Regulatory Updates

Distribution date: 08 July 2025

The present Order was issued for the implementation of Law No. 403/2023 on the placing on the market of plant protection products and for the amendment of certain legislative acts. Furthermore, the provisions of this Order transpose the requirements of Annex III to Regulation (EC) No. 1107/2009 of the European Parliament and of the Council of 21 October 2009 concerning the placing of plant protection products on the market and repealing Council Directives 79/117/EEC and 91/414/EEC.These provisions aim to align national regulations with EU standards, thereby facilitating the placing on the market of plant protection products, promoting their free movement, and ensuring that agricultural producers have access to the necessary products containing acceptable co-formulants. This contributes to the protection of public health, the environment, and consumer safety.The annexed list of unacceptable co-formulants prohibits their use in plant protection products, aligning the Republic of Moldova framework with EU rules and helping to ensure safety and transparency in international trade.

Products Covered: Miscellaneous chemical products (HS code(s): 38); Detailed HS code: Plant protection products: 3808

Regulation Type: Regular notification

Distribution date: 08 July 2025

The present Order was issued for the implementation of Article 5, paragraph (1) of Law No. 403 of 21 December 2023 on the placing on the market of plant protection products and the amendment of certain legislative acts. It also transposes Commission Implementing Regulation (EU) No. 540/2011 of 25 May 2011, implementing Regulation (EC) No. 1107/2009 of the European Parliament and of the Council as regards the list of approved active substances. The purpose of these provisions is to harmonize the authorization procedure for plant protection products with the European Union's authorization procedures, aiming to prevent risks through a comprehensive risk assessment process for each active substance and for the products containing that substance, before they are authorized for marketing and use. At the same time, these provisions aim to enhance the transparency of the regulatory process, providing clarity for manufacturers and distributors regarding the substances allowed on the market, thereby improving food safety, environmental quality, and supporting agricultural exports.

Products Covered: Miscellaneous chemical products (HS code(s): 38); Detailed HS code: Plant protection products: 3808

Regulation Type: Regular notification

Distribution date: 07 July 2025 | Final date for Comment: 05 September 2025

Technical Standard No. 82, version 01-2025, seeks to establish requirements for demonstrating the bioequivalence and therapeutic equivalence of multi-origin medicines in order to guarantee their safety, quality and efficacy. It applies to multi-origin medicines manufactured in Guatemala and those imported by natural or legal persons that must demonstrate therapeutic equivalence, for the purpose of applying for and maintaining sanitary registration with the Department for the Regulation and Control of Pharmaceutical and Related Products.

Products Covered: Medicaments (excluding goods of heading 3002, 3005 or 3006) 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 3002, 3005 or 3006) 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: 07 July 2025 | Final date for Comment: 23 July 2025

Updating Appendix No. 1 to the Rules of Good Manufacturing Practice (Requirements for the Production of Sterile Medicines), taking into account updated approaches to the production of sterile products, the emergence of new technologies for their production (including new technologies for sterilization and aseptic production), revision of international acts in the field of sterile products (documents of the International Council for Harmonization (ICH)), as well as the law enforcement practices of the authorized bodies of the member States of the Eurasian Economic Union

Products Covered: 3003 , 3004 (Pharmaceuticals)

Regulation Type: Regular notification

Distribution date: 04 July 2025 | Final date for Comment: 03 August 2025

The Therapeutic Goods Administration (TGA) administers Australia’s regulatory framework for the quality, safety and efficacy of therapeutic goods in Australia.There are provisions under the Therapeutic Goods Act 1989 (the Act) to establish Manufacturing Principles that are to be applied in the manufacture of therapeutic goods. The Therapeutic Goods (Manufacturing Principles) Determination 2020 (the Determination) is the legislative instrument that specifies the manufacture of therapeutic goods must comply with the applicable procedures and requirements in the Pharmaceutical Inspection Co-operation Scheme (PIC/S) Guide to Good Manufacturing Practice (GMP).As a PIC/S member, Australia is expected to adopt and enforce the latest revisions to the GMP guide to achieve international harmonisation between member countries. Adoption of the PIC/S Guide to GMP as Australia’s Manufacturing Principles negates the need for Australian-specific standards, facilitates international trade and supports our international reputation. The TGA is proposing to amend the Determination to adopt version 17 of the PIC/s Guide to GMP except for Annexes 4, 5 and 14 as the manufacturing principles and register the amended Determination on the Federal Register of Legislation in September 2025.The adoption of an internationally harmonised standard minimises regulatory burden for companies involved in the manufacture, import and export of medicines, facilitating trade and helping to ensure the availability of medicines to the Australian public.  Please note: The uploaded measure is the current version of the Determination. A legislative instrument will be used to amend the definition of PIC/S Guide to GMP under Section 4 of the Determination to reflect Version 17 except for Annexes 4, 5 and 14. 

Products Covered: PHARMACEUTICAL PRODUCTS (HS code(s): 30)

Regulation Type: Regular notification

Distribution date: 04 July 2025

Proposal for the additional designation of 3 substances as Shitei Yakubutsu, and their proper uses under the Act.

Products Covered: Substances with probable effects on the central nervous system

Regulation Type: Regular notification

Distribution date: 03 July 2025 | Final date for Comment: 02 August 2025

The Minimum Requirements for Radiopharmaceuticals are to be partially amended to add the standards for radiopharmaceuticals to be newly approved.

Products Covered: Pharmaceutical products (HS: 30)

Regulation Type: Regular notification

Distribution date: 03 July 2025 | Final date for Comment: 02 August 2025

The Minimum Requirements for Biological Products will be amended as follows:Regarding the article of “Inactivation test” in the section of “Tests on final product” of the monograph for “High dose Influenza HA Vaccine”, the rule of inoculating with the allantoic fluid into allantoic cavities of eggs in case there are positive hemagglutination test results will be partially amended. And regarding the standard for “Pneumococcal Polyvalent Vaccine”, the section of “Serological identification test” will be deleted. In addition, the standard for “21-valent Pneumococcal Conjugate Vaccine” that is to be newly approved will be added. The Public Notice on National Release Testing will be amended as follows: The criterion, fee, quantity and Institution for National Release Testing for “21-valent Pneumococcal Conjugate Vaccine” that is to be newly approved will be added.

Products Covered: Pharmaceutical products (HS: 30)

Regulation Type: Regular notification

Distribution date: 03 July 2025

The proposed maximum residue limits (MRLs) for Quinofumelin notified in G/SPS/N/JPN/1281 (dated 9 September 2024) were adopted and published on 10 February 2025. The specified MRLs are available as below:

Products Covered: Meat and edible meat offal (HS codes: 02.01, 02.02, 02.03, 02.04, 02.05, 02.06, 02.07, 02.08 and 02.09)Aquatic animals and crustaceans, molluscs and other aquatic invertebrates (HS codes: 03.02, 03.03, 03.04, 03.06, 03.07 and 03.08)Dairy produce, birds' eggs and natural honey (HS codes: 04.01, 04.07, 04.08 and 04.09)Animal originated products (HS code: 05.04)Edible vegetables and certain roots and tubers (HS codes: 07.02, 07.03, 07.04, 07.05, 07.07, 07.09, 07.10 and 07.13)Edible fruit and nuts, peel of citrus fruit (HS codes: 08.04, 08.05, 08.06, 08.07, 08.08, 08.09, 08.10,08.11 and 08.14)Tea and spices (HS codes: 09.02, 09.04, 09.05, 09.06, 09.07, 09.08, 09.09 and 09.10)Cereals (HS code: 10.06)Oil seeds and oleaginous fruits, miscellaneous grains, seeds and fruit (HS codes: 12.07 and 12.12)Animal fats and oils (HS codes: 15.01, 15.02 and 15.06)                      

Regulation Type: Addendum to Regular Notification

Distribution date: 03 July 2025

The proposed maximum residue limits (MRLs) for Fenitrothion notified in G/SPS/N/JPN/1282 (dated 9 September 2024) were adopted and published on 10 February 2025. The specified MRLs are available as below:

Products Covered: Meat and edible meat offal (HS codes: 02.01, 02.02, 02.03, 02.04, 02.05, 02.06, 02.07, 02.08 and 02.09)Aquatic animals and crustaceans, molluscs and other aquatic invertebrates (HS codes: 03.02, 03.03, 03.04, 03.06, 03.07 and 03.08)Dairy produce, birds' eggs and natural honey (HS codes: 04.01, 04.07, 04.08 and 04.09)Animal originated products (HS code: 05.04)Edible vegetables and certain roots and tubers (HS codes: 07.01, 07.02, 07.03, 07.04,  07.07, 07.08, 07.09, 07.10, 07.13 and 07.14)Edible fruit and nuts, peel of citrus fruit (HS codes: 08.02, 08.04, 08.05, 08.06, 08.07, 08.08, 08.09, 08.10, 08.11 and 08.14)Tea, mate and spices (HS codes: 09.02, 09.03, 09.04, 09.05, 09.06, 09.07, 09.08, 09.09 and 09.10)Cereals (HS codes: 10.01, 10.02, 10.03, 10.04, 10.05, 10.06, 10.07 and 10.08)Oil seeds and oleaginous fruits, miscellaneous grains, seeds and fruit (HS codes: 12.01, 12.02, 12.04, 12.07 and 12.12)Animal fats and oils (HS codes: 15.01, 15.02 and 15.06)

Regulation Type: Addendum to Regular Notification