List of radiopharmaceuticals to prove the safety and effectiveness.
Distribution date: 19 January 2021 | Final date for Comment: 14 May 2025
The Draft Resolution number 705, 23 August 2019 – previously notified through G/TBT/N/BRA/910 – which is a complement for the revision of the Resolution – RDC number 64, 18 December 2009, and establishes the list of radiopharmaceuticals that can present the literature for security and efficacy demonstration, was adopted as Normative Instruction number 81, 16 December 2020. The final text is available only in Portuguese and can be downloaded at: http://antigo.anvisa.gov.br/documents/10181/3633045/IN_81_2020_.pdf/b895af2b-0d17-4a71-8fca-f83fa574ea35
Products Covered: HS CODE: 3006 (radiopharmaceuticals)
Regulation Type: Addendum to Regular Notification
Register, notification, import and quality control of radiopharmaceuticals
Distribution date: 19 January 2021 | Final date for Comment: 14 May 2025
The Draft Resolution number 703, 23 August 2019 – previously notified through G/TBT/N/BRA/908 – which proposes the revision of the Resolution – RDC number 64, 18 December 2009, which establishes the market authorization for radiopharmaceuticals, was adopted as Resolution – RDC number 451, 16 December 2020. The final text is available only in Portuguese and can be downloaded at: http://antigo.anvisa.gov.br/documents/10181/3633045/RDC_451_2020_.pdf/de07a86f-b7a4-4680-aae7-99ffa1bed369
Products Covered: HS CODE: 3006 (radiopharmaceuticals)
Regulation Type: Addendum to Regular Notification
Trichloroethylene (TCE); Regulation of Use in Vapor Degreasing Under TSCA Section 6(a)
Distribution date: 20 January 2021 | Final date for Comment: 14 May 2025
TITLE: Withdrawal of Proposed Rules; Discontinuing Three Rulemaking Efforts Listed in the Semiannual Regulatory Agenda AGENCY: Environmental Protection Agency (EPA) ACTION: Withdrawal of proposed rules SUMMARY: The Environmental Protection Agency (EPA) is withdrawing the proposed regulatory requirements described in the three proposed rules that are identified in this document. This document summarizes the proposed rules and provides a brief explanation for the Agency's decision not to finalize the proposed actions. DATES: As of 15 January 2021, the proposed rule published on 16 December 2016 (81 FR 91592; FRL-9949-86)(USA/1247); the proposed rule published on 19 January 2017 (82 FR 7432; FRL-9950-08)(USA/1270); and the portion of the proposed rule published on 19 January 2017 (82 FR 7464; FRL-9958-57)(USA/1271) that pertains to n-Methylpyrrolidone (NMP) and methylene chloride in commercial paint and coating removal, are withdrawn. This withdrawal of proposed rules and earlier actions notified under the symbol G/TBT/N/USA/1270 is identified by Docket Number EPA-HQ-OPPT-2016-0387. The Docket Folder is available on Regulations.gov at https://www.regulations.gov/docket?D=EPA-HQ-OPPT-2016-0387 and provides access to primary and supporting documents as well as comments received. Documents are also accessible from Regulations.gov by searching the Docket Number. G/TBT/N/USA/1271 and subsequent addenda - Methylene Chloride and N-Methylpyrrolidone; Regulation of Certain Uses Under TSCA Section 6(a) G/TBT/N/USA/1247 and subsequent addenda - Trichloroethylene; Regulation of Certain Uses Under TSCA Sec. 6(a)
Products Covered: Trichloroethylene (TCE)
Regulation Type: Addendum to Regular Notification
Methylene Chloride and N-Methylpyrrolidone; Regulation of Certain Uses Under TSCA Section 6(a)
Distribution date: 20 January 2021 | Final date for Comment: 14 May 2025
TITLE: Withdrawal of Proposed Rules; Discontinuing Three Rulemaking Efforts Listed in the Semiannual Regulatory Agenda AGENCY: Environmental Protection Agency (EPA) ACTION: Withdrawal of proposed rules SUMMARY: The Environmental Protection Agency (EPA) is withdrawing the proposed regulatory requirements described in the three proposed rules that are identified in this document. This document summarizes the proposed rules and provides a brief explanation for the Agency's decision not to finalize the proposed actions. DATES: As of 15 January 2021, the proposed rule published on 16 December 2016 (81 FR 91592; FRL-9949-86)(USA/1247); the proposed rule published on 19 January 2017 (82 FR 7432; FRL-9950-08)(USA/1270); and the portion of the proposed rule published on 19 January 2017 (82 FR 7464; FRL-9958-57)(USA/1271) that pertains to n-Methylpyrrolidone (NMP) and methylene chloride in commercial paint and coating removal, are withdrawn. This withdrawal of proposed rules and earlier actions notified under the symbol G/TBT/N/USA/1271 is identified by Docket Number EPA-HQ-OPPT-2016-0231. The Docket Folder is available on Regulations.gov at https://www.regulations.gov/docket?D=EPA-HQ-OPPT-2016-0231 and provides access to primary and supporting documents as well as comments received. Documents are also accessible from Regulations.gov by searching the Docket Number. G/TBT/N/USA/1270 and subsequent addenda - Trichloroethylene (TCE); Regulation of Use in Vapor Degreasing Under TSCA Section 6(a) G/TBT/N/USA/1247 and subsequent addenda - Trichloroethylene; Regulation of Certain Uses Under TSCA Sec. 6(a)
Products Covered: Methylene chloride and N-Methylpyrrolidone
Regulation Type: Addendum to Regular Notification
Ingredientes Farmacéuticos Activos (IFA) - Ranitidina (Active pharmaceutical ingredients (APIs) - Ranitidine) (3 pages, in Spanish) Text available at: http://www.puntofocal.gov.ar/formularios/notific_arg.php https://members.wto.org/crnattachments/2021/TBT/ARG/21_0618_00_s.pdf
Distribution date: 21 January 2021 | Final date for Comment: 14 May 2025
As a preventive measure, the marketing throughout the national territory of medicinal preparations containing ranitidine as an active pharmaceutical ingredient (API), as a monodrug or in association with other APIs, in its oral pharmaceutical forms, and in all its concentrations and presentations, has been suspended. (DI-2020-9209-APN-ANMAT#MS)
Products Covered: Active pharmaceutical ingredients (APIs); (HS: 30)
Regulation Type: Regular notification
Partial amendment to the Minimum Requirements for Radiopharmaceuticals.
Distribution date: 21 January 2021 | Final date for Comment: 20 February 2021
The Minimum Requirements for Radiopharmaceuticals will be partially amended to add standards for a radiopharmaceutical to be newly approved.
Products Covered: PHARMACEUTICAL PRODUCTS (HS code(s): 30); (ICS code(s): 11.120)
Regulation Type: Regular notification
This corrigendum aims to inform that the Ministry of Agriculture, Livestock and Food Supply - MAPA has published one rectification on the Technical Regulation no. 94, 18 September 2020, setting the identity and minimum quality requirements for whey and acid whey, regarding the indication of physical-chemical standard values and for the indication of numerical powers in the whey RTIQ, as follows: in Table 3, of Annex I, which deals with the physical-chemical parameters of partially demineralized whey powder and demineralized whey powder, for the parameter referring to ash, where it reads: 1.5 to 1.7, must be read: 1.5 to 7. In the Table 4, of Annex II, which deals with microbiological criteria for whey powder which deals with the microbiological criteria for whey powder, for the criteria of viable mesophilic aerobes/gram, where it reads; m=3,0x104; M=1,0x105, must be read m=3,0x104; M=1,0x105
Distribution date: 22 January 2021 | Final date for Comment: 14 May 2025
Products Covered:
Regulation Type: Corrigendum to Regular Notification
Se adjunta el texto notificado que fuera omitido en la G/TBT/N/ARG/412.
Distribution date: 22 January 2021 | Final date for Comment: 14 May 2025
Products Covered: Active pharmaceutical ingredients (APIs); (HS: 30)
Regulation Type: Corrigendum to Regular Notification
Partial amendment to the Ministerial Order for the Standard of Manufacturing Control and Quality Control for Drugs and Quasi-Drugs.
Distribution date: 27 January 2021 | Final date for Comment: 28 March 2021
The Ministerial Order for the Standard of Manufacturing Control and Quality Control for Drugs and Quasi-Drugs will be partially amended to reflect the Good Manufacturing Practice (GMP) Guide of the Pharmaceutical Inspection Convention/Pharmaceutical Inspection Cooperation Scheme (PIC/S), which is amended in 2018.
Products Covered: PHARMACEUTICAL PRODUCTS (HS code(s): 30); (ICS code(s): 11.120)
Regulation Type: Regular notification
Ban on certain products containing mercury
Distribution date: 28 January 2021 | Final date for Comment: 14 May 2025
Please be advised that the draft Resolution on the technical quality and safety requirements to be met by certain products, whether or not containing added mercury, produced in or imported into the Argentine Republic, which was notified in document G/TBT/N/ARG/356/Add.1, has been withdrawn. The notification in question should therefore be considered null and void. Punto Focal OTC-OMC de la República Argentina (TBT-WTO Focal Point of the Argentine Republic) Avda. Julio A. Roca 651 Piso 4° Sector 23A (C1067ABB) Ciudad Autónoma de Buenos Aires, Argentina Email: [email protected] __________
Products Covered: Alkali or alkaline-earth metals; rare-earth metals, scandium and yttrium, whether or not intermixed or interalloyed; mercury (HS code(s): 2805); Products of the chemical industry (ICS code(s): 71.100)
Regulation Type: Addendum to Regular Notification
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