Revision of the Specifications and Standards for Foods, Food Additives, Etc. under the Food Sanitation Act (Revision of agricultural chemical residue standards)
Distribution date: 07 December 2021 | Final date for Comment: 08 May 2025
Proposal of maximum residue limits (MRLs) for the following agricultural chemical: Veterinary drug: Maduramicin.
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: Regular notification
Revision of the Specifications and Standards for Foods, Food Additives, Etc. under the Food Sanitation Act (Revision of agricultural chemical residue standards)
Distribution date: 07 December 2021 | Final date for Comment: 08 May 2025
Proposal of maximum residue limits (MRLs) for the following agricultural chemical: Veterinary drug: Trimethoprim.
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: Regular notification
Revision of the Specifications and Standards for Foods, Food Additives, Etc. under the Food Sanitation Act (Revision of agricultural chemical residue standards)
Distribution date: 07 December 2021 | Final date for Comment: 08 May 2025
Proposal of maximum residue limits (MRLs) for the following agricultural chemical: Veterinary drug: Robenidine.
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: Regular notification
Resolution – RDC number 301, 21 August 2019
Distribution date: 07 December 2021 | Final date for Comment: 08 May 2025
Resolution – RDC number 301, 21 August 2019 - previously notified through G/TBT/N/BRA/870/Add.1 - which establishes Good Practice Guidelines for the Manufacture of Medicines, was changed Resolution – RDC number 580, 26 November 2021. The final text is available only in Portuguese and can be downloaded at: http://antigo.anvisa.gov.br/documents/10181/6359266/RDC_580_2021_.pdf/e9498832-cfe6-43f3-b175-0986c6bc5d5c
Products Covered: HS Codes: 3003; 3004; 3005; 2941.
Regulation Type: Addendum to Regular Notification
Inmetro Ordinance No. 473, 29 November 2021
Distribution date: 07 December 2021 | Final date for Comment: 08 May 2025
Inmetro Ordinance No. 473 consolidates the control of the liquid content for the quantitative indication of cosmetic and toilet products sold in nominal quantities of 5 g or mL to 20 g or mL.
Products Covered: ESSENTIAL OILS AND RESINOIDS; PERFUMERY, COSMETIC OR TOILET PREPARATIONS (HS code(s): 33); Cosmetics. Toiletries (ICS code(s): 71.100.70)
Regulation Type: Regular notification
Resolution – RDC number 579, 25 November 2021.
Distribution date: 07 December 2021 | Final date for Comment: 08 May 2025
The resolution provides for import, sale and donation of used and reconditioned medical devices.
Products Covered: Medical devices (HS 3006)
Regulation Type: Regular notification
Partial amendment to the Minimum Requirements for Radiopharmaceuticals
Distribution date: 08 December 2021 | Final date for Comment: 07 January 2022
The Minimum Requirements for Radiopharmaceuticals will be partially amended to revise the purity test for a radiopharmaceutical.
Products Covered: PHARMACEUTICAL PRODUCTS (HS code(s): 30); (ICS code(s): 11.120)
Regulation Type: Regular notification
Amendment of The Korean Pharmacopoeia
Distribution date: 09 December 2021 | Final date for Comment: 07 February 2022
The purpose of the revision is to enable adequate quality control of pharmaceuticals by harmonizing national standards and specifications with internationally established practices, and to facilitate the distribution of advanced pharmaceuticals of high quality in line with cutting-edge scientific technology by reflecting the latest R&D outcomes in the Pharmacopoeia. a. Modification and modernization of validation methods, including revisions and error corrections (18 cases, Monographs Part I & Part II, General Tests, General Information) b. Addition of an item “Gemifloxacin Mesylate Tab” (1 case, Monographs Part I)
Products Covered: Pharmaceuticals
Regulation Type: Regular notification
Notice of Amendment: Prescription Drug List (PDL): Epinephrine (topical solution)
Distribution date: 09 December 2021 | Final date for Comment: 08 May 2025
The purpose of this Notice of Amendment is to announce that Health Canada’s notified addition of Epinephrine topical solution for hemostasis when sold at a concentration equal to or greater than 1 mg/ml (1:1000) to the Prescription Drug List has now entered into force. Both the Human and the Veterinary parts of the List have been updated.
Products Covered: Prescription status of medicinal ingredients for human use (ICS: 11.120; HS 3004.90)
Regulation Type: Addendum to Regular Notification
DEAS 1075:2021, Disposable wet wipes — Specification, First Edition
Distribution date: 13 December 2021 | Final date for Comment: 11 February 2022
This Draft East African Standard specifies requirements, sampling and test methods for non-woven disposable wet wipes applicable for general personal hygiene and sanitizing purposes
Products Covered: Disposable wet wipes
Regulation Type: Regular notification
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