Private label supplements for Bolivia

Bolivia

Who registers food supplements in Bolivia

According to the AGEMED registration manual, food supplements in Bolivia are suplementos dietéticos, registered with AGEMED, the state medicines agency, under Ley 1737 del Medicamento and Decreto Supremo 25235, and the registro sanitario is valid for 5 years. A Bolivian importer with a regente farmacéutico applies; Pharma Manufacture manufactures in Mārupe, Latvia, from 150 units of a ready-made tablet or capsule formula, and supplies the manufacturer’s documents.

SENASAG, the food safety service, covers ordinary food, so the importer confirms the classification of a specific product with both AGEMED and SENASAG. The details below come from the AGEMED manual, published among its circulars of 2021; the applicant confirms with AGEMED that it is still the current version.

Steps

Steps to your first shipment to Bolivia

1. A Bolivian importadora or laboratory with an AGEMED Certificado de Empresa and a regente farmacéutico agrees to apply (Bolivian applicant).
2. Pharma Manufacture makes two batches of the new product and releases each with a Certificate of Analysis, because AGEMED asks for results from at least two (Pharma Manufacture; from 4 weeks, about 8 weeks for a typical run).
3. The certificate of free sale is obtained in Latvia with an apostille or consularisation (issued in Latvia).
4. The applicant pays by deposit at Banco Unión, one payment order per product, and files the dossier on the platform, on paper and with a sample of the product at the AGEMED window (Bolivian applicant).
5. AGEMED issues the registro sanitario within 30 working days of filing, once the first quality control is paid; observations get 30 working days for an answer (AGEMED; the registration lasts 5 years).
6. The label carries the registration number, printed or added as a sticker or stamp for a small batch, and the goods travel overland from a neighbouring country’s port (Bolivian importer).

Steps and terms from the AGEMED manual of 2021, checked 30 October 2026; the applicant confirms it is still the current version.

What you pay. The applicant pays AGEMED the registration fee set by Resolución Ministerial 0265 of 25 May 2018, whose amounts the manual does not give, and then the first quality control. In Latvia the certificate of free sale costs EUR 50 + VAT or EUR 100 + VAT at LTRK and an apostille EUR 30 at a sworn notary. Bolivia has no EU trade agreement, so duty follows the Bolivian tariff for the tariff line. The Pharma Manufacture quote covers the product under your brand, made to the agreed formula and volume; help with the label artwork is part of the service, and every batch leaves with a Certificate of Analysis. Prices are sent on request.

Documents

AGEMED sanitary registration: documents from the manufacturer

For a new product AGEMED wants the Certificate of Analysis of at least two batches, so two batches are made before the file is complete. Every batch at our plant is tested in our laboratory and released with a Certificate of Analysis.

A certificate without an expiry date counts as valid for 2 years from issue, and every site that takes part, packing included, has to be covered.

In Latvia, certificates of free sale are issued to exporters by the Latvian Chamber of Commerce and Industry (LTRK), in Latvian and English, on a written application; LTRK lists the fee as EUR 50 + VAT for members and EUR 100 + VAT for non-members. An apostille on a Latvian public document is issued by any sworn notary for EUR 30, or EUR 50 within two hours, and only as an e-apostille.

Label

The Bolivian label: number, seller and language

The label and carton are in Spanish. If the batch is too small to print the Bolivian registration number at the plant, a sticker or stamp with the number and year of registration is accepted. The pack also identifies the selling company in Bolivia (art. 149 D.S. 25235).

Logistics

Shipping to Bolivia, a country without a sea port

The factory in Mārupe is two minutes from Riga International Airport and close to the Free Port of Riga, so air and sea freight both start next to the plant; the buyer’s forwarder chooses the mode. Bolivia has no coast, so sea cargo is landed in a neighbouring country and continues overland in transit.

The importer of record is on the Bolivian side, so the terms leave import clearance there: FCA, goods handed to your forwarder in Latvia, or DAP, goods delivered to your port or warehouse for your side to clear. Under DDP the seller would clear import, a step the local rules give to the importer.

Production takes from 4 weeks, about 8 weeks for a typical run from confirmed order and brief to despatch. The AGEMED registration, the two batches for the file and transit come on top of that.

Working with us

Supplement maquila for Bolivia: what the buyer gets

Frequently asked questions

Common questions about supplements for Bolivia

What is AGEMED?

Bolivia’s State Agency for Medicines and Health Technologies. Under its 2021 registration manual, it registers dietary supplements under Medicines Law 1737 and Supreme Decree 25235, with a 5-year registro sanitario applied for by a Bolivian importer or laboratory.

Who registers food supplements in Bolivia, AGEMED or SENASAG?

AGEMED, according to its 2021 registration manual: suplementos dietéticos are registered under Ley 1737 del Medicamento and Decreto Supremo 25235, with form AGEMED FORM. 005, and the registro sanitario is valid for 5 years. SENASAG covers ordinary food, so the importer confirms the classification of a specific product with both agencies.

Who can apply for the registration?

A Bolivian importadora or laboratory with a Resolución Ministerial, an AGEMED Certificado de Empresa and legal representation of the manufacturer, filing with a regente farmacéutico.

Does the GMP certificate need an apostille for AGEMED?

No. The manual asks for no consularisation or apostille on the BPM certificate and also lists a quality management system certificate. The free sale certificate does need an apostille or consularisation.

Why are two batches needed before registration?

For a new product AGEMED asks for the Certificate of Analysis of at least two finished batches. Pharma Manufacture releases every batch with one, so plan two runs before filing.

Can the Bolivian registration number be added after import?

Yes. When the batch is too small to print the number at the plant, AGEMED accepts a self-adhesive sticker or a stamp with the number and year of registration.

What shelf life can be declared for Bolivia?

Up to 24 months on the manufacturer’s simple declaration; a longer one needs long-term stability studies for climate zone IVb.

Is there an EU trade agreement with Bolivia?

Bolivia is not a party to the EU agreement with Colombia, Peru and Ecuador. Duty follows the Bolivian tariff for the product’s tariff line, confirmed by your customs broker.

What is the minimum order for Bolivia?

Pharma Manufacture starts from 150 units for a ready-made formula in tablets or capsules and from 80,000 for powder sachets. Production takes from 4 weeks, about 8 weeks for a typical run.

Sources

• AGEMED, Ministry of Health of Bolivia, “Manual para Registro Sanitario de Suplementos Dietéticos” (circular, 2021), agemed.gob.bo, checked 30 October 2026.
• Latvian Chamber of Commerce and Industry (LTRK), “Free Sales (brīvās tirdzniecības sertifikātu izsniegšana)”, ltrk.lv, checked 30 October 2026.
• Ministry of Foreign Affairs of Latvia, “Latvijā izsniegtu dokumentu izmantošana ārvalstīs” (updated 12 June 2026), mfa.gov.lv, checked 30 October 2026.
• Latvian Council of Sworn Notaries, notary tariffs from 16 April 2026, latvijasnotars.lv, checked 30 October 2026.
• European Commission, Access2Markets, “EU-Colombia-Peru-Ecuador trade agreement”, trade.ec.europa.eu, checked 30 October 2026.