Provisions for Imported Medicinal Materials (Revised Draft)

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Distribution date: 18 March 2019 | Final date for Comment: 17 May 2019

The "Provisions for Imported Medicinal Materials" consists of 7 chapters and 43 articles. It is drafted in accordance with the import process of medicinal materials, including application and approval, registration, port inspection, supervision and management, etc. Measures as decentralizing approval authority, administrating by categories and traceability management are taken to facilitate applicants and strengthen the quality management of imported medicinal materials.

Products Covered: medicinal materials (HS: 05,06,09,12,13,30)

Regulation Type: Regular notification

Provisions for Imported Medicinal Materials (Revised Draft)

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Distribution date: 18 March 2019 | Final date for Comment: 17 May 2019

The "Provisions for Imported Medicinal Materials" consists of 7 chapters and 43 articles. It is drafted in accordance with the import process of medicinal materials, including application and approval, registration, port inspection, supervision and management, etc. Measures as decentralizing approval authority, administrating by categories and traceability management are taken to facilitate applicants and strengthen the quality management of imported medicinal materials.

Products Covered: medicinal materials (HS: 05,06,09,12,13,30)

Regulation Type: Regular notification

Partial revision of the Japanese Pharmacopoeia, Seventeenth edition

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Distribution date: 18 March 2019 | Final date for Comment: 17 May 2019

Under Article 41 of the Act on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices, the Japanese Pharmacopoeia, Seventeenth edition are to be revised.

Products Covered: Pharmaceutical Products (HS:30)

Regulation Type: Regular notification

Partial revision of the Japanese Pharmacopoeia, Seventeenth edition

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Distribution date: 18 March 2019 | Final date for Comment: 17 May 2019

Under Article 41 of the Act on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices, the Japanese Pharmacopoeia, Seventeenth edition are to be revised.

Products Covered: Pharmaceutical Products (HS:30)

Regulation Type: Regular notification

Amendment of the Compulsory Specification for Canned Meat Products (VC8019)

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Distribution date: 18 March 2019 | Final date for Comment: 17 May 2019

This Compulsory Specification requires that canned meat products, for human consumption, which are to be offered for sale, comply with this Compulsory Specification and the requirements of the latest edition of the South African National Standard (SANS) 1675 that apply to the manufacture, production, processing, and treatment of the products covered by this specification. The hygiene requirements for the product, as well as chemical and microbiological contaminant requirements for the product, and the requirements for employees at the packing facility, shall comply with the requirements of the latest edition of SANS 1675.

Products Covered: Canned/hermitically sealed meat products (either commerically sterile or pasteurised/semi-preserves)

Regulation Type: Regular notification

Food safety Human health

Amendment of the Compulsory Specification for Canned Meat Products (VC8019)

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Distribution date: 18 March 2019 | Final date for Comment: 17 May 2019

This Compulsory Specification requires that canned meat products, for human consumption, which are to be offered for sale, comply with this Compulsory Specification and the requirements of the latest edition of the South African National Standard (SANS) 1675 that apply to the manufacture, production, processing, and treatment of the products covered by this specification. The hygiene requirements for the product, as well as chemical and microbiological contaminant requirements for the product, and the requirements for employees at the packing facility, shall comply with the requirements of the latest edition of SANS 1675.

Products Covered: Canned/hermitically sealed meat products (either commerically sterile or pasteurised/semi-preserves)

Regulation Type: Regular notification

Food safety Human health

Draft resolution number 613, 28 February 2019, regarding the active ingredient G01 - GLYPHOSATE of the Monograph List of Active Ingredients for Pesticides, Household Cleaning Products and Wood Preservers, published by Resolution - RE n° 165 of 29 August 2003, on the Brazilian Official Gazette (DOU - Diário Oficial da União) of 2 September 2003

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Distribution date: 13 March 2019 | Final date for Comment: 06 June 2019

This Draft resolution is the result of the risk assessment for the active ingredient G01 - GLYPHOSATE ofthe Relation of Monographies of Active Ingredients of Pesticides, Household Cleaning Products and Wood Preservers, and proposes the following changes: – Rural workers and the population near the farming fields: Prohibition of EW formulation (oil-in-water emulsion) Rotation between workers for aplication activities with tractors (mixing, filling and applying)Personal protective equipment (PPE) and period for reentry of the worker into the treated areaDrift reduction technologySafe zone of 10 meters when there is population 550 meters way from farming fieldsDefinition of exposure and tolerance limits for rural workers – Urban use and food consuming: Adjustment for cronic exposure tolerance limitsDefinition of acute exposure limitsProhibition of the concentraded product for amateur gardeningProhibition of POEA (polyoxyethyleneamine) above 20% in glyphosate products

Products Covered: HS Code(s): 52, 0809, 1006, 0803, 18, 09, 1212, 0805, 08011, 24, 0808, 080720, 071040, 1201, 1001, 0806; ICS Code(s): 13, 65

Regulation Type: Regular notification

Maximum residue limits (MRLs) Human health Pesticides Food safety

Draft resolution number 613, 28 February 2019, regarding the active ingredient G01 - GLYPHOSATE of the Monograph List of Active Ingredients for Pesticides, Household Cleaning Products and Wood Preservers, published by Resolution - RE n° 165 of 29 August 2003, on the Brazilian Official Gazette (DOU - Diário Oficial da União) of 2 September 2003

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Distribution date: 13 March 2019 | Final date for Comment: 06 June 2019

This Draft resolution is the result of the risk assessment for the active ingredient G01 - GLYPHOSATE ofthe Relation of Monographies of Active Ingredients of Pesticides, Household Cleaning Products and Wood Preservers, and proposes the following changes: – Rural workers and the population near the farming fields: Prohibition of EW formulation (oil-in-water emulsion) Rotation between workers for aplication activities with tractors (mixing, filling and applying)Personal protective equipment (PPE) and period for reentry of the worker into the treated areaDrift reduction technologySafe zone of 10 meters when there is population 550 meters way from farming fieldsDefinition of exposure and tolerance limits for rural workers – Urban use and food consuming: Adjustment for cronic exposure tolerance limitsDefinition of acute exposure limitsProhibition of the concentraded product for amateur gardeningProhibition of POEA (polyoxyethyleneamine) above 20% in glyphosate products

Products Covered: HS Code(s): 52, 0809, 1006, 0803, 18, 09, 1212, 0805, 08011, 24, 0808, 080720, 071040, 1201, 1001, 0806; ICS Code(s): 13, 65

Regulation Type: Regular notification

Maximum residue limits (MRLs) Human health Pesticides Food safety

Footwear — Specification for children's shoes — Part 1: (2 years and below)

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Distribution date: 13 March 2019 | Final date for Comment: 12 May 2019

This Draft East African Standard specifies the requirements, sampling and methods of test for children's shoes (2 years and below).

Products Covered: (HS code(s): 64); Footwear (ICS code(s): 61.060)

Regulation Type: Regular notification

Footwear — Specification for children's shoes — Part 1: (2 years and below)

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Distribution date: 13 March 2019 | Final date for Comment: 12 May 2019

This Draft East African Standard specifies the requirements, sampling and methods of test for children's shoes (2 years and below).

Products Covered: (HS code(s): 64); Footwear (ICS code(s): 61.060)

Regulation Type: Regular notification

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