Food supplements for South America: registration country by country

Short answer

Is there one supplement registration for South America?

No. Each of the nine countries has its own regulator and procedure, from a notification in Brazil to a permit for every import consignment in Chile, five-year registrations in Uruguay and Bolivia and a five-year notification in Ecuador. In every country the applicant is a local company. Pharma Manufacture manufactures in Latvia from 150 units and supplies the documents that applicant files.

Brazil, Argentina, Chile, Uruguay and Paraguay regulate a supplement as a food. Peru and Bolivia handle it through their medicines authorities, DIGEMID and AGEMED, as a dietary product. The paperwork, the label wording and the permitted ingredients differ by country, so one EU product usually becomes several national versions of the same formula.

Nine countries

Supplement registration in nine countries: regulator and procedure

Colombia has applied the EU agreement with Colombia, Peru and Ecuador since 1 August 2013; its supplement procedure is described on the Colombia page.

Duty preferences under these agreements depend on the tariff code of each product. No official rate for supplements was found for any of the nine countries, so the importer checks the code in the European Commission’s Access2Markets tool before the landed price is set.

Time and fees

Review time and regulator’s fee by country

A published review time is the regulator’s own term, not a guarantee, and the clock usually stops while the regulator waits for documents. All terms and fees were checked on 30 October 2026 against the sources listed below.

Steps

Steps to your first shipment, country by country

1. Choose the local applicant: an importer, laboratory or droguería registered with the national authority (local company; before anything is filed).
2. Choose a ready-made formula or send your own; Pharma Manufacture returns formula options, a price and the factory documents on that country’s list (you and Pharma Manufacture; first reply within 24 hours).
3. Where the file needs a certificate of free sale, in Uruguay, Ecuador, Paraguay, Peru and Bolivia, and in Chile on request, start it early: it is issued in Latvia and then apostilled (issued in Latvia).
4. The applicant files and pays the regulator (local company; terms and fees in the table above).
5. Pharma Manufacture makes the batch alongside the file (from 4 weeks, about 8 weeks for a typical run); in Bolivia two batches come first, because AGEMED asks for the results of two.
6. Each shipment clears with the batch documents; in Chile every consignment needs its own SEREMI authorisation (importer and broker).

What you pay. The regulator’s fee and the import duty are paid in the country of sale by the local company; the table above gives every fee the regulators publish. In Latvia a certificate of free sale costs EUR 50 + VAT or EUR 100 + VAT at LTRK and an apostille EUR 30 at a sworn notary. 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.

Terminology

Dietario, dietético or alimenticio: the legal name by country

Each country uses its own term on the label and in the file, so the national word is taken from the table below rather than carried over from a neighbouring market.

From the factory

Registration requirements: the documents from the factory

The lists differ by country, but the same papers come back again and again:

• Certificate of free sale from the country of origin, apostilled or consularised: required in Uruguay, Ecuador, Paraguay and Bolivia, in Peru as a Certificado de Libre Comercialización, and Chile’s SEREMI may request one. Colombia asks for a certificate from the health authority of the exporting country.
• GMP certificate: Peru asks for the manufacturer’s BPM certificate or its equivalent; Bolivia also accepts a quality management system certificate, without apostille.
• Certificate of Analysis: Paraguay requires it for every batch at import; Bolivia wants results for two batches of a new product.
• Formula with quantities for the file in Uruguay, Paraguay, Peru and Bolivia.
• Shelf life evidence: stability data in Brazil; a stability study or the manufacturer’s shelf-life justification in Peru; Bolivia accepts 24 months on the manufacturer’s declaration.
• Label project built to the national rules: in Spanish for Peru, Ecuador and Bolivia, where the official documents say so.

Pharma Manufacture releases every batch with a Certificate of Analysis and holds GMP-FS-01, HACCP-01 and ISO 22000:2018 MSC-22-1384, scope tablets, capsules and powders. Whether a regulator accepts GMP-FS-01 as its BPM equivalent is that regulator’s decision, made in the applicant’s file.

Latvia has been a party to the Hague Apostille Convention since 30 January 1996, and all nine countries are parties too, so a Latvian public document can be apostilled for any of them. Which certificate a regulator accepts is that regulator’s decision.

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.

Shipping

How to import food supplements into South America

The factory in Mārupe is 2 minutes from Riga Airport and close to the Free Port of Riga, so both air and sea freight start next to the plant; the buyer’s forwarder chooses the mode and the port of arrival. Paraguay and Bolivia have no coast, so sea cargo continues overland from a port in a neighbouring country. In all nine countries the local importer or registration holder clears the goods, which is why FCA (handover to the buyer’s forwarder in Latvia) or DAP (delivery to the agreed place, duties on the buyer) fit, and delivered duty paid terms leave the import step with the wrong party.

Production runs from 4 weeks, about 8 weeks for a typical run from confirmed order and specification to despatch.

Frequently asked questions

Common questions about supplements for South America

Is one registration valid across South America?

No. Each country has its own regulator, from Anvisa in Brazil to AGEMED in Bolivia, and a product approved in one is not approved in the next. Even within Mercosur, the Argentine exemption for products from member states does not cover a product made in the EU.

How do you register a food supplement in South America?

Country by country, always through a local company that files the dossier with its national regulator, from Anvisa in Brazil to AGEMED in Bolivia, using the factory documents Pharma Manufacture supplies. Brazil and Ecuador use a notification, Chile an authorisation for each import consignment and the other countries a product registration.

Who files a supplement registration in South America?

A local company in every country: an importer, a laboratory, a droguería or another holder registered with the national authority. That company holds the registration or notification; Pharma Manufacture, the manufacturer in Latvia, supplies it with the factory documents for the file.

Where in South America is no product registration needed?

In Chile, Brazil and Ecuador, with conditions. Chile’s SEREMI de Salud authorises each import consignment for the importer’s warehouse instead of registering the product. Brazil and Ecuador use a notification instead: automatic in Brazil, filed with Anvisa before sale, and reviewed by ARCSA in Ecuador, with up to two corrections allowed.

Which documents does Pharma Manufacture supply for South America?

A Certificate of Analysis for every batch, the formula with quantities, copies of the GMP-FS-01, HACCP-01 and ISO 22000 certificates, and help with the label artwork as part of the service. A sample of each batch is kept for at least three years.

What are the requirements to import food supplements?

Three requirements repeat in every country: a local importer who handles the product with its health authority, the product registered, notified or authorised in that country, and the factory documents. Pharma Manufacture supplies a Certificate of Analysis per batch, the formula with quantities and copies of GMP-FS-01, HACCP-01 and ISO 22000; Uruguay, Ecuador, Paraguay, Peru and Bolivia also ask for an apostilled or legalised certificate of free sale, which in Latvia LTRK issues.

What is maquila in the supplement trade?

Maquila is contract manufacturing of a supplement under the client’s brand. Pharma Manufacture manufactures in Latvia under your brand, from one of its 350 ready formulas or from your own formula. In Ecuador the word appears in the ARCSA file; in Peru the DIGEMID form speaks of fabricación por encargo.

What is the difference between private label and white label?

With white label, the buyer picks a ready formula from the manufacturer and sells it under its own brand; with private label, the product carries the buyer’s brand and can also start from a formula developed for that buyer. Pharma Manufacture works both ways: 350 ready formulas in the catalogue or a custom formula, with a higher minimum order.

Which South American countries have a trade agreement with the EU?

All except Bolivia, for which none was found. Peru and Colombia have applied the EU agreement since 2013 and Ecuador since 2017. Chile has an interim trade agreement with the EU. For Argentina, Brazil and Uruguay the Commission announced on 23 March 2026 that the EU-Mercosur interim agreement would apply provisionally from 1 May 2026; Paraguay’s start date is unconfirmed.

Can an EU label be used unchanged in South America?

No. Brazil requires “SUPLEMENTO ALIMENTAR” in bold capitals and accepts claims only from its own list, so a claim authorised in the EU under Regulation (EU) No 432/2012 is rewritten from the Brazilian list. Argentina prescribes mandatory warnings, and Bolivia accepts a multilingual label only if Spanish is one of the languages.

What is the minimum order for a South American launch?

Pharma Manufacture starts at 150 units for a ready-made formula in tablets or capsules, with 350 ready-made formulas in the catalogue. Powder sachets start at 80,000, set by the laminate print run, and a formula developed from scratch has a higher minimum. Registration is per product, so fewer SKUs means fewer files.