Normative Instruction number 70, 1 September 2020

Distribution date: 19 October 2020 | Final date for Comment: 16 May 2025
This Normative Instruction establishes the inclusion of a declaration in the label of sanitizing products informing the existence of a new formula changing its composition.
Products Covered: Mixtures of odoriferous substances and mixtures, incl. alcoholic solutions, based on one or more of these substances, of a kind used as raw materials in industry (excl. food or drink industries) (HS code(s): 330290); Soap in the form of flakes, granules, powder, paste or in aqueous solution (HS code(s): 340120); Organic surface-active agents (excl. soap); surface-active preparations, washing preparations, incl. auxiliary washing preparations, and cleaning preparations, whether or not containing soap (excl. those of heading 3401) (HS code(s): 3402); Surface active agents (ICS code(s): 71.100.40)
Regulation Type: Regular notification
Normative Instruction number 70, 1 September 2020

Distribution date: 19 October 2020 | Final date for Comment: 16 May 2025
This Normative Instruction establishes the inclusion of a declaration in the label of sanitizing products informing the existence of a new formula changing its composition.
Products Covered: Mixtures of odoriferous substances and mixtures, incl. alcoholic solutions, based on one or more of these substances, of a kind used as raw materials in industry (excl. food or drink industries) (HS code(s): 330290); Soap in the form of flakes, granules, powder, paste or in aqueous solution (HS code(s): 340120); Organic surface-active agents (excl. soap); surface-active preparations, washing preparations, incl. auxiliary washing preparations, and cleaning preparations, whether or not containing soap (excl. those of heading 3401) (HS code(s): 3402); Surface active agents (ICS code(s): 71.100.40)
Regulation Type: Regular notification
Normative Instruction number 73, 1 September 2020

Distribution date: 19 October 2020 | Final date for Comment: 16 May 2025
This Normative Instruction establishes the inclusion of a declaration in the label of pesticides informing the existence of a new formula changing its composition. This regulation will be also notified to the SPS committee.
Products Covered: HS Code(s): 38089910 (pesticides)
Regulation Type: Regular notification
Normative Instruction number 73, 1 September 2020

Distribution date: 19 October 2020 | Final date for Comment: 16 May 2025
This Normative Instruction establishes the inclusion of a declaration in the label of pesticides informing the existence of a new formula changing its composition. This regulation will be also notified to the SPS committee.
Products Covered: HS Code(s): 38089910 (pesticides)
Regulation Type: Regular notification
A draft revision of “Pharmaceutical Affairs Act”

Distribution date: 20 October 2020 | Final date for Comment: 19 December 2020
The Ministry of Food and Drug Safety of the Republic of Korea is partly revising the “Pharmaceutical Affairs Act”. The main contents are: For the pharmaceutical imported, similar to pharmaceutical manufactured, the distribution has been managed thoroughly by prescribing the prohibition another pharmaceutical that is not identical with the approved and reported information such as ingredient and amount from importing, storing and displaying for the purpose of marketing. Under “Safety Control Act of Household Chemicals and Biocidal Product” (Established on 20 Mar 2018; Implemented on 1 Jan 2019), the managing body shall be excluded in the scope of quasi-drug as nematicide and humidifier disinfectant of fly and mosquito that were controlled as quasi-drug according to “Pharmaceutical Affairs Act” was changed. (Article 2, 62 and 68-4)
Products Covered: Pharmaceuticals, Quasi-drug
Regulation Type: Regular notification
A draft revision of “Pharmaceutical Affairs Act”

Distribution date: 20 October 2020 | Final date for Comment: 19 December 2020
The Ministry of Food and Drug Safety of the Republic of Korea is partly revising the “Pharmaceutical Affairs Act”. The main contents are: For the pharmaceutical imported, similar to pharmaceutical manufactured, the distribution has been managed thoroughly by prescribing the prohibition another pharmaceutical that is not identical with the approved and reported information such as ingredient and amount from importing, storing and displaying for the purpose of marketing. Under “Safety Control Act of Household Chemicals and Biocidal Product” (Established on 20 Mar 2018; Implemented on 1 Jan 2019), the managing body shall be excluded in the scope of quasi-drug as nematicide and humidifier disinfectant of fly and mosquito that were controlled as quasi-drug according to “Pharmaceutical Affairs Act” was changed. (Article 2, 62 and 68-4)
Products Covered: Pharmaceuticals, Quasi-drug
Regulation Type: Regular notification
(1) Partial amendment to the Minimum Requirements for Biological Products (2) Partial amendment to the Public Notice on National Release Testing

Distribution date: 20 October 2020 | Final date for Comment: 19 November 2020
(1) The Minimum Requirements for Biological Products shall be partially amended to add the standard for a blood product to be newly approved. (2) The Public Notice on National Release Testing shall be partially amended to provide for the above-mentioned blood product.
Products Covered: Pharmaceutical Products (HS: 30)
Regulation Type: Regular notification
(1) Partial amendment to the Minimum Requirements for Biological Products (2) Partial amendment to the Public Notice on National Release Testing

Distribution date: 20 October 2020 | Final date for Comment: 19 November 2020
(1) The Minimum Requirements for Biological Products shall be partially amended to add the standard for a blood product to be newly approved. (2) The Public Notice on National Release Testing shall be partially amended to provide for the above-mentioned blood product.
Products Covered: Pharmaceutical Products (HS: 30)
Regulation Type: Regular notification
Update of Annex I of the Collegiate Board Resolution - RDC No. 405 of 22 July 2020

Distribution date: 20 October 2020 | Final date for Comment: 16 May 2025
The Annex I of the Resolution – RDC number 405, 22 July 2020 – previously notified through G/TBT/N/BRA/1061 – which establishes control measures for medicines that contain substances mentioned by the Annex I of this resolution, isolated or in association with other drugs, due to the international public health emergency of the new coronavirus (SARS-CoV-2), was changed by the Resolution – RDC number 420, 1 September 2020.
Products Covered:
Regulation Type: Addendum to Regular Notification
Update of Annex I of the Collegiate Board Resolution - RDC No. 405 of 22 July 2020

Distribution date: 20 October 2020 | Final date for Comment: 16 May 2025
The Annex I of the Resolution – RDC number 405, 22 July 2020 – previously notified through G/TBT/N/BRA/1061 – which establishes control measures for medicines that contain substances mentioned by the Annex I of this resolution, isolated or in association with other drugs, due to the international public health emergency of the new coronavirus (SARS-CoV-2), was changed by the Resolution – RDC number 420, 1 September 2020.
Products Covered:
Regulation Type: Addendum to Regular Notification
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