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 here.

  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 here.

  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 here.

  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 here.

****

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

Significant reforms in Paraguay’s new arbitration law  

On December 23, 2025, the Executive Branch enacted Arbitration Law No. 7561, which entered into force that same day. This statute comprehensively modernizes the arbitration regime in Paraguay and aligns it with advanced international standards. Law 7561 fully repeals the arbitration regime of Law 1879/2002, which from now on remains in force solely to govern mediation (Articles 53 to 67) and is renamed the “Mediation Law.”

From its entry into force, the new law applies to all arbitrations commenced thereafter, as well as to awards rendered under this new framework, ensuring a clear transition toward an updated, efficient arbitration system consistent with global best practices.

The new framework is built on three fundamental pillars: modernizing the legal framework by incorporating international practices; strengthening arbitral activity by guaranteeing certainty and coherence in proceedings and in the enforcement of awards; and optimizing the relationship with the Judiciary, preserving the independence of the tribunal and limiting its intervention to strictly necessary cases.

The most significant reforms of Law 7561 can be summarized in the following points:

  1. Arbitrability of certain cases

One of the most far-reaching reforms of Law 7561 is the expansion of the matters that may be submitted to arbitration, incorporating areas that were previously excluded. Under the new framework, the following are considered arbitrable:

  • Disputes of a patrimonial nature, eliminating the previous prohibition on arbitrating matters that required the involvement of the Public Prosecutor’s Office. The only exclusion that remains is that relating to individual labor disputes.
    • Succession disputes, including matters relating to inventories, appraisals, administration, and partition of the estate, as well as disputes among heirs, executors, or legatees.
    • Disputes in the professional sports arena, in accordance with the regime under Law 2874/2006 “On Sports.”
    • Disputes involving public entities, municipalities, and binational bodies, provided that the matter is not governed exclusively by public-law rules.
  1. “Pro-arbitration” principle and minimal judicial intervention

Law 7561 consolidates a marked pro-arbitration principle, establishing that, in case of doubt, any interpretation must favor the appropriateness of arbitration and the full effectiveness of the arbitration clause. This statutory criterion requires prioritizing the validity and operability of the arbitration agreement over restrictive or formalistic interpretations.

In line with this, the new law introduces a decisive rule: faced with an objection based on an arbitration agreement, the judge may refuse to refer the matter to arbitration only when the nullity, invalidity, or inoperability of the agreement is manifest and evident. This standard—based on the prima facie— significantly limits the ability of state courts to examine in depth the validity of the arbitration agreement, reinforcing the presumption of the agreement’s validity and protecting the autonomy of the arbitral tribunal, in keeping with modern trends in international commercial arbitration.

Law 7561 also decisively strengthens the principle of minimal judicial intervention, enshrining the functional independence of the arbitral tribunal and highlighting these main innovations:

  • An absolute prohibition on ordinary courts suspending an arbitration by any means or mechanism.
    • Classification as misconduct of any improper intervention aimed at controlling or interfering with the exercise of arbitral functions before the award.
    • Strengthening of the kompetenz-kompetenzprinciple: the arbitral tribunal is the only authority competent to decide on its own jurisdiction, and the civil judge may intervene only when the invalidity of the agreement is manifest.

These provisions consolidate a framework that affords greater certainty and stability to arbitration, avoiding delays, reducing the possibility of obstructionist maneuvers, and guaranteeing the autonomy of the proceeding.

  1. Extension of the arbitration agreement to non-signatories

Law 7561 expressly incorporates the possibility of extending the arbitration agreement to non-signatory parties in exceptional situations. This extension is based on the principle of good faith and applies when, from the third party’s conduct, its tacit consent to submit to arbitration can be reasonably inferred.

In particular, the arbitral tribunal may include persons or companies that, without having signed the arbitration clause:

  • have actively and decisively participated in the negotiation, conclusion, performance, or termination of the contract; or
    • have obtained direct benefits or seek to derive rights from the contract containing the arbitration clause.

This flexible approach makes it possible to prevent opportunistic conduct, ensures contractual coherence within economic groups or commercial chains, and aligns Paraguayan legislation with modern international arbitration practices.

  1. New regime for interim measures: precise and effective

Under Law 7561, the new Article 25 establishes a comprehensive and modern regime, inspired by the UNCITRAL Model Law:

  • It incorporates a detailed definition of interim measures and allows them to be ordered inaudita parte (ex parte),
    • grants the arbitral tribunal the power to directly enforce its decisions,
    • requires adequate counter-security,
    • imposes liability for damages in the event of unjustified measures, and sets out a swift judicial enforcement procedure, without objection or review of the merits.

This regime operates consistently with the principle of minimal judicial intervention provided for in Law 7561, guaranteeing urgent protection without the need to resort to a judge except in strictly necessary cases.

  1. Strictly limited setting-aside system

The annulment action replaces the former “remedy,” confirming that:

  • It is available only on exhaustive and restrictive grounds.
    • The Judiciary may not review the merits of the award, maintaining the criterion of restricted judicial intervention; Law 7561 establishes that the annulment action is the sole means of reviewing the arbitral award, limited to strict grounds that are to be interpreted restrictively.
    • In international arbitration, the parties may contractually waive annulment.

This would mean that awards are more stable, predictable, and respected, which reduces subsequent time and costs.

  1. Simpler recognition and enforcement of awards

Law 7561 introduces key improvements:

  • Awards rendered in Paraguay do not require prior recognition and may be enforced directly as domestic judgments.
    • The grounds of non-arbitrability or public policy are no longer examined ex officio and must be raised by the interested party.
  1. Arbitration and public-policy rules

One of the most relevant innovations of the new framework is that the public-policy nature of a rule no longer constitutes an impediment to submitting the dispute to arbitration.

Nevertheless, where the dispute involves matters of public policy:

  • equity arbitration (ex aequo et bono) may not be agreed upon, and
    • the arbitrators may not decide ex aequo et bono,
      because they must strictly apply the law in force.

This opening considerably broadens the scope of arbitration without sacrificing respect for the legal system’s fundamental rules.

8. Limitation periods

Consistent with international standards and modern commercial arbitration practice, Law 7561 establishes that the commencement of the arbitral proceeding interrupts the limitation period.

The interruption occurs both when:

  • the arbitration request is notified to the other party, and when
    • the request is filed with an arbitral institution.

This change provides legal certainty to the parties, especially in long-term contracts or disputes with extended periods of prior negotiation.

9. Impugnación y ejecución del laudo

Law 7561 clearly defines the regime of judicial review of the arbitral award:

  • The annulment action is the only means of challenging an award.
    • Its grounds are exhaustive and to be interpreted strictly, avoiding broad or merits-based reviews by the courts.
    • The exequatur is eliminated for domestic awards, which may now be enforced directly before the competent judge, just like a court judgment.

This scheme strengthens the effectiveness of arbitration, reduces time, and ensures that arbitral decisions are final and enforceable with minimal judicial intervention.

In conclusion, Law 7561 marks a true turning point in dispute resolution in Paraguay. For business owners and executives, it introduces a more reliable, modern, and efficient framework for managing contractual and commercial risks. With this reform, arbitration is consolidated as a strategic tool: it protects investments, strengthens commercial relationships, and guarantees agile, specialized dispute resolution mechanisms, aligned with international standards.

For further information and assistance with arbitration proceedings, you may contact our dispute resolution team: Mirtha Dos Santos (mdsantos@vouga.com.py ); Silvia Benitez (sbenitez@vouga.com.py ); Sebastian Silva (ssilva@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  

****

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).   

Registro Unificado Nacional (RUN) – Paraguay

El RUN es un sistema nuevo, centralizado y único que fusiona el Servicio Nacional de Catastro y Registros Públicos en una sola estructura operativa, creada por la Ley 7424/2025 y reglamentada por Decreto del Poder Ejecutivo N° 5305/2026. Su finalidad es eliminar duplicaciones, reducir el riesgo inmobiliario y dar seguridad jurídica plena en las transacciones.

El RUN une en una sola institución funciones que antes estaban dispersas entre:

  • Dirección General de Registros Públicos
  • Servicio Nacional de Catastro
  • Departamentos de Mensura y Geodesia del MOPC

Con la implementación del RUN toda información física y jurídica de un inmueble depende de un único órgano técnico-administrativo del Poder Judicial.

Qué cambio implica en la práctica la implementación del RUN:

  • Un solo trámite, una sola mesa de entrada, una sola numeración. Desde enero 2026, cada trámite se ingresa en un solo lugar y recibe un número único para seguimiento.

Antes, había que ir al Servicio Nacional de Catastro, Registros Públicos, Mensura, etc.
Ahora, todo se hará en una sola ventanilla física o a través del sistema RUN.

  • Un solo certificado para cualquier operación inmobiliaria

El RUN reemplaza dos certificados (catastral + dominio) por uno solo: el Certificado Catastro Registral Inmobiliario, incluirá en un único documento:

  • Ubicación
  • Superficie y mensura
  • Linderos
  • Superposiciones existentes
  • Restricciones ambientales o de seguridad
  • Titularidad jurídica
  • Hipotecas, embargos y otras medidas

Esto cambia totalmente la práctica notarial y será el documento básico para comprar, vender, hipotecar, etc.

  • Publicidad obligatoria de las superposiciones

El RUN permitirá visibilizar si un inmueble tiene superposición o conflicto antes de firmar la escritura.

Esto:

  • Reducirá el riesgo histórico de títulos duplicados.
  • Permitirá que comprador y vendedor sepan exactamente el riesgo antes de cerrar una operación.
  • Limitará reclamos o juicios posteriores.
  • Cada inmueble tendrá una identidad única (Código Único Catastral Registral)

El RUN asignará un código alfanumérico inmutable para cada propiedad del país, lo que asegurará coherencia entre el plano, la mensura y el título.

  • Trazabilidad total del expediente

Una vez se encuentre totalmente implementado el RUN, cualquier ciudadano con contraseña podrá ver en qué etapa está su trámite en tiempo real.

  • Cómo se podrá realizar un trámite en el RUN

El escribano público o el usuario deberá ingresar la escritura y la documentación técnica en una única mesa de entrada, y obtendrá un número RUN.

Un mismo órgano verificará:

  • Mensura (coherencia geográfica)
  • Titularidad (coherencia jurídica)
  • Superposiciones
  • Restricciones legales

Si bien la implementación del RUN en las primeras semanas presentó retrasos en las gestiones y trámites debido a problemas en la fiscalización electrónica, se espera que una vez que se solucionen los problemas de la transición y se avance hacia la digitalización total de los documentos, el sistema asegure mayor agilidad, trazabilidad y seguridad.

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.

   here.

Vouga Abogados advised FMO on the granting of a USD 45 million loan to BANCOP S.A.

We are proud to have advised FMO, the Dutch entrepreneurial development bank, on the granting of a USD 45 million loan to BANCOP S.A., intended to finance agricultural producers and green projects.

The primary objective of this loan is to support agricultural producers in rural areas, contributing to job creation in regions where nearly one-third of the population lives below the poverty line. 90% of the funds will be allocated to the financing of agricultural producers, while the remaining 10% will be dedicated to projects related to green lending.

We congratulate the team led by our partner Carlos Vouga, along with associates Belén Rodríguez and Yvo Salum, for their outstanding work on this transaction.

For us, it is a true honor to contribute to the development of projects that promote financial inclusion and sustainability, reaffirming our commitment to providing legal advice on sustainable finance, international lending, and economic development in Paraguay.

Vouga Abogados Advises on the Acquisition of Tigo Money by Grupo Azeta

Vouga Abogados advised Las Ardenas S.A., part of Grupo Azeta, in the acquisition of Tigo Money, with the closing subject to regulatory approvals.

Grupo Azeta’s entry into this market will strengthen the development of the platform to meet demands for innovation and efficiency in the sector, thereby promoting financial inclusion for a large segment of the Paraguayan population.  

The Vouga Abogados team, led by partners Rodolfo G. Vouga and Manuel Acevedo, and comprising senior associate Cecilia Vera, associates Lucas Rolón, Belén Rodriguez, Camila Dutra, and other team members, was responsible for managing the legal and regulatory due diligence, drafting and negotiating the transaction documents, as well as advising on regulatory requirements before the Central Bank of Paraguay and the National Competition Commission.

At Vouga Abogados, we are proud to support strategic transactions of this magnitude, reaffirming our commitment to legal advisory in mergers and acquisitions, fintech, and financial regulation, while contributing to the development of the digital financial ecosystem in Paraguay.

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.