Distribution date: 31 January 2024

The proposed maximum residue limits (MRLs) for Inpyrfluxam notified in G/SPS/N/JPN/1206 (dated 31 May 2023) were adopted and published on 7 November 2023.The specified MRLs are available as below:

Products Covered: ・Fish and crustaceans, molluscs and other aquatic invertebrates (HS codes: 03.02, 03.03, 03.04, 03.06, 03.07 and 03.08)・Edible vegetables and certain roots and tubers (HS codes: 07.01, 07.02, 07.03, 07.04, 07.05, 07.06, 07.07, 07.08, 07.09, 07.10 and 07.13)・Edible fruit and nuts, peel of citrus fruit (HS codes: 08.05, 08.06, 08.08, 08.09, 08.10, 08.11 and 08.14)・Mate and spices (HS codes: 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, 10.06, 10.07 and 10.08)・Oil seeds and oleaginous fruits, miscellaneous grains, seeds and fruit (HS codes: 12.01, 12.07 and 12.12)

Regulation Type: Addendum to Regular Notification

Distribution date: 30 January 2024 | Final date for Comment: 26 February 2024

Amends the production of NP and NPK Organomineral Fertilizers without the use of basic slag, partially soluble phosphate rock, partially soluble magnesium phosphate rock, dicalcium phosphate, calcined phosphate, aluminium-calcium phosphate and ground soft phosphate rock.As the season of use of the fertilizer in question is approaching, this measure needs to be taken quickly.

Products Covered: NP(Nitrogen and phosphorus)  and NPK (Nitrogen, phosphorus, and potassium) Organomineral Fertilizer

Regulation Type: Regular notification

Distribution date: 26 January 2024 | Final date for Comment: 25 February 2024

Under the current Act on the Safety of Regenerative Medicine, when entrusting the manufacturing of processed cells used in regenerative medicine to a business which manufactures them in a foreign country, it is limited to a business which has obtained accreditation by the Minister of Health, Labour and Welfare prescribed in the Act.Gene therapy, etc. which does not use processed cells (medical care which uses nucleic acid, etc.) will be added to the scope of the Act, due to the partial amendment of the Act. Therefore, when entrusting the manufacturing of nucleic acid, etc. used for such medical care to a business which manufactures them in a foreign country, it is limited to a business which has obtained accreditation by the Minister of Health, Labour and Welfare prescribed in the Act as well as processed cells used in regenerative medicine.

Products Covered: Nucleic acid, etc. (HS:30)

Regulation Type: Regular notification

Distribution date: 24 January 2024 | Final date for Comment: 24 March 2024

This draft Law amends and supplements a number of articles of Law No. 105/2016/QH13 on Pharmacy. These Articles include 2, 4, 6, 7, 8, 10, 17, 24, 28, 32, 33, 34, 35, 37, 42, 43, 44, 46, 47, 48, 49, 53, 54, 55, 56, 58, 59, 60, 61, 64, 65, 76, 78, 79, 87, 89, 107, 109, 110, 112, 113; This draft Law abolishes point c and d, clause 26, Article 2, point a, clause 10, Article 6, point b, clause 4, Article 7 of Law No. 105/2016/QH13 on Pharmacy.Transitional provisions:1. Certificates of drug information and advertising content issued under the provisions of Law No. 105/2016/QH13 on Pharmacy will continue to be used until the expiry of the Certificate’s validity2. Dossier submitted before the entry into force of this draft Law and requesting the issuance, extension, amendment or supplementation of the registration certificate for the circulation of drugs and medicinal ingredients shall be implemented in accordance with the provisions of Law No. 105/2016 /QH13 on Pharmacy, except in cases where the establishment requests to comply with the provisions of this draft Law.3. For dossiers applying for a License to import toxic drugs and toxic medicinal ingredients; drugs and medicinal ingredients that are on the list of substances whose use is prohibited in a number of industries and fields used for testing, research, and manufacturing of drugs for export in accordance with the provisions of the 2016 Law on Pharmacy and its guiding Decrees.4. Chain pharmacy businesses that have had a chain pharmacy system prior to the effective date of this Law shall complete procedures to apply for a certificate of authority to do business as a chain within 45 days of the effective date of this draft Law.The regulations on granting, extending, amendment and supplementing circulation registration certificates for drugs and medicinal ingredients, except for regulations on issuing medical oxygen product declaration forms, shall be applied from January 1, 2025The Draft Law was formulated based on the basis of 05 policies submitted to the Government and the National Assembly of Vietnam in the proposal No. 09/TTr-BYT dated on January 5th, 2023 as well as other difficulties and issues encountered during the implementation process, as follows: 1. Policy 1: Further strengthen the sufficient and timely supply of quality-assured medicines to meet people's need for disease prevention and treatment.2. Policy 2: Ensure sufficient and timely supply of drugs that meet the demands of security, national defense, coping with the consequences of natural disasters, and preventing epidemics and diseases in the new situation3. Policy 3: Improve the efficiency of import/export management of drugs/medicinal materials to the socio-economic development situation and international practice4. Policy 4: Promote the development of the pharmaceutical industry with emphasis on research, technology transfer and production of high-tech drugs, biological drugs/medicinal materials, standardized herbal medicines, and raw materials from domestically available pharmaceutical sources.5. Policy 5: Organize and rearranging the business and distribution system for drugs/medicinal materials to cope with socio-economic development and international integration. 

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

Regulation Type: Regular notification

Distribution date: 24 January 2024 | Final date for Comment: 24 March 2024

This draft Law amends and supplements a number of articles of Law No. 105/2016/QH13 on Pharmacy. These Articles include 2, 4, 6, 7, 8, 10, 17, 24, 28, 32, 33, 34, 35, 37, 42, 43, 44, 46, 47, 48, 49, 53, 54, 55, 56, 58, 59, 60, 61, 64, 65, 76, 78, 79, 87, 89, 107, 109, 110, 112, 113; This draft Law abolishes point c and d, clause 26, Article 2, point a, clause 10, Article 6, point b, clause 4, Article 7 of Law No. 105/2016/QH13 on Pharmacy.Transitional provisions:1. Certificates of drug information and advertising content issued under the provisions of Law No. 105/2016/QH13 on Pharmacy will continue to be used until the expiry of the Certificate’s validity2. Dossier submitted before the entry into force of this draft Law and requesting the issuance, extension, amendment or supplementation of the registration certificate for the circulation of drugs and medicinal ingredients shall be implemented in accordance with the provisions of Law No. 105/2016 /QH13 on Pharmacy, except in cases where the establishment requests to comply with the provisions of this draft Law.3. For dossiers applying for a License to import toxic drugs and toxic medicinal ingredients; drugs and medicinal ingredients that are on the list of substances whose use is prohibited in a number of industries and fields used for testing, research, and manufacturing of drugs for export in accordance with the provisions of the 2016 Law on Pharmacy and its guiding Decrees.4. Chain pharmacy businesses that have had a chain pharmacy system prior to the effective date of this Law shall complete procedures to apply for a certificate of authority to do business as a chain within 45 days of the effective date of this draft Law.The regulations on granting, extending, amendment and supplementing circulation registration certificates for drugs and medicinal ingredients, except for regulations on issuing medical oxygen product declaration forms, shall be applied from January 1, 2025The Draft Law was formulated based on the basis of 05 policies submitted to the Government and the National Assembly of Vietnam in the proposal No. 09/TTr-BYT dated on January 5th, 2023 as well as other difficulties and issues encountered during the implementation process, as follows: 1. Policy 1: Further strengthen the sufficient and timely supply of quality-assured medicines to meet people's need for disease prevention and treatment.2. Policy 2: Ensure sufficient and timely supply of drugs that meet the demands of security, national defense, coping with the consequences of natural disasters, and preventing epidemics and diseases in the new situation3. Policy 3: Improve the efficiency of import/export management of drugs/medicinal materials to the socio-economic development situation and international practice4. Policy 4: Promote the development of the pharmaceutical industry with emphasis on research, technology transfer and production of high-tech drugs, biological drugs/medicinal materials, standardized herbal medicines, and raw materials from domestically available pharmaceutical sources.5. Policy 5: Organize and rearranging the business and distribution system for drugs/medicinal materials to cope with socio-economic development and international integration. 

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

Regulation Type: Regular notification

Distribution date: 19 January 2024 | Final date for Comment: 19 March 2024

Revision of the Mandatory Standard SI 562 part 3, dealing with the migration of certain chemical elements from toys. This draft standard revision adopts the European Standard EN-71-3: 2019 + A1: April 2021, with a few changes that appear in the standard's Hebrew section. Both the old standard and this new revised standard will apply from entry into force of this revision for 12 months. During this time, products may be tested according to the old or the new revised standard.

Products Covered: Toys

Regulation Type: Regular notification

Distribution date: 19 January 2024 | Final date for Comment: 19 March 2024

Revision of the Mandatory Standard SI 562 part 3, dealing with the migration of certain chemical elements from toys. This draft standard revision adopts the European Standard EN-71-3: 2019 + A1: April 2021, with a few changes that appear in the standard's Hebrew section. Both the old standard and this new revised standard will apply from entry into force of this revision for 12 months. During this time, products may be tested according to the old or the new revised standard.

Products Covered: Toys

Regulation Type: Regular notification

Distribution date: 17 January 2024 | Final date for Comment: 11 March 2024

The Food and Drug Administration (FDA or we) is announcing that we have filed a color additive petition, submitted by Environmental Defense Fund, et al., proposing that the color additive regulations be amended to remove three specified solvents.  The color additive petition was filed on 21 December 2023.

Products Covered: Halogenated derivatives of hydrocarbons (HS code(s): 2903); Food technology (ICS code(s): 67)

Regulation Type: Regular notification

Distribution date: 17 January 2024 | Final date for Comment: 11 March 2024

The Food and Drug Administration (FDA or we) is announcing that we have filed a color additive petition, submitted by Environmental Defense Fund, et al., proposing that the color additive regulations be amended to remove three specified solvents.  The color additive petition was filed on 21 December 2023.

Products Covered: Halogenated derivatives of hydrocarbons (HS code(s): 2903); Food technology (ICS code(s): 67)

Regulation Type: Regular notification

Distribution date: 17 January 2024 | Final date for Comment: 11 March 2024

The Food and Drug Administration (FDA or we) is announcing that we have filed a food additive petition, submitted by Environmental Defense Fund, et al., proposing that the food additive regulations be amended to remove four specified solvents. The food additive petition was filed on 21 December 2023.

Products Covered: Cyclic hydrocarbons (HS code(s): 2902); Halogenated derivatives of hydrocarbons (HS code(s): 2903); Food technology (ICS code(s): 67)

Regulation Type: Regular notification