025 Revision No.: 1 Effective Date: 20/02/2022 Page 19 of 46 Guideline for Registration and Licensing of Food Premises 3) The chemical and microbiological quality of water used in production should be specified and monitored. 4) Water for injections should be produced, stored and distributed in a manner which prevents microbial growth, for example by constant circulation at a temperature above 70°C. 3.9. CONTAINERS TO BE CLEANED All processing containers, vessels and utensils shall be cleaned and labeled as such before they are stored and shall be rechecked for cleanliness before being issued out to the manufacturing areas. 3.10. DESCRIPTIVE MATERIALS TO BE KEPT SECURE 1) All product labels, printed packaging and descriptive materials shall: a. Be stored in a secure manner; and b.Be accessed by only authorized personnel. 2) Proper records shall be kept for the labels, printed packaging and descriptive materials issued, to avoid any mix-up. 3.11. FIRE-FIGHTING EQUIPMENT The premises shall have sufficient fire-fighting equipment which shall, at all times, be in good condition and readily accessible. 3.12. WEIGHING, MEASURING, TESTING AND RECORDING EQUIPMENT TO BE CHECKED The equipment used for weighing, measuring, testing and recording shall be subjected to recorded checks for accuracy in accordance with a regular set schedule. 3.13. QUALITY CONTROL AREAS 1) Quality Control laboratories shall be separated from production areas. This is particularly important for laboratories for the control of biological, microbiological and radioisotopes, which shall also be separated from each other. 2) Quality Control laboratories shall be designed to suit the operations to be carried out in them. Sufficient space shall be given to avoid mix-ups and cross- contamination. There shall be adequate suitable storage space for samples and records. 3) Separate rooms may be necessary to protect sensitive instruments from vibration, electrical interference, humidity, etc. 3.14. RECALLS, REJECT AND WITHDRAWAL OF PRODUCTS 3.8.1. The applicant shall show a capacity to prompt and effective system of traceability and recall from the market of products known or suspected to be defective or hazardous, Doc. No.: DIS/GDL/005 Revision Date: 29/9/2021 Review Due Date: 20/02/2025 Revision No.: 1 Effective Date: 20/02/2022 Page 20 of 46 Guideline for Registration and Licensing of Food Premises 3.8.2. In case of recall of product initiated by the dealer himself, the Authority shall be notified of the reason for recall. 3.8.3. Recall operations shall be capable of being initiated promptly, at least down to the level of retailers. 3.8.4. The distribution records shall be readily available to the person(s) responsible for recalls and they shall contain sufficient information related to the product, e.g. Name of product, Manufacturer, Dates of Manufacture and Expire, and Batch Number. 3.8.5. The disposal of recalled/rejected/withdrawn products from the market shall be effected within one month after completion of exercise. Disposal exercise shall be carried under supervision of Rwanda FDA Inspectors/ Food Inspectors and representatives from other Government Institutions. 3.15. REGULATORY ACTIONS a) The following section provides the regulatory actions that shall be taken by the Authority when making decisions on the inspections findings. b) The Authority shall take the regulatory actions based on Minor, Major and Critical category of non-compliances: 1⁰ Referred to the inspection findings, minor non-compliances imply a recommended corrective action within a given time frame and are requested for compliance reports. 2⁰ Referred to the inspection findings, major non-compliances imply issuing a warning letter, recommend corrective action within a given time frame, recommend temporary withdrawal or suspension of operational license, request for comprehensive compliance report, follow-up inspection to verify implementation if necessary. 3⁰ Referred to the inspection findings, critical non-compliances imply temporarily closure of the establishment, permanent withdrawal/revocation of operational license, not granting the operational license. c) The above- mentioned non-compliances shall be detailed in other regulatory documents (e.g.: Standard Operating Procedures). Doc. No.: DIS/GDL/005 Revision Date: 29/9/2021 Review Due Date: 20/02/2025 Revision No.: 1 Effective Date: 20/02/2022 Page 21 of 46 Guideline for Registration and Licensing of Food Premises CHAPTER 4. ADMINISTRATIVE SANCTIONS AND FINES 4.1.1. The authority shall cancel, suspend or withdraw the license to operate a food processing premise/ food outlet if: a) The circumstances under which it was licensed no longer exist b) The grounds on which it was licensed are later found to be false or any provision under which it was licensed has been contravened. 4.1.2. A warning letter may be issued to the applicant or the authorization be suspended or revoked where the Authority finds the applicant not complying with any of the requirements or conditions in this guideline or has ceased to be fit to carry on the business. 4.1.3. Where non- adherence to this guideline results in exposure of consumers to food safety risk, the Authority may consider prosecution. 4.1.3. Administrative fines are provided in the Regulations related to regulatory service tariff/fees and fines available on Rwanda FDA website. Doc. No.: DIS/GDL/005 Revision Date: 29/9/2021 Review Due Date: 20/02/2025 Revision No.: 1 Effective Date: 20/02/2022 Page 22 of 46 Guideline for Registration and Licensing of Food Premises REFERENCES 1. Law nº 003/2018 of 09/02/2018 establishing Rwanda food and drugs authority and determining its mission, organization and functioning. 2. Rwanda FDA. 2019. Guideline for registration and licensing of food premises. Rev.0 3. TFDA. 2011. Guidelines for registration and licensing of food premises. 4. FDA Ghana. 2013. Guideline of Licensing of Manufacturing facility (Revised on 20th April 2020). Doc. No.: DIS/GDL/005 Revision Date: 29/9/2021 Review Due Date: 20/02/2025 Revision No.: 1 Effective Date: 20/02/2022 Page 23 of 46 Guideline for Registration and Licensing of Food Premises ANNEXES 1. LIST OF REQUIREMENTS FOR PREMISE REGISTRATION AND LICENSING OF FOOD PREMISES 2. APPLICATION LETTER AND APPLICATION FORM FOR PREMISE REGISTRATION AND LICENSING OF FOOD PREMISES 3. FORMAT OF PREMISE INSPECTION REPORT 4. NARATIVE REPORT FORMAT 5. FORMATS OF LICENSES Doc. No.: DIS/GDL/005 Revision Date: 29/9/2021 Review Due Date: 20/02/2025 Revision No.: 1 Effective Date: 20/02/2022 Page 24 of 46 Guideline for Registration and Licensing of Food Premises ANNEX 1. LIST OF REQUIREMENTS FOR PREMISE REGISTRATION AND LICENSING OF FOOD PREMISES Doc. No.: DIS/GDL/005 Revision Date: 29/9/2021 Review Due Date: 20/02/2025 Revision No.: 1 Effective Date: 20/02/2022 Page 25 of 46 Guideline for Registration and Licensing of Food Premises QMS N0: DIS/CKL/082 Revision No: 0 Effective Date: 21/02 2022 Ref. Doc: Guidelines DIS/GDL/005 P.O. Box 1948 Kigali [email protected] www.rwandafda.gov.rw 0.A. SITE LOCATION APPROVAL Premise name : …………………….……………………………………… Date : …./…../...… Documents YES NO 1 Letter of intent 2 Site master plan (indicating the location /plan of the premise and the surroundings activities) 3 Environmental impact assessment 0.B. ARCHITECTAL PLAN APPROVAL Premise name : …………………………………………………………. Date : …./…../...…. Documents YES NO 1 Approval letter for site location from the Authority 2 Architecture plan showing but not limited to the following: 3 i) Production process flow chart. ii) Sanitation facilities (Clean water and waste water treatment system) iii) Mechanical ventilation /Air handling unit /Heat, Ventilation and Air Conditioning (HVAC). iv) Construction and process materials (food grade material) v) Finishing materials (food production floor, ceiling and walls should be seamless, easy to clean). Doc. No.: DIS/GDL/005 Revision Date: 29/9/2021 Review Due Date: 20/02/2025 Revision No.: 1 Effective Date: 20/02/2022 Page 26 of 46 Guideline for Registration and Licensing of Food Premises QMS N0: DIS/CKL/067 Revision No: 1 Effective Date: 21/02 2022 Ref. Doc: Guidelines DIS/GDL/005 P.O. Box 1948 Kigali [email protected] www.rwandafda.gov.rw I. REQUIREMENTS FOR PREMISE REGISTRATION AND Additional branch Change ownership Change technician LICENSING OF FOOD MANUFACTURING PREMISE Change location New application Additional line Premise name: ……………………………..………………………… Renewal Date : …./…../...…. Documents YES NO 1 Application letter addressed to Director General 2 A dully filled application form for premises registration and licensing of food premise 3 Certificate of RDB / RCA 4 The Identity Card/Passport of the Managing Director or representative 5 Recent photo passport of the managing Director or representative 6 Proof of Payment of the prescribed fees to Rwanda FDA Account. 7 Most recent plant layout/ architectural site plan 8 Process flowchart(s) 9 Lease contract of the premise at least one year (if applicable) Certificate of qualified personnel (notarized) or equivalent 10 degree of technician (notarized) Curriculum vitae of the responsible technician 11 12 Copy of work contract between employer and responsible technician 13 Letter of commitment of the responsible technician 14 Identity Card/Passport of the responsible technician 15 Recent photo passport of the responsible technician 16 Original license Doc. No.: DIS/GDL/005 Revision Date: 29/9/2021 Review Due Date: 20/02/2025 Revision No.: 1 Effective Date: 20/02/2022 Page 27 of 46 Guideline for Registration and Licensing of Food Premises QMS N0: DIS/CKL/079 Revision No: 0 Effective Date: 21/02/2022 Ref. Doc: Guidelines DIS/GDL/005 P.O. Box 1948 Kigali [email protected] www.rwandafda.gov.rw REQUIREMENTS FOR RE – INSPECTION Premise name: ………………………………………………… ………..… Date : …../….../...…. Documents YES NO 1 Re-inspection application letter addressed to the Director General of Rwanda FDA, mentioning the proposed dates. 2 The proof of payment of prescribed re-inspection fees 3 A Corrective Actions and Preventive Actions (CAPA) report, detailing what has been implemented with respective visual proof and timelines for non-implemented recommendations. Doc. No.: DIS/GDL/005 Revision Date: 29/9/2021 Review Due Date: 20/02/2025 Revision No.: 1 Effective Date: 20/02/2022 Page 28 of 46 Guideline for Registration and Licensing of Food Premises QMS N0: DIS/CKL/081 Revision No: 0 Effective Date: 21/02 2022 Ref. Doc: Guidelines DIS/GDL/005 P.O. Box 1948 Kigali [email protected] www.rwandafda.gov.rw II. REQUIREMENTS FOR PREMISE REGISTRATION Change ownership Additional branch AND LICENSING OF WHOLESALE OF FOOD Change location New application PRODUCTS Premise name : ………………………………………………………… Renewal Date : ……./….../...…. Documents YES NO 1 Application letter addressed to Director General 2 Application form for premises registration and licensing of food premise 3 Certificate of RDB / RCA 4 The Identity Card/Passport of the managing Director or representative 5 Recent photo passport of the managing Director or representative 6 Proof of Payment of prescribed fees to Rwanda FDA Accounts. 7 Lease contract of the premise at least one year (if applicable) 8 Original license Doc. No.: DIS/GDL/005 Revision Date: 29/9/2021 Review Due Date: 20/02/2025 Revision No.: 1 Effective Date: 20/02/2022 Page 29 of 46 Guideline for Registration and Licensing of Food Premises QMS N0: DIS/CKL/080 Revision No: 0 Effective Date: 21/02 2022 Ref. Doc: Guidelines DIS/GDL/005 P.O. Box 1948 Kigali [email protected] www.rwandafda.gov.rw III. REQUIREMENTS FOR PREMISE REGISTRATION Change ownership Additional branch AND LICENSING OF RETAIL OF FOOD PRODUCTS Change location New application Premise name: ………………………………………………………….. Renewal Date : ……./….../...…. Documents YES NO 1 Application letter addressed to Director General 2 Application form for premises registration and licensing of food premise 3 Certificate of RDB / RCA 4 The Identity Card/Passport of the managing Director or representative 5 Recent photo passport of the managing Director or representative 6 Proof of Payment of prescribed fees to Rwanda FDA Accounts. 7 Original license Doc. No.: DIS/GDL/005 Revision Date: 29/9/2021 Review Due Date: 20/02/2025 Revision No.: 1 Effective Date: 20/02/2022 Page 30 of 46 Guideline for Registration and Licensing of Food Premises QMS N0: DIS/CKL/083 Revision No: 0 Effective Date: 21/02 2022 Ref. Doc: Guidelines DIS/GDL/005 P.O. Box 1948 Kigali [email protected] www.rwandafda.gov.rw IV. REQUIREMENTS FOR PREMISE Change ownership Change technician Additional branch REGISTRATION OF RESTAURANT AND/OR Change location New application RELATED PREMISES Premise name: …………………………………………………. Renewal Date :……./…../...…. Documents YES NO 1 Application letter addressed to Director General 2 A duly filled application form for premises registration of food premise. 3 Certificate of RDB or RCA (if applicable) 4 Identity card or Passport of the representative (Owner, Managing Director or any legal representative of the premise). 5 Recent passport photo of the representative (owner, managing director or any legal representative) 6 Proof of Payment of prescribed fees to Rwanda FDA Accounts. 7 Plant layout 8 Lease contract of the premise of at least one year (if applicable) 9 Qualification of the Specialized personnel 10 Curriculum Vitae of responsible specialized personnel 11 Contract of specialized personnel 12 The Identity card/ passport photo of specialized personnel 13 Recent passport photo of specialized personnel 14 Original license Doc. No.: DIS/GDL/005 Revision Date: 29/9/2021 Review Due Date: 20/02/2025 Revision No.: 1 Effective Date: 20/02/2022 Page 31 of 46 Guideline for Registration and Licensing of Food Premises QMS N0: DIS/CKL/069 Revision No: 1 Effective Date: 21/02 2022 Ref. Doc: Guidelines DIS/GDL/005 P.O. Box 1948 Kigali [email protected] www.rwandafda.gov.rw IV. V. REQUIREMENTS FOR PREMISE REGISTRATION OF Change ownership Change technician WHOLESALE/ RETAIL OF FOOD SUPPLEMENTS Additional branch Change location New application AND/OR INFANT FORMULA Premise name : ………………………………………………….. Renewal Date : …./…../...…. Documents YES NO 1 Application letter addressed to Director General 2 A duly filled application form for premises registration of food premise. 3 Certificate of RDB 4 The copy of Identity Card/Passport of the owner 5 Lease contract of the premise at least one year (if applicable) 6 Proof of payment of the prescribed fees to Rwanda FDA Accounts 7 A Degree of Responsible Technician (notarized) or equivalent degree of technician (notarized) if granted abroad (notarized) 8 A Valid License to Practice the Profession of Responsible Technician (notarized) 9 A Curriculum Vitae of the Responsible Technician 10 Commitment letter of the Responsible Technician. 11 Signed Professional agreement/ Contract 12 The Identity Card/Passport of the Responsible Technician 13 Recent photo passport of the Responsible Technician 14 Original license Doc. No.: DIS/GDL/005 Revision Date: 29/9/2021 Review Due Date: 20/02/2025 Revision No.: 1 Effective Date: 20/02/2022 Page 32 of 46 Guideline for Registration and Licensing of Food Premises ANNEX 2. APPLICATION LETTER FORMAT AND APPLICATION FORM FOR PREMISE REGISTRATION AND LICENSING OF FOOD PREMISES Doc. No.: DIS/GDL/005 Revision Date: 29/9/2021 Review Due Date: 20/02/2025 Revision No.: 1 Effective Date: 20/02/2022 Page 33 of 46 Guideline for Registration and Licensing of Food Premises APPLICATION LETTER Dear Sir/ Madam, Subject: Application for premise registration of < company name/ cooperative name> We are pleased to submit our application dossier for a registration of our premise registered under TIN number located in. The company is directed by and the food products are under responsibility of. We are a of with brand name. We. Your sincerely,. Doc. No.: DIS/GDL/005 Revision Date: 29/9/2021 Review Due Date: 20/02/2025 Revision No.: 1 Effective Date: 20/02/2022 Page 34 of 46 Guideline for Registration and Licensing of Food Premises Rwanda Food and Drugs Authority Format: DIS/FORM/169 Rue. KG 9 Avenue, Nyarutarama Plaza Revision No: 1 P.O. Box 1948, Kigali, Rwanda. Effective Date: 20/02/2022 Email:[email protected] Ref. Doc: Guidelines Website: www.rwandafda.gov.rw DIS/GDL/005 Tel: +250 789 193 529 APPLICATION FORM FOR LICENSE OF FOOD PREMISE Name of Application date: Premise: …… / ……/.......... (DD / MM/ YYYY) RDB/ First Registration date RCA No : in Rwanda FDA : …… / ……/.......... (DD / MM/ YYYY) Physical location : GPS (Province/ District/ Sector/Cell) coordinates: Official Official e-mail: Telephone : Name of Position : Owner : Partners’ name(s): Email of Tel. of Owner: Owner: Name of responsible Qualification: Technician (if applicable): Email of resp.technician: Telephone of (if applicable) resp. technician: Financial resources committed Prescribed fees : to business : Receipt number : FACILITY TYPE : TYPE OF PRODUCTS TYPE OF APPLICATIONS ( Please tick below) ( Please tick below) ( Please tick below) FOOD MANUFACTURER Cereals products Site location approval LARGE SCALE Maize flour Wheat flour NEW APPLICATION SMALL SCALE & MEDIUM (SME) Rice RENEWAL FOOD OUTLET Alcoholic beverages VARIATION Liquors Wines Beer Change of ownership WHOLESALE OF FOOD PRODUCTS Plant based alc. beverages Change of location RETAIL OF FOOD PRODUCTS Non-alcoholic beverage Change responsible technician RESTAURANT & RELATED Drinking water Additional line HOTEL KITCHEN Daily products Additional branch BAR & RESTAURANT Meat products REINSPECTION FAST FOOD Vegetable products OTHER …….…………………………. Other ……………………….. OTHER …….…………………. Declaration I, …………………………………………………………………, certify that the above information is correct and hereby apply for Premise License in Rwanda FDA for the above-named premises. Applicant signature …………………………………………………..…………… Date ……./……/…….. FOR OFFICIAL USE ONLY: Date Received : ……./……./…… Approved/ Rejected: A / R. Approval/Rejection date : …../……./…… Doc. No.: DIS/GDL/005 Revision Date: 29/9/2021 Review Due Date: 20/02/2025 Revision No.: 1 Effective Date: 20/02/2022 Page 35 of 46 Guideline for Registration and Licensing of Food Premises ANNEX 3. FORMAT OF PREMISE INSPECTION REPORT Doc. No.: DIS/GDL/005 Revision Date: 29/9/2021 Review Due Date: 20/02/2025 Revision No.: 1 Effective Date: 20/02/2022 Page 36 of 46 Guideline for Registration and Licensing of Food Premises P.O. Box 1948 Kigali [email protected] www.rwandafda.gov.rw PREMISE INSPECTION REPORT CONDUCTED AT X INDUSTRIES I. INTRODUCTION II. OBJECTIVES III. BUILDING IV. EQUIPMENT V. PERSONNEL VI. STORAGE FACILITIES VII. SANITATION AND HYGIENE VIII. DOCUMENTS AND RECORD KEEPING IX. RECOMMENDATION(S) X. APPENDIX(ES) Prepared by: Name, signature, date Name, signature, date Position Position Reviewed by: Name, signature, date Division Manager of FDIC Approved: Name, signature, date Head of Department of FDISM Doc. No.: DIS/GDL/005 Revision Date: 29/9/2021 Review Due Date: 20/02/2025 Revision No.: 1 Effective Date: 20/02/2022 Page 37 of 46 Guideline for Registration and Licensing of Food Premises ANNEX 4. NARRATIVE REPORT FORMAT Doc. No.: DIS/GDL/005 Revision Date: 29/9/2021 Review Due Date: 20/02/2025 Revision No.: 1 Effective Date: 20/02/2022 Page 38 of 46 Guideline for Registration and Licensing of Food Premises P.O. Box 1948 Kigali [email protected] www.rwandafda.gov.rw NARRATIVE INSPECTION REPORT CONDUCTED AT (LOCATION) DURING THE PERIOD FROM (DATE) TO (DATE) I. INTRODUCTION II. OBJECTIVES III. KEYS FINDING(S) AND RECOMMEDATION(S) COMPANY /NAME PURP KEY GENERAL Product Owned by: OSE FINDINGS/ RECOMMEND Located at: (Province/ OBSERVATI ATIONS District/ Sector / Cell/ Inspection date: ON 1. NAME OF THE - - COMPANY - - - - - - Product: - - xxxxxxxxxxxxxx Owned by: XXXXX XX XX Located at: ………/ …….. / …………../ ……………... Inspection date: …/…/… Doc. No.: DIS/GDL/005 Revision Date: 29/9/2021 Review Due Date: 20/02/2025 Revision No.: 1 Effective Date: 20/02/2022 Page 39 of 46 Guideline for Registration and Licensing of Food Premises 2. GENERAL CONCLUSION No Name of Post / Institution Email Telephone inspectors 1 2 Done at XXX, on day/ month/year. Reviewed by: Name, signature, date Division Manager of FDIC Approved: Name, signature, date Head of Department of FDISM Doc. No.: DIS/GDL/005 Revision Date: 29/9/2021 Review Due Date: 20/02/2025 Revision No.: 1 Effective Date: 20/02/2022 Page 40 of 46 Guideline for Registration and Licensing of Food Premises ANNEX 5. FORMATS OF LICENSES Doc. No.: DIS/GDL/005 Revision Date: 29/9/2021 Review Due Date: 20/02/2025 Revision No.: 1 Effective Date: 20/02/2022 Page 41 of 46 Guideline for Registration and Licensing of Food Premises QMS No: DIS/FMT/048 Rev. No: 1 Effective Date: 08/12/2021 Ref. Doc.: DIS/GDL/005 P.O. Box 1948 Kigali [email protected] www.rwandafda.gov.rw LICENSE OF PREMISE FOR FOOD PRODUCT MANUFACTURING Issued under Article 9 of the Law Nº 003/2018 of 09/02/2018 Establishing Rwanda Food and Drugs Authority and Determining its Mission, Organization and Functioning, and articles 3 &4 of the Law Nº 47/2012 of 14/01/2013 relating to the regulation and inspection of food and pharmaceutical products. This is to certify that License No: DIS/ /FDA/20_ Name of the Company: Name of the company as on RDB certificate Company Code: Tin number Location of the premise: XXXXXX City/Province, XXXXXXX District, XXXXX Sector, XXXXXXI, Cell Name of the Managing Director: Name of managing mentioned on RDB o Telephone N : (+xxx) xxxxxxxxxxx Head of Production Department: xxxxxxxxxxxxxxxxx was granted to to carry out the following manufacturing activities: Product category Product type Manufacturing activities Production, packaging, labeling, storage and distribution Validity: This license is valid for one (1) year renewable from the date of issuance. This authorization may be suspended or withdrawn if the conditions under which it was granted are violated. The products are put on market after assessment and registration by Rwanda FDA. The application for renewal of license shall be due one month before its expiry. Done at Kigali on …………...………. Name and signature of Director General + Stamp of the institution Director General Doc. No.: DIS/GDL/005 Revision Date: 29/9/2021 Review Due Date: 20/02/2025 Revision No.: 1 Effective Date: 20/02/2022 Page 42 of 46 Guideline for Registration and Licensing of Food Premises QMS No: DIS/FMT/142 Rev. No: 0 Effective Date : 08 Dec 2021 P.O. Box 1948 Kigali [email protected] www.rwandafda.gov.rw LICENSE TO OPERATE AS WHOLESALE & RETAIL OF PROCESSED FOODS ǀ ANIMAL FEEDS ǀ … Issued under Article 9 of LAW Nº 003/2018 of 09/02/2018 Establishing Rwanda Food and Drugs Authority and Determining its Mission, Organization and Functioning, and the LAW No 47/2012 of 14/01/2013 relating to the regulation and inspection of food and pharmaceutical products, especially article 3&4, Ref No: DIS/ /FDA/20xx This is to certify that Name of the Company : Name of the company on RDB/RCA Certificate Company Code : TIN number Managing Director : Name of managing mentioned on RDB Certificate Telephone No : (+xxx) xxxxxxxxxxx was granted the license to operate as wholesaler/ importer/ distributor/ retailer of food products, animal feeds, on the following locations: Sales room: xxx Province/ City, xxx District, xxx Sector, xxx Cell. Building/ plot/ street /house no, P.O. Box xxxxxx, xxxxx,xxxxx Stock room: xxxxxxxxx Province /City, xxx District, xxxxx Sector, xxxxx Cell. Building/ plot/ street /house no Validity: This license is valid for one (1) year renewable from the date of issuance N.B.: 1. This license must be prominently displayed in the premises to which it refers to. 2. Any change made on details of the company name, physical location, management or closure of the premise shall be notified and approved by Rwanda FDA. 3. This license is not transferrable and its misuse will result into suspension or revocation. 4. The application for renewal of license shall be done one month before its expiration. Done at Kigali on ……………… Name and signature of Director General + Stamp of the institution Director General Doc. No.: DIS/GDL/005 Revision Date: 29/9/2021 Review Due Date: 20/02/2025 Revision No.: 1 Effective Date: 20/02/2022 Page 43 of 46 Guideline for Registration and Licensing of Food Premises QMS No: DIS/FMT/147 Rev. No: 0 Effective Date : 21/02/2022 P.O. Box 1948 Kigali [email protected] www.rwandafda.gov.rw LICENSE TO OPERATE AS RESTAURANT ǀ FAST FOOD … Issued under Article 9 of LAW Nº 003/2018 of 09/02/2018 Establishing Rwanda Food and Drugs Authority and Determining its Mission, Organization and Functioning, and the LAW No 47/2012 of 14/01/2013 relating to the regulation and inspection of food and pharmaceutical products, especially article 3&4, Ref No: DIS/ /FDA/20xx This is to certify that Name of the Company : Name of the company on RDB/RCA Certificate Company Code : TIN number Managing Director : Name of managing mentioned on RDB Certificate Telephone No : (+xxx) xxxxxxxxxxx Specialized Personnel : Name of specialized personnel was granted the license to operate as restaurant of food, on the following locations: Sales room: xxx Province/ City, xxx District, xxx Sector, xxx Cell. Building/ plot/ street /house no, P.O. Box xxxxxx, xxxxx,xxxxx Stock room: xxxxxxxxx Province /City, xxx District, xxxxx Sector, xxxxx Cell. Building/ plot/ street /house no Validity: This license is valid for one (1) year renewable from the date of issuance N.B.: 1. This license must be prominently displayed in the premises to which it refers to. 2. Any change made on details of the company name, physical location, management or closure of the premise shall be notified and approved by Rwanda FDA. 3. This license is not transferrable and its misuse will result into suspension or revocation. 4. The application for renewal of license shall be done one month before its expiration. Done at Kigali on ……………… Name and signature of Director General + Stamp of the institution Director General Doc. No.: DIS/GDL/005 Revision Date: 29/9/2021 Review Due Date: 20/02/2025 Revision No.: 1 Effective Date: 20/02/2022 Page 44 of 46 Guideline for Registration and Licensing of Food Premises QMS N0: DIS/FMT/141 Revision No: 0 Effective Date: 08 Dec 2021 P.O. Box 1948 Kigali [email protected] www.rwandafda.gov.rw Ref N°: DIS/ /FDA/20__ LICENSE TO OPERATE A WHOLESALE / RETAIL FOOD SUPPLEMENTS/ INFANT FORMULAE Reference is made to the Law Nº 003/2018 of 09/02/2018 establishing Rwanda Food and Drugs Authority and determining its mission, organization and functioning especially in its article 3; and considering the provisions of the Law No 47/2012 of 14/01/2013 relating to the regulation and inspection of food and pharmaceutical products especially in its article 3 & 4; This is to certify that NAMES OF ESTABLISHMENT, registered under company code TIN NUMBER is licensed to operate as a retail food supplements shop located in XXXX City/Province, XXXX District, XXXX Sector, XXXX Cell. Names of the Managing Director: Mr(s)/Ms NAMES OF MANAGING DIRECTOR Telephone Number: +2507xxxxxxxx Names of responsible technician: Mr(s) /Ms NAMES OF RESPONSIBLE TECHNICIAN Professional bodies Registration No: COUNCIL REGISTRATION NUMBER (If applicable) Validity: This license is valid for one (1) year renewable from the date of its issuance. NB: 1. This license must be prominently displayed in the premises to which it refers to. 2. Any change made on details of the company name, physical location, management or responsible technician shall be notified and approved by Rwanda FDA. 3. This license is not transferrable and its misuse will result into suspension or revocation. 4. The application for renewal of license shall be done one month before its expiration. Done at Kigali on, dd/mm/yyyy Name and signature of Director General + Stamp of the institution Director General Doc. No.: DIS/GDL/005 Revision Date: 29/9/2021 Review Due Date: 20/02/2025 Revision No.: 1 Effective Date: 20/02/2022 Page 45 of 46 Guideline for Registration and Licensing of Food Premises END OF THE DOCUMENT Doc. No.: DIS/GDL/005 Revision Date: 29/9/2021 Review Due Date: 20/02/2025 Revision No.: 1 Effective Date: 20/02/2022 Page 46 of 46
