Rwanda FDA Food Premises Guidelines
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Questions and Answers

What is the name of the regulatory body established by Law N° 003/2018 of 09/02/2018?

Rwanda Food and Drugs Authority

What is the main function of RWANDA FDA?

  • To regulate matters related to the quality and safety of food (correct)
  • To regulate matters related to the quality and safety of drugs
  • To regulate the development of new pharmaceuticals
  • To regulate waste management practices in Rwanda

    • Food premises are categorized into two major categories namely facilities for food manufacturers and food outlets.

    True (A)

    What are the two main types of facilities for food manufacturers as categorized by RWANDA FDA?

    <p>Food manufacturing facilities and food outlets</p> Signup and view all the answers

    What are the criteria used by RWANDA FDA to classify food manufacturing facilities?

    <p>Production capacity</p> Signup and view all the answers

    What criteria are used to classify food outlets by Rwanda FDA?

    <p>All of the above (D)</p> Signup and view all the answers

    What are the main types of food products regulated by RWANDA FDA?

    <p>Processed foods, fortified foods, food supplements, and animal feeds</p> Signup and view all the answers

    What is the definition of processed food?

    <p>Food products transformed from their original state to extend/prolong their shelf life, packaged, labeled complying to all specified standards, and ready for consumption.</p> Signup and view all the answers

    Any organization or company intending 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.

    <p>True (A)</p> Signup and view all the answers

    What are the four types of applications for premise registration classified by Rwanda FDA?

    <p>New application for premise registration, renewal for premise registration, variation of registered premise, re-inspection of food premise</p> Signup and view all the answers

    What are the required documents for a new application for premise registration?

    <p>Letter of intent, site master plan, environmental impact assessment, approval letter for site location, architecture plan, production process flow chart, sanitation facilities, mechanical ventilation, construction and process materials, finishing materials</p> Signup and view all the answers

    What are the required documents for a new application for premise licensing of a food manufacturing premises?

    <p>Application letter, application form, certificate of Rwanda Development Board or Rwanda Cooperative Agency, identity card or passport of representative, recent passport photo of representative, proof of payment of prescribed fees, most recent plant layout, process flowchart, lease contract, notarized degree of qualified responsible technician, curriculum vitae of responsible technician, contract of responsible technician, commitment letter of responsible technician, identity card or passport of responsible technician, recent passport photo of responsible technician</p> Signup and view all the answers

    What are the required documents for a new application for premise licensing of a wholesale of food products?

    <p>Application letter, application form, certificate of Rwanda Development Board or Rwanda Cooperative Agency, identity card or passport of representative, recent passport photo of representative, proof of payment of prescribed fees, lease contract, original license</p> Signup and view all the answers

    What are the required documents for a new application for premise licensing of a retail of food products?

    <p>Application letter, application form, certificate of Rwanda Development Board or Rwanda Cooperative Agency, identity card or passport of representative, recent passport photo of representative, proof of payment of prescribed fees, original license</p> Signup and view all the answers

    What are the required documents for a new application for premise licensing of a restaurant and related food businesses?

    <p>Application letter, application form, certificate of Rwanda Development Board or Rwanda Cooperative Agency, identity card or passport of representative, recent passport photo of representative, proof of payment of prescribed fees, lease contract, qualification of specialized personnel, curriculum vitae of specialized personnel, contract of specialized personnel, identity card or passport of specialized personnel, recent passport photo of specialized personnel, original license</p> Signup and view all the answers

    What are the required documents for a new application for premise licensing of a wholesale or retail of food supplements and/or infant formula shop?

    <p>Application letter, application form, certificate of Rwanda Development Board or Rwanda Cooperative Agency, identity card or passport of representative, recent passport photo of representative, proof of payment of prescribed fees, lease contract, degree of responsible technician, valid license to practice profession of responsible technician, curriculum vitae of responsible technician, commitment letter of responsible technician, signed professional agreement or contract of responsible technician, identity card or passport of responsible technician, recent photo passport of responsible technician, original license</p> Signup and view all the answers

    The minimum space required for a retail of food supplements premise in Kigali is 40m² which can be separated into a minimum sales area of 30m² and 10m² for storage.

    <p>True (A)</p> Signup and view all the answers

    A premise license grants the authorization to manufacture food products and to sell the products on market.

    <p>False (B)</p> Signup and view all the answers

    The processing time for applications for manufacturing facilities and food outlets should not exceed 30 working days from the application date.

    <p>True (A)</p> Signup and view all the answers

    For renewal of a premise license, an application must be made at least one month prior to the expiry of the existing registration.

    <p>True (A)</p> Signup and view all the answers

    A change of responsible technician is considered as a variation of registered premise license.

    <p>True (A)</p> Signup and view all the answers

    The Authority may consider prosecution for non-adherance to the guidelines only if the situation poses a risk of food safety to consumers.

    <p>True (A)</p> Signup and view all the answers

    What are the three classes of non-compliance used by RWANDA FDA to define the appropriate regulatory action?

    <p>Minor non-compliance, major non-compliance, critical non-compliance (C)</p> Signup and view all the answers

    For minor non-compliance, the Authority will recommend a corrective action within a given time frame and request for compliance reports.

    <p>True (A)</p> Signup and view all the answers

    For major non-compliance, the Authority will recommend a corrective action within a given time frame, and request for a comprehensive compliance report.

    <p>True (A)</p> Signup and view all the answers

    For critical non-compliance, the Authority may implement temporary closure of the establishment, permanent withdrawal/revocation of operational license, and not grant the operational license.

    <p>True (A)</p> Signup and view all the answers

    The food premises must be a permanent structure and must be located away from any sites or activities that emit obnoxious material like fumes, dust smoke, offensive trade or breeding sites for vermin.

    <p>True (A)</p> Signup and view all the answers

    The food premise should have sufficient space for the carrying out and supervision of the necessary operations.

    <p>True (A)</p> Signup and view all the answers

    The physical address of the premise should be clearly indicated in the application form.

    <p>True (A)</p> Signup and view all the answers

    The food premise should be located within a residential area.

    <p>False (B)</p> Signup and view all the answers

    The food premises should be designed for the intended purpose and should not have any direct link with any business or occupation that may lead to contamination of food.

    <p>True (A)</p> Signup and view all the answers

    The food premises should be of suitable layout, constructed to facilitate easy maintenance, sanitation and good flow of operations.

    <p>True (A)</p> Signup and view all the answers

    The food premises and facilities installed shall have adequate space for placement and storage of materials which are necessary for sanitary operations.

    <p>True (A)</p> Signup and view all the answers

    The food premises and facilities installed shall have adequate space for each activity that may cause contamination of food.

    <p>True (A)</p> Signup and view all the answers

    The walls and ceiling of food premises shall be adequately seamless, cleanable and maintained in a clean and good state of repair.

    <p>True (A)</p> Signup and view all the answers

    The fixtures, ducts and pipes may be suspended over areas where drips or condensate may contaminate food and raw materials or food contact surfaces

    <p>False (B)</p> Signup and view all the answers

    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.

    <p>True (A)</p> Signup and view all the answers

    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.

    <p>True (A)</p> Signup and view all the answers

    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.

    <p>True (A)</p> Signup and view all the answers

    Every food premise should present the Managing Director the responsible technician and a trained personnel from a recognized institution.

    <p>True (A)</p> Signup and view all the answers

    Persons suffering from communicable diseases shall be involved in handling of food or food contact surfaces.

    <p>False (B)</p> Signup and view all the answers

    Thorough medical examination for food handlers shall be carried out prior to employment.

    <p>True (A)</p> Signup and view all the answers

    Medical examination records for each worker shall be kept properly and accessible for inspection.

    <p>True (A)</p> Signup and view all the answers

    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.

    <p>True (A)</p> Signup and view all the answers

    Storage facilities should be provided to protect products from deterioration and shall be maintained accordingly.

    <p>True (A)</p> Signup and view all the answers

    Storage conditions should be monitored and maintained accordingly.

    <p>True (A)</p> Signup and view all the answers

    Controlled storage environments should be made available and monitored using suitable temperature recording devices.

    <p>True (A)</p> Signup and view all the answers

    All food products shall be stored on the floor in well-fitted shelves or pallets.

    <p>False (B)</p> Signup and view all the answers

    Storage facilities for grains should be monitored for humidity, temperature and pests and records should be kept properly

    <p>True (A)</p> Signup and view all the answers

    All food premises shall be provided with adequate and easily accessible sanitary conveniences to cater separately for both genders, for employees and/or customers

    <p>True (A)</p> Signup and view all the answers

    Food premises should be provided with an adequate supply of potable water.

    <p>True (A)</p> Signup and view all the answers

    There should be a proper waste disposal system.

    <p>True (A)</p> Signup and view all the answers

    Food handlers shall be clean in person and shall avoid unhygienic practices.

    <p>True (A)</p> Signup and view all the answers

    Food premises should be provided with adequate hand washing facilities with hot & cold running water, nail brushes and disinfectant liquid soap.

    <p>True (A)</p> Signup and view all the answers

    Doors may be designed to open by pushing from all sides or self-operating doors to avoid contaminating the food handler's hands.

    <p>True (A)</p> Signup and view all the answers

    Food premises need to ensure regular water supply of an appropriate quality.

    <p>True (A)</p> Signup and view all the answers

    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.

    <p>True (A)</p> Signup and view all the answers

    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.

    <p>True (A)</p> Signup and view all the answers

    All product labels, printed packaging and descriptive materials shall: be stored in a secure manner, accessed by only authorized personnel, and records should be kept for the labels, printed packaging and descriptive materials issued, to avoid any mix-up.

    <p>True (A)</p> Signup and view all the answers

    The premises shall have sufficient fire-fighting equipment which shall, at all times, be in good condition and readily accessible.

    <p>True (A)</p> Signup and view all the answers

    The equipment used for weighing, measuring, testing and recording shall be subjected to recorded checks for accuracy in accordance with a regular set schedule.

    <p>True (A)</p> Signup and view all the answers

    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.

    <p>True (A)</p> Signup and view all the answers

    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.

    <p>True (A)</p> Signup and view all the answers

    In case of recall of a product, the applicant shall notify the Authority of the reason for the recall.

    <p>True (A)</p> Signup and view all the answers

    Recall operations shall be capable of being initiated promptly, at least down to the level of retailers.

    <p>True (A)</p> Signup and view all the answers

    The distribution records shall contain sufficient information related to the product.

    <p>True (A)</p> Signup and view all the answers

    The disposal of recalled, rejected, or withdrawn products from the market shall be effected within one month after completion of exercise.

    <p>True (A)</p> Signup and view all the answers

    The Authority shall take regulatory actions based on Minor, Major, and Critical category of non-compliances.

    <p>True (A)</p> Signup and view all the answers

    For minor non-compliances, the Authority will implement a warning letter, recommend corrective action within a given time frame, recommend temporary withdrawal or suspension of an operational license, request for a comprehensive compliance report.

    <p>False (B)</p> Signup and view all the answers

    For major non-compliances, the Authority will implement temporarily closure of the establishment, permanent withdrawal/revocation of operational license, and not grant the operational license.

    <p>False (B)</p> Signup and view all the answers

    For critical non-compliances, the Authority will implement a warning letter, recommend corrective action within a given time frame, and request for a comprehensive compliance report.

    <p>False (B)</p> Signup and view all the answers

    The authority shall cancel, suspend, or withdraw the license to operate a food processing premise/ food outlet if the circumstances under which it was licensed no longer exist.

    <p>True (A)</p> Signup and view all the answers

    The authority shall cancel, suspend, or withdraw the license to operate a food processing premise/ food outlet if the grounds on which it was licensed are later found to be false, or any provision under which it was licensed has been contravened.

    <p>True (A)</p> Signup and view all the answers

    The authority may suspend, or revoke the authorization if the applicant is not complying with any of the requirements or conditions in the guideline, or has ceased to be fit to carry on the business.

    <p>True (A)</p> Signup and view all the answers

    The authority may consider prosecution for non- adherence to the guidelines if the situation poses a risk of food safety to consumers.

    <p>True (A)</p> Signup and view all the answers

    Administrative fines are provided in the Regulations related to regulatory service tariff/fees and fines available on Rwanda FDA website.

    <p>True (A)</p> Signup and view all the answers

    Signup and view all the answers

    Study Notes

    Rwanda FDA Guidelines for Registration and Licensing of Food Premises

    • Document Title: Guidelines for Registration and Licensing of Food Premises
    • Authority: Rwanda Food and Drugs Authority (RWANDA FDA)
    • Date: February, 2022
    • Document Revision Number: 1
    • Effective Date: February 20, 2022
    • Review Due Date: February 20, 2025

    Guideline Development History

    • Draft Zero: May 7, 2019
    • Adoption by RWANDA FDA: May 13, 2019
    • Stakeholder Consultation: May 13, 2019
    • Adoption of Stakeholder Comments: May 13, 2019
    • Revision 0: May 13, 2019
    • Revision 1: September 29, 2021
    • Stakeholder Consultation: November 8, 2021
    • Adoption of Stakeholder Comments: November 12, 2021

    Document Revision History

    • Date of Revision: 07/05/2019, 14/09/2021
    • Revision Number: 0, 1
    • Changes Made: Included scope, food premise classification for products regulated by Rwanda FDA, renamed chapter, added administrative sanctions, and updated premise licensing requirements

    Foreword

    • RWANDA FDA: A regulatory body established by Law N° 003/2018 of 09/02/2018
    • Purpose: Regulate food quality and safety to protect the public from health hazards.
    • Consumer Health: Dealers prioritize consumer health, ensure food safety and quality, and well-maintained premises.

    Table of Contents

    • Guideline Development History: Page 1
    • Table of Contents: Page 3
    • Abbreviations and Acronyms: Page 5
    • Definitions of Terms: Page 6
    • Chapter 1. Introduction Page 8
      • Scope: Page 8
      • Classification of Food Premises: Page 8
        • Food Manufacturing Facilities: 1.2.1
        • Food Outlets: 1.2.2
          • Wholesalers of Food Products: 1.2.2.1
          • Retailers of Food Products: 1.2.2.2
      • Food Products Regulated by Rwanda FDA: 1.3
    • Chapter 2. Application Requirements for Premise Registration and Operational License: Page 10
      • General Application Requirements: 2.1
      • Types of Applications: 2.2
        • New application for premise registration: 2.2.1
        • Renewal for premise registration: 2.2.2
        • Variation of registered premise: 2.2.3
        • Re-inspection of food premise: 2.2.4
      • Requirements for new premise licensing: 2.3
        • Food Manufacturing Premises: 2.3.1, 2.3.2
        • Wholesalers of Food Products: 2.3.3
        • Retailers of Food Products: 2.3.4
        • Restaurants and Related Food Businesses: 2.3.5
        • Renewal of Premise License: 2.4
          • Duration of Processing Applications: 2.2.1, 2.2.2
    • Chapter 3. Inspection of Premises for Suitability: Page 17
    • Chapter 4. Administrative Sanctions and Fines: Page 21
    • References: Page 23
    • Annexes: Page 24

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    Rwanda FDA Guidelines for Food Premises Registration and Licensing PDF

    Description

    This quiz covers the guidelines established by the Rwanda Food and Drugs Authority (RWANDA FDA) for the registration and licensing of food premises. It includes details on the development and revision history of the guidelines, emphasizing compliance and administrative requirements. Test your knowledge on the major elements of these regulations.

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