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

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

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

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

Distribution date: 18 December 2023 | Final date for Comment: 31 January 2024

The Therapeutic Goods Administration (TGA) administers Australia’s national system of controls for the quality, safety, efficacy and timely availability of therapeutic goods in Australia. There are provisions under the Therapeutic Goods Act 1989 to establish quality standards for therapeutic goods. These standards, known as TGOs, can specify things such as procedures to be carried out in the manufacture of the goods, labelling, or other requirements. Once approved, TGOs are registered as legislative instruments on the Federal Register of Legislation in Australia. The TGA has developed two new quality standards that will be registered as legislative instruments on the Federal Register of Legislation in Australia as Therapeutic Goods Orders (TGOs):Standard for MDMA hydrochloride, and Standard for PsilocybinThe TGA is undertaking a public consultation between Friday 8 December 2023 to Wednesday 31 January 2024 to seek feedback on the appropriateness of the requirements in the TGOs. Until 1 July 2023 Australian patients only had access to therapy with ,4‑methylenedioxy‑N-methylamphetamine hydrochloride (MDMA) and psilocybin as part of clinical trials. Effective from 1 July 2023, the TGA amended the Poisons Standard to add MDMA and psilocybin to Schedule 8 (S8), permitting their use as Controlled Drugs only for the treatment of post-traumatic stress disorder (PTSD) and treatment resistant depression (TRD), respectively. Only authorised medical practitioners are permitted to prescribe S8 MDMA and psilocybin.There are no quality standards such as pharmacopoeial monographs or TGOs for MDMA or psilocybin. The TGA has developed manufacturing and testing requirements that will form the basis of proposed new TGOs for each of these medicines.  

Products Covered: Medicines

Regulation Type: Regular notification

Distribution date: 18 December 2023 | Final date for Comment: 31 January 2024

The Therapeutic Goods Administration (TGA) administers Australia’s national system of controls for the quality, safety, efficacy and timely availability of therapeutic goods in Australia. There are provisions under the Therapeutic Goods Act 1989 to establish quality standards for therapeutic goods. These standards, known as TGOs, can specify things such as procedures to be carried out in the manufacture of the goods, labelling, or other requirements. Once approved, TGOs are registered as legislative instruments on the Federal Register of Legislation in Australia. The TGA has developed two new quality standards that will be registered as legislative instruments on the Federal Register of Legislation in Australia as Therapeutic Goods Orders (TGOs):Standard for MDMA hydrochloride, and Standard for PsilocybinThe TGA is undertaking a public consultation between Friday 8 December 2023 to Wednesday 31 January 2024 to seek feedback on the appropriateness of the requirements in the TGOs. Until 1 July 2023 Australian patients only had access to therapy with ,4‑methylenedioxy‑N-methylamphetamine hydrochloride (MDMA) and psilocybin as part of clinical trials. Effective from 1 July 2023, the TGA amended the Poisons Standard to add MDMA and psilocybin to Schedule 8 (S8), permitting their use as Controlled Drugs only for the treatment of post-traumatic stress disorder (PTSD) and treatment resistant depression (TRD), respectively. Only authorised medical practitioners are permitted to prescribe S8 MDMA and psilocybin.There are no quality standards such as pharmacopoeial monographs or TGOs for MDMA or psilocybin. The TGA has developed manufacturing and testing requirements that will form the basis of proposed new TGOs for each of these medicines.  

Products Covered: Medicines

Regulation Type: Regular notification

Distribution date: 20 December 2023 | Final date for Comment: 18 February 2024

The Swiss rules and conditions for the admission of Plant Protection Products continue to be harmonised with those of the European Union.

Products Covered: 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); Microbiology (ICS code(s): 07.100); Environmental protection (ICS code(s): 13.020); Air quality (ICS code(s): 13.040); Water quality (ICS code(s): 13.060); Soil quality. Pedology (ICS code(s): 13.080); Explosion protection (ICS code(s): 13.230); Farming and forestry (ICS code(s): 65.020); Pesticides and other agrochemicals (ICS code(s): 65.100)

Regulation Type: Regular notification

Distribution date: 20 December 2023 | Final date for Comment: 18 February 2024

The Swiss rules and conditions for the admission of Plant Protection Products continue to be harmonised with those of the European Union.

Products Covered: 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); Microbiology (ICS code(s): 07.100); Environmental protection (ICS code(s): 13.020); Air quality (ICS code(s): 13.040); Water quality (ICS code(s): 13.060); Soil quality. Pedology (ICS code(s): 13.080); Explosion protection (ICS code(s): 13.230); Farming and forestry (ICS code(s): 65.020); Pesticides and other agrochemicals (ICS code(s): 65.100)

Regulation Type: Regular notification

Distribution date: 21 December 2023 | Final date for Comment: 19 February 2024

Limit values for the characteristics of olive oil set out in Regulation (EU) 2022/2104 are set in accordance with the IOC Trade Standard applying to olive oil and olive-pomace oil (IOC Trade Standard). The IOC Trade Standard changed with regard to one chemical parameter, Δ-7-stigmastenol, and Delegated Regulation (EU) 2022/2104 should be amended accordingly.

Products Covered: 1509, Olive oil and its fractions, whether or not refined, but not chemically modified; 1510, Other oils and their fractions, obtained solely from olives, whether or not refined, but not chemically modified, including blends of these oils or fractions with oils or fractions of heading 1509;

Regulation Type: Regular notification

Distribution date: 21 December 2023 | Final date for Comment: 19 February 2024

Limit values for the characteristics of olive oil set out in Regulation (EU) 2022/2104 are set in accordance with the IOC Trade Standard applying to olive oil and olive-pomace oil (IOC Trade Standard). The IOC Trade Standard changed with regard to one chemical parameter, Δ-7-stigmastenol, and Delegated Regulation (EU) 2022/2104 should be amended accordingly.

Products Covered: 1509, Olive oil and its fractions, whether or not refined, but not chemically modified; 1510, Other oils and their fractions, obtained solely from olives, whether or not refined, but not chemically modified, including blends of these oils or fractions with oils or fractions of heading 1509;

Regulation Type: Regular notification