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.
Rigoberto Paredes – Oficina de Abogados
Departamento de Propiedad Intelectual
Submission of the application form for registration and quality control of medicines (DINAMED Form 005).
Presentation of legal-administrative documentation of the companies:
Presentation of general product documentation
Presentation of technical information of the active ingredient
Presentation of technical information of the finished product
Presentation of biopharmaceutical technical documentation
Presentation of labels, tags, inserts or leaflets
Pharmacological evaluation presentation
Sample presentation
Payment for service.
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:
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.
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.
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.
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.
Si te preguntas si debes o no realizar un registro de marcas en Bolivia, es importante que comprendas lo siguiente:
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.
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.
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.
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.
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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…)
On November 29, 2016, Rigoberto Paredes & Asociados participated in the international event “Commercial Mission of the Software Sector” organized by the Chamber of Software and Information Services Companies (CESSI), the Argentine Embassy in Bolivia, the Consulate General and the Center of Promotion of Argentina. In this event our Firm taken part with three exhibitors: Mr. Rigoberto Paredes Ayllon Director of our Firm, Ms. Carla Pozo de la Barra and Ms. María Esperanza Balderrama. Intellectual Property, Commercial and Tax Law were the the key issues dealt.
Rigoberto Paredes & Asociados participated actively in the Annual Conference of the International Bar Association (IBA) held from September 18 to 23, 2016 in Washington DC. In this important event were panelists Christine Lagarde, Managing Director of the International Monetary Fund; Loretta Lynch, Attorney General of the United States; Colin Powell, Secretary of State of the United States (2001 – 2005). The IBA Annual Conference is a key event on the agenda of the international legal community as it provides an opportunity for the exchange of knowledge and the creation of a global network of colleagues and business contacts.
On September the Law Firm Rigoberto Paredes & Asociados jointly with the US real estate company Gomez Loayza Realty P.A. participated in the International Fair of Santa Cruz Expocruz-2016. At this event, our Firm performed a Due Diligence of real estate products offered and legally assisted Bolivian investors in the United States. (more…)
On July 27, 2016, the Commercial Office of Ecuador (Pro Ecuador) carried out a commercial mission of Ecuadorian entrepreneurs interested in investing in Bolivia. In this event, our Firm had the opportunity to talk about basic aspects regarding how to start an investment in Bolivia. This important event was held in the Auditorium of our Firm.
Rigoberto Paredes & Asociados participated actively in the annual meeting of the prestigious international association INTA – International Trademark Association held from May 21 to 25 in the city of Orlando, Florida. It should be noted that this meeting of firms specialized in Intellectual Property was considered one of the most important in the history of INTA. This was due to the fact that attendance at this event was the highest recorded to date in similar events organized by this prestigious association.
Our Legal Director, LLM Rigoberto Paredes Ayllón, was nominated by Who is Who in Bolivia for the 2016 management, this in the following three categories: Business Crime Defense for Corporates, Business Crime Defense for Individuals and Business Crime Defense in Money Laundering.
On April 6, 2015 Rigoberto Paredes & Asociados made the official presentation of the Draft Industrial Property and Infringements Law. This important event was held in the auditorium of the Federation of Private Employers of Cochabamba – FEPC and with the presence of the authorities of the National Intellectual Property Service SENAPI and a massive participation of the business sector.
Rigoberto Paredes & Asociados was selected by the European Union to carry out the writing of the Law of Industrial Property of Bolivia. The selection process has been carried out based on the qualifications and experience of the most important law firms in Bolivia. We regard this has been a recognition of our hard work and commitment to Industrial Property.
Rigoberto Paredes & Asociados is working on the legal management of transportation and lifting of the important national project to build the Ammonio and Urea plant in Bulo Bulo, known as Bolivia YPFB Ammonia / Urea Project and carried out by SAMSUNG ENGINEERING CO. , LTD.
On March 16, 2014 our legal director, LLM. Rigoberto Paredes Ayllón, has taught a course to senior management and leaders of the company YPFB Chaco S.A. about the applicability of Law 004 in the Mixed State Societies.
The prestigious IFLR 1000 publication has assessed and rated Rigoberto Paredes & Asociados as a leading Corporate and Financial Law Firm in Bolivia in 2014. This international guide evaluates the main law firms of the world on a yearly basis.
