Distribution date: 21 February 2025 | Final date for Comment: 19 April 2025

Resolution temporarily suspending the issuance of animal health import documents for animal products of the bovine and porcine species coming from Germany.

Products Covered: Product UseBovine albumin Laboratory materialBile, whether or not dried; glands Laboratory materialand other animal products usedin the preparation ofpharmaceutical productsBile, whether or not dried; glands Diagnosticsand other animal products usedin the preparation ofpharmaceutical productsMatured (unpasteurized) cheese Human consumptionPorcine liver extract Commercial/animal consumptionPorcine pancreatin Human medicinePorcine haemoglobin Animal consumption

Regulation Type: Emergency notifications (SPS)

Distribution date: 21 February 2025 | Final date for Comment: 22 April 2025

The draft Order proposes the approval of Hygienic requirements for edible caseins and caseinates, which define the information required for labeling the final product.The draft Order is also notified under the SPS Agreement. 

Products Covered: Edible caseins and caseinates,  (HS code(s): 3501)

Regulation Type: Regular notification

Distribution date: 24 February 2025 | Final date for Comment: 25 April 2025

Annex IV of Regulation (EU) 2019/1009 lays down conformity assessment procedures for the assessment of fertilising products. Module A1 is amended as to introduce the requirement that detonation resistance tests for ammonium nitrate fertilisers of high nitrogen content shall be carried out only by laboratories with proven technical capacity. Module D1 is amended as to set a general audit frequency for recovered component materials, independent from the required output material sampling.

Products Covered: Fertilising products

Regulation Type: Regular notification

Distribution date: 24 February 2025 | Final date for Comment: 29 April 2025

The purpose of this Notice of Consultation is to provide an opportunity for the public and other interested stakeholders to comment on the proposal to revise the listing for "Nicotine or its salts" on the human use part of the Prescription Drug List (PDL).The proposal is to clarify the non-prescription use of nicotine buccal pouches by:amending part "d" of the qualifier of the listing to be specific to sprays and inhalers only, andadding a new part "f" to the qualifier that is specific to nicotine buccal pouches.

Products Covered: Prescription status of medicinal ingredients for human use (ICS: 11.120; HS 3004.90)

Regulation Type: Regular notification

Distribution date: 24 February 2025 | Final date for Comment: 29 April 2025

The purpose of this Notice of Consultation is to provide an opportunity for the public and other interested stakeholders to comment on the proposal to revise the listing for "Nicotine or its salts" on the human use part of the Prescription Drug List (PDL). The proposal is to allow the non-prescription use of orally disintegrating or sublingual tablets by:adding a new part "g" to the qualifier of the listing to specifically exempt orally disintegrating or sublingual tablets containing 4 milligrams or less of nicotine per dosage unit.

Products Covered: Prescription status of medicinal ingredients for human use (ICS: 11.120; HS 3004.90)

Regulation Type: Regular notification

Distribution date: 25 February 2025 | Final date for Comment: 21 April 2025

The Amendment to Ministry of Health Supreme Decree No. 239, of 2003, approving the Regulations of the National Cosmetics Control System pursuant to Law No. 21.646, is being submitted for public consultation. The amendments incorporate the necessary regulatory changes to implement and enforce Law No. 21.646. This Law amends the Health Code in order to prohibit, from its entry into force, the introduction into the domestic market of cosmetics that have been tested on animals to demonstrate their safety and efficacy.

Products Covered: Cosmetics

Regulation Type: Regular notification

Distribution date: 27 February 2025 | Final date for Comment: 28 April 2025

This document specifies the classification and coding, technical requirements, test methods, marking and packaging of chemical protective clothing.This document applies to chemical protective clothing used in workplace operations and emergency rescue.

Products Covered: chemical protective clothing(HS code(s): 621710); (ICS code(s): 13.340.10)

Regulation Type: Regular notification

Distribution date: 27 February 2025 | Final date for Comment: 28 April 2025

The purpose of the "Regulations on the Supervision and Administration of Drug Production for Export" is to regulate the drug manufacturing activities of Chinese manufacturers exporting drugs to other countries or regions, and to require the implementation of GMP. It mainly includes  the following contents: general provisions, basic requirements, entrusted manufacturing for export, export drug archives, export certification documents (general requirements for export certification documents, Certificate of a Pharmaceutical product, Written confirmation for active substances exported to EU), supervision and management, and supplementary provisions. 

Products Covered: drug (HS code(s): 30); (ICS code(s): 11.120.10)

Regulation Type: Regular notification

Distribution date: 27 February 2025 | Final date for Comment: 28 April 2025

This regulation is the revised draft version from Regulation of The Indonesian FDA Number 21 Year 2022 on Procedures for Cosmetic Notify Submission. Once this new regulation is enacted, the previous regulation (Regulation of The Indonesian FDA Number 21 Year 2022 on Procedures for Cosmetic Notify Submission) will be revoked.The content of this draft regulation primarily outlines the requirements for cosmetics to be notified, which must include a valid PIF (Product Information File) to ensure that products meet the necessary standards both prior to and during their distribution in Indonesia.The company or person responsible for placing the cosmetic product in the market shall keep the following information readily accessible to the regulatory of the Member State concerned at the address specified on the label.

Products Covered: Cosmetic

Regulation Type: Regular notification

Distribution date: 03 March 2025 | Final date for Comment: 02 May 2025

This document specifies the classification, technical requirements, test methods, labeling, packaging, storage, and shelf life of skin-protective agent for workers. This document applies to skin-protective agent for workers used in the workplace.

Products Covered: Skin-protective agent(HS code(s): 330499); (ICS code(s): 13.340.10)

Regulation Type: Regular notification