Regulatory Updates

Distribution date: 26 August 2022

The Draft resolution number 1109, 18 August 2022 - previously notified through  G/TBT/N/BRA/1441  - which is regarded to an extraordinary and temporary authorization of the free sale and donation of ethyl alcohol at a concentration  of 70% p/p (seventy percent, expressed in weight by weight), in liquid physical form, duly regularized at Anvisa, due to the emergence of public health of international importance arising from the Monkeypox outbreak, was rectified.   The rectified text is available only in Portuguese and can be downloaded at:   https://www.in.gov.br/en/web/dou/-/retificacao-424467149

Products Covered: Ethers, ether-alcohols, ether-phenols, ether-alcohol-phenols, alcohol peroxides, ether peroxides, ketone peroxides (whether or not chemically defined), and their halogenated, sulphonated, nitrated or nitrosated derivatives. (HS code(s): 2909)

Regulation Type: Corrigendum to Regular Notification

Distribution date: 26 August 2022 | Final date for Comment: 14 October 2022

This Draft Resolution is regarded to a proposal for a Normative Instruction that establishes the modalities and criteria applied for the optimized analysis procedure, in which the evaluations conducted by the Equivalent Foreign Regulatory Authority (EFRA) are used to analyze the market authorization and post-market authorization petitions of medicines and biological products, and a letter of adequacy of active pharmaceutical ingredient (CADIFA), in national territory. According to the proposal, it is designated as Equivalent Foreign Regulatory Authority (EFRA), the institution that has similar measures and controls in relation to the regulatory process adopted by Anvisa and meets, among other requirements, the adoption of international standards and norms equivalent to those currently adopted by Anvisa applicable to active pharmaceutical ingredient, medicines and biological products and their active substances, in particular those established by the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) and the World Health Organization (WHO);

Products Covered: 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 code(s): 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 code(s): 3004)

Regulation Type: Regular notification

Distribution date: 25 August 2022

This Resolution contains provisions on the exceptional and temporary exemption from market authorization and the requirements for exceptional authorization for the importation of medicines and vaccines acquired by the Ministry of Health for the prevention or treatment of Monkeypox, due to a public health emergency of international importance.  

Products Covered: 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 code(s): 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 code(s): 3004)

Regulation Type: Regular notification

Distribution date: 25 August 2022 | Final date for Comment: 13 September 2022

This Draft Resolution is regarded to an extraordinary and temporary authorization of the free sale and donation of ethyl alcohol at a concentration of 70% p/p (seventy percent, expressed in weight by weight), in liquid physical form, duly regularized at Anvisa, due to the emergence of public health of international importance arising from the Monkeypox outbreak.

Products Covered: Ethers, ether-alcohols, ether-phenols, ether-alcohol-phenols, alcohol peroxides, ether peroxides, ketone peroxides (whether or not chemically defined), and their halogenated, sulphonated, nitrated or nitrosated derivatives. (HS code(s): 2909)

Regulation Type: Regular notification

Distribution date: 25 August 2022 | Final date for Comment: 24 October 2022

MFDS is proposing to amend the “Enforcement Rule on the Act on In Vitro Diagnostic Medical Devices” as follows:A. Enable the elimination of the manufacturer’s address on the outer packaging of small size In Vitro Diagnostic Medical Devices. B. Enable the elimination of duplicate information written on both the outer packaging and attached documents of In Vitro Diagnostic Medical Devices. C. Simplified the submission data required for the application of Clinical Performance Study Plan approval of low-risk In Vitro Diagnostic Medical Devices 

Products Covered:  In Vitro Diagnostic Medical Devices (HS code 3822.00)

Regulation Type: Regular notification

Distribution date: 22 August 2022

Act No. 106 of 11 August 2022 regarding Carbendazim's production, distribution, commerce, imports and exports.

Products Covered: Carbendazim

Regulation Type: Regular notification

Distribution date: 19 August 2022

The Draft Resolution number 760, 27 December 2019 - previously notified through G/TBT/N/BRA/955 - which establishes the minimal technical requirements for relative bioavailability and bioequivalence studies that supports dossier of consent for clinical research, market authorization or post-market authorization of medicines, in the terms of this resolution, was adopted as Resolution - RDC number 742, 10 August 2022   The final text is available only in Portuguese and can be downloaded at:  http://antigo.anvisa.gov.br/documents/10181/5740831/RDC_742_2022_.pdf/192ff67b-ff34-4925-a4e7-ec2115b1244e The text final text of Resolution - RDC number 742, 10 August 2022, was rectified.The rectifed text is available only in Portuguese and can be downloaded at:https://www.in.gov.br/en/web/dou/-/retificacao-423195860

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

Regulation Type: Addendum to Regular Notification

Distribution date: 17 August 2022 | Final date for Comment: 16 October 2022

The purpose of the notified text is to establish: The regulations governing the presentation of the documents required for the registration and re-registration of biological products: other biological products. The information to be included in the documents required for the registration and re-registration of biological products: other biological products.

Products Covered: Pharmaceutical products classified under Chapter 30 of the Harmonized System or Customs Tariff

Regulation Type: Regular notification

Distribution date: 15 August 2022

The aim of this addendum is to inform WTO Members that the Draft Uganda Standard; FDUS EAS 790:2013, Liquid soap — Specification; notified in G/TBT/N/UGA/366 was withdrawn on 14 May 2022.

Products Covered: SOAP, ORGANIC SURFACE-ACTIVE AGENTS, WASHING PREPARATIONS, LUBRICATING PREPARATIONS, ARTIFICIAL WAXES, PREPARED WAXES, POLISHING OR SCOURING PREPARATIONS, CANDLES AND SIMILAR ARTICLES, MODELLING PASTES, 'DENTAL WAXES' AND DENTAL PREPARATIONS WITH A BASIS OF PLASTER (HS code(s): 34); Surface active agents (ICS code(s): 71.100.40)

Regulation Type: Addendum to Regular Notification

Distribution date: 15 August 2022

The aim of this addendum is to inform WTO Members that the Draft Uganda Standard; FDUS EAS 787:2013, Synthetic industrial detergent powder — Specification; notified in G/TBT/N/UGA/363 was withdrawn on 14 May 2022.

Products Covered: SOAP, ORGANIC SURFACE-ACTIVE AGENTS, WASHING PREPARATIONS, LUBRICATING PREPARATIONS, ARTIFICIAL WAXES, PREPARED WAXES, POLISHING OR SCOURING PREPARATIONS, CANDLES AND SIMILAR ARTICLES, MODELLING PASTES, 'DENTAL WAXES' AND DENTAL PREPARATIONS WITH A BASIS OF PLASTER (HS code(s): 34); Surface active agents (ICS code(s): 71.100.40)

Regulation Type: Addendum to Regular Notification