NOVEDADES LEGISLATIVAS EN MATERIA REGULATORIA Y PROPIEDAD INTELECTUAL

Executive Summary

Norma/DocumentoDateContent
Salud | Régimen para el uso de cannabis medicial19/12/2025La Dinavisa emitió la Resolución Nro. 488/2025 que reglamenta cuáles son los productos de uso medicinal derivados del cannabis.
Juegos | Licitaciones para Concesiones05/02/2026La Conajzar emitió la Resolución Nro. 28/2026 que establece el calendario del llamado a licitación pública para la concesión de la explotación de la “quiniela””.
Resolución Dinapi Nro. 609/20252/11/2025“Por la cual se aprueba el Reglamento General Técnico Registral del Departamento de Actos Jurídicos de la Dirección General de Propiedad Industrial (DGPI)”.
Resolución Dinavisa Nro. 047/202611/02/2026“Por la cual se establece una Unidad Estratégica de Trabajo para la incorporación de inteligencia artificial en los procesos regulatorios del sector sanitario”.

More information:

  1. Salud | Nuevo régimen para uso medicinal del cannabis

El pasado 19 de diciembre de 2025  la Dirección Nacional de Vigilancia Sanitaria (“DINAVISA”) aprobó la Resolución Nro. 488 (“Resolución 488”) que  establece un plan piloto excepcional y temporal mediante el cual reglamenta el uso de productos medicinales derivados del cannabis. La Resolución 488 autoriza el uso de combinaciones de Tetrahidrocannabinol (“THC”), Cannabidiol (“CBD”) y otros cannabinoides para pacientes con necesidades urgentes de salud.

El objetivo principal de la nueva regulación es facilitar el acceso seguro y controlado a medicamentos derivados del cannabis sin la necesidad de un registro sanitario previo, basándose en una declaración de «necesidad excepcional para la salud pública» emitida por el Ministerio de Salud.

Este plan busca, además, desarrollar evidencia científica local y promover la industrialización controlada en Paraguay, asegurando que los productos cumplan con estándares de calidad y trazabilidad total.

  1. Patologías y Condiciones Médicas Admitidas

La resolución especifica una lista de condiciones médicas que pueden ser tratadas con estos productos combinados (THC/CBD), siempre bajo la decisión y supervisión de un médico especialista.

Entre las condiciones médicas con acceso a estos productos, se citan: (i) el dolor crónico, (ii) la esclerosis múltiple; (iii) tratar efectos adversos derivados de la quimioterapia; (iv) los trastornos neurológicos; y, otras condiciones tales como la pérdida de apetito en pacientes con VIH/SIDA o cáncer, así como cualquier otra patología que el médico especialista considere necesaria bajo su criterio profesional.

  1. Requisitos para la Producción y Comercialización

Para garantizar la seguridad del paciente y el rigor científico, solo las empresas que cumplan con el estricto ecosistema regulado pueden participar en este plan. La supervisión recae en tres pilares institucionales:

  1. Dirección Nacional de Vigilancia Sanitaria (“DINAVISA”): Como autoridad principal de aplicación, es la encargada de otorgar la «Licencia de Producción Controlada«. Los laboratorios autorizados tienen la obligación de informar directamente a esta institución sobre cualquier reacción adversa o efecto secundario reportado por los usuarios.
  2. Servicio Nacional de Calidad y Sanidad Vegetal y de Semillas (“SENAVE”): Toda la materia prima vegetal debe provenir obligatoriamente de semillas certificadas por esta institución e inscritas en el Registro Nacional de Cultivares. Además, coordina con DINAVISA la autorización del cultivo y manejo de las plantas.
  3. Secretaría Nacional Antidrogas (“SENAD”): Actúa como el organismo de fiscalización y control de seguridad. Su rol es ejercer el control administrativo y operativo para evitar el desvío de sustancias, trabajando de forma coordinada en la trazabilidad de la producción e industrialización.

Los laboratorios interesados en participar deben gestionar sus solicitudes directamente ante la DINAVISA. Es importante destacar que, según la Resolución 488, una misma entidad sí puede actuar como productora y comercializadora a la vez; para ello, se requiere una única Licencia de Producción Controlada, la cual habilita legalmente al titular tanto para la producción como para la comercialización de los productos derivados, siempre que cada producto específico sea notificado a la DINAVISA.

En cuanto a la trazabilidad, los laboratorios licenciatarios deben garantizar un sistema de trazabilidad total; lo que significa que cada producto debe ser rastreable desde su origen como semilla hasta el frasco final que recibe el paciente.

  1. Control del uso de medicamentos a base de cannabis

La Resolución 488 establece controles estrictos con el fin de garantizar el uso seguro y racional de estos medicamentos. Solo profesionales con registro vigente y que estén inscriptos en el Programa Nacional para el Estudio y la Investigación Médica y Científica del Uso Medicinal del Cannabis (“PROINCUMEC”) pueden recetar estos productos.

Los pacientes que necesiten estos medicamentos deben, asimismo, registrarse formalmente en el PROINCUMEC siguiendo los procedimientos de DINAVISA. La entrega de estos productos se realiza bajo un régimen de vigilancia que permite el seguimiento médico continuo.

  1. Compromiso Social: Donaciones

Un aspecto clave de la resolución es la obligación a cargo de los laboratorios privados licenciatarios de donar hasta el 2% de su producción final. Estas donaciones se destinan exclusivamente a cubrir las necesidades de los pacientes de escasos recursos inscritos en el registro público del programa.

Consideraciones Finales

El régimen instaurado por la Resolución 488 tiene un carácter temporal y transitorio de duración de 2 (dos) años contados a partir de la entrada en vigencia de la Resolución, y concebido como una fase de aprendizaje regulatorio. En este contexto, el Estado paraguayo busca generar evidencia práctica y capacidades institucionales que permitan evaluar, ajustar y eventualmente consolidar un marco permanente, equilibrando el acceso urgente a tratamientos médicos con los estándares de seguridad, control y trazabilidad exigibles para sustancias sujetas a fiscalización.

El texto íntegro de la resolución se encuentra en el siguiente link.

  1. Juego | Concesión para la Quiniela

  1. Objeto y aspectos relevantes

El pasado 05 de febrero del 2026, la Comisión Nacional de Juegos de Azar (CONAJZAR) ha emitido la Resolución Nro. 28/2026, mediante la cual se modifica el cronograma del llamado a Licitación Pública N° 01/2025 (“Resolución 249”). La Resolución tiene por fin el otorgamiento, mediante procesos licitatorios, de hasta 3 concesiones para la explotación del juego de azar denominado «Quiniela» con alcance en todo el territorio nacional.

El cronograma de licitaciones establecido en la resolución es el siguiente:

  1. Presentación de Ofertas: el plazo límite para la presentación de ofertas vence el lunes 27 de marzo del 2026, a las 09:30 horas, en las oficinas de la CONAJZAR.
  2. Apertura de Ofertas: El acto oficial se llevará a cabo el mismo lunes 27 de marzo de 2026, a las 10:00 horas.
  3. Informes de Ofertas: La Conajzar contará con un plazo para presentar estos informes es de 10 días hábiles tras la apertura, prorrogable por 5 días más.
  4. Adjudicación: Se realizará dentro de los 5 días hábiles posteriores a la recepción del informe de revisión (con opción a prórroga por igual periodo).
  5. Recursos de Reconsideración: Los oferentes podrán presentarlos dentro de los 10 días hábiles siguientes a la notificación del resultado. La resolución de dichos recursos se dará en un plazo de 20 días hábiles adicionales.

El texto íntegro de la resolución y el pliego de bases y condiciones se encuentra en el siguiente link.

  1. Propiedad Intelectual | Nuevo Reglamento en DINAPI para ACTOS JURÍDICOS

La Dirección Nacional de Propuedad Intelectual emitió la Resolución DINAPI n.º 609/2025 (“Resolución 609”) mediante la cual se introducen cambios operativos relevantes para el registro de actos ante la Dirección de Actos Jurídicos que es la sección de la DINAPI que se encarga de registrar y anotar los actos que modifican la situación jurídica de los derechos de propiedad industrial (v.gr. transferencias, licencias, cambios de nombre o domicilio, fusión, entre otros). La resolución empezó a regir desde el 1 de enero de 2026.

A continuación, señalamos las novedades más relevantes que establece la Resolución 609:

  1. Plazos de perentorios: Anteriormente, la falta de plazos específicos permitía que los trámites quedaran pendientes indefinidamente. Con la resolución se introducen plazos perentorios de 10 días hábiles para:
  1. Subsanación de errores: En caso de que la documentación presentada resulte observada. En caso de incumplimiento del plazo el trámite se archivará automáticamente.
  2. Publicaciones: Una vez recibida la orden, el comprobante de publicación debe presentarse en un plazo de 10 días hábiles para evitar el archivo.

El archivo de los antecedentes se ordenará de forma definitiva en los siguientes escenarios:

  • Falta de subsanación: Cuando no se cumplan los requisitos formales dentro del plazo otorgado.
  • Vencimiento de publicación: Por no presentar el anuncio en tiempo y forma.
  • Finalización: Una vez concluido exitosamente el proceso de inscripción.

  1. Actos jurídicos presentados en renovaciones: Cuando se trate de la inscripción de actos jurídicos (por ejemplo, cesiones, cambios de nombre, fusiones u otras modificaciones relativas al titular del registro), y el registro se encuentre en trámite de renovación, la solicitud de inscripción deberá presentarse dentro del expediente administrativo de renovación correspondiente, y no como un trámite independiente.

  1. Medidas Cautelares: Las anotaciones judiciales tendrán una vigencia de 5 años desde su inscripción, extinguiéndose de pleno derecho si no se solicita su reinscripción.

  1. Documentación: Se reconoce plena validez a la firma digital a todos los documentos electrónicos firmados con firma digital, emitidos en el país o en el extranjero siempre que se cumpla con los requisitos de autenticidad e integridad.

Plazo de regularización

Aquellas solicitudes presentadas antes de la vigencia de la Resolución 609 tienen como fecha límite para regularizar los procesos ante la Dirección de Actos Jurídicos hasta el 31 de marzo de 2026.

El texto íntegro de la resolución se encuentra en el siguiente link.

  1. Propiedad Intelectual | DINAVISA crea unidad para el uso de inteligencia artificial en regulación sanitaria

El 11 de febrero de 2026, la Dirección Nacional de Vigilancia Sanitaria (DINAVISA) emitió la Resolución Nro. 047/2026, mediante la cual se establece una Unidad Estratégica de Trabajo destinada a orientar la incorporación de inteligencia artificial en sus procesos regulatorios.

La resolución fija como objetivos principales coordinar lineamientos técnicos, evaluar riesgos y oportunidades de la IA en la gestión sanitaria, y promover su utilización bajo criterios de ética, transparencia y protección de datos.

Entre las funciones asignadas se incluyen la elaboración de buenas prácticas, el impulso de proyectos piloto, y la coordinación de un equipo multidisciplinario que integre áreas técnicas, jurídicas y tecnológicas.  La medida entró en vigor desde su firma y compromete a las distintas dependencias de DINAVISA a colaborar en su implementación. En la práctica, esto supone principalmente un proceso de adaptación interna dentro de la institución, orientado a modernizar sus procedimientos regulatorios mediante el uso de inteligencia artificial.

El texto íntegro de la resolución se encuentra en el siguiente link.

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Para obtener más información respecto de alguno de los temas abordados en esta edición de Newsletter, por favor póngase en contacto con nuestros expertos: Manuel Acevedo (macevedo@vouga.com.py); Laura Lezcano (llezcano@vouga.com.py); Grecia Florentín (gflorentin@vouga.com.py); Stephanie Medina (smedina@vouga.com.py

Paraguay Advances in a New Framework for Convergent Industries and Power-to-X Projects

The Executive Branch has recently promulgated Decrees No. 5306/2026 and No. 5307/2026, introducing a new public policy framework aimed at fostering the installation and development of energy, technology, and innovation-intensive industries in Paraguay.

Decree No. 5306/2026 establishes, as a sector-specific public policy, the development of "Convergent Industries." This concept encompasses highly sophisticated technical activities that utilize stable, renewable electric energy as a critical input for value creation. This includes high-performance computing (HPC) infrastructure, artificial intelligence, cloud services, advanced manufacturing processes, and other energy-intensive industrial transformations. Furthermore, the Decree creates a new electricity consumption category for these industries, applicable to various voltage levels (500, 220, 66, and 23 kV), with tariffs denominated in U.S. dollars and a horizon of up to 15 years, subject to update mechanisms.

As part of the same scheme, Decree No. 5306/26 creates a Biministerial Commission composed of the Ministry of Industry and Commerce (MIC) and the Ministry of Information and Communication Technologies (MITIC). This commission will be responsible for accrediting companies that qualify as Convergent Industries, based on the submission of a "Productive Linkage Plan" aimed at maximizing local economic and technological impact.

In addition to this general framework, Decree No. 5307/2026 introduces a specific treatment for "Power-to-X Convergent Industries" — projects that convert renewable energy into energy carriers and raw materials such as hydrogen, ammonia, methanol, synthetic fuels, and others. This Decree formally incorporates these ventures into the Convergent Industries regime and creates a specific consumption category for Power-to-X projects connected to Very High Voltage (220 kV), with tariffs also denominated in U.S. dollars and a planned duration of up to 15 years. Unlike the general regime, the MIC acts as the direct enforcement authority for the accreditation and authorization of these projects.

Both Decrees align with the objectives of the Paraguay 2050 National Development Plan and an investment attraction strategy based on leveraging the country's comparative energy advantage, promoting higher value-added activities, know-how transfer, and integration into global productive chains.

From a practical perspective, this framework is still in the implementation phase. While the National Electricity Administration (ANDE) must adapt its tariff structure and the Decrees provide for administrative periods for their rollout, the effective application of the new regimes will depend on additional regulations and the accreditation of specific projects, which will reasonably take time.

In conclusion, Decrees No. 5306/26 and No. 5307/26 constitute a significant signal in terms of industrial and energy policy. While they do not resolve the challenges of implementation, predictability, and institutional coordination on their own, they represent a positive step toward creating a more attractive environment for investments in strategic sectors such as technology, advanced industry, and energy transition in Paraguay.

To access the full text of the Decrees, click here: Decree No. 5306/26Decree No. 5307/26  

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For more information regarding these Decrees and other energy-related matters, please contact: Rodolfo G. Vouga (rgvouga@vouga.com.py); Manuel Acevedo (macevedo@vouga.com.py); Lucas Rolón (lrolon@vouga.com.py); Yvo Salum (ysalum@vouga.com.py).   

An exceptional and transitional regime is established for the regularization of tax debts

Through Decree No. 5,154/2025 (the "Decree"), the Executive Branch established an exceptional and temporary regime for the regularization of certain tax debts, with the aim of facilitating compliance with past-due tax obligations and reducing the financial impact of accumulated surcharges and interest.

This special regime will remain in effect until August 31, 2026, and provides for the application of a monthly interest rate or surcharge of 0% and the possibility of requesting payment plans for overdue tax obligations corresponding to:

  1. Monthly tax periods closed through December 2023, and
  2. Annual obligations corresponding to fiscal years closed on December 31, 2023.

The special regime applies to: (i) final, liquid, and enforceable tax debt certificates; and (ii) tax adjustments and penalties (pending or finalized) provided that there is express agreement or acquiescence by the taxpayer.

Debts arising from the filing or amendment of tax returns, as well as advance payments of corporate income tax (IRE), are excluded from the regime.

Development

The benefits established in the Decree apply to the following tax debts:

  1. Final, liquid, and enforceable debt certificates, even when they are being collected by the Treasury Attorney's Office.
  2. Tax adjustments and penalties that are pending, arising from tax assessments, audit processes, administrative proceedings, or appeals for reconsideration, whether in administrative or judicial proceedings, provided that the taxpayer expressly agrees or acquiesces to the total amount owed.
  3. Adjustments arising from completed audit processes or administrative proceedings, under the same conditions of express agreement or acquiescence.

The regime does not apply to IRE advance payments or debts arising from payment facilities that have lapsed due to non-compliance. Likewise, debts arising from the filing or rectification of tax returns are excluded.

To qualify for the regime, taxpayers must submit the note authorized by the National Tax Revenue Directorate ("DNIT"), available on its websitehttps://www.dnit.gov.py/web/portal-institucional/pagos), which must be submitted exclusively through the institutional reception desk of the DNIT or the Ministry of Economy and Finance ("MEF"), as applicable. For all purposes, the date recorded in the respective administrative file shall be considered the valid date. Debts that do not qualify for the regime will continue to be subject to the interest and surcharges provided for in the general regime.

The Decree empowers the DNIT to grant exceptional payment plans, with a minimum payment equivalent to 10% of the debt and a financing rate of 0%, according to the following scale:

  • Up to 24 monthly installments, when the debt does not exceed G. 500,000,000.
  • Up to 36 monthly installments, when the debt exceeds that amount.
  • Exceptionally, more than 36 installments, when the debt exceeds G. 1,000,000,000, with the express authorization of the National Director of Tax Revenue.

Failure to comply with the agreed installments will result in the loss of the benefits of the regime and the application of the interest and surcharges provided for in the general regime.

Additionally, a 50% discount on the penalty for fraud is provided for in cases of prompt payment, provided that the resulting amount is not less than the minimum legal penalty. In ongoing proceedings, the taxpayer's express agreement or acquiescence will allow for the direct application of the minimum penalty provided for such an offense. In cases being processed in court, adherence to the regime must be approved and communicated to the court or tribunal involved.

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Information Center of the Stock Market

Through Resolution SV. SG. No. 022/2025 dated December 11, 2025 (the "Resolution"), the Superintendency of Securities ("SIV") of the Central Bank of Paraguay approved the Regulations of the Central Securities Market and Products Information Center (“Central Information System”) and provided for the creation of a single and standardized scheme for the submission of regulatory information by supervised entities.

The Central Information System is a unique and mandatory standard for the submission of regulatory information. Its technical structure is detailed in the Annex to the Resolution and defines the formats, validations and quality rules that must be met by the reports submitted to the SIV.

The new regime is mandatory for the following: (i) brokerage firms; (ii) investment fund management companies; (iii) stock exchange; (iv) central securities depositories; and (v) other entities or market agents that the SIV determines.

Likewise, the Resolution introduces the principle of the reporting entity, prioritizing that the information is sent directly by the entity that originates the data, in accordance with its role within the securities market.

The SIV has provided for a pilot testing phase and technical validations, under the conditions and with the entities to be determined subsequently by Circular. During this period, the selected entities will be required to submit test information, report incidents, and participate in technical follow-up sessions, while, in parallel, the submission of information under the currently applicable reporting schemes will be maintained.

The obligation to submit information exclusively through the Central Information System will become effective as of the date of final production launch to be established by the SIV.

SEPRELAD reminds Obligated Entities of deadlines and reporting obligations

Through Circular UIF-SEPRELAD/SE No. 02/2025 dated November 14, 2025 (the "Circular"), the Secretariat for the Prevention of Money or Property Laundering ("SEPRELAD") reminds the obligated entities of the continued validity of reporting obligations and the applicable deadlines for their compliance through the Integrated Operations Reporting System ("SIRO").

The Circular does not introduce new obligations; rather, it consolidates the required reports, their respective deadlines, and the administrative procedures associated with SIRO. It is addressed to obligated entities in general and, in particular, to sectors such as: remittance companies, real estate companies, non-profit organizations (NPOs), importers and dealers of motor vehicles, dealers in jewelry and precious metals, virtual asset service providers (VASPs), pawnshops, lawyers, accountants, cash-in-transit companies, custodial services and safe-deposit box rental services, among others.

The Circular details the reports that must be submitted through the SIRO:

ObligationExpiration
Annual FormMay 31
Objective Operations ReportRemittance companies: Monthly, from 20 to 30 Other obligated entities: Quarterly, from 11 to 20
Negative ReportQuarterly
Internal Audit ReportMarch 30
External Audit ReportJune 30
Compliance Officer's ReportAs triggered in accordance with each applicable sectoral regulation
Suspicious Transaction ReportIn accordance with the applicable sectoral regulation

Likewise, the Circular recalls the administrative procedures that must be carried out before SEPRELAD through the SIRO, and that are subject to the payment of tariffs. Among them:

Procedure in SIRO environmentGeneral
Registration of an obligated entity in the registry of non-naturally supervised obligated entities before SEPRELADResolution No. 07/2018 – Collection of Fees Resolution No. 235/2020 – Extension of Resolution No. 07/2018
User of SIROResolution No. 48/2025 – Annual fee for obligated entities, by the ROS_WEB application, for the fiscal year 2025
Registration in the Registry of Specialized AML/CFT/CPF AuditorsResolution No. 29/2023 – Five minimum wages established for various activities not specified in the Republic of Paraguay

Finally, the Circular clarifies that external management or advisory services are authorized for the purpose of processing compliance with the obligations applicable to obligated entities, specifically in matters related to AML/CFT/CPF prevention and control measures. Such assistance may include the preparation and updating of prevention manuals, codes of ethics, self-assessments and risk matrices, internal and external audit reports, verification mechanisms and watchlist screening and monitoring, as well as the preparation and submission of the reports required by SEPRELAD.

Roles, Registration, and Information Security for Payment Service Providers

Through Resolution No. 25 Minute No. 58 dated December 18, 2025, the Board of Directors of the Central Bank of Paraguay ("BCP") approved the Regulations for the Definition of Roles, Registration and Information Transparency and Information Security for Payment Service Providers ("PSPs") of the National Payment System (the "Regulation").

The Regulation defines the roles that PSPs may perform, based on the payment services they provide and the responsibilities they assume towards users, merchants, other system participants and the BCP.

The roles defined include, among others, acquirer, issuer, payment gateway, payment processor, digital wallet provider, and sub-acquirer. The Regulation expressly admits that the same PSP can perform multiple roles, clarifying that this does not exempt it from the individual compliance of the obligations associated with each function.

The Regulation establishes the mandatory registration of PSPs in a registry administered by the BCP. The General Management will will determine, through supplementary regulations, the deadlines, forms and requirements for registration, and the BCP will be empowered to request additional information to verify compliance with the associated obligations.

PSPs that maintain a direct contractual relationship with users and/or businesses must comply with the following obligations of information transparency: (i) clear and accessible publication of commissions, rates and other applicable economic conditions; (ii) prior notice of contractual modifications thirty (30) calendar days in advance; (iii) the use of contracts drafted in clear and accessible language; and, (iv) the implementation of effective, free and documented mechanisms for attention and resolution of complaints.

In addition, PSPs must make available to merchants and/or users, on an ongoing basis, detailed and exportable reports on the status of transactions, the costs applied to each transaction, net amounts credited, and settlement timeframes. 

The Regulation introduces the obligation to segregate funds for those PSPs that manage or custody funds of users or businesses, particularly issuers and sub-acquirers, by maintaining differentiated accounts that protect such funds against creditor claims. Acquirers, processors and payment networks that do not hold funds are exempt from this obligation, although they must guarantee the traceability, security and correct reconciliation of the transactions processed.

Another component of the Regulation is the establishment of minimum standards in terms of information security, based on a risk approach and proportionate to the scale and complexity of each PSP.

Among other aspects, PSPs must implement an Information Security Management System (ISMS) that includes formal security policies, access controls, data encryption, vulnerability management, business continuity plans, and incident notification procedures to the BCP. Compliance must be evidenced through external audits based on internationally recognized standards, such as ISO/IEC 27001.

Interoperability and interconnection in the card system

Through Resolution No. 24 Act No. 57 dated December 11, 2025, the Board of Directors of the Central Bank of Paraguay ("BCP") approved the Regulation on Interoperability and Interconnection in the Credit and/or Debit Card System (the "Regulation"), establishing a mandatory regulatory framework aimed at guaranteeing non-discriminatory conditions of access, security, efficiency and competition in the card payment ecosystem.

The Regulation was issued within the framework of the powers conferred upon the BCP by Law 7503/2025 "National Payment System" and responds to the need to correct structural and contractual limitations that have hindered the development of a fully interoperable environment in the card payment market.

The Regulation is mandatory for all Payment Service Providers (PSP) that are directly or indirectly involved in the processing of credit and/or debit card transactions. This includes, but is not limited to, issuers, acquirers, subcontractors, processors, and other actors that intermediate in the processing of card payment transactions.

One of the key pillars of the Regulation is the obligation of the relevant entities to: (i) submit to the BCP, within six (6) months following the entry into force of the Regulation, the agreements and implementation plans for interoperability, and (ii) accompany said agreements and plans with a technical, operational and cybersecurity schedule that allows interoperability and interconnection to be achieved within a maximum period of thirty-six (36) months.

In the event of non-compliance, the BCP is empowered to unilaterally define the applicable technical, operational and security requirements.

Additionally, it is established that all payment terminals must allow the processing of credit and/or debit card operations of any national issuer, regardless of the initiation method used.

The Regulation introduces specific obligations in terms of transparency of promotions and benefits, interoperability of promotions, confidentiality of the commercial and strategic information of the participants. In addition, interoperability contracts may not contain clauses that are exclusionary, discriminatory or that condition access to the system.

The contracts signed between the parties must be available to the BCP and any breach thereof must be promptly reported both to the counterparty and to the Sub-General Management of Financial Operations (“SGGOF”).

The SGGOF may require reports of incidents that have occurred, detailing the affected systems or services, their impact and any other information it deems relevant.

Likewise, should the BCP identify indications of, or receive complaints regarding, conduct or practices that may constitute violations of competition law, it will forward the relevant information to the National Competition Commission (CONACOM). 

Energy | Lower House Passes the Renewable Energy Bill

On 18 November 2025, the Chamber of Deputies approved the Senate’s version of the bill titled “Law for the Modernization of the Regime that Regulates and Promotes Electricity Generation from Non-Conventional Renewable Energy Sources” (“Bill”).

With this approval, the Bill is now fully passed and moves to the Executive Branch for promulgation.

Once promulgated, the Bill will repeal Law 6977/2023, currently in force, introducing significant changes to the existing legal framework. Among the most relevant modifications, we highlight:

  • New ERNC methodology: the ERNC Reference Tariff will be calculated by ANDE based on background information, relevant data and available information, replacing the current average generation cost criterion.
  • Large consumer: this category is introduced (demand ≥ 30 MW), enabling for the first time direct energy sales between private parties.
  • Removal of distinctions: the differentiation between interruptible and non-interruptible generation sources is eliminated.
  • Longer terms: licenses and contracts will extend from 15 to 30 years, improving predictability and bankability.
  • New trust fund: an administration and payment trust will be created to manage the resources allocated to Generators.
  • Tax benefits: licensees will be able to access the incentives under Law 523/1995 on Free Trade Zones, a benefit not available under Law 6977.

For a broader analysis of Paraguay’s energy regulatory framework, you may consult our specialized article.

Superintendency of Insurance establishes conditions for the issuance of electronic policies

Through Resolution SS.SG. No. 231 dated October 29, 2025 (the “Resolution”), the Superintendency of Insurance updated the regulatory framework applicable to the issuance of insurance policies and other insurance coverage instruments in electronic format, abolishing Resolution SS.SG. No. 136/2018.

This measure forms part of the ongoing digital transformation process within the insurance sector and the implementation of Law No. 6822/2021, which regulates trust services for electronic transactions and recognizes the legal validity of the qualified electronic signature, equating it to a handwritten signature.

As of the Resolution’s effective date, no new policies may be issued using facsimile signatures, which will be replaced by secure digital mechanisms. In other words, electronic policies must be signed using a qualified electronic signature by the authorized representatives of the insurance company. 

The Resolution sets forth the minimum conditions that insurance companies must comply with to issue policies in electronic format. Insurers that have not yet been authorized to do so must notify the Superintendency at least 10 business days in advance of their decision to issue electronic policies, submitting the list of authorized signatories, the qualified electronic signature certificates, and the report issued by the information technology department.

Policyholders must indicate in the insurance proposal the electronic means through which they wish to receive the policy. Should a printed copy be requested, it must include a secure verification code allowing for the authentication of the digital document.

Insurers must implement systems that enable the verification of the existence and validity of electronic policies, such as QR codes, tools for validating qualified electronic signature certificates, or accessible online consultation platforms.

The Resolution further requires insurers to maintain adequate technological infrastructure, cybersecurity measures, data backup and recovery procedures, and to conduct periodic assessments of technological risks.

Superintendency of Insurance regulates the marketing of insurance through electronic means and non-face-to-face channels

Through Resolution SS.SG. No. 210 dated September 25, 2025 (the “Resolution”), the Superintendency of Insurance (“SIS”) established the minimum conditions for the marketing of insurance through electronic means and non-face-to-face channels.

Insurance products may now be marketed through mobile applications, websites, social media, messaging platforms, or telephone calls, whether made from fixed or mobile lines.

Insurance proposals and pre-contractual documents must be signed by the applicant using a qualified electronic signature or, alternatively, a simple electronic signature, if it is supported by an appropriate authentication mechanism.

Before executing the contract, the policyholder must receive clear information regarding the rights, obligations, and terms of the insurance, and must express consent freely, expressly, and unequivocally. Likewise, insurers must ensure that consumers have access to accurate and comprehensive information on coverages, exclusions, costs, claims procedures, and contact details of the intermediary or insurance company.

It is worth noting that insurers are required to retain electronic records, including metadata, IP addresses, and validation codes, which demonstrate the traceability and validity of the policyholder’s consent. These records must be kept for at least 2 years following the expiration of the policy.

Finally, insurers must implement internal control systems, technological risk management frameworks, contingency plans, and incident-response protocols to address security breaches or data leaks.