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Logotipo - Rigoberto Paredes Abogados Bolivia - Law Firm
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In the current context of world pandemic, the production and commercialization of pharmaceutical products has increased considerably, for this reason we decided to provide our clients with basic information about the sanitary registration of pharmaceutical products in Bolivia. 



The State Agency of Medicines and Health (AGEMED) is the authority in charge of making the corresponding sanitary registrations of all types of pharmaceuticals products in Bolivia. This agency has the capacity to regulate, regulate, monitor, control and promote the rational use of medicines. Through policies that propose two main pillars: The National System for the Surveillance and Control of Medicines and the Single National Supply System, systems that together make it possible to achieve the general objective of the National Medicines Policy.


Sanitary registration is mandatory for the manufacture, distribution, importation, exportation, sale and marketing of the following medications: 

  • a) Generic drugs (International Nonproprietary Name – INN); 
  • b) Brand name drugs;
  • c) Homeopathic medications; 
  • d) Products of vegetable, animal or mineral origin having medicinal properties (with specific standard; 
  • d) Products of plant, animal or mineral origin having medicinal properties (with specific standard); 
  • e) Special medicines, biologicals (specific regulation), blood derivatives, dietetic, dental, radio-pharmaceuticals; f) Vaccines and biologicals (specific regulation), blood products, dietetic, dental, radio-pharmaceuticals;
  • f) Vaccines and biologicals (specific regulation);
  • g) Cosmetics (specific regulations); 
  • h) Medical devices (specific regulations); 
  • i) Diagnostic and clinical laboratory reagents (specific regulation); and; 
  • j) Handcrafted traditional natural products (specific regulation).

Una vez que se haya apostillado el poder, el mismo debe ser enviado a la siguiente dirección

Rigoberto Paredes – Oficina de Abogados
Departamento de Propiedad Intelectual


In order to carry out the sanitary registration of pharmaceutical products, the following requirements must be met: 

Submission of the application form for registration and quality control of medicines (DINAMED Form 005).

Presentation of legal-administrative documentation of the companies:

  • Photocopy of Ministerial or Secretarial Resolution
  • Photocopy of Company Certificate in force
  • General License and Manufacturer Information
  • Format for Clarification of Particularities

Presentation of general product documentation

  • Technical Director of Pharmaceutical Regent Certificate
  • Good Manufacturing Practices Certificate
  • Contract Manufacturing or Quality Control by third parties
  • Certificate of Pharmaceutical Products Subject to International Trade
  • Photocopy of previous Sanitary Registration
  • Photocopy of Customs Clearance certificate

Presentation of technical information of the active ingredient

  • Photocopy of the certificate of analysis of the raw material.
  • Generic name and anatomic-therapeutic chemical classification.
  • Chemical name, structural formula, molecular formula and molecular weight.
  • Physical and chemical characteristics of the active ingredient.
  • Organoleptic characteristics.
  • Other.

Presentation of technical information of the finished product

  • Galenic development of the product
  • Qualia-Quantitative Formula
  • Photocopy of the Certificate of Analysis of the finished product.
  • Photocopy of the Quality Control Certificate
  • Others.

Presentation of biopharmaceutical technical documentation

  • Bioavailability Studies
  • Bioequivalence Studies

Presentation of labels, tags, inserts or leaflets

  • Labels, tags and cases
  • Inserts or leaflets

Pharmacological evaluation presentation

  • DINAMED qualification request form, form 007
  • Efficacy and safety qualification form DINAMED form. 019
  • Others

Sample presentation

Payment for service.

Maintenance of the Health Registration Number

When the application for re-registration is submitted after the 5 years of validity of the Health Registration, the Health Registration number granted for the previous registration or re-registration may be maintained, and the payment for the service corresponding to the registration must be made.

Re-registration of a drug not marketed: Any pharmaceutical product that was not marketed during the 5 years of validity of the Sanitary Registration of drugs in AGEMED, in case of re-registration, the payment corresponding to a registration must be cancelled, maintaining the number that was initially assigned to it.


With the exception of cosmetics, the Sanitary Registration of medicines in AGEMED is valid for five years from the date of issuance, with the following subsequent processes:

Re-registration Process: Any re-registration request submitted before the 5 years of validity of the Registration or up to 30 working days after, will be considered as a re-registration process, being valid the Sanitary Registration for its manufacture, importation, distribution and commercialization, as long as it is subject to technical specifications and Pharmacological Standards in force.

Commercialization with expired Sanitary Registration: In some cases, the commercialization of a medicine whose Sanitary Registration has expired will be allowed, provided that one of the following situations is demonstrated:

  • To have filed the Request for Qualification and documentation corresponding to the re-registration of the product before or up to 30 working days after its expiration.
  • b) When the customs clearance certificate has been granted or the commercialization of the batch or batches has been reported before the expiration of the Sanitary Registration of medicines in AGEMED.
  • c) In accordance with the aforementioned points, medicines may be marketed with the printing of the previous Health Registration number, until the stock already printed is exhausted.

Agende una consulta hoy con uno de nuestros especialistas

In this article we explore the understanding that the Supreme Court of Justice in Bolivia has about Job Abandonment without a cause. The information contained in this presentation has been extracted from a jurisprudential line that explains the position of the Bolivian magistrates vis-à-vis a doctrinal classification that passes by dividing: i) Abandonment renounces; and, ii) Abandonment of non-compliance. Next, we will explain both types of abandonment according to this classification. 

Abandonment Resignation 


This type of abandonment of work implies that the worker voluntarily expresses his intention to terminate the employment contract, when there is a prolonged absence from the labor source (rejecting the itinerant absences or absences), without reason or explanation, added to the fact that from the behavior of the same and the characteristics of the case it can be unequivocally concluded that there is a clear intention not to continue the employment relationship, without there being causes caused by the employer. 

Default Abandonment

This type of abandonment of work underlies the same factual assumption above, which is the continued absence from the source of work without any external factor attributable to the employer, it has its distinctive note in the non-evident evidence of terminating the employment contract. work on the part of the worker; that is, the absence does not show a clear intention to definitively end the employment relationship. In this case, although the abandonment transmits an affectation to the work agreement, it does not necessarily affect an area of ​​rupture, but rather it is situated in a path of disciplinary reproach, as long as it does not have a repetitive character and is based on duly justified reasons.

Crear una empresa

Abandonment of Work and Justified Dismissal 

Returning to the first assumption, which is resignation, there is no doubt that it concerns a cause of justified dismissal, due to causes attributable to the worker, so that dismissal is one of the acts of greater significance within the employment contract due to its transversal affectation to a series of linked rights, the applicable rules must be interpreted and applied within the framework of the greatest possible rigidity, since the decision entails not only the destination of the employment contract but also of the worker himself, whom the National Constitution mandates to protect on a preferential basis.

Do you want to know more about the regulation of abandonment of work in Bolivia?

Contact one of our lawyers


Si te preguntas si debes o no realizar un registro de marcas en Bolivia, es importante que comprendas lo siguiente:

  1. En Bolivia rige el Sistema Atributivo para la adquisición del Derecho Propietario sobre una marca. Eso significa que por más de que hayas usado e invertido en una marca mucho tiempo y dinero a cambio no obtienes un derecho oponible sobre la misma. En otras palabras, conforme al sistema atributivo se establece que el uso de una marca no significa la adquisición automática del Derecho Propietario de la misma, por el contrario, sólo el registro de la marca en el SENAPI confieren este derecho.
  2. De igual manera, en Bolivia está vigente el principio de territorialidad por medio del cual el registro de tu marca en otro país, no significa que en Bolivia esté protegida. Dicho de otro modo, el alcance del derecho o protección sobre su marca, está limitado a la jurisdicción del territorio en el cual se encuentra registrado. Por ello, si usted tiene un registro en otro país y quiere iniciar operaciones en Bolivia, debe verificar si su marca está disponible en la jurisdicción boliviana y/o no se encuentra registrada.

Estos dos aspectos son muy importantes para decidir si realizas un registro de marcas en Bolivia


Si es necesario contar con un poder para proceder al registro de marcas en Bolivia. Al respecto, debemos mencionarle que Bolivia forma parte de la Apostilla de la Haya del 5 de Octubre de 1961. Esto facilita enormemente el trámite. Por ello, para realizar el registro de una marca, usted simplemente necesita apostillar el poder (que nosotros le enviaremos).

Apostillar consiste en que el gobierno boliviano a través del Ministerio de Relaciones Exteriores, certifica la veracidad de la firma y/o la calidad en virtud de la cual el signatario del documento ha actuado y cuando corresponda, la identidad del sello o timbre colocado en el documento. Nuestra firma ha realizado un manual didáctico y especial para cada uno de nuestros clientes con el cual usted podrá obtener la apostilla de los documentos de manera muy sencilla.

Nuestra Firma tiene formatos de poderes aprobados a lo largo de los años que venimos trabajando, con lecciones aprendidas en la materia. Por su propia seguridad le recomendamos que no realice modificaciones en nuestros modelos. Simplemente, llene los espacios en blanco con la información correcta. Si usted tuviese alguna duda en referencia al llenado del poder, no dude en consultarnos, de esta manera ahorraremos tiempo y dinero en el desarrollo del trámite.

Una vez que se haya apostillado el poder, el mismo debe ser enviado a la siguiente dirección

Rigoberto Paredes – Oficina de Abogados
Departamento de Propiedad Intelectual


En la práctica cotidiana de propiedad intelectual, es común que se pretenda dar la máxima rapidez al inicio del trámite de registro de marcas en Bolivia por diferentes razones.

Por tal motivo, se dan casos que aunque los miembros de nuestra Firma no cuenten con el poder apostillado del cliente, se vean urgidos de solicitar el registro de la marca, sin el poder de representación apostillado.

Esta práctica está permitida por la Ley boliviana siempre y cuando se subsane la presentación del mismo en el plazo de 60 días de iniciado el trámite. De no cumplirse con la presentación del poder en este lapso de tiempo, la solicitud será rechazada y tenida como no presentada. Si este fuera el caso, nos veremos forzados a pagar nuevamente los costos y valores oficiales del trámite de registro de derecho de autor debido a la presentación tardía del mismo.


El registro de marcas en Bolivia ha adoptado para sí el régimen “uniclases”, por lo que la protección sólo alcanza a las clases en las cuales ha sido solicitada la marca de acuerdo a la novena clasificación de Niza y dentro de las delimitaciones en caso de existir éstas.

Las marcas pueden ser presentadas en base a una denominación solamente (marcas denominativas), con denominación y logotipo (marcas mixtas) o simplemente con un logotipo (marcas figurativas).

Es importante mencionar que las meras solicitudes de registros sólo generan un derecho de prioridad, por lo que al ser un derecho expectaticio, se deberá contar con el correspondiente título para gozar de las prerrogativas que otorga la Ley al propietario del título.



Una vez que contemos con el poder de representación, para el registro de marcas se requiere la siguiente información:


Nombre del titular


Domicilio del titularr


Denominación de la marca


Especificación de los productos o servicios a distinguir, indicando la Clase Internacionalr


Logotipo (si existiere)


Si se desea reivindicar prioridad en base al Convenio de París o a la Decisión 486, requerimos una copia de la solicitud presentada originalmente.

Contáctese con nuestros abogados


En caso de solicitar un signo figurativo o mixto se nos debe proporcionar el diseño del mismo en tres ejemplares de 4×4 cm y una copia en formato electrónico.

  • Para el registro de una Marca Colectiva se requiere una copia legalizada de los estatutos de la asociación, organización o grupo de personas que solicite el registro de la misma, la lista de integrantes, la indicación de las condiciones y la forma cómo la marca colectiva debe utilizarse en los productos o servicios.
  • Para el registro de una Marca de Denominación de Origen se requiere:
  • El nombre, domicilio, residencia y nacionalidad del o los solicitantes, así como la demostración de su legítimo interés.La zona geográfica delimitada de producción, extracción o elaboración del producto que se designa con la denominación de origen.
  • La zona geográfica delimitada en un plano oficial.
  • Una memoria descriptiva de las calidades, reputación u otras características esenciales de los productos designados por la denominación de origen.
  • La indicación de las condiciones y la forma cómo la denominación de origen debe utilizarse.


  • Una vez recibida la solicitud, ésta atraviesa el examen de forma para determinar si reúne todos los requisitos formales para luego ordenar su publicación en la Gaceta Oficial de Bolivia.
  • Una vez publicada la solicitud, se abre un plazo de 30 días en los cuales se deben presentar las oposiciones que correspondan, en caso de existir conflicto de terceros afectados.
  • Posteriormente si no se presentan oposiciones, la solicitud pasa el examen de fondo para determinar si la misma reúne los requisitos de registrabilidad y si no se encuentra incursa en alguna de las prohibiciones de la ley, con lo cual se procede a la extensión del título marcario.
  • El proceso del registro de una marca, de no encontrar oposiciones, dura aproximadamente entre 6 y 8 meses.
  • El registro marcario (marca otorgada y concedida) concede a su titular el goce y uso exclusivo de su marca, así como la posibilidad de impedir que otros la utilicen sin su consentimiento y tiene una validez de 10 años, contados a partir de la fecha de concesión del título marcario.

Agende una consulta hoy con uno de nuestros especialistas

Rigoberto Paredes & Asociados has been one of the leading law firms in Bolivia in offering Compliance services, with the objective of improving the internal and external procedural compliance of companies. This, regardless of the fact that Compliance Policies implementation in Bolivia has been considerably low. Not only in the private sector but mainly in the public administration, since there is a lack of regulation on that matter. (more…)

The Criminal Law Attorneys of our firm diligently addressed a shocking case in the city of Santa Cruz de la Sierra, since it was a possible arson attempt in the Viru Viru Airport.

On July 13, 2017, Dr. Erika Defilippis and LLM Rigoberto Paredes participated as invited guests by the Chamber of Business of Integration Bolivian Argentina CEIBA to discuss the topic of tax offenses and the criminal responsibility of the company with the new penal code. (more…)


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Right now, our attorneys in La Paz are incorporating branches and subsidiaries for private foreign investments and our attorneys in Santa Cruz are incorporating LLCs and corporations for private Bolivian or foreign investments. Our Law Firm specializes in the incorporation of Bolivian companies.(See more)
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