Regulatory Updates
Decreto Supremo Ministerio de Salud N° 54/2019 y N° 65/2019: Proceso de Registro Sanitario de Productos Farmacéuticos (Ministry of Health Supreme Decrees No. 54/2019 and No. 65/2019: Sanitary registration process for pharmaceutical products) (3 pages, in Spanish; 2 pages, in Spanish)
Distribution date: 08 September 2020 | Final date for Comment: 08 October 2020
The purposes of the notified Ministry of Health Supreme Decrees No. 54/2019 and No. 65/2019 are to simplify the processes associated with administrative procedures for the sanitary registration of pharmaceutical products for human use in Chile and deal with the demonstration of therapeutic equivalence. Both Supreme Decrees amend Ministry of Health Supreme Decree No. 3 of 2010 and, for reasons of urgency, were published in the Official Journal of Chile on 21 August 2020.
Products Covered: Pharmaceutical products
Regulation Type: Regular notification
Classification Rules and Catalogue of Cosmetics (Draft for Comments)
Distribution date: 08 September 2020 | Final date for Comment: 07 November 2020
This document is drafted to carry out detailed classification of cosmetics which is applied to the statistics and supervision of cosmetics products, as well as the clarification of the catalogue of products.
Products Covered: Cosmetics ICS: 71.100.70; HS: 33
Regulation Type: Regular notification
Classification Rules and Catalogue of Cosmetics (Draft for Comments)
Distribution date: 08 September 2020 | Final date for Comment: 07 November 2020
This document is drafted to carry out detailed classification of cosmetics which is applied to the statistics and supervision of cosmetics products, as well as the clarification of the catalogue of products.
Products Covered: Cosmetics ICS: 71.100.70; HS: 33
Regulation Type: Regular notification
Guidelines for Cosmetic Safety Assessment (Draft for Comments)
Distribution date: 08 September 2020 | Final date for Comment: 07 November 2020
The Guidelines are intended to guide and standardize the safety assessment of cosmetics and cosmetic ingredients to ensure the safety of cosmetics.
Products Covered: Cosmetics ICS: 71.100.70; HS: 33
Regulation Type: Regular notification
Guidelines for Cosmetic Safety Assessment (Draft for Comments)
Distribution date: 08 September 2020 | Final date for Comment: 07 November 2020
The Guidelines are intended to guide and standardize the safety assessment of cosmetics and cosmetic ingredients to ensure the safety of cosmetics.
Products Covered: Cosmetics ICS: 71.100.70; HS: 33
Regulation Type: Regular notification
Draft Commission Directive amending Directive 2009/48/EC of the European Parliament and of the Council as regards specific limit values for aniline in certain toys
Distribution date: 08 September 2020 | Final date for Comment: 07 November 2020
Inclusion, in Directive 2009/48/EC, of limit values for aniline in certain toy materials, both for free aniline and for total aniline after reductive cleavage, in order to increase children's safety.
Products Covered: Children's toys, i.e. products designed or intended, whether or not exclusively, for use in play by children under 14 years of age.
Regulation Type: Regular notification
Draft Commission Directive amending Directive 2009/48/EC of the European Parliament and of the Council as regards specific limit values for aniline in certain toys
Distribution date: 08 September 2020 | Final date for Comment: 07 November 2020
Inclusion, in Directive 2009/48/EC, of limit values for aniline in certain toy materials, both for free aniline and for total aniline after reductive cleavage, in order to increase children's safety.
Products Covered: Children's toys, i.e. products designed or intended, whether or not exclusively, for use in play by children under 14 years of age.
Regulation Type: Regular notification
Resolution Nº 825, 28 August 2020
Distribution date: 03 September 2020
This Resolution provides for the specification and control of the quality of liquefied petroleum gases (GLP) marketed by economic agents in the national territory. It revokes: I - ANP Resolution No. 18, 2 September 2004; II - Articles 9 and 10 of ANP Resolution No. 681, 5 June 2017
Products Covered: Natural gas (HS code(s): 271111); Natural gas (ICS code(s): 75.060)
Regulation Type: Regular notification
Resolution Nº 825, 28 August 2020
Distribution date: 03 September 2020
This Resolution provides for the specification and control of the quality of liquefied petroleum gases (GLP) marketed by economic agents in the national territory. It revokes: I - ANP Resolution No. 18, 2 September 2004; II - Articles 9 and 10 of ANP Resolution No. 681, 5 June 2017
Products Covered: Natural gas (HS code(s): 271111); Natural gas (ICS code(s): 75.060)
Regulation Type: Regular notification
Draft Normative Instruction number 896, 12 August 2020.
Distribution date: 02 September 2020 | Final date for Comment: 26 October 2020
This draft normative instruction establishes technical requirements for the inclusion or alteration of substances in the list of preservatives that are allowed in the manufacturing of sanitizing products. Comment form: http://formsus.datasus.gov.br/site/formulario.php?id_aplicacao=58220
Products Covered: 340119
Regulation Type: Regular notification
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