Regulations, No.: DFAR/HMDAR/TRG/002 Rev_2,  Governing Registration of Medical Devices including In Vitro Diagnostics

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Distribution date: 22 February 2023 | Final date for Comment: 23 April 2023

The purpose of these regulations is to enforce the legal framework to ensure effective and efficient registration of human and veterinary Medical Devices including In Vitro Diagnostics, and to provide an open, transparent and non-discriminatory process for the registration of Medical Devices including In Vitro Diagnostics.

Products Covered: Wadding, gauze, bandages and the like, e.g. dressings, adhesive plasters, poultices, impregnated or covered with pharmaceutical substances or put up for retail sale for medical, surgical, dental or veterinary purposes (HS code(s): 3005); - Other : (HS code(s): 30069)

Regulation Type: Regular notification

Human health

Regulations governing licensing of public and private manufacturers,distributors, wholesalers and retailers of medical Products

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Distribution date: 22 February 2023 | Final date for Comment: 23 April 2023

These Regulations enforce the legal framework for application, inspection, storage, distribution, andlicensing of public and private manufacturers, distributors, wholesalers and retailers of MedicalProducts. These Regulations apply to public, and private manufacturers, distributors, wholesalers and retailersof medical products involved in the manufacture, storage, sale, distribution, and dispensing ofmedical products.

Products Covered: PHARMACEUTICAL PRODUCTS (HS code(s): 30)

Regulation Type: Regular notification

Human health

DRAFT LAW N° …….……….. OF ………..……. GOVERNING THE EXPORTATION OF AGRICULTURAL PRODUCTS

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Distribution date: 22 February 2023

This Law applies to activities related to export or re-export of agricultural products; and value chain management of agricultural products.

Products Covered: LIVE ANIMALS (HS code(s): 01)MEAT AND EDIBLE MEAT OFFAL (HS code(s): 02); FISH AND CRUSTACEANS, MOLLUSCS AND OTHER AQUATIC INVERTEBRATES (HS code(s): 03); DAIRY PRODUCE; BIRDS' EGGS; NATURAL HONEY; EDIBLE PRODUCTS OF ANIMAL ORIGIN, NOT ELSEWHERE SPECIFIED OR INCLUDED (HS code(s): 04); PRODUCTS OF ANIMAL ORIGIN, NOT ELSEWHERE SPECIFIED OR INCLUDED (HS code(s): 05); LIVE TREES AND OTHER PLANTS; BULBS, ROOTS AND THE LIKE; CUT FLOWERS AND ORNAMENTAL FOLIAGE (HS code(s): 06); EDIBLE VEGETABLES AND CERTAIN ROOTS AND TUBERS (HS code(s): 07); EDIBLE FRUIT AND NUTS; PEEL OF CITRUS FRUIT OR MELONS (HS code(s): 08); COFFEE, TEA, MATÉ AND SPICES (HS code(s): 09); CEREALS (HS code(s): 10); PRODUCTS OF THE MILLING INDUSTRY; MALT; STARCHES; INULIN; WHEAT GLUTEN (HS code(s): 11); OIL SEEDS AND OLEAGINOUS FRUITS; MISCELLANEOUS GRAINS, SEEDS AND FRUIT; INDUSTRIAL OR MEDICINAL PLANTS; STRAW AND FODDER (HS code(s): 12); LAC; GUMS, RESINS AND OTHER VEGETABLE SAPS AND EXTRACTS (HS code(s): 13); VEGETABLE PLAITING MATERIALS; VEGETABLE PRODUCTS NOT ELSEWHERE SPECIFIED OR INCLUDED (HS code(s): 14); ANIMAL OR VEGETABLE FATS AND OILS AND THEIR CLEAVAGE PRODUCTS; PREPARED EDIBLE FATS; ANIMAL OR VEGETABLE WAXES (HS code(s): 15); PREPARATIONS OF MEAT, OF FISH OR OF CRUSTACEANS, MOLLUSCS OR OTHER AQUATIC INVERTEBRATES (HS code(s): 16); SUGARS AND SUGAR CONFECTIONERY (HS code(s): 17); PREPARATIONS OF CEREALS, FLOUR, STARCH OR MILK; PASTRYCOOKS' PRODUCTS (HS code(s): 19); PREPARATIONS OF VEGETABLES, FRUIT, NUTS OR OTHER PARTS OF PLANTS (HS code(s): 20); MISCELLANEOUS EDIBLE PREPARATIONS (HS code(s): 21); BEVERAGES, SPIRITS AND VINEGAR (HS code(s): 22); RESIDUES AND WASTE FROM THE FOOD INDUSTRIES; PREPARED ANIMAL FODDER (HS code(s): 23); ESSENTIAL OILS AND RESINOIDS; PERFUMERY, COSMETIC OR TOILET PREPARATIONS (HS code(s): 33)

Regulation Type: Regular notification

Regulations, No.: FDISM/FDIC/TRG/001 Rev_3,  governing licensing of public and private manufacturers, distributors, wholesalers and retailers of medical Products

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Distribution date: 22 February 2023 | Final date for Comment: 23 April 2023

These Regulations apply to public, and private manufacturers, distributors, wholesalers and retailers of medical products involved in the manufacture, storage, sale, distribution, and dispensing of medical products.

Products Covered: PHARMACEUTICAL PRODUCTS (HS code(s): 30)

Regulation Type: Regular notification

Human health

REGULATIONS NO CBD/TRG/011 REV-0: GOVERNING CONTROL OF MEDICATED COSMETIC

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Distribution date: 22 February 2023 | Final date for Comment: 23 April 2023

The purpose of these regulations is to provide a legal framework for the effective and efficient of Control of medicated cosmetics and providing an open transparent and non-discriminatory process and minimum requirements for the registration, manufacture, importation, distribution and use of Medicated Cosmetic products in Rwanda. The implementation of these Regulations will enhance safety and effectiveness of medicated cosmetics on Rwanda markets and protect public health from substandard, counterfeit, mislabelled or unsafe medicated cosmetics.

Products Covered: ESSENTIAL OILS AND RESINOIDS; PERFUMERY, COSMETIC OR TOILET PREPARATIONS (HS code(s): 33); Scent sprays and similar toilet sprays, and mounts and heads therefor; powder puffs and pads for the application of cosmetics or toilet preparations (HS code(s): 9616)

Regulation Type: Regular notification

LAW No 47/2012 OF 14/01/2013 RELATING TO THE REGULATION AND INSPECTION OF FOOD AND PHARMACEUTICAL PRODUCTS

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Distribution date: 22 February 2023 | Final date for Comment: 23 April 2023

This Law relates to the regulation and inspection of food and pharmaceutical products.

Products Covered: COFFEE, TEA, MATÉ AND SPICES (HS code(s): 09); CEREALS (HS code(s): 10); PRODUCTS OF THE MILLING INDUSTRY; MALT; STARCHES; INULIN; WHEAT GLUTEN (HS code(s): 11); SUGARS AND SUGAR CONFECTIONERY (HS code(s): 17); PREPARATIONS OF CEREALS, FLOUR, STARCH OR MILK; PASTRYCOOKS' PRODUCTS (HS code(s): 19); PREPARATIONS OF VEGETABLES, FRUIT, NUTS OR OTHER PARTS OF PLANTS (HS code(s): 20); BEVERAGES, SPIRITS AND VINEGAR (HS code(s): 22); RESIDUES AND WASTE FROM THE FOOD INDUSTRIES; PREPARED ANIMAL FODDER (HS code(s): 23); SALT; SULPHUR; EARTHS AND STONE; PLASTERING MATERIALS, LIME AND CEMENT (HS code(s): 25); PHARMACEUTICAL PRODUCTS (HS code(s): 30); ESSENTIAL OILS AND RESINOIDS; PERFUMERY, COSMETIC OR TOILET PREPARATIONS (HS code(s): 33); SOAP, ORGANIC SURFACE-ACTIVE AGENTS, WASHING PREPARATIONS, LUBRICATING PREPARATIONS, ARTIFICIAL WAXES, PREPARED WAXES, POLISHING OR SCOURING PREPARATIONS, CANDLES AND SIMILAR ARTICLES, MODELLING PASTES, ‘DENTAL WAXES’ AND DENTAL PREPARATIONS WITH A BASIS OF PLASTER (HS code(s): 34)

Regulation Type: Regular notification

Regulations Governing Registration of Medicinal Products 

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Distribution date: 22 February 2023 | Final date for Comment: 23 April 2023

The purpose of these Regulations is to put in place a legal framework to ensure effective andefficient registration of medicinal products, and to provide an open, transparent and nondiscriminatory process for the registration of all medicinal products regulated by Rwanda Food and Drugs authority. These regulations cover human and veterinary medicinal products, vaccines and biologicalproducts for human and animal use, herbal medicinal products, disinfectant and antisepticsexcluding cosmetics as well as laboratory and household chemicals. The regulations apply toall medicinal products to be registered in Rwanda.

Products Covered: PHARMACEUTICAL PRODUCTS (HS code(s): 30)

Regulation Type: Regular notification

Human health

Letter of the Federal Service for Veterinary and Phytosanitary Surveillance No. FS-ARe-7/5000-5 as of 17 February 2023

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Distribution date: 21 February 2023

This letter introduces a temporary restriction on import of life poultry and poultry products from Bolivia to the territory of the Russian Federation and on transit of live poultry through the Russian territory due to the outbreak of high pathogenic avian influenza.

Products Covered: Live poultry, egg products, meat and edible offal of poultry, poultry meat products, daily chicks, incubation egg of poultry, Incubation egg (except poultry egg), live bird (except poultry), feed and feed additives for birds, equipment for the maintenance, slaughter and cutting of birds (HS codes: 0105; 0407, 0408; 0207; 0208, 0209, 0210, 0410 00 000 0, 0504 00 000 0, 0505, 0511, 1501, 1506 00 000 0, 1516 10, 1518 00, 1601 00, 1602, 1603 00, 1902 20, 1904 20, products from group 20, from 2104, from 2106, 4206 00 000 0, 0106; 508 10 000 0, 0106, 9705 00 000 0; 9508 10 000 0, 0106; 2102, 2309, 2936, 3504, 3507, 3808, 3824; 3923, 3926, 4415 4416 00 000 0, 4421, 7020 00, 7309 00, 7310, 7326, 7616, 8436 10 000 0, 8436 21 000 0, 8436 29 000 0, 8436 80 900 0, 8606 91 800 0, 8609 00, 8716 39 800)

Regulation Type: Emergency notifications (SPS)

Avian Influenza Human health Animal health Food safety Zoonoses Animal diseases

Letter of the Federal Service for Veterinary and Phytosanitary Surveillance No. FS-ARe-7/4954-5 as of 24 January 2023

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Distribution date: 21 February 2023

This letter introduces a temporary restriction on import of life poultry and poultry products from Ecuador to the territory of the Russian Federation and on transit of live poultry through the Russian territory due to the outbreak of high pathogenic avian influenza.

Products Covered: Live poultry, egg products, meat and edible offal of poultry, poultry meat products, daily chicks, incubation egg of poultry, Incubation egg (except poultry egg), live bird (except poultry), feed and feed additives for birds, equipment for the maintenance, slaughter and cutting of birds (HS codes: 0105; 0407, 0408; 0207; 0208, 0209, 0210, 0410 00 000 0, 0504 00 000 0, 0505, 0511, 1501, 1506 00 000 0, 1516 10, 1518 00, 1601 00, 1602, 1603 00, 1902 20, 1904 20, products from group 20, from 2104, from 2106, 4206 00 000 0, 0106; 508 10 000 0, 0106, 9705 00 000 0; 9508 10 000 0, 0106; 2102, 2309, 2936, 3504, 3507, 3808, 3824; 3923, 3926, 4415 4416 00 000 0, 4421, 7020 00, 7309 00, 7310, 7326, 7616, 8436 10 000 0, 8436 21 000 0, 8436 29 000 0, 8436 80 900 0, 8606 91 800 0, 8609 00, 8716 39 800)

Regulation Type: Emergency notifications (SPS)

Animal diseases Food safety Animal health Human health Avian Influenza Zoonoses

Letter of the Federal Service for Veterinary and Phytosanitary Surveillance No. FS-ARe-7/4955-5 as of 23 January 2023

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Distribution date: 21 February 2023

This letter introduces a temporary restriction on import of life poultry and poultry products from Peru to the territory of the Russian Federation and on transit  of  live poultry through the Russian territory due to the outbreak of high pathogenic avian influenza.

Products Covered: Live poultry, egg products, meat and edible offal of poultry, poultry meat products, daily chicks, incubation egg of poultry, Incubation egg (except poultry egg), live bird (except poultry), feed and feed additives for birds, equipment for the maintenance, slaughter and cutting of birds (HS codes: 0105; 0407, 0408; 0207; 0208, 0209, 0210, 0410 00 000 0, 0504 00 000 0, 0505, 0511, 1501, 1506 00 000 0, 1516 10, 1518 00, 1601 00, 1602, 1603 00, 1902 20, 1904 20, products from group 20, from 2104, from 2106, 4206 00 000 0, 0106; 508 10 000 0, 0106, 9705 00 000 0; 9508 10 000 0, 0106; 2102, 2309, 2936, 3504, 3507, 3808, 3824; 3923, 3926, 4415 4416 00 000 0, 4421, 7020 00, 7309 00, 7310, 7326, 7616, 8436 10 000 0, 8436 21 000 0, 8436 29 000 0, 8436 80 900 0, 8606 91 800 0, 8609 00, 8716 39 800)

Regulation Type: Emergency notifications (SPS)

Avian Influenza Human health Animal health Food safety Zoonoses Animal diseases

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