MINISTRY OF HEALTH
Regulation and Control Regulation of Hazardous Substances for Domestic, Industrial and/or Public Health Use
Through Supreme Decree No. 031-2023-SA, the new “Regulation and Control Regulation of Hazardous Substances for Domestic, Industrial and/or Public Health Use” was published
The Regulation will enter into force on June 3, 2024.
This regulation applies, only, to natural and legal persons that carry out activities related to the importation, manufacture, formulation, elaboration, manufacture, distribution, commercialization, storage, use, handling and destruction of the following products containing hazardous substances: -Chemical products for industrial use. -Disinfectant products (not used for the disinfection of medical devices or food) of inert surfaces for domestic, industrial and/or public health use, and disinfectant products for swimming pool water. -Pesticide products for domestic, industrial and/or public health use. -Hazardous products under the Rotterdam Convention.
On the other hand, this regulation does not apply to the following products: -Pharmaceuticals, including narcotic drugs, medicines for human use and psychotropic substances. -Food additives. -Hydrocarbons and their derivatives. -Disinfection products for medical devices. -Products for agricultural and veterinary use. -Chemical inputs and controlled products. -Radioactive chemical substances. -Chemical substances controlled by Law No. 29239. -Methyl and ethyl alcohol regulated by Law No. 27645. -Disinfectant products for domestic use only, regulated by Decision 706.
This regulation regulates the labeling of the product’s packaging and container. It is important to highlight that imported products may use stickers, which must be firmly and indelibly adhered to the primary or secondary packaging.
The regulation of those products containing hazardous substances is carried out through compliance with the conditions established in the respective health authorization. The health authorizations of the products are regulated independently for each type of product and enable the holder to manufacture, import, distribute, commercialize and store them: -The health authorization for chemical products for industrial use is valid for 3 years. -The health authorization for disinfectants is valid for 3 years. -The health authorization for pesticides is valid for 3 years. -The health authorization for the importation of hazardous products under the Rotterdam Convention is valid for 1 year.
Health authorizations are also provided for the importation and non-commercial use of the products in research studies, marketing studies or for the applicant’s own use: -The health authorization for disinfectants or pesticides is effective for importing the amount requested. Finally, this regulation also regulates DIGESA’s supervisory and sanctioning powers.
CHEMICAL INPUTS AND CONTROLLED PRODUCTS, MACHINERY AND EQUIPMENT
Legislative Decree No. 1600 amended Legislative Decree No. 1126, Legislative Decree that establishes control measures for chemical inputs and controlled products, machinery and equipment.
The most important modifications are the following: – The National Police of Peru and SUNAT will have competence for control and inspection actions. -The suspension of the Register for the Control of Controlled Goods will proceed in the following cases: – The user submits inconsistent information on the records of operations. – The user performs controlled activities related to controlled goods with users that exceed the amounts indicated in the registry.
EPIDEMIOLOGICAL SURVEILLANCE IN PUBLIC HEALTH AND HEALTH INTELLIGENCE
Law No. 31961, “Law that strengthens the steering role of the Ministry of Health in Epidemiological Surveillance in Public Health and Health Intelligence” was published. This law amends Legislative Decree No. 1504, “Legislative Decree that strengthens the National Health Institute for the prevention and control of diseases”.
Health institutions should share relevant health data for epidemiological surveillance, through the interoperability of information systems and electronic data exchange, respecting the protocols for data anonymization within the framework of Law 29733, Law for the Protection of Personal Data. https://busquedas.elperuano.pe/dispositivo/NL/2245634-1
EXTENSION OF THE “CATEGORIZATION” OR “RECATEGORIZATION” OF IPRESSES
By means of Supreme Decree No. 033-2023-SA, the deadlines to obtain the categorization or recategorization, as well as the approval of the Activity Plan of the IPRESS before the Health Directorates were extended. – Until December 31, 2024, the IPRESSs registered or in the process of registration in the RENIPRESS, may obtain the categorization or recategorization – Until June 30, 2024, the approval of the Plan of Activities.
This extension was made through the modification of the Ninth Final Complementary Provision of the Regulation of Infractions and Sanctions of the National Superintendence of Health – SUSALUD, approved by Supreme Decree No. 031-2014-SA.
As of January 1, 2025, SUSALUD will proceed to cancel ex officio the Registration of IPRESSs that do not have a current category. IPRESSs that do not have Registration in the RENIPRESS cannot provide health services.
EXTENSION OF THE IMPLEMENTATION OF SETI-IPRESS FOR FIRST LEVEL OF CARE IPRESSES
By means of Superintendence Resolution No. 110-2023-SUSALUD/S, the deadline for category I IPRESS to implement the Electronic Information Transfer System (SETI-IPRESS) was extended.
The extensions differ in time, depending on the category of the First Level of Care IPRESS: – Category I-4 has a term that expires on December 31, 2024 – Category I-3 has a term that expires on December 31, 2025 – Category I-2 has a term that expires on December 31, 2026 – Category I-1 has a term that expires on December 31, 2027.
This extension was made through the modification of the First Transitory Complementary Provision of the “Regulation for the Collection, Transfer and Dissemination of Information on Health Benefits Generated by Health Service Provider Institutions (IPRESS) and IPRESS Management Units“, approved by Superintendence Resolution No. 092-2014-SUSALUD/S.
SETI-IPRESS is an application intended for IPRESS and UGIPRESS to enter and validate the information to be submitted to SUSALUD by electronic means.
PERUVIAN TECHNICAL STANDARDS FOR CHOCOLATE AND COCOA LIQUOR
By Directorial Resolution No. 018-2023-INACAL/DN, two Implementation Guides for Peruvian Technical Standards were approved, within the framework of the project “Strengthening the quality of coffee and cocoa for Peruvian exports”: – GIP 114:2023 Implementation Guide for the Peruvian Technical Standard NTP-CODEX CXS 87:2017 (revised 2022) STANDARD FOR CHOCOLATE AND CHOCOLATE PRODUCTS. 1st Edition
– GIP 117:2023 Implementation Guide of Peruvian Technical Standard NTP 107.303:2022 COCOA AND CHOCOLATE. Guidelines for the sensory evaluation of cocoa liquor. 1st Edition
