Bolivia - Import Requirements and DocumentationBolivia - Import Requirements
Imports must have the following documentation:
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Invoice (unless a commercial sample under $25 in value)
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Ocean bill of lading, inland bill of lading, through bill of lading, air waybill (when applicable)
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Proof of insurance
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Certificate of pre-shipment inspection (when applicable)
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Port expenditures (when applicable)
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Transportation invoice
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Packing list
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Certificate of origin (when applicable)
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Other certificates (as needed)
Air cargo shipments require airway bills instead of bills of lading. Exporters should follow IATA or ICAO rules governing labeling and packaging of dangerous and restricted goods and check with air carriers for further information and appropriate forms. Individuals may receive parcel post shipments valued at less than $5,000 by filling out a customs form at a Bolivian post office.
The following additional requirements apply to specific products:
Cotton Fiber
In September 2009, the government of Bolivia removed a previous fumigation requirement for cotton fiber (not carded or combed) imported from the United States (Resolution 162). The current requirements are that importers must register with the National Service for Agricultural Health and Food Safety (Servicio Nacional de Sanidad Agropecuaria e Inocuidad - SENASAG) and receive a Phytosanitary Import Permit from the U.S. Phytosanitary Protection Organization that shows that the shipment is free of Anthonomus Grandis Boheman 1843 (boll weevil). In addition, packaging must be new and include required labels and seals.
Insecticides
Insecticide imports must have sanitary certificates issued by the National Institute of Occupational Health, along with sale permit certificates from the Vice Ministry of Rural Development, Agriculture, and Livestock and from the National Service for Food Safety and Security (SENASAG) Pest and Fertilizer Division.
Pesticides
The import of pesticides for agricultural use is regulated by SENASAG. SENASAG registers companies seeking to import pesticides as well as the pesticides themselves, issuing import permits as required.
Tobacco and Tobacco Products
Imports of tobacco and tobacco products must have import licenses issued by SENASAG and the Ministry of Health. Supreme Decree 27053 issued in May 2003 specifies regulations related to packaging and labeling.
Livestock, Swine and Poultry
In May 2015 and after three years of negotiations with the government of Bolivia, the United States Department of Agriculture (USDA) Animal and Plant Health Inspection Service (APHIS) signed an agreement with SENASAG Bolivia to approve export health certificates for live animals, products, by-products and genetics. Eight certificates were finalized and significant progress was made on other certificates for eggs, processed meats, live animals, and genetics. The finalized certificates include the Egg Product Inspection and Grading, the Veterinary Health Certificate for Live Cattle, horses, swine and the Sanitary Certificate for Dairy Exports.
Although the certificates for beef and poultry meat were approved in 2015 by SENASAG, the regulations have not yet been changed, so the processing plants and slaughterhouses must be inspected in situ and approved before the first shipment. All importing companies must be registered in SENASAG and must pay a fee for this registration. Negotiations still continue for products considered by Bolivian regulations to be in risk categories 1 and 2 (fresh beef and poultry meat). Significant progress has been made in casings as SENASAG no longer inspects the plants in situ; approval is based on documents and the permissions are granted for two years. The negotiation of one-day-chicks continues and SENASAG agreed with the certification offered by APHIS. However, SENASAG still insists on in situ inspection. USDA APHIS and Bolivia have agreed to continue dialogue to finalize the pending certificates for meat and meat products.
Seeds (Treated and Non-Treated) and Plants
All products of vegetable origin must have SENASAG certificates, in addition to phytosanitary certificates issued by agricultural authorities in the country of origin and certified by a Bolivian consulate. Importers must inform Bolivian customs authorities regarding the arrival of seeds at least one week in advance, and arrange for storage in an adequate warehouse prior to inspection. All seeds must comply with the quality and phytosanitary requirements of SENASAG and the National Seed Program.
The application for the importation of seeds, plants or parts of plants for propagation should be sent to SENASAG. Depending on the case, a pest risk analysis will be initiated, a process that could last up to six months or more. An alternative would be an application for import of seeds or propagation materials for research purposes, a procedure that could be approved in a shorter time. Seeds must also comply with the minimum quality and genetic purity requirements established in Supreme Decree 23069 issued on February 1992.
Pharmaceuticals
Products must 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). The agency grants sales permit certificates to products approved by the U.S. Food and Drug Administration. All pharmaceutical products, including generics, brand name, and over-the-counter medicines, must have sanitary registrations as established by the Pharmaceutical Law (Law 1737) and related regulations.
AGEMED requires a detailed description (monografia farmacologica, or monograph, as defined by the U.S. Food and Drug Administration) of each new product, with the exception of essential pharmaceutical products. The monograph must include the quantitative formula (specifying active ingredients), the pharmaceutical formula, the recommended dosage, expected product benefits, and possible side effects. Three samples of the product must also be provided to the National Laboratory (Instituto Nacional de Laboratorios de Salud or INLASA) so that specialists can verify content. AGEMED requires that products comply with World Health Organization (WHO) and Pan-American Health Organization guidelines. For imported products, AGEMED requires a certificate issued by the relevant authorities of the country of origin in the WHO format for the certification of pharmaceutical products subjected to international trade.
AGEMED takes an average of six to twelve months to review new products and one month to review essential products. Its full address is as follows:
Ministerio de Salud
Agencia Estatal de Medicamentos y Tecnologias en Salud
Capitán Ravelo (Escuela de Salud) No. 2199
La Paz, Bolivia
Phone/Fax: (591-2) 244-0122
Website
The regulation of the Pharmaceutical Law (Supreme Decree 25235) provides specific details about drugs registration process in Bolivia.
If pharmaceutical products contain drugs covered by the United Nations Convention against Illicit Traffic in Narcotic Drugs and Psychotropic Substances, importers must obtain special import permits from the Ministry of Health and Sports. This may also include an authorization from the National Controlled Substances office with the Ministry of Government (webpage in Spanish).
To import, manufacture, or distribute pharmaceuticals, companies must register with the Ministry of Health and Sports, a process that requires between ten and 30 days. Imported products may be sold through established agents or distributors, or through subsidiaries.
Given their direct access to UNIMED, it may be easier to market products through agents or representatives. If the latter registers pharmaceutical imports, they must have exclusive rights to import and be qualified to act as legal representatives. Pharmaceutical brand names must also be registered with the National Intellectual Property Service (SENAPI) at the following address:
Servicio Nacional de Propiedad Intelectual (SENAPI)
Av. Arce, esquina Gozalvez No. 228
La Paz, Bolivia
Phone/Fax: 591-2-211-5700
E-mail
U.S. firms should note that Bolivia does not have a law prohibiting brand infringement or other forms of copycat registration of pharmaceutical products. Firms may experience difficulties protecting their intellectual property rights and should not expect chemical information to remain confidential (see additional information on intellectual property protection in the section on "Protection of Property Rights").
In October 2017, the Bolivian government issued Supreme Decree 3376 to change the regulatory requirements to import medicines.
AGEMED argued that this regulation did not add any additional requirements. However, pharmaceutical importers have commented that it added more bureaucracy, including a requirement that forces importers to notarize their importation documents at the nearest Bolivian diplomatic post in their country. In April 2018, the Bolivian Chamber of Commerce filed a case against Supreme Decree 3376.
Fishery Products
Imports of perishable items, such as seafood products, must have sanitary health certificates issued in the country of origin of the product and comply with product specification, labeling, and marking standards. Sanitary regulations are available through SENASAG.
Food Products
Food imports must have sanitary certificates issued by the appropriate authorities in the exporting country, e.g., from the U.S. Department of Agriculture (USDA) for goods exported from the United States. Foodstuffs may be subject to analysis by an official entity in Bolivia, and most food and beverage labels must be registered with the SENASAG office in Bolivia. Exporters to Bolivia are encouraged to check with local importers regarding relevant policies prior to shipment.
Wheat
In July 2013, SENASAG established phytosanitary requirements for the importation of wheat (Triticum aestivum) for flour production.
Certificates are now required to specify: "wheat in this shipment has been inspected according to official procedures and is considered free of Sitophilus granarius and Trogoderma granarium and that they come from areas where karnal bunt (KB) is not present."
The new regulations also change the limits of phosphine fumigation dosage and duration of treatment to be in line with United States Environmental Protection Agency regulations to use no more than 66 grams/1,000 cubic feet for a maximum period of not more than 240 hours.