Regulatory Updates

Distribution date: 12 August 2020 | Final date for Comment: 06 October 2020

Proposed rule - The Environmental Protection Agency (EPA) is proposing to revise regulations governing the production and import of class I ozone-depleting substances in the United States to extend indefinitely the global essential laboratory and analytical use exemption. This exemption currently expires on 31 December 2021. This change would allow for continued production and import of class I substances in the United States solely for laboratory and analytical uses that have not been identified by the EPA as nonessential. This action is proposed under the Clean Air Act and is consistent with a decision by the Parties to the Montreal Protocol on Substances that Deplete the Ozone Layer to extend the global laboratory and analytical use exemption indefinitely beyond 2021.

Products Covered: Ozone-depleting substances

Regulation Type: Revision to Regular Notification

Distribution date: 06 August 2020

This resolution establishes the temporary opening of entrance and exit points of substances subject to special control, due to the international public health emergency related to the new Coronavirus (SARS-CoV-2).

Products Covered: HS Code(s): 2941; 3003; 3004; 3005; 3006 (pharmaceutical products).

Regulation Type: Regular notification

Distribution date: 06 August 2020

This resolution establishes the temporary opening of entrance and exit points of substances subject to special control, due to the international public health emergency related to the new Coronavirus (SARS-CoV-2).

Products Covered: HS Code(s): 2941; 3003; 3004; 3005; 3006 (pharmaceutical products).

Regulation Type: Regular notification

Distribution date: 06 August 2020 | Final date for Comment: 05 October 2020

This draft normative instruction establishes the lists of medicinal gases subject to notification. 

Products Covered: Medicaments (excluding goods of heading No. 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 informs or packings for retail sale. (HS code(s): 3003); Medicaments (excluding goods of heading No. 3002, 3005 or 3006) consisting of mixed or unmixed products for therapeutic or prophylactic uses, put up in measured doses or in forms or packings for retail sale. (HS code(s): 3004); Wadding, gauze, bandages and similar articles (for example, dressings, adhesive plasters, poultices), impregnated or coated with pharmaceutical substances or put up in forms or packings for retail sale for medical, surgical, dental or veterinary purposes. (HS code(s): 3005); Pharmaceutical goods specified in Note 3 to this Chapter. (HS code(s): 3006); Anaesthetic, respiratory and reanimation equipment (ICS code(s): 11.040.10)

Regulation Type: Regular notification

Distribution date: 06 August 2020 | Final date for Comment: 05 October 2020

This draft normative instruction establishes the lists of medicinal gases subject to notification. 

Products Covered: Medicaments (excluding goods of heading No. 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 informs or packings for retail sale. (HS code(s): 3003); Medicaments (excluding goods of heading No. 3002, 3005 or 3006) consisting of mixed or unmixed products for therapeutic or prophylactic uses, put up in measured doses or in forms or packings for retail sale. (HS code(s): 3004); Wadding, gauze, bandages and similar articles (for example, dressings, adhesive plasters, poultices), impregnated or coated with pharmaceutical substances or put up in forms or packings for retail sale for medical, surgical, dental or veterinary purposes. (HS code(s): 3005); Pharmaceutical goods specified in Note 3 to this Chapter. (HS code(s): 3006); Anaesthetic, respiratory and reanimation equipment (ICS code(s): 11.040.10)

Regulation Type: Regular notification

Distribution date: 06 August 2020

This resolution changes the Resolution – RDC number 22, 13 May 2015 in order to update the specification references for nutrient sources and other substances for use in formulas of enteral nutrition.

Products Covered: HS Code(s): 38220090 (nutricional formulas)

Regulation Type: Regular notification

Distribution date: 06 August 2020

This resolution changes the Resolution – RDC number 22, 13 May 2015 in order to update the specification references for nutrient sources and other substances for use in formulas of enteral nutrition.

Products Covered: HS Code(s): 38220090 (nutricional formulas)

Regulation Type: Regular notification

Distribution date: 06 August 2020 | Final date for Comment: 05 October 2020

This draft resolution establishes technical requirements for the notification, market authorization, and post market authorization for medicinal gases. 

Products Covered: Medicaments (excluding goods of heading No. 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 informs or packings for retail sale. (HS code(s): 3003); Medicaments (excluding goods of heading No. 3002, 3005 or 3006) consisting of mixed or unmixed products for therapeutic or prophylactic uses, put up in measured doses or in forms or packings for retail sale. (HS code(s): 3004); Wadding, gauze, bandages and similar articles (for example, dressings, adhesive plasters, poultices), impregnated or coated with pharmaceutical substances or put up in forms or packings for retail sale for medical, surgical, dental or veterinary purposes. (HS code(s): 3005); Pharmaceutical goods specified in Note 3 to this Chapter. (HS code(s): 3006); Anaesthetic, respiratory and reanimation equipment (ICS code(s): 11.040.10)

Regulation Type: Regular notification

Distribution date: 06 August 2020 | Final date for Comment: 05 October 2020

This draft resolution establishes technical requirements for the notification, market authorization, and post market authorization for medicinal gases. 

Products Covered: Medicaments (excluding goods of heading No. 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 informs or packings for retail sale. (HS code(s): 3003); Medicaments (excluding goods of heading No. 3002, 3005 or 3006) consisting of mixed or unmixed products for therapeutic or prophylactic uses, put up in measured doses or in forms or packings for retail sale. (HS code(s): 3004); Wadding, gauze, bandages and similar articles (for example, dressings, adhesive plasters, poultices), impregnated or coated with pharmaceutical substances or put up in forms or packings for retail sale for medical, surgical, dental or veterinary purposes. (HS code(s): 3005); Pharmaceutical goods specified in Note 3 to this Chapter. (HS code(s): 3006); Anaesthetic, respiratory and reanimation equipment (ICS code(s): 11.040.10)

Regulation Type: Regular notification

Distribution date: 06 August 2020 | Final date for Comment: 05 October 2020

This draft resolution establishes the simplified procedure for the request of market authorization, post market authorization, and renewal of market authorization for medicines. Comment form:  http://formsus.datasus.gov.br/site/formulario.php?id_aplicacao=58219

Products Covered: HS Code(s): 2941; 3003; 3004; 3005; 3006 (pharmaceutical products).

Regulation Type: Regular notification