Distribution date: 29 July 2022 | Final date for Comment: 27 September 2022

The purpose of the revision is to secure pharmaceutical quality control based on achieved international harmonization of criteria/specification in 「Korean Pharmacopoeia」, to improve some criteria/specifications and general tests to the latest scientific level with reflecting opinions from the pharmaceutical industries, ultimately, to advance criteria/specifications and circulate high quality pharmaceuticals. A term 'Rubber Closures for Aqueous Infusions' was changed into the term ' 'Rubber Closures for injectable drug' in General Notice, General Requirements for Pharmaceutical Preparations and General Test and the subject of application of the test method was expanded. An international harmonization for the test method including addition of performance test of the rubber closures and replacement of animal test by the biological reactivity test.A definition 'In principle, there should be no foreign substances in an ophthalmic solution.' and a paragraph ‘'foreign insoluble matter test for Ophthalmic Suspension is not performed in the the General Requirements for Pharmaceutical Preparations.A test method for 9 items including herbal medicinal preparations such as Soyo Granule in Part 2 of any article was revised.A term ‘LOD(Limit of Detection) in items such as 5. Verification and 5.2. Quantitative test(lower concentration e,g, quantitative test for impurity) was deleted, test parameters including specificity, accuracy, precision was changed into parameters including specificity and LOD in an item, 5.4 Limit test (reference concentration close to the limit of quantitation) and an item 5.5. Limit test (reference concentration significantly higher than the limit of quantitation) was deleted in 'Guideline of Validation of Analytical Procedures for Pharmaceuticals' in General Information.

Products Covered: Pharmaceuticals

Regulation Type: Regular notification

Distribution date: 28 July 2022

Ministry of Agriculture, Livestock and Food Supply – MAPA issued SDA Ordinance No. 626, 22 July 2022 that extends the deadline for compliance with the arts. 6th and 15th of Ordinance SDA No. 384, of August 25, 2021, which approves the standards of identity and quality for gelatin, hydrolyzed gelatin and edible collagen.

Products Covered: 3503.00 - gelatin

Regulation Type: Addendum to Regular Notification

Distribution date: 27 July 2022

The proposed maximum residue limits (MRLs) for Tylvalosin notified in G/SPS/N/JPN/897 (dated 7 December 2021) were adopted and published on 17 March 2022.The specified MRLs are available as below:

Products Covered: - Meat and edible meat offal (HS Codes: 02.03, 02.06, 02.07 and 02.09) - Animal originated products (HS Code: 05.04)- Animal fats and oils (HS Code: 15.01)

Regulation Type: Addendum to Regular Notification

Distribution date: 27 July 2022

The proposed maximum residue limits (MRLs) for Maduramicin notified in G/SPS/N/JPN/893 (dated 7 December 2021) were adopted and published on 17 March 2022.The specified MRLs are available as below:

Products Covered: - Meat and edible meat offal (HS Codes: 02.07 and 02.09) - Animal originated products (HS Code: 05.04)- Animal fats and oils (HS Code: 15.01)

Regulation Type: Addendum to Regular Notification

Distribution date: 27 July 2022

The proposed maximum residue limits (MRLs) for Halofuginone notified in G/SPS/N/JPN/891 (dated 6 December 2021) were adopted and published on 17 March 2022.The specified MRLs are available as below:

Products Covered: - Meat and edible meat offal (HS Codes: 02.01, 02.02, 02.06, 02.07 and 02.09) - Animal originated products (HS Code: 05.04)- Animal fats and oils (HS Codes: 15.01 and 15.02)

Regulation Type: Addendum to Regular Notification

Distribution date: 27 July 2022

The proposed maximum residue limits (MRLs) for Metamifop notified in G/SPS/N/JPN/888 (dated 6 December 2021) were adopted and published on 17 March 2022.The specified MRLs are available as below:

Products Covered: - Meat and edible meat offal (HS Codes: 02.01, 02.02, 02.03, 02.04, 02.05, 02.06, 02.08 and 02.09) - Fish and crustaceans, molluscs and other aquatic invertebrates (HS Codes: 03.02, 03.03, 03.04, 03.06, 03.07 and 03.08) - Dairy produce (HS Code: 04.01) - Animal originated products (HS Code: 05.04) - Cereals (HS Code: 10.06)- Animal fats and oils (HS Codes: 15.01, 15.02 and 15.06)

Regulation Type: Addendum to Regular Notification

Distribution date: 27 July 2022

The proposed maximum residue limits (MRLs) for Isoeugenol notified in G/SPS/N/JPN/892 (dated 6 December 2021) were adopted and published on 17 March 2022.The specified MRLs are available as below:

Products Covered: - Fish (HS Codes: 03.02, 03.03 and 03.04)

Regulation Type: Addendum to Regular Notification

Distribution date: 27 July 2022

The proposed maximum residue limits (MRLs) for Trimethoprim notified in G/SPS/N/JPN/896 (dated 7 December 2021) were adopted and published on 17 March 2022.The specified MRLs are available as below:

Products Covered: - Meat and edible meat offal (HS Codes: 02.01, 02.02, 02.03, 02.04, 02.05, 02.06, 02.07, 02.08 and 02.09) - Fish and crustaceans, molluscs and other aquatic invertebrates (HS Codes: 03.02, 03.03, 03.04, 03.06, 03.07 and 03.08) - Dairy produce and birds' eggs (HS Codes: 04.01, 04.07 and 04.08) - Animal originated products (HS Code: 05.04)- Animal fats and oils (HS Codes: 15.01, 15.02 and 15.06)       

Regulation Type: Addendum to Regular Notification

Distribution date: 27 July 2022

The proposed maximum residue limits (MRLs) for Robenidine notified in G/SPS/N/JPN/895 (dated 7 December 2021) were adopted and published on 17 March 2022.The specified MRLs are available as below:

Products Covered: - Meat and edible meat offal (HS Codes: 02.07 and 02.09) - Animal originated products (HS Code: 05.04)- Animal fats and oils (HS Code: 15.01)

Regulation Type: Addendum to Regular Notification

Distribution date: 27 July 2022

The proposed maximum residue limits (MRLs) for Fluazinam notified in G/SPS/N/JPN/884 (dated 6 December 2021) were adopted and published on 17 March 2022.The specified MRLs are available as below:

Products Covered: - Meat and edible meat offal (HS Codes: 02.01, 02.02 and 02.06) - Dairy produce (HS Code: 04.01) - Animal originated products (HS Code: 05.04) - Edible vegetables and certain roots and tubers (HS Codes: 07.01, 07.03, 07.04, 07.05, 07.06, 07.09, 07.10, 07.13 and 07.14) - Edible fruit and nuts, peel of citrus fruit (HS Codes: 08.04, 08.05, 08.06, 08.08, 08.09, 08.10, 08.11 and 08.14) - Tea, mate and spices (HS Codes: 09.02, 09.03, 09.04, 09.05, 09.06, 09.07, 09.08, 09.09 and 09.10) - Cereals (HS Code: 10.01) - Oil seeds and oleaginous fruits, miscellaneous grains, seeds and fruit (HS Codes: 12.02 and 12.07) - Animal fats and oils (HS Code: 15.02)

Regulation Type: Addendum to Regular Notification