Revision of the Federal Act on Medicinal Products and Medical Devices (Therapeutic Products Act, TPA)
Distribution date: 18 December 2023 | Final date for Comment: 22 March 2024
The Therapeutic Products Act, which has been in force since 2002, is currently being revised . Topics which are affected:Advanced therapy medicinal products (ATMPs)Digitalisation in the prescription, dispensing and use of therapeutic productsVeterinary medicinal productsSwiss law is harmonised with EU law in order to reduce technical barriers to trade. The proposed changes are intended to bring greater clarity and certainty to the authorisation of advanced therapy medicinal products (ATMPs). In the area of veterinary medicinal products, a legal basis is created to prohibit the use of certain antimicrobial medicinal products (prevention of antibiotic resistance), to authorise innovative therapies and to permit authorisations to be valid for an unlimited period.
Products Covered: PHARMACEUTICAL PRODUCTS (HS code(s): 30); Generalities. Terminology. Standardization. Documentation (ICS code(s): 01); Natural and applied sciences (ICS code(s): 07); Health care technology (ICS code(s): 11)
Regulation Type: Regular notification
Draft Commission Delegated Regulation amending Regulation (EU) No 528/2012 of the European Parliament and of the Council to include nitrogen generated from ambient air as an active substance in Annex I thereto
Distribution date: 18 December 2023 | Final date for Comment: 16 February 2024
This draft Commission Delegated Regulation amends Regulation (EU) No 528/2012 of the European Parliament and of the Council to include nitrogen generated from ambient air as an active substance in Annex I thereto.
Products Covered: Biocidal products
Regulation Type: Regular notification
Draft Commission Delegated Regulation amending Regulation (EU) No 528/2012 of the European Parliament and of the Council to include nitrogen generated from ambient air as an active substance in Annex I thereto
Distribution date: 18 December 2023 | Final date for Comment: 16 February 2024
This draft Commission Delegated Regulation amends Regulation (EU) No 528/2012 of the European Parliament and of the Council to include nitrogen generated from ambient air as an active substance in Annex I thereto.
Products Covered: Biocidal products
Regulation Type: Regular notification
Amendment to the List of Ingredients Prohibited in Cosmetic Products (Draft)
Distribution date: 15 December 2023 | Final date for Comment: 13 February 2024
The Food and Drug Administration (FDA) proposes to revise the list of ingredients prohibited in cosmetic products. Details of the regulated scope are specified in the attached documents.
Products Covered: Cosmetics; ESSENTIAL OILS AND RESINOIDS; PERFUMERY, COSMETIC OR TOILET PREPARATIONS (HS 33)
Regulation Type: Regular notification
Amendment to the List of Ingredients Prohibited in Cosmetic Products (Draft)
Distribution date: 15 December 2023 | Final date for Comment: 13 February 2024
The Food and Drug Administration (FDA) proposes to revise the list of ingredients prohibited in cosmetic products. Details of the regulated scope are specified in the attached documents.
Products Covered: Cosmetics; ESSENTIAL OILS AND RESINOIDS; PERFUMERY, COSMETIC OR TOILET PREPARATIONS (HS 33)
Regulation Type: Regular notification
Draft resolution number 734, 22 October 2019.
Distribution date: 15 December 2023
The Draft resolution number 734, 22 October 2019 - previously notified through G/TBT/N/BRA/929 - which proposes the updating of the Resolution 36, 26 August 2015, which establishes the risk classification, control scheme of notification, registration, market authorization and technical requirements for labelling and usage instructions of medical devices for in vitro diagnosis, was adopted as Resolution 830, 6 December 2023. The final text is available only in Portuguese and can be downloaded at: http://antigo.anvisa.gov.br/documents/10181/5673188/RDC_830_2023_.pdf/0dcc96d1-7bfa-4a01-9e33-69676fd1eba9
Products Covered: HS Code(s): 3002300, 3822 (In vitro diagnosis products)
Regulation Type: Addendum to Regular Notification
Draft resolution number 734, 22 October 2019.
Distribution date: 15 December 2023
The Draft resolution number 734, 22 October 2019 - previously notified through G/TBT/N/BRA/929 - which proposes the updating of the Resolution 36, 26 August 2015, which establishes the risk classification, control scheme of notification, registration, market authorization and technical requirements for labelling and usage instructions of medical devices for in vitro diagnosis, was adopted as Resolution 830, 6 December 2023. The final text is available only in Portuguese and can be downloaded at: http://antigo.anvisa.gov.br/documents/10181/5673188/RDC_830_2023_.pdf/0dcc96d1-7bfa-4a01-9e33-69676fd1eba9
Products Covered: HS Code(s): 3002300, 3822 (In vitro diagnosis products)
Regulation Type: Addendum to Regular Notification
Regulation on the regulation and control of hazardous and similar substances for domestic, industrial and/or public health use
Distribution date: 14 December 2023
The Regulation on the regulation and control of hazardous and similar substances for domestic, industrial and/or public health use has been approved pursuant to Supreme Decree No. 031-2023-SA and will enter into force six months after publication in the Official Journal, El Peruano. Ministerio de Comercio Exterior y Turismo, MINCETUR (Ministry of Foreign Trade and Tourism) Calle Uno Oeste Nº 50 - Urb. Corpac - Lima 27 - Peru Tel.: (+51-1) 513-6100, Ext. 1223 and 1239 Email: [email protected][ mailto:[email protected] ] (1) This information can be provided by including a website address, a PDF attachment, or other information on where the text of the final measure/change to the measure/interpretative guidance can be obtained.
Products Covered: Sustancias peligrosas y similares de uso doméstico, industrial y/o en salud pública
Regulation Type: Addendum to Regular Notification
Regulation on the regulation and control of hazardous and similar substances for domestic, industrial and/or public health use
Distribution date: 14 December 2023
The Regulation on the regulation and control of hazardous and similar substances for domestic, industrial and/or public health use has been approved pursuant to Supreme Decree No. 031-2023-SA and will enter into force six months after publication in the Official Journal, El Peruano. Ministerio de Comercio Exterior y Turismo, MINCETUR (Ministry of Foreign Trade and Tourism) Calle Uno Oeste Nº 50 - Urb. Corpac - Lima 27 - Peru Tel.: (+51-1) 513-6100, Ext. 1223 and 1239 Email: [email protected][ mailto:[email protected] ] (1) This information can be provided by including a website address, a PDF attachment, or other information on where the text of the final measure/change to the measure/interpretative guidance can be obtained.
Products Covered: Sustancias peligrosas y similares de uso doméstico, industrial y/o en salud pública
Regulation Type: Addendum to Regular Notification
Kerry Inc.; Filing of Food Additive Petition; Notification of Petition
Distribution date: 14 December 2023
The Food and Drug Administration (FDA or we) is announcing that we have filed a petition, submitted by Kerry, Inc., proposing that the food additive regulations be amended to provide for the safe use of sodium alginate as a stabilizer and thickener in plant protein products at a level not to exceed 3 percent.
Products Covered: Peptones and their derivatives; other protein substances and their derivatives, not elsewhere specified or included; hide powder, whether or not chromed. (HS code(s): 3504); Food technology (ICS code(s): 67)
Regulation Type: Regular notification
Submit your email ID to receive notifications about upcoming courses and events
