National Standards of the P.R.C., General Security Technical Specification for Domestic Sanitary Insecticide
Distribution date: 23 September 2020 | Final date for Comment: 22 November 2020
This standard specifies the terms and definitions, requirements and test methods for domestic sanitary insecticide products. This standard applies to general requirements related to human health, environmental protection and safety of domestic sanitary insecticide products.
Products Covered: Domestic sanitary insecticide ICS: 65.100.10 HS: 3808
Regulation Type: Regular notification
National Standards of the P.R.C., General Security Technical Specification for Domestic Sanitary Insecticide
Distribution date: 23 September 2020 | Final date for Comment: 22 November 2020
This standard specifies the terms and definitions, requirements and test methods for domestic sanitary insecticide products. This standard applies to general requirements related to human health, environmental protection and safety of domestic sanitary insecticide products.
Products Covered: Domestic sanitary insecticide ICS: 65.100.10 HS: 3808
Regulation Type: Regular notification
Import recommendation and health certificate requirements on toothpaste importing under the Cosmetics Order (1/2010) dated 15 October 2010.
Distribution date: 23 September 2020 | Final date for Comment: 15 May 2025
In accordance with the Cosmetics Order (1/2010), the following certificates are required when importing the toothpaste into Myanmar: For importation of toothpaste, Acknowledgement of Cosmetic Notification is only required to harmonise the ASEAN Cosmetic Regulatory Committee Meeting during May 2015 as redundancy to reduce technical barriers by releasing Import Recommendation and Health Certificate. The importer only needs to apply the Acknowledgement of Cosmetic Notification for toothpaste before market distribution at Department of Food and Drug Administration. Acknowledgement of cosmetic notification from the country of origin or any other ASEAN country and full ingredient listing and the percentage of restricted ingredients are needed to be attached.
Products Covered: Toothpaste
Regulation Type: Regular notification
Import recommendation and health certificate requirements on toothpaste importing under the Cosmetics Order (1/2010) dated 15 October 2010.
Distribution date: 23 September 2020 | Final date for Comment: 15 May 2025
In accordance with the Cosmetics Order (1/2010), the following certificates are required when importing the toothpaste into Myanmar: For importation of toothpaste, Acknowledgement of Cosmetic Notification is only required to harmonise the ASEAN Cosmetic Regulatory Committee Meeting during May 2015 as redundancy to reduce technical barriers by releasing Import Recommendation and Health Certificate. The importer only needs to apply the Acknowledgement of Cosmetic Notification for toothpaste before market distribution at Department of Food and Drug Administration. Acknowledgement of cosmetic notification from the country of origin or any other ASEAN country and full ingredient listing and the percentage of restricted ingredients are needed to be attached.
Products Covered: Toothpaste
Regulation Type: Regular notification
Procedure for the processing of petitions for the market authorization of medicines, biological products, and in vitro diagnosis products
Distribution date: 23 September 2020 | Final date for Comment: 15 May 2025
The Resolution – RDC number 348, 17 March 2020 – previously notified through G/TBT/N/BRA/990 – which establishes exceptional and temporary criteria and procedure for the processing of petitions for the market authorization of medicines, biological products, and in vitro diagnosis products; and for the post-market authorization of medicines and biological products due to the international public health emergency of the new coronavirus (Covid-19), was updated by Resolution – RDC number 415, 26 August 2020. This Resolution will enter into force on the day of its publication in the Brazilian Official Gazette.
Products Covered: HS Code(s): 2941; 3002300; 3003; 3004; 3005; (pharmaceutical products, in vitro diagnosis products, biological products).
Regulation Type: Addendum to Regular Notification
Procedure for the processing of petitions for the market authorization of medicines, biological products, and in vitro diagnosis products
Distribution date: 23 September 2020 | Final date for Comment: 15 May 2025
The Resolution – RDC number 348, 17 March 2020 – previously notified through G/TBT/N/BRA/990 – which establishes exceptional and temporary criteria and procedure for the processing of petitions for the market authorization of medicines, biological products, and in vitro diagnosis products; and for the post-market authorization of medicines and biological products due to the international public health emergency of the new coronavirus (Covid-19), was updated by Resolution – RDC number 415, 26 August 2020. This Resolution will enter into force on the day of its publication in the Brazilian Official Gazette.
Products Covered: HS Code(s): 2941; 3002300; 3003; 3004; 3005; (pharmaceutical products, in vitro diagnosis products, biological products).
Regulation Type: Addendum to Regular Notification
The draft regulation on the Approval of Advanced Biopharmaceuticals and the Safety about Advanced Biological Products
Distribution date: 23 September 2020 | Final date for Comment: 13 October 2020
Republic of Korea is proposing the regulation on the “Approval of Advanced Biopharmaceuticals and the Safety about Advanced Biological Products". The main contents are: As the Act on the Safety and Support of Advanced Biological Products was established, the regulations on the approval of advanced biopharmaceuticals and the regulation on safety about biological products was enacted to stipulate document requirements and evaluation criteria.
Products Covered: Advanced Biological Products (HS: 3004-90-9900)
Regulation Type: Regular notification
The draft regulation on the Approval of Advanced Biopharmaceuticals and the Safety about Advanced Biological Products
Distribution date: 23 September 2020 | Final date for Comment: 13 October 2020
Republic of Korea is proposing the regulation on the “Approval of Advanced Biopharmaceuticals and the Safety about Advanced Biological Products". The main contents are: As the Act on the Safety and Support of Advanced Biological Products was established, the regulations on the approval of advanced biopharmaceuticals and the regulation on safety about biological products was enacted to stipulate document requirements and evaluation criteria.
Products Covered: Advanced Biological Products (HS: 3004-90-9900)
Regulation Type: Regular notification
National Standard of the P.R.C., Limits of certain heavy metal in printing ink
Distribution date: 23 September 2020 | Final date for Comment: 22 November 2020
This standard stipulates the maximum limit requirements, sample preparation and determination methods for lead, cadmium, mercury, hexavalent chromium and soluble heavy metals (soluble antimony, soluble arsenic, soluble barium, soluble cadmium, soluble chromium, soluble lead, soluble mercury, soluble selenium) in printing inks.
Products Covered: Printing ink ICS:87.080 HS：3215
Regulation Type: Regular notification
National Standard of the P.R.C., Limits of certain heavy metal in printing ink
Distribution date: 23 September 2020 | Final date for Comment: 22 November 2020
This standard stipulates the maximum limit requirements, sample preparation and determination methods for lead, cadmium, mercury, hexavalent chromium and soluble heavy metals (soluble antimony, soluble arsenic, soluble barium, soluble cadmium, soluble chromium, soluble lead, soluble mercury, soluble selenium) in printing inks.
Products Covered: Printing ink ICS:87.080 HS：3215
Regulation Type: Regular notification
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