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Loi nº 003/2018 du 09/02/2018 portant création de l’Office Rwandais des produits alimentaires et pharmaceutiques et déterminant sa mission, son organisation et son fonctionnement.

Country/Territory
Rwanda
Document type
Legislation
Date
2018
Source
FAO, FAOLEX
Subject
Livestock, Food & nutrition, Cultivated plants
Keyword
Basic legislation Institution Food additives Food quality control/food safety Monitoring Transport/storage Internal trade International trade Authorization/permit Animal health Drugs Plant protection Pesticides
Geographical area
Africa, Eastern Africa, Landlocked Developing Nations, Least Developed Countries
Abstract

La présente loi crée l’Office rwandais des produits alimentaires et pharmaceutiques et détermine sa mission, son organisation et son fonctionnement. La présente loi régit les médicaments à usage humain et vétérinaire; les vaccins à usage humain et animal et autres produits biologiques utilisés en médecine comme produits pharmaceutiques; aliments à usage humain et animal transformés, compléments alimentaires et aliments fortifiés; les produits toxiques; les substances phyto-thérapeutiques; produits cosmétiques médicamenteux; les dispositifs médicaux à usage humain et vétérinaire ; la gestion des produits pharmaceutiques impropres; les essais cliniques sur les médicaments à usage humain et vétérinaire; la surveillance et surveillance post-commercialisation des produits pharmaceutiques; le respect des normes de qualité applicables à la fabrication, à l’importation, au stockage, à la vente, à la distribution, à l’usage et à l’exportation des produits réglementés par la présente loi; les locaux servant à la fabrication des produits réglementés par la présente loi; les étiquettes, emballages et matières premières utilisés dans la fabrication des produits réglementés par la présente loi; et les produits chimiques de laboratoire, de nettoyage et pesticides.

Full text
English/French
Website
www.primature.gov.rw

References - Legislation

Repeals

Loi Nº 74/2013 du 11/09/2013 portant création de l’Office Rwandais des produits alimentaires et pharmaceutiques et déterminant ses missions,son organisation et son fonctionnement.

Legislation | Rwanda | 2013

Keyword: Food additives, Food quality control/food safety, Inspection, Nutrition, Institution

Source: FAO, FAOLEX

Implemented by

Regulations Governing Licensing of public and private Manufacturers, Distributors, Wholesalers and Retailers of Medical Products

Legislation | Rwanda | 2022

Keyword: Authorization/permit, Data collection/reporting, Education, Inspection, Internal trade, International trade, Monitoring, Offences/penalties, Packaging/labelling, Standards, Transport/storage, Hazardous substances, Equipment, Cleaning agents/detergents, Disinfection/disinfestation, Animal health, Pests/diseases, Drugs

Source: FAO, FAOLEX

Regulations governing licensing to manufacture, to store, to operate as wholesale and retail seller of processed foods and related products.

Legislation | Rwanda | 2022

Keyword: Food additives, Food quality control/food safety, Fraud, Inspection, Institution, Internal trade, Processing/handling, Public health, Research, Standards, Transport/storage, Treated food, Authorization/permit, Toxicity/poisoning, Offences/penalties, Animal health, Pests/diseases

Source: FAO, FAOLEX

Regulations Governing Recall, Treatment and Disposal of Unfit Products.

Legislation | Rwanda | 2021

Keyword: Access-to-information, Liability/compensation, Classification/declassification, Internal trade, International trade, Offences/penalties, Procedural matters, Public health, Quarantine, Transport/storage, Vaccination, Hazardous substances, Food additives, Toxicity/poisoning, Treated food, Food quality control/food safety, Animal health, Animal feed/feedstuffs, Drugs, Waste disposal, Waste management

Source: FAO, FAOLEX

Regulations Governing Promotion, Advertisement and Marketing of regulated products.

Legislation | Rwanda | 2021

Keyword: Hazardous substances, Internal trade, Offences/penalties, Tobacco, Consumer protection, International trade, Authorization/permit, Public health, Food additives, Treated food, Food quality control/food safety, Animal feed/feedstuffs, Animal health, Drugs

Source: FAO, FAOLEX

Regulations Related to Regulatory Service Tariff/fees and Fines.

Legislation | Rwanda | 2021

Keyword: Authorization/permit, Certification, Classification/declassification, Cleaning agents/detergents, Inspection, Institution, International trade, Pesticides, Tobacco, Toxicity/poisoning, Registration, Public health, Beverages, Cereals/grains/rice, Food additives, Food quality control/food safety, Breastfeeding/infant food, Vegetables/legumes, Meat, Milk/dairy products, Condiments/herbs/spices, Sugar, Coffee/cocoa/tea, Treated food, Agricultural commodities, Nutrition, Animal feed/feedstuffs, Animal health, Pests/diseases, Drugs

Source: FAO, FAOLEX

Regulations Governing Registration of Medical Devices.

Legislation | Rwanda | 2020

Keyword: Certification, Classification/declassification, Offences/penalties, Procedural matters, Public health, Registration, Vaccination, Packaging/labelling, Processing/handling, Animal health

Source: FAO, FAOLEX

Regulations Governing Control of Importation and Exportation of Pharmaceutical Products and Medical Devices.

Legislation | Rwanda | 2021

Keyword: Authorization/permit, Disinfection/disinfestation, International trade, Hygiene/sanitary procedures, Inspection, Processing/handling, Transport/storage, Food quality control/food safety, Animal health, Pests/diseases, Vaccination

Source: FAO, FAOLEX

Regulations Governing Registration of Medicinal Products.

Legislation | Rwanda | 2021

Keyword: Authorization/permit, Disinfection/disinfestation, Enforcement/compliance, Packaging/labelling, Procedural matters, Public health, Registration, Vaccination, Animal health, Drugs, Pests/diseases

Source: FAO, FAOLEX

Regulations Governing the Registration of Pesticides, Laboratory and Cleaning Chemicals.

Legislation | Rwanda | 2020

Keyword: Cleaning agents/detergents, Hazardous substances, Internal trade, International trade, Offences/penalties, Packaging/labelling, Pesticides, Procedural matters, Registration

Source: FAO, FAOLEX

Regulations Governing Good Manufacturing Practices for Medical Products.

Legislation | Rwanda | 2022

Keyword: Public health, Certification, Education, Inspection, Liability/compensation, Marking/identification, Monitoring, Offences/penalties, Packaging/labelling, Procedural matters, Transport/storage, Vaccination, Animal health, Birds, Insects, Pests/diseases, Drugs, Animal feed/feedstuffs, Cleaning agents/detergents, Effluent waste water/discharge, Hazardous substances, Hazardous waste, Organic waste, Pesticides, Solid waste, Waste disposal, Waste management, Waste non-domestic sources

Source: FAO, FAOLEX

Regulations Governing Good Storage and Good Distribution Practices of Medical products.

Legislation | Rwanda | 2022

Keyword: Authorization/permit, Certification, Data collection/reporting, Disinfection/disinfestation, Enforcement/compliance, Fraud, Inspection, Internal trade, International trade, Packaging/labelling, Procedural matters, Public health, Quarantine, Standards, Transport/storage, Traceability/product tracing, Hazardous substances, Animal health, Pests/diseases, Drugs

Source: FAO, FAOLEX

Regulations for Analysis of Products regulated by Rwanda FDA.

Legislation | Rwanda | 2021

Keyword: Tobacco, Food additives, Food quality control/food safety, Processing/handling, Inspection, Institution, International trade, Monitoring, Registration, Treated food, Hygiene/sanitary procedures, Procedural matters, Animal feed/feedstuffs, Contract/agreement, Hazardous substances, Hazardous waste, Packaging/labelling, Organic waste, Protection of environment, Public health, Transport/storage, Waste disposal, Waste management

Source: FAO, FAOLEX

Regulations Governing Post-Marketing Surveillance of Regulated Products.

Legislation | Rwanda | 2021

Keyword: Access-to-information, Authorization/permit, Enforcement/compliance, Fraud, Inspection, Institution, Internal trade, International trade, Monitoring, Public health, Registration, Research, Standards, Transport/storage, Animal health, Drugs

Source: FAO, FAOLEX

Regulations Governing Online Pharmacy Practice.

Legislation | Rwanda | 2020

Keyword: Authorization/permit, Contract/agreement, Disinfection/disinfestation, Public health, Transport/storage, Hygiene/sanitary procedures, Processing/handling, Food quality control/food safety, Animal health, Drugs

Source: FAO, FAOLEX

Guidelines for good manufacturing practices of food.

Legislation | Rwanda | 2019

Keyword: Consumer protection, Contract/agreement, Data collection/reporting, Enforcement/compliance, Food quality control/food safety, HACCP, Hygiene/sanitary procedures, Internal trade, International trade, Packaging/labelling, Liability/compensation, Monitoring, Standards, Treated food

Source: FAO, FAOLEX

Guidelines for Importation and Exportation of Pharmaceutical Products and Medical Devices.

Legislation | Rwanda | 2021

Keyword: Authorization/permit, Hazardous substances, Inspection, Internal trade, International trade, Procedural matters, Public health, Standards, Certification, Animal health, Drugs

Source: FAO, FAOLEX

Guidelines for investigation and control of food borne diseases.

Legislation | Rwanda | 2019

Keyword: Early warning system, Education, Pests/diseases, Processing/handling, Inspection, Beverages, Consumer protection, Data collection/reporting, Food additives, Food quality control/food safety, Hygiene/sanitary procedures, Public health, Toxicity/poisoning

Source: FAO, FAOLEX

Guidelines for Good Distribution Practices of Medical Products.

Legislation | Rwanda | 2020

Keyword: Contract/agreement, Data collection/reporting, Disinfection/disinfestation, Education, Fraud, Hazardous substances, Hygiene/sanitary procedures, Internal trade, International trade, Packaging/labelling, Pests/diseases, Procedural matters, Quarantine, Transport/storage, Inspection, Biological control agents, Vaccination, Processing/handling, Animal health

Source: FAO, FAOLEX

Guidelines on submission of Documentation for Registration of Veterinary Medicinal Products

Legislation | Rwanda | 2020

Keyword: Animal health, Authorization/permit, Data collection/reporting, Packaging/labelling, Procedural matters, Registration, Research, Transport/storage, Vaccination, Drugs

Source: FAO, FAOLEX