The Ministry of Health of Chile has officially approved the "Norma Técnica para el Registro Sanitario de Productos Farmacéuticos Hemoderivados" (Technical Standard No. 240), a new regulation aimed a...

The Ministry of Health of Chile has officially approved the "Norma Técnica para el Registro Sanitario de Productos Farmacéuticos Hemoderivados" (Technical Standard No. 240), a new regulation aimed at ensuring the quality, safety, and efficacy of hemoderivative pharmaceuticals in the country. The decree was published in the Diario Oficial de la República de Chile and will come into effect seven months after its publication.

The standard, developed by the National Agency for Medicines (ISP) and the Department of Pharmaceutical Policies and Regulations, was created to address regulatory gaps in the oversight of raw materials used in hemoderivative products. These medications, derived from human blood or plasma, require strict quality control due to their biological nature and critical role in treating various medical conditions.

The Ministry of Health emphasized that the new regulation aligns with international commitments, including those established by the World Trade Organization (WTO). Following a 60-day public consultation period, no objections were raised at the national or international level, allowing for its swift approval.

The Norma Técnica N° 240 will serve as a complementary framework to existing pharmaceutical regulations in Chile, reinforcing sanitary oversight and regulatory standards for hemoderivative medicines. The full text of the regulation will be made available on the Ministry of Health’s official website. 

This development marks a significant step in Chile's ongoing efforts to strengthen pharmaceutical regulations and enhance patient safety by ensuring that all registered hemoderivative products meet the highest scientific and regulatory standards.

The Chilean Ministry of Health has officially incorporated immunohematological reagents into the sanitary control regime established under Article 111 of the Sanitary Code. This measure, enacted throu...

The Chilean Ministry of Health has officially incorporated immunohematological reagents into the sanitary control regime established under Article 111 of the Sanitary Code. This measure, enacted through Decree 5 Exempt, was promulgated on February 4, 2025, and published in the Official Gazette on February 21, 2025. The regulation will come into effect one year later, on February 22, 2026.

According to the Ministry of Health, this regulatory update aims to enhance patient safety by enforcing strict compliance with quality standards for these devices. The decree mandates that all immunohematological reagents must undergo a verification of conformity and certification process, in accordance with the following standards:

• NCh-ISO 16142/2:2021 – Essential Principles of Safety and Performance for In Vitro Medical Devices.

• Evaluation of first-lot performance – Sensitivity and specificity assessments conducted by the Chilean Institute of Public Health (ISP).

Key Provisions of Decree 5 Exempt

The new regulation establishes that:

1. Mandatory Certification: Immunohematological reagents must comply with regulatory quality and safety standards before they can be manufactured, imported, marketed, or distributed within Chile.

2. Risk Classification: These reagents are classified under risk classes C and D (III and IV), in accordance with Chilean medical device regulations.

3. Regulatory Oversight: The Institute of Public Health (ISP) will oversee the verification of conformity and certification process, ensuring adherence to the designated quality standards.

4. Post-Market Surveillance: Any modifications to the design, manufacturing process, intended use, raw materials, labeling, or performance of these devices must be reported to the ISP for further evaluation and approval.

Impact on the Healthcare Sector

This regulatory update is expected to improve patient safety, ensure blood transfusion reliability, and align Chilean medical device regulations with international standards. The Pan American Health Organization (PAHO) has strongly recommended that national regulatory authorities take responsibility for verifying the quality, safety, and efficacy of blood-related medical devices and reagents. Chile's adoption of these measures follows international trends in strengthening healthcare safety frameworks.

The public consultation process, conducted between February and April 2023, gathered input from industry representatives and healthcare professionals. This feedback contributed to refining the regulation, ensuring a smoother transition and effective implementation. The Ministry of Health encourages all stakeholders, including healthcare providers and medical device manufacturers, to review the decree and take necessary steps for compliance before the regulation comes into force in 2026. 

The implementation of Decree 5 Exempt represents a significant step toward enhancing Chile’s regulatory oversight of medical devices. For further details you can find the Decree (in Spanish) here.

The Chilean Ministry of Environment has announced the notification requirements for new industrial chemicals under Supreme Decree No. 57/19, the regulation governing classification, labeling, and not...

The Chilean Ministry of Environment has announced the notification requirements for new industrial chemicals under Supreme Decree No. 57/19, the regulation governing classification, labeling, and notification of hazardous substances and mixtures.

Following the notification process conducted in 2024, which covered industrial-use substances manufactured or imported in 2023 and 2024, the Ministry issued Resolution No. 7595 on December 30, 2024. This resolution approved a list of  over 850 notified industrial-use substances. According to Articles 295 and 296 of Supreme Decree No. 57/19, any chemical substance imported or manufactured after the notification deadline will be considered a new substance and must be notified prior to importation, production, or commercialization.

Key Definitions 

Industrial-use substances those whose intended use and application is carried out in manufacturing activity and productive processes. (D.S. 57/19, article 3)

Notification Details

For 2025, any new industrial-use substance not listed in Resolution No. 7595/2024 must be notified via an Excel form submitted to notificacion.sqi@mma.gob.cl before its importation or production.

In the case of importatition of a substance for industrial use, the notification must be made only the first time the substance is imported in 2025, regardless of the quantity imported and the estimated amount that will be imported throughout 2025.

In the case of manufacturing a substance, report will be needed whether it has been been manufactured it and placed on the market previously (but not notified) or before commencing use or marketing.

Entities must provide:

• Chemical name and common name (if applicable)
• CAS number (if available)
• Physical state
• Hazard classification and categories
• Estimated manufactured quantity or actual and estimated imported quantity for 2025
• Industrial-use purpose

For further details, visit the Ministry of Environment’s official notification platform.

The notification period for non-industrial chemical substances under Decree 57 will commence on February 9, 2025. This marks a futher advancement in Chile’s regulatory framework for chemical substan...

The notification period for non-industrial chemical substances under Decree 57 will commence on February 9, 2025. This marks a futher advancement in Chile’s regulatory framework for chemical substances, reinforcing the nation’s commitment to environmental and human health protection.

Companies that manufacture and/or import non-industrial chemical substances in Chile must submit their notifications by August 30, 2025. The process aims to establish a comprehensive database of chemical substances in use, enhancing risk management and regulatory oversight.

Who Must Notify?

Entities handling non-industrial chemical substances including manufacturers and importers are required to submit their  notifications.

What is a Non Industrial Chemical Substance ?

As defined in Decree 57, non-industrial chemicals are considered all substances whose intended use and application do not involve manufacturing activities or production processes. 

Key Dates to Remember:

• February 9, 2025: Start of the notification period
• August 30, 2025: Deadline for submission

For further details on the notification process, requirements, and necessary documentation, stakeholders are advised to consult Chile’sDecree 57 here (in Spanish). 

In a significant step towards modernizing its agricultural sector, Chile’s Ministry of Agriculture, through the Agricultural and Livestock Service (SAG), has issued Resolución 243 Exenta (Resoluti...

In a significant step towards modernizing its agricultural sector, Chile’s Ministry of Agriculture, through the Agricultural and Livestock Service (SAG), has issued Resolución 243 Exenta (Resolution 243), a comprehensive regulatory framework designed to enhance the safety and sustainability of pesticide use in the country. The resolution, published on January 14, 2025, introduces strict obligations for all stakeholders involved in the lifecycle of agricultural pesticides, from distributors to farmers and applicators.

A New Era for Agricultural Practices

The Resolution reflects Chile’s commitment to aligning its agricultural practices with international environmental and public health standards. By addressing critical issues such as pesticide drift, worker safety, and environmental contamination, it aims to reduce the risks associated with pesticide use while promoting sustainable farming practices. “This resolution is a milestone in our efforts to protect people and the environment,” said the Minister of Agriculture. “It ensures that our agricultural sector remains productive while adhering to the highest standard of safety and sustainability”.

Key Provisions of Resolución 243 Exenta

1. Sale and Distribution

   • Pesticides must be sold in their original, SAG-approved packaging.

   • Distributors must provide detailed documentation, including product names, SAG authorization numbers, and lot numbers.

   • Pesticides that are about to expire or that have been cancelled may only be sold with explicit buyer consent.

2. Storage Requirements

   • Pesticides must be stored in secure, restricted access facilities with proper hazard signage.

   • Inventories must be maintained, and expired products must be disposed of in accordance with SAG guidelines.

3. Handling and Application Practices 

   • Pesticides should only be handled by certified applicators with SAG credentials.

   • Equipment must be regularly maintained and calibrated to prevent leaks or dosage errors.

   • Pesticide applications must be announced 48 hours in advance, with exceptions for emergencies.

4. Worker Safety Protocols

   • Workers cannot re-enter treated areas before the re-entry period specified on the pesticide label.

   • Written authorization from the farm administration is required for re-entry.

5. Empty Container Management

   • Empty pesticide containers must be disposed of in accordance with label instructions and regulations.

   • Traceability records must be maintained to ensure proper disposal.

6. Service Providers

   • Companies offering pesticide application services must register with the SAG and comply with training and record keeping requirements.

Implications for Stakeholders

• Farmers and Distributors:
  The Resolution introduces enhanced record keeping and storage requirements, which may increase operational costs but will improve product safety and traceability.

• Applicators:
  Mandatory training and certification will raise professional standards, but may require additional time and financial investment.

• Environmental and Public Health:
  The regulation’s focus on minimizing pesticide drift, protecting pollinators, and ensuring proper disposal of containers is in line with global sustainability goals.

Enforcement and Compliance

SAG inspectors will oversee compliance through regular audits and field inspections. Violations of the Resolution will be subject to penalties under existing laws, including Decreto Ley Nº 3.557 and Ley Nº 18.755. Resolution 243 will take effect on January 20 2026, giving stakeholders 12 months to comply. Small-scale and indigenous farmers have been granted a 24-month transition period to comply with the training requirements, provided they obtain certification through government programs.

Resolution 243 Exenta represents a significant step forward in Chile’s efforts to balance agricultural productivity with environmental protection and worker safety. For further details, Resolution 243 can be found here (in Spanish).

In February 2021, Chile became the first country in Latin America to adopt a comprehensive national chemicals regulation, Decree 57 and its implementing Resolution 777/2021. This regulation establishe...

In February 2021, Chile became the first country in Latin America to adopt a comprehensive national chemicals regulation, Decree 57 and its implementing Resolution 777/2021. This regulation establishes a structured system for the notification and prioritization of substances, allowing for the risk assessment of selected chemicals, whether manufactured or imported. Decree 57, formally issued on February 9, 2021, aims to protect human health and the environment by mandating the implementation of Globally Harmonized System (GHS) labeling for chemical products. 

The legislation addresses both chemical substances and hazardous mixtures and mandates notification protocols under the Ministry of Health (MINSAL) and the Ministry of Environment (MMA). Notifications are required every two years, with the deadline of August 30 each year. The first notification deadline for industrial use substances was scheduled for August 30, 2024, but a revised deadline will be set, after which authorities will publish a Chemical Inventory. Non-compliance with the notification requirements will result in penalties, with specific enforcement details to be defined in future regulations.

Key News for 2024

• Chile Introduces Decree on Lubricant Oil Recycling
  On November 11, 2024, Chile issued a Supreme Decree to improve the collection, recycling, and disposal of lubricant oils in support of its sustainability goals. The Decree establishes recycling targets, producer accountability, consumer participation, and labeling requirements, with a 24-month transition period for compliance. Read more here.

• Chile Strengthens Pesticide Rules to Protect Bees
  On October 18, 2024, Chile's Ministry of Agriculture introduced Exempt Resolution No. 7,068 to improve ecotoxicological standards for pesticides, with an emphasis on bee protection. The regulation mandates clear toxicity classifications, bee hazard pictograms, and notification requirements for beekeepers prior to pesticide application. Read more here.

• Chile Opens Public Consultation on Fertilizer and Biostimulant Regulation
  Chile’s Agricultural and Livestock Service (SAG) has opened a public consultation to update the fertilizer and biostimulant regulation under Law No. 21.349. The proposed updates include revised labelling standards, improved traceability measures, and phased compliance schedules. Stakeholders are invited to review the draft regulation and provide feedback by December 16, 2024, with SAG publishing responses to comments by January 29, 2025. Read more here.

The Chilean Ministry of the Environment has issued Resolution No. 7595, of December 17, 2024, which officially approves the list of hazardous substances for industrial use notified in 2024. This resol...

The Chilean Ministry of the Environment has issued Resolution No. 7595, of December 17, 2024, which officially approves the list of hazardous substances for industrial use notified in 2024. This resolution, which is in line with Supreme Decree No. 57 of 2019, ensures compliance with regulations on the classification, labeling, and notification of hazardous substances and mixtures.

Key Highlights of Resolution No. 7595

• Promulgation Date: December 17, 2024

• Publication Date: December 30, 2024

• Public Access: The full list of notified hazardous substances is available on the Ministry of the Environment’s official platform: https://plataformasqi.mma.gob.cl.

Background to Supreme Decree No. 57

Supreme Decree No. 57, published on February 9, 2021,  establishes the regulatory framework for the classification, labeling, and notification of hazardous substances and mixtures. According to the decree:

• Manufacturers or importers of hazardous substances, or substances in mixtures exceeding 1 tonne per year, are required to notify the Ministry of the Environment.

• The notification must include relevant safety and classification information in accordance with Title III of the Regulation.

Notification Challenges and Timeline Adjustments

The initial notification deadline for industrial hazardous substances was August 30, 2024. However, due to challenges with the electronic system, Resolution No. 4141 extended the deadline to September 30, 2024 and provided temporary procedures for manufacturers and importers to fulfil their obligations.

Publication of the 2024 Hazardous Substances List

As stipulated by the regulation, the Ministry of the Environment must issue a resolution listing all notified substances by December 31, 2024. Resolution No. 7595 fulfils this requirement by publishing the approved list, ensuring transparency and public access to this important information.

Importance of Compliance

This resolution reinforces Chile’s commitment to chemical safety and ensures the responsible use of hazardous substances in industrial applications.