Regulatory Updates

Distribution date: 10 January 2022 | Final date for Comment: 11 March 2022

The Amendment to the Regulation on Designation, and Approval Procedure and Method of Pharmaceutical Products for National Lot Release: Clarifies details, including quantity of samples, period for the procedure, etc., of SARS-CoV-2 viral vector vaccines and other newly authorized pharmaceutical products subject to national lot release; Clarifies products subject to be classified as carrying risk level 3 (subject to summary protocol review and test on entire items) as products (A) which have received national lot release inappropriately, (B) of which master formula is not provided during on-site inspection, or (C) for which false test results were submitted; and Modifies quantity for samples of items including anti-tetanus immunoglobulin.

Products Covered: Pharmaceuticals

Regulation Type: Regular notification

Distribution date: 07 January 2022

The article 3º of the Normative Instruction number 101, 30 August 2021  – previously notified through G/TBT/N/BRA/1248 – which establishes specific criteria for grouping materials for health use into families for market authorization and notification purposes, was rectified. The rectified text is available only in Portuguese and can be downloaded at:  https://www.in.gov.br/web/dou/-/retificacao-370943345

Products Covered: HS (3001-3006) - grouping materials for health use

Regulation Type: Addendum to Regular Notification

Distribution date: 07 January 2022

This Normative Instruction approves the list of Technical Standards for the certification of conformity of devices under the Sanitary Surveillance regime.

Products Covered: HS (3006)

Regulation Type: Regular notification

Distribution date: 07 January 2022

This resolution contains provisions on the identification of regularized medical devices at Anvisa, through the Unique Device Identification (UDI) system.

Products Covered: HS (3006)

Regulation Type: Regular notification

Distribution date: 07 January 2022 | Final date for Comment: 08 March 2022

The Food and Drug Administration (FDA) proposes to revise the list of ingredients prohibited in cosmetic products. Details of the regulated scope are specified in the attached documents.

Products Covered: Cosmetics

Regulation Type: Regular notification

Distribution date: 07 January 2022 | Final date for Comment: 08 March 2022

Proposal of maximum residue limits (MRLs) for the following agricultural chemical Pesticide: Cadusafos

Products Covered: - Edible vegetables and certain roots and tubers (HS Codes: 07.01, 07.02, 07.03, 07.04, 07.06, 07.07, 07.08, 07.09, 07.10 and 07.14) - Edible fruit and nuts, peel of citrus fruit (HS Codes: 08.03, 08.05, 08.07, 08.10, 08.11 and 08.14) - Spices (HS Code: 09.10) - Oil seeds and oleaginous fruits, miscellaneous grains, seeds and fruit (HS Codes: 12.01, and 12.12)

Regulation Type: Regular notification

Distribution date: 07 January 2022

Proposal of maximum residue limits (MRLs) for the following agricultural chemical Pesticide: Broflanilide

Products Covered: - Natural honey (HS Code: 04.09) - Edible vegetables and certain roots and tubers (HS Codes: 07.01, 07.03, 07.04, 07.05, 07.06, 07.08, 07.09, 07.10 and 07.14) - Spices (HS Code: 09.10)

Regulation Type: Regular notification

Distribution date: 06 January 2022 | Final date for Comment: 03 February 2022

To amend the provisions for the pyrogen test, to delete the test for leukopenic toxicity, and to introduce the endotoxin test instead of the test for toxicity to mouse weight gain in the section for “Influenza HA Vaccine”.

Products Covered: PHARMACEUTICAL PRODUCTS (HS code(s): 30); (ICS code(s): 11.120)

Regulation Type: Regular notification

Distribution date: 06 January 2022 | Final date for Comment: 09 January 2022

All wastepaper and metal scrap intended to be imported into Malaysia are subject to inspection process and issuance of Certificate of Approval  as per the Customs (Prohibition of Imports) (Amendment) (No.X) Order 2021. The requirements on all incoming importation of wastepaper and metal scrap into Malaysia are specified in the Guidelines for Importation and Inspection of Waste Paper and the Guidelines for Importation and Inspection of Metal Scrap. The two guidelines have been published on SIRIM QAS website for comments from 27 February 2021 until 15 March 2021. Various engagements with local and international stakeholders have been conducted from February 2021 until November 2021. Interim measure have been enforced pending the implementation of the Guidelines for Importation and Inspection of Metal Scrap.  

Products Covered: i. Recovered (waste and scrap) paper and paperboard: HS Code 4707.10: Unbleached kraft paper or paperboard or corrugated paper or paperboard HS Code 4707.20: Other paper or paperboard made mainly of bleached chemical pulp, not coloured in the mass HS Code 4707.30: Paper or paperboard made mainly of mechanical pulp (for example, newspapers, journals and similar printed matter) ii. Waste and scrap metal: HS Code 7204: Ferrous waste and scrap; re-melting scrap ingots of iron or steel HS Code 7404: Copper waste and scrap HS Code 7602: Aluminium waste or scrap

Regulation Type: Regular notification

Distribution date: 05 January 2022 | Final date for Comment: 07 March 2022

The purpose of this Notice of Consultation is to provide an opportunity to comment on the proposal to remove the prescription status for veterinary use by removing this ingredient from the Veterinary Prescription Drug List (PDL). 

Products Covered: Prescription status of medicinal ingredients for veterinary use in feed (ICS: 11.220; HS 3004.50.55)

Regulation Type: Regular notification