Distribution date: 23 February 2021 | Final date for Comment: 13 April 2021

The final date for comments of the Draft Resolution number 987, 15 December 2020 – previously notified through G/TBT/N/BRA/1119 – which establishes the guidelines for the risk assessment of exposure of operators, workers, residents, and bystanders to pesticides for the purpose of market authorization, post-market authorization alterations, reassessment, monitoring, and inspection procedures, was extended for 15 days.

Products Covered: HS Code(s): 38089910 (pesticides)

Regulation Type: Addendum to Regular Notification

Distribution date: 23 February 2021 | Final date for Comment: 04 March 2021

The final date for comments of the Draft Resolution number 989, 15 December 2020 – previously notified through G/TBT/N/BRA/1118 – which changes the Resolution – RDC number 47, 8 September 2009, which establishes technical requirements for the development, harmonization, updating, publication, and provision of medicine leaflets to patients and healthcare professionals, was extended for 15 days.

Products Covered: Antibiotics (HS code(s): 2941); Medicaments consisting of two or more constituents mixed together for therapeutic or prophylactic uses, not in measured doses or put up for retail sale (excl. goods of heading 3002, 3005 or 3006) (HS code(s): 3003); Medicaments consisting of mixed or unmixed products for therapeutic or prophylactic uses, put up in measured doses "incl. those in the form of transdermal administration" or in forms or packings for retail sale (excl. goods of heading 3002, 3005 or 3006) (HS code(s): 3004); Wadding, gauze, bandages and the like, e.g. dressings, adhesive plasters, poultices, impregnated or covered with pharmaceutical substances or put up for retail sale for medical, surgical, dental or veterinary purposes (HS code(s): 3005); Pharmaceutical preparations and products of subheadings 3006.10.10 to 3006.60.90 (HS code(s): 3006); Pharmaceutics (ICS code(s): 11.120)

Regulation Type: Addendum to Regular Notification

Distribution date: 23 February 2021 | Final date for Comment: 02 March 2021

The final date for comments of the Draft Resolution number 970, 7 December 2020 – previously notified through G/TBT/N/BRA/1106 – which establishes the procedures and technical requirements for the registry of furniture paint with sanitizing action, was extended for 15 days.

Products Covered: Organic surface-active agents (excl. soap); surface-active preparations, washing preparations, incl. auxiliary washing preparations, and cleaning preparations, whether or not containing soap (excl. those of heading 3401) (HS code(s): 3402); Insecticides, rodenticides, fungicides, herbicides, anti-sprouting products and plant-growth regulators, disinfectants and similar products, put up for retail sale or as preparations or articles, e.g. sulphur-treated bands, wicks and candles, and fly-papers (HS code(s): 3808); Pesticides and other agrochemicals (ICS code(s): 65.100); Surface active agents (ICS code(s): 71.100.40)

Regulation Type: Addendum to Regular Notification

Distribution date: 23 February 2021 | Final date for Comment: 13 March 2021

The final date for comments of the Draft Normative Instruction number 931, 13 October 2020 – previously notified through G/TBT/N/BRA/1094 – which establishes new codes for the administrative request of market authorization for new and innovative synthetic and semisynthetic medicines, was extended for 15 days.

Products Covered: Medicaments consisting of two or more constituents mixed together for therapeutic or prophylactic uses, not in measured doses or put up for retail sale (excl. goods of heading 3002, 3005 or 3006) (HS code(s): 3003); Medicaments consisting of mixed or unmixed products for therapeutic or prophylactic uses, put up in measured doses "incl. those for transdermal administration" or in forms or packings for retail sale (excl. goods of heading 3002, 3005 or 3006) (HS code(s): 3004); Wadding, gauze, bandages and the like, e.g. dressings, adhesive plasters, poultices, impregnated or covered with pharmaceutical substances or put up for retail sale for medical, surgical, dental or veterinary purposes (HS code(s): 3005); Pharmaceutical preparations and products of subheadings 3006.10.10 to 3006.60.90 (HS code(s): 3006); Pharmaceutics (ICS code(s): 11.120)

Regulation Type: Addendum to Regular Notification

Distribution date: 23 February 2021 | Final date for Comment: 13 March 2021

The final date for comments of the Draft Resolution number 932, 13 October 2020 – previously notified through G/TBT/N/BRA/1095 – which establishes criteria for the concession of market authorization for medicines with synthetic and semisynthetic active principles for human use categorized as new, innovative, generic, and similar, was extended for 15 days.

Products Covered: Medicaments consisting of two or more constituents mixed together for therapeutic or prophylactic uses, not in measured doses or put up for retail sale (excl. goods of heading 3002, 3005 or 3006) (HS code(s): 3003); Medicaments consisting of mixed or unmixed products for therapeutic or prophylactic uses, put up in measured doses "incl. those for transdermal administration" or in forms or packings for retail sale (excl. goods of heading 3002, 3005 or 3006) (HS code(s): 3004); Wadding, gauze, bandages and the like, e.g. dressings, adhesive plasters, poultices, impregnated or covered with pharmaceutical substances or put up for retail sale for medical, surgical, dental or veterinary purposes (HS code(s): 3005); Pharmaceutical preparations and products of subheadings 3006.10.10 to 3006.60.90 (HS code(s): 3006); Pharmaceutics (ICS code(s): 11.120)

Regulation Type: Addendum to Regular Notification

Distribution date: 22 February 2021 | Final date for Comment: 23 April 2021

The notified Executive Decree sets out the implementing regulations for Law No. 1 of 10 January 2001, which regulates all aspects relating to the functions of the National Pharmacy and Drugs Directorate; the charging of fees for the Directorate's services; and all aspects relating to the registration of the following pharmaceutical products: · Topical antiseptics · Bactericides and disinfectants · Biological and biotechnological products · Cosmetics · Herbal medicines · Chemically synthesized medicines · Homeopathic medicines · Orphan medicines · Pesticides for household and public health use · Household and hospital cleaning products with antiseptic and fungicidal properties · Radiopharmaceuticals · Vitamin or dietary supplements It also sets out implementing regulations for all aspects relating to the accelerated registration procedure; labelling; stability; interchangeability; manufacture, control and inspection and other provisions; marketing; prior and post- verification of pharmaceutical products; the National Pharmacovigilance System; pharmacotherapy; regulation and inspection of pharmaceutical establishments; good manufacturing practices for cosmetic, antiseptic and disinfectant products and household pesticides; registration requirements for raw materials, excipients and packaging inputs in industries producing medicines, cosmetics, disinfectants, pesticides and other products; product distribution; good pharmaceutical practices; prescriptions; and government procurement of human health products.

Products Covered: Pharmaceutical products (HS code(s): 30); Essential oils and resinoids; perfumery, cosmetic or toilet preparations (HS code(s): 33); Insecticides, rodenticides, fungicides, herbicides, anti-sprouting products and plant-growth regulators, disinfectants and similar products, put up in forms or packings for retail sale or as preparations or articles (for example, sulphur-treated bands, wicks and candles, fly-papers). (HS code(s): 3808); Pharmaceutics (ICS code(s): 11.120); Pesticides and other agrochemicals (ICS code(s): 65.100); Cosmetics. Toiletries (ICS code(s): 71.100.70)

Regulation Type: Regular notification

Distribution date: 19 February 2021 | Final date for Comment: 20 April 2021

NEA is proposing the following enhancements to the control of lead in paints: The manufacture and import of all paints, except zinc-based anti-corrosion and copper-based anti-fouling paints, with total lead concentration exceeding 90 ppm will not be allowed, unless solely for export; and Zinc-based anti-corrosion and copper-based anti-fouling paints with total lead concentration exceeding the limit of 90 ppm can only be used for industrial applications and the following label must be affixed on the paint containers, unless solely for export: “This paint contains lead. Restricted to industrial applications only. Do not use on furniture, buildings or in publicly accessible areas”. The manufacture/import of all paints with total lead concentration exceeding 90ppm for export will require a Hazardous Substance license from NEA.

Products Covered: HS heading Description 32081020 Anti-fouling or anti-corrosive paints for ships’ hulls based on polyesters in non-aqueous medium 32081090 Other paints based on polyesters in non-aqueous medium & solutions 32082040 Anti-fouling or anti-corrosive paints of acrylic or vinyl polymers in non-aqueous medium for ship hull 32082090 Other paints & varnishes in non-aqueous medium & solutions based on acrylic or vinyl polymers 32089030 Anti-fouling or anti-corrosive paints for ships’ hulls based on other polymers in non-aqueous medium 32089090 Other paints in non-aqueous medium & solutions based on other polymers 32091050 Anti-fouling or anti-corrosive paints of acrylic or vinyl polymers in aqueous medium for ships hulls 32091090 Other paints & varnishes of acrylic or vinyl polymers in aqueous medium 32099000 Other paints & varnishes of synthetic or chemically modified natural polymers in aqueous medium 32100091 Anti-fouling or anti-corrosive paints for ships hulls 32100099 Other paints & varnishes

Regulation Type: Regular notification

Distribution date: 19 February 2021 | Final date for Comment: 20 April 2021

The order contains a draft of the new provisions regarding a new registration-obligation for a number of companies dealing with Commercial use of pesticides. The registration-obligation requires the Companies to inform whether they have pesticides in stock and their name, address etc. The order obliges Companies to do this yearly as a prerequisite to dealing with Commercial use of pesticides and for the to pay a small fee in connection to this.

Products Covered: Pesticides

Regulation Type: Regular notification

Distribution date: 18 February 2021 | Final date for Comment: 19 April 2021

The executive order implements parts of Directive 2013/29/EU of the European Parliament and of the Council on the harmonisation of the laws of the Member States relating to the making available on the market pyrotechnic articles and Implementing Directive 2014/58/EU setting up, pursuant to directive 2007/23/EC of the European Parliament and of the Council, a system for the traceability of pyrotechnic articles. The executive order lays down requirements for retailers who place fireworks or other pyrotechnic articles on the market or make them available on the market. In addition, the essential safety requirements for fireworks and other pyrotechnic articles is laid down, as well as requirements for the categorization and marking of fireworks and other pyrotechnic articles. The executive order also lays down requirements for the communication with the authorities and lays down penalties for breaches of the rules.

Products Covered: Fireworks, signalling flares, rain rockets, fog signals and other pyrotechnic articles (excl. cartridge blanks) (HS code(s): 3604); Explosives. Pyrotechnics and fireworks (ICS code(s): 71.100.30)

Regulation Type: Regular notification

Distribution date: 18 February 2021 | Final date for Comment: 19 April 2021

The executive order implements parts of Directive 2013/29/EC of the European Parliament and of the Council on the harmonisation of the laws of the Member States relating to the making available on the market of pyrotechnic articles and implements parts of Directive 2006/123/EC. The executive order lays down requirements for the import, manufacture, storage, transfer, acquisition and use of fireworks and other pyrotechnic articles in Denmark. Primarily, the executive order consists of national rules.

Products Covered: Fireworks, signalling flares, rain rockets, fog signals and other pyrotechnic articles (excl. cartridge blanks) (HS code(s): 3604); Explosives. Pyrotechnics and fireworks (ICS code(s): 71.100.30)

Regulation Type: Regular notification