Resolution – RDC number 659, 30 March 2022

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Distribution date: 12 April 2022 | Final date for Comment: 06 May 2025

This resolution contains provisions on the control of import and export of substances, plants and medicines subject to special control.

Products Covered: HS (3003-3004) Medicaments

Regulation Type: Regular notification

Human health

Resolution – RDC number 659, 30 March 2022

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Distribution date: 12 April 2022 | Final date for Comment: 06 May 2025

This resolution contains provisions on the control of import and export of substances, plants and medicines subject to special control.

Products Covered: HS (3003-3004) Medicaments

Regulation Type: Regular notification

Human health

Normative Instruction number 136, 30 March 2022

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Distribution date: 12 April 2022 | Final date for Comment: 06 May 2025

This normative instruction contains provisions on Good Manufacturing Practices complementary to Experimental Medicines.

Products Covered: HS (3003-3004) - Medicaments

Regulation Type: Regular notification

Human health

Normative Instruction number 136, 30 March 2022

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Distribution date: 12 April 2022 | Final date for Comment: 06 May 2025

This normative instruction contains provisions on Good Manufacturing Practices complementary to Experimental Medicines.

Products Covered: HS (3003-3004) - Medicaments

Regulation Type: Regular notification

Human health

Normative Instruction number 135, 30 March 2022

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Distribution date: 12 April 2022 | Final date for Comment: 06 May 2025

This normative instruction contains provisions on Good Manufacturing Practices complementary to Ionizing Radiation in the manufacture of medicines.

Products Covered: HS (3003-3004) - Medicaments

Regulation Type: Regular notification

Human health

Normative Instruction number 135, 30 March 2022

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Distribution date: 12 April 2022 | Final date for Comment: 06 May 2025

This normative instruction contains provisions on Good Manufacturing Practices complementary to Ionizing Radiation in the manufacture of medicines.

Products Covered: HS (3003-3004) - Medicaments

Regulation Type: Regular notification

Human health

Normative Instruction number 127, 30 March 2022

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Distribution date: 12 April 2022 | Final date for Comment: 06 May 2025

This normative instruction contains provisions on Good Manufacturing Practices complementary to Biological Inputs and Medicines.

Products Covered: HS (3003-3004) - Medicaments

Regulation Type: Regular notification

Human health

Normative Instruction number 127, 30 March 2022

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Distribution date: 12 April 2022 | Final date for Comment: 06 May 2025

This normative instruction contains provisions on Good Manufacturing Practices complementary to Biological Inputs and Medicines.

Products Covered: HS (3003-3004) - Medicaments

Regulation Type: Regular notification

Human health

The Toys and Cosmetic Products (Restriction of Chemical Substances) Regulations 2022

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Distribution date: 13 April 2022 | Final date for Comment: 14 June 2022

These measures will amend the Toys (Safety) Regulation 2011 as applicable in GB (“the Toys Regulations”) and the Cosmetics Regulation 1223/2009 as applicable in GB (“the Cosmetics Regulations”) as they apply in England, Wales and Scotland. They will amend permitted levels of certain chemicals in both the Toys Regulations and the Cosmetics Regulations. They will amend the Toy Regulations, to reduce the permitted limits of aluminium, aniline and formaldehyde as well as including provisions on three allergens used in fragrances, under the list of prohibited allergens in toys. We will be amending the Cosmetics Regulations to permit the use of salicylic acid for uses other than as a preservative only in specific product types, prohibit the use of deoxyarbutin and a set of chemicals classified as Carcinogenic, Mutagenic or Reprotoxic (CMR) under GB Classification, Labelling and Packaging (CLP) Regulations.

Products Covered: Toys and cosmetics products. More detail on product coverage can be found in regulation 4 of the Toys (Safety) Regulations 2011 and cosmetic products are defined by Article 2(1)(a) of Regulation (EC) No 1223/2009.  HS code:HS 95 (http://tariffdata.wto.org/ReportersAndProducts.aspx) for toys HS 33 http://tariffdata.wto.org/ReportersAndProducts.aspx for cosmetics ICS codes: ICS 97.200.50 https://www.iso.org/ics/97.200.50/x  for toysICS 71.100.70 https://www.iso.org/ics/71.100.70/x/ for cosmetics

Regulation Type: Regular notification

Human health

The Toys and Cosmetic Products (Restriction of Chemical Substances) Regulations 2022

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Distribution date: 13 April 2022 | Final date for Comment: 14 June 2022

These measures will amend the Toys (Safety) Regulation 2011 as applicable in GB (“the Toys Regulations”) and the Cosmetics Regulation 1223/2009 as applicable in GB (“the Cosmetics Regulations”) as they apply in England, Wales and Scotland. They will amend permitted levels of certain chemicals in both the Toys Regulations and the Cosmetics Regulations. They will amend the Toy Regulations, to reduce the permitted limits of aluminium, aniline and formaldehyde as well as including provisions on three allergens used in fragrances, under the list of prohibited allergens in toys. We will be amending the Cosmetics Regulations to permit the use of salicylic acid for uses other than as a preservative only in specific product types, prohibit the use of deoxyarbutin and a set of chemicals classified as Carcinogenic, Mutagenic or Reprotoxic (CMR) under GB Classification, Labelling and Packaging (CLP) Regulations.

Products Covered: Toys and cosmetics products. More detail on product coverage can be found in regulation 4 of the Toys (Safety) Regulations 2011 and cosmetic products are defined by Article 2(1)(a) of Regulation (EC) No 1223/2009.  HS code:HS 95 (http://tariffdata.wto.org/ReportersAndProducts.aspx) for toys HS 33 http://tariffdata.wto.org/ReportersAndProducts.aspx for cosmetics ICS codes: ICS 97.200.50 https://www.iso.org/ics/97.200.50/x  for toysICS 71.100.70 https://www.iso.org/ics/71.100.70/x/ for cosmetics

Regulation Type: Regular notification

Human health

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