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Bolivia Drug registration process

Bolivia Drug registration process

MoH:  Ministry of Health (Bolivia)

MoH website: https://www.minsalud.gob.bo/       

Regulatory Authority: Agencia Estatal de Medicamentos y Tecnologías en Salud ,AGEMED (Agency of Medicines and Health)

Link for Regulatory Authority:   https://www.agemed.gob.bo/

FSC Required: Yes

Local Authorised Representative: Yes

Regulation: Supreme Decree 25235

Registration time: 6 to 12 months

Valid:  up to 5 years

 Fees: 300 to 500 USD

Note:

  1. Dossiers must be submitted in CTD format.

WHO GMP/USFDA/EU-GMP all this are valid.

Overview

  • Products needs to be registered with the Ministry of Health and approved by the Ministry’s National Pharmacology and Health Technologies Agency (Agencia Estatal de Medicamentos y Tecnologias en Salud, or AGEMED).
  • Products that have been given the go-ahead by the US Food and Drug Administration are awarded sales permission certificates by the organization. According to the Pharmaceutical Law (Law 1737) and associated regulations, sanitary registrations are required for all pharmaceutical goods, including brand-name, generic, and over-the-counter medications.
  • Every new product, excluding critical pharmaceuticals, must have a comprehensive description (monografia farmacologica, or monograph, as defined by the U.S. Food and Drug Administration) submitted to AGEMED. The pharmaceutical formula, the suggested dose, the anticipated benefits of the medication, any potential negative effects, and the quantitative formula (which specifies the active substances) must all be included in the monograph. For experts to confirm composition, three product samples must also be sent to the National Laboratory, commonly known as the Instituto Nacional de Laboratorios de Salud, or INLASA. Products must adhere to Pan-American and World Health Organization (WHO) requirements to be certified by AGEMED. For the certification of pharmaceutical items subject to international commerce, AGEMED requires a certificate issued by the competent authorities of the country of origin in the WHO format for imported goods.
  • The Bolivian Constitution guarantees public access to medicines and prioritizes domestic production of generic drugs. Each geographic department in Bolivia is responsible for its own procurement.  Departments often buy large quantities of equipment and supplies at once and often favor U.S. products.  Several departmental governments are in the process of investing substantial resources to their third-tier hospitals long overdue for expansion and updates. Bolivia permits the importation of medical devices and pharmaceuticals. There is virtually no local production of medical devices and products, so importation of those products is necessary. Bolivia produces a limited number of pharmaceutical products, mainly for domestic consumption.  S. firms should note that Bolivia does not have a law prohibiting brand infringement or other forms of copycat registration of pharmaceutical products.   
  • Businesses should not anticipate chemical knowledge to remain private and may have trouble defending their intellectual property rights (see more on intellectual property protection in the “Protection of Property Rights” section). Bolivia’s health system is under risk from non-communicable illnesses. Municipality-run first- and second-tier hospitals have acquired more oxygen treatment equipment and ventilators in response to the COVID-19 epidemic.
  • The specifics of Bolivia’s drug registration procedure are provided by the Pharmaceutical Law regulation (Supreme Decree 25235).
  • Importers are required to seek special import licenses from the Ministry of Health and Sports if pharmaceutical items include medications that are covered by the United Nations Convention against Illicit Traffic in Narcotic medications and Psychotropic Substances. An approval from the Ministry of Government’s National Controlled Substances office may also be necessary for this.
    • Companies must register with the Ministry of Health and Sports, a procedure takes 10 to 30 days, to import, produce, or distribute drugs. Imported goods may be marketed through subsidiaries or through reputable agents or distributors.
    • Marketing items through agents or representatives could be simpler because of their direct connection to UNIMED. The latter must possess the sole right to import and be eligible to serve as legal agents if they register pharmaceutical imports.  It is also necessary to register pharmaceutical brand names at the following location with the National Intellectual Property Service (SENAPI):

    Servicio Nacional de Propiedad Intelectual (SENAPI)
    Av. Arce, esquina Gozalvez No. 228
    La Paz, Bolivia
    Phone/Fax: 591-2-211-5700

    Email: //www.senapi.gob.bo [HTTP://www.senapi.gob.bo]

    • The Bolivian government modified the import regulations for medications in October 2017 by issuing Supreme Decree 3376.
    • AGEMED contended that no new criteria were added by this rule. Nevertheless, importers of pharmaceuticals have complained that it has increased red tape, particularly regarding the necessity for importers to notarize their importation paperwork at the Bolivian diplomatic station that is closest to their place of residence.  The Bolivian Chamber of Commerce filed a lawsuit against Supreme Decree 3376 in April 2018.