Regulatory Updates
The following communication, received on 22 February 2023, is being circulated at the request of the delegation of Morocco.
Distribution date: 24 February 2023
Physical and chemical specifications for couscous and pasta Order No. 3092-22 of the Minister of Agriculture, Marine Fisheries, Rural Development, Water Resources and Forestry of 14 November 2022[ https://www.onssa.gov.ma/wp-content/uploads/2023/01/ARR.3092-22.FR_.pdf ], establishing physical and chemical specifications for couscous and pasta, was published in Official Journal No. 7158 of 5 January 2023. NB: This Order revokes Order No. 250596 of the Minister of Agriculture and Agricultural Development of 9 Chaabane 1417 (20 December 1996) on the manufacture and marketing of pasta and couscous. https://www.onssa.gov.ma/reglementation-sectorielle-produits-alimentaires-2/ https://members.wto.org/crnattachments/2023/SPS/MAR/23_1288_00_f.pdf
Products Covered: Couscous et pâtes alimentaires
Regulation Type: Addendum to Regular Notification
Regulations No.: CBD/TRG/017 Rev_1 Governing Promotion, Advertisement and Marketing of regulated products
Distribution date: 23 February 2023 | Final date for Comment: 24 April 2023
These regulations shall apply to all activities related to the advertisements or promotion and marketing of regulated products that are manufactured, imported, distributed, stored, sold or used in Rwanda.
Products Covered: PHARMACEUTICAL PRODUCTS (HS code(s): 30)
Regulation Type: Regular notification
Regulations, No.: FDISM/FDIEC/TRG/001 Rev_2, Governing Control of Importation and Exportation of Pharmaceutical Products and Medical Devices
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 control of importation and exportation of pharmaceutical products, medical devices, and their respective raw materials in a transparent, non-discriminatory manner.
Products Covered: PHARMACEUTICAL PRODUCTS (HS code(s): 30)
Regulation Type: Regular notification
Regulations, No.: DFAR/HMDAR/TRG/002 Rev_2, Governing Registration of Medical Devices including In Vitro Diagnostics
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
Regulations governing licensing of public and private manufacturers,distributors, wholesalers and retailers of medical Products
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
DRAFT LAW N° …….……….. OF ………..……. GOVERNING THE EXPORTATION OF AGRICULTURAL PRODUCTS
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
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
REGULATIONS NO CBD/TRG/011 REV-0: GOVERNING CONTROL OF MEDICATED COSMETIC
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
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
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
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