DECRETO N° 2942/2024 "POR EL CUAL SE REGLAMENTA EL ARTÍCULO 39 DE LA LEY N° 1119/1997, "DE PRODUCTOS PARA LA SALUD Y OTROS", Y EL ARTÍCULO 5° DE LA LEY N° 6788/2021, MODIFICADA POR LEY N° 7361/2024, RESPECTO A LA REGULACIÓN DE LOS PRODUCTOS DE HIGIENE PERSONAL, COSMÉTICOS Y PERFUMES Y SE ABROGA EL DECRETO N° 3636/2020" (Decree No. 2942/2024 regulating Article 39 of Law No. 1119/1997 on health and other products, and Article 5 of Law No. 6788/2021, as amended by Law No. 7361/2024, regarding the regulation of personal hygiene products, cosmetics and perfumes; and repealing Decree No. 3636/2020) (14 pages, in Spanish)
Distribution date: 07 February 2025 | Final date for Comment: 19 April 2025
The notified Decree regulates Article 39 of Law No. 1119/1997 on health and other products, and Article 5 of Law No. 6788/2021, as amended by Law No. 7361/2024, regarding the regulation of personal hygiene products, cosmetics and perfumes; and repeals Decree No. 3636/2020.
Products Covered: Essential oils and resinoids; perfumery, cosmetic or toilet preparations (HS code: 33)
Regulation Type: Regular notification
Draft Decree to provide guidelines for a number of articles and implementation of the revised Pharmaceutical Law
Distribution date: 10 February 2025 | Final date for Comment: 11 April 2025
The Draft Decree will provide guidelines on the Law No. 44/2024/QH 15 revising the Pharmaceutical Law No. 105/2016/QH13, including:+ Provisions on policies of pharmaceuticals.+ Provisions on investment incentives for promoting the development of the pharmaceutical industry.+ Provisions on updating and sharing judicial record database for receiving agencies.+ Provisions on establishment of mobile drug retail in ethnic minorities, mountainous, island, socio-economically disadvantaged or extremely disadvantaged areas.+ Provisions on disclosure of all information regarding to business licenses, pharmacy practice certificate of the responsible pharmacists, approved information on drug.+ Provisions on wholesale and retail of medicinal products and pharmaceutical ingredients via e-commercial method. + Provisions on responsibility of the Ministry of Finance in regular sharing with MOH information on special controlled drug cleared for import and export. + Detailed provisions on: (i) Criteria, documentation, procedures, timelines for granting and withdrawing import and export licenses for medicinal products and pharmaceutical ingredients as specified in Clauses 2, 3, 4, and 5 of Article 60 of the 2016 Law on Pharmacy (as amended and supplemented); (ii) Catalogue of medicinal products and pharmaceutical ingredients prohibited from import and manufacture; (iii) Forms for declaration serving the import of clinical trial drugs and dossiers, procedures, processing time for the change of purpose of use of ingredients;(iv) the transfer of drugs as stipulated in Point c, Clause 2, Article 60 of the 2016 Pharmaceutical law (as amended and supplemented), provision of drugs imported by medical examination and treatment establishments for special treatment needs of other medical examination and treatment establishments.+ Specific provisions on withdrawal of pharmaceutical ingredients, procedures for managing withdrawn pharmaceutical ingredients.+ Specific provisions on pharmaceutical advertising content, documentation, procedures for submission, assessment, and approval of advertising content; provisions on the responsibilities of entities and individuals engaged in and involved in pharmaceutical advertising.+ Specific provisions on the publication and republication of anticipated wholesale drug prices for prescription medicines and Clauses 4 and 10 of Article 107 of the 2016 Law on Pharmacy (as amended and supplemented).+ Revise and amendment of some Articles of Decree No. 54/2017/NĐ-CP dated 08/5/2017 providing guidelines on implementation of Pharmaceutical Law (as amended and supplemented by the Decree Noe 155/2018/NĐ-CP dated 12/11/2018, Decree No 88/2023/NĐ-CP dated 11/12/2023) to timely address the difficulties and in line with the current situations. + Incorporate other provisions of Decree No. 54/2017/ND-CP (as amended and supplemented by Decree No. 155/2018/ND-CP and Decree No. 88/2023/ND-CP of the Government) that are consistent with Law No. 44/2024/QH15 and do not pose any implementation challenges.
Products Covered: Pharmaceuticals
Regulation Type: Regular notification
National Standard of the P.R.C., Feed additives—Part 1：Amino acids, their salts and analogues—Taurine
Distribution date: 11 February 2025 | Final date for Comment: 12 April 2025
This document specifies the chemical name, molecular formula, relative molecular weight and structural formula of taurine, specifies the technical requirements, inspection rules, labeling, packaging, transportation, storage and shelf life of feed additive taurine, and describes the sampling and testing methods.This document applies to feed additive taurine obtained by chemical synthesis using ethylene oxide or 2- aminoethanol as the main raw material, with a small amount or no addition of anti-caking agents.
Products Covered: Taurine
Regulation Type: Regular notification
National Standard of the P.R.C.,Feed additives—Part 8：Preservatives and acidity regulators—Sodium diacetate
Distribution date: 11 February 2025 | Final date for Comment: 12 April 2025
This document specifies the technical requirements, test methods, inspection rules, as well as the labeling, packaging, transportation, and storage of the feed additive sodium diacetate.This document applies to the feed additive sodium diacetate products synthesized by chemical methods.
Products Covered: Sodium diacetate
Regulation Type: Regular notification
National Standard of the P.R.C., Feed additives—Part 3:Minerals and their complexes (or chelates)—Ferrous lactate
Distribution date: 11 February 2025 | Final date for Comment: 12 April 2025
This document specifies the technical requirements, sampling, test methods, inspection rules, labeling, packaging, transportation, storage, and shelf life of the feed additive ferrous lactate.This document applies to feed additives ferrous lactate dihydrate and ferrous lactate trihydrate products synthesized by chemical methods.
Products Covered: Ferrous lactate
Regulation Type: Regular notification
National Standard of the P.R.C., Feed additives—Part 6: Non-protein nitrogen—Diammonium hydrogen phosphate
Distribution date: 11 February 2025 | Final date for Comment: 12 April 2025
This document specifies requirements, test methods, inspection rules and labeling, packaging, transportation and storage of feed additives diammonium hydrogen phosphate.This document applies to diammonium hydrogen phosphate obtained by chemical synthesis as a non-protein nitrogen feed additive.
Products Covered: Diammonium hydrogen phosphate
Regulation Type: Regular notification
National Standard of the P.R.C., Feed additives—Part 2：Vitamins, provitamins and chemically well-defined substances having similar effect— Riboflavin（vitamin B2）
Distribution date: 11 February 2025 | Final date for Comment: 12 April 2025
This document specifies the chemical name, molecular formula, relative molecular weight and structural formula of Riboflavin（vitamin B2）, specifies the technical requirements, inspection rules, labeling, packaging, transportation, storage, and shelf life of feed additive Riboflavin（vitamin B2） products, and describes sampling and testing methods.This document applies to the feed additive Riboflavin（vitamin B2） produced by biological fermentation.
Products Covered: Riboflavin（vitamin B2）
Regulation Type: Regular notification
National Standard of the P.R.C., Feed additives—Part 8:Preservatives,mildew preventives and acidity regulators—Calcium formate
Distribution date: 11 February 2025 | Final date for Comment: 12 April 2025
This document specifies the technical requirements, test methods, inspection rules, labeling, packaging, transportation, storage, and shelf life of feed additive calcium formate.This document applies to the by-product of calcium formate when producing trimethylolpropane through acetalization process using formaldehyde and butyraldehyde as raw materials, , or product of calcium formate producing by reacting formic acid with calcium carbonate or calcium hydroxide to produce a calcium formate solution, which is then filtered, concentrated, separated, and dried.
Products Covered: Calcium formate
Regulation Type: Regular notification
Order Repealing Certain Marketing Authorizations Issued Under the Food and Drugs Act
Distribution date: 13 February 2025 | Final date for Comment: 19 April 2025
The proposed order notified under the title “Marketing Authorization repealing certain Marketing Authorizations issued under the Food and Drugs Act” in G/SPS/N/CAN/1544 (dated 2 February 2024) was adopted on 31 January 2025 and published in the Canada Gazette, Part II on 12 February 2025. The order repeals sixteen redundant food marketing authorizations; fifteen of which relate to permitted food additives, and one regarding the fortification of Milk, Goat's Milk and Margarine with vitamin D.
Products Covered: Food products in general (ICS code: 67.040)
Regulation Type: Addendum to Regular Notification
National Standard of the P.R.C., Feed additives—Part 2: Vitamins, provitamins and chemically well-defined substances having similar effect—Nicotinamide
Distribution date: 14 February 2025 | Final date for Comment: 15 April 2025
This document specifies the chemical name, molecular formula and relative molecular mass of nicotinamide, specifies the technical requirements, inspection rules, labeling, packaging, transportation, storage and shelf life of the feed additive nicotinamide, and describes the sampling and test methods.This document applies to feed additive nicotinamide made by chemical synthesis.
Products Covered: nicotinamide(HS code(s): 293624; 293629); (ICS code(s): 65.120)
Regulation Type: Regular notification
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