Distribution date: 29 June 2020 | Final date for Comment: 07 September 2020

This draft resolution establishes warning phrases for substances and or therapeutic classes in leaflets and packaging of medicines.

Products Covered: HS Code(s): 3003; 3004; 3005; 2941 (pharmaceutical products).

Regulation Type: Regular notification

Distribution date: 29 June 2020 | Final date for Comment: 14 May 2025

This resolution establishes temporary and extraordinary criteria for the application of exceptionalities to specific technical requirements of the Good Manufacturing and Import Practice of Medicinal Products and Active Pharmaceutical Ingredients, due to the international public health emergency of the new coronavirus (Covid-19).

Products Covered: HS Code(s): 2941; 3003; 3004; 3005; 3006 (pharmaceutical products).

Regulation Type: Regular notification

Distribution date: 29 June 2020 | Final date for Comment: 14 May 2025

This resolution establishes temporary and extraordinary criteria for the application of exceptionalities to specific technical requirements of the Good Manufacturing and Import Practice of Medicinal Products and Active Pharmaceutical Ingredients, due to the international public health emergency of the new coronavirus (Covid-19).

Products Covered: HS Code(s): 2941; 3003; 3004; 3005; 3006 (pharmaceutical products).

Regulation Type: Regular notification

Distribution date: 30 June 2020 | Final date for Comment: 29 August 2020

The measure notified as G/SPS/N/TPKM/522 on 24 March 2020, was promulgated on 19 June 2020, and will come into effect on 1 July 2020. Commodities classified under four specific CCC codes shall follow the "Regulations of Inspection of Imported Foods and Related Products" if they are used for foods, food additives, food utensils, food containers or packaging. The importers shall apply for inspection to the Food and Drug Administration, Ministry of Health and Welfare.

Products Covered:

Regulation Type: Addendum to Regular Notification

Distribution date: 30 June 2020 | Final date for Comment: 29 August 2020

The measure notified as G/SPS/N/TPKM/522 on 24 March 2020, was promulgated on 19 June 2020, and will come into effect on 1 July 2020. Commodities classified under four specific CCC codes shall follow the "Regulations of Inspection of Imported Foods and Related Products" if they are used for foods, food additives, food utensils, food containers or packaging. The importers shall apply for inspection to the Food and Drug Administration, Ministry of Health and Welfare.

Products Covered:

Regulation Type: Addendum to Regular Notification

Distribution date: 01 July 2020 | Final date for Comment: 30 August 2020

Proposal for the amendments of the Extraneous Maximum Residue Limit maximum limits (EMRLs) for the pesticide: Heptachlor. Commodity (for feed)                        Proposed MRL(mg/kg)    Current MRL(mg/kg) Compound feed for cattle, sheep,                  0.02                             0.02   goat or deer Compound feed for pig                                 0.02                             0.02 Compound feed for chicken or quail               0.02                             0.02 Rice straw                                                   0.02                               - Rice whole crop silage                                  0.02                               - Unprocessed rice                                         0.02                               - Residue definition for enforcement: Sum of heptachlor and heptachlor epoxide

Products Covered: Compound feed (HS Code: 23.09), Rice straw, Rice whole crop silage, Unprocessed rice (HS Code: 23.08)

Regulation Type: Regular notification

Distribution date: 01 July 2020 | Final date for Comment: 30 August 2020

Proposal for the amendments of the Extraneous Maximum Residue Limit maximum limits (EMRLs) for the pesticide: Heptachlor. Commodity (for feed)                        Proposed MRL(mg/kg)    Current MRL(mg/kg) Compound feed for cattle, sheep,                  0.02                             0.02   goat or deer Compound feed for pig                                 0.02                             0.02 Compound feed for chicken or quail               0.02                             0.02 Rice straw                                                   0.02                               - Rice whole crop silage                                  0.02                               - Unprocessed rice                                         0.02                               - Residue definition for enforcement: Sum of heptachlor and heptachlor epoxide

Products Covered: Compound feed (HS Code: 23.09), Rice straw, Rice whole crop silage, Unprocessed rice (HS Code: 23.08)

Regulation Type: Regular notification

Distribution date: 02 July 2020 | Final date for Comment: 31 August 2020

Proposal for the amendments of the maximum residue limits (MRLs) for the agricultural chemical: Fipronil. Commodity (for feed)                      Proposed MRL(mg/kg)           Current MRL(mg/kg) Compound feed for cattle, sheep,              - (withdraw)                           0.02   goat or deer Compound feed for pig                              - (withdraw)                          0.02 Compound feed for chicken or quail            - (withdraw)                          0.01 Maize                                                            0.02                                   - Miro                                                              0.01                                   - Barley                                                          0.002                                   - Wheat                                                          0.002                                   - Rye                                                              0.002                                   - Oat                                                              0.002                                   - Hay                                                          - (withdraw)                            0.2 Residue definition for enforcement: Fipronil Hay includes hay and fodder (dry), straw, forage (green) and silage. The MRL is set as 90% dry matter base.

Products Covered: Compound feed (HS Code: 23.09),  Oats (HS Code:10.04), barley (HS Code:10.03), wheat (HS Code:10.01), maize (HS Code:10.05), miro (HS Code:10.07), rye (HS Code:10.02) and hay (HS Codes:12.13, 12.14) for feed

Regulation Type: Regular notification

Distribution date: 02 July 2020 | Final date for Comment: 31 August 2020

Proposal for the amendments of the maximum residue limits (MRLs) for the agricultural chemical: Fipronil. Commodity (for feed)                      Proposed MRL(mg/kg)           Current MRL(mg/kg) Compound feed for cattle, sheep,              - (withdraw)                           0.02   goat or deer Compound feed for pig                              - (withdraw)                          0.02 Compound feed for chicken or quail            - (withdraw)                          0.01 Maize                                                            0.02                                   - Miro                                                              0.01                                   - Barley                                                          0.002                                   - Wheat                                                          0.002                                   - Rye                                                              0.002                                   - Oat                                                              0.002                                   - Hay                                                          - (withdraw)                            0.2 Residue definition for enforcement: Fipronil Hay includes hay and fodder (dry), straw, forage (green) and silage. The MRL is set as 90% dry matter base.

Products Covered: Compound feed (HS Code: 23.09),  Oats (HS Code:10.04), barley (HS Code:10.03), wheat (HS Code:10.01), maize (HS Code:10.05), miro (HS Code:10.07), rye (HS Code:10.02) and hay (HS Codes:12.13, 12.14) for feed

Regulation Type: Regular notification

Distribution date: 02 July 2020 | Final date for Comment: 30 August 2020

The notified draft Regulation provides for major and minor changes in the sanitary register, as they may have repercussions on the quality, safety and effectiveness of medical devices, and establishes the conditions and documents required for such changes.

Products Covered: Medical devices; Glands and other organs for organo-therapeutic uses, dried, whether or not powdered; extracts of glands or other organs or of their secretions for organo-therapeutic uses; heparin and its salts; other human or animal substances prepared for therapeutic or prophylactic uses, not elsewhere specified or included (HS 3001); Human blood; animal blood prepared for therapeutic, prophylactic or diagnostic uses; antisera, other blood fractions and immunological products, whether or not modified or obtained by means of biotechnological processes; vaccines, toxins, cultures of micro-organisms and similar products (excluding yeasts).(HS 3002); Medicaments (excluding goods of heading 30.02, 30.05 or 30.06) consisting of two or more constituents which have been mixed together for therapeutic or prophylactic uses, not put up in measured doses or in forms or packings for retail sale (HS 3003); Medicaments (excluding goods of heading 30.02, 30.05 or 30.06) consisting of mixed or unmixed products for therapeutic or prophylactic uses, put up in measured doses (including those in the form of transdermal administration systems) or in forms or packings for retail sale (HS 3004); Wadding, gauze, bandages and similar articles (for example, dressings, adhesive plasters, poultices), impregnated or coated with pharmaceutical substances or put up in forms or packings for retail sale for medical, surgical, dental or veterinary purposes (HS 3005); Pharmaceutical goods specified in Note 4 to Chapter 30 and included in subheadings 3006.10.10 to 3006.60.90 (HS 3006)

Regulation Type: Regular notification