Private label supplements for Ecuador

Ecuador

ARCSA sanitary notification: requirements for a food supplement

In Ecuador a food supplement is a suplemento alimenticio and needs a notificación sanitaria from ARCSA before it is sold. According to the ARCSA procedure page updated on 1 January 2026, for a product made abroad the fee is $904.34 and the notification is valid for 5 years. Any company or person with a RUC can hold it. Pharma Manufacture manufactures in Mārupe, Latvia, and supplies the manufacturer’s part of the file.

The ARCSA page gives no review time for this procedure, so plan the notification before the first production slot, not after it.

Steps

Steps to your first shipment to Ecuador

1. The brand owner (titular) signs the legalised authorisation for the applicant, the maquila declaration and the power of attorney, and the certificate of free sale is obtained in Latvia with an apostille (brand owner; certificate issued in Latvia).
2. You choose a ready-made formula or send your own; Pharma Manufacture returns formula options and a price (you and Pharma Manufacture; first reply within 24 hours).
3. The holder’s representante técnico fills in form 129-AL-002-REQ-01 in the VUE (Ecuapass) with the Spanish label draft, and the representante legal submits it (holder with a RUC).
4. Once the status reads Pago Autorizado, the holder pays $904.34 at Banco del Pacífico within 5 working days (holder).
5. ARCSA reviews the file, and observations are answered within 15 working days, with two corrections at most (holder; ARCSA publishes no review time).
6. ARCSA issues the notification, valid 5 years; Pharma Manufacture makes the batch with the approved label (from 4 weeks, about 8 weeks for a typical run), and the importer clears it at Guayaquil (importer).

Steps, fee and terms from the ARCSA procedure page (updated 1 January 2026), checked 30 October 2026.

What you pay. The holder pays ARCSA $904.34 for a product made abroad, once per 5-year notification. 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; legalising the titular’s authorisation is the brand owner’s cost. Duty depends on the tariff line under the EU agreement. 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

Supplement maquila: what ARCSA asks from the foreign manufacturer

When a product is made under contract, which ARCSA calls maquila, the file carries a declaration of the product owner (titular) next to the national requirements. This is who provides each document.

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.

Logistics

How to import supplements into Ecuador: Guayaquil and Incoterms

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. Sea freight for Ecuador arrives at Guayaquil.

The importer of record is on the Ecuadorian 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 ARCSA notification and transit come on top of that.

Working with us

What an Ecuadorian buyer gets from Pharma Manufacture

Frequently asked questions

Common questions about supplements for Ecuador

Is a registro sanitario or a notificación needed in Ecuador?

A notificación sanitaria from ARCSA. The procedure is the inscription of a notificación sanitaria for suplementos alimenticios, made in Ecuador or abroad, under Resolución ARCSA-DE-028-2016-YMIH.

What are the requirements for ARCSA sanitary notification?

A holder with an RUC, whose technical representative fills in the form and whose legal representative files and pays, plus a label draft in Spanish. For a foreign product, an apostilled or legalised Certificate of Free Sale, the holder’s legalised authorisation and, under maquila, the holder’s declaration are added; the manufacturer’s technical documents are agreed per product.

How much does the ARCSA notification cost and how long is it valid?

For a product manufactured abroad the fee is $904.34, and the notification is valid for 5 years, according to the ARCSA page updated on 1 January 2026. ARCSA gives 15 working days to answer observations and allows two corrections.

Who can hold the notification?

Any company or individual with a RUC, including a foreign individual. The representante técnico fills in the form and the representante legal submits and pays. Pharma Manufacture supplies the manufacturer’s part of the holder’s file.

Which documents does Pharma Manufacture provide for Ecuador?

Pharma Manufacture provides the invoice, the Certificate of Analysis of each batch and copies of the GMP-FS-01, HACCP-01 and ISO 22000 certificates. The technical documents for the notification are agreed for each product.

Is there customs duty on EU-made supplements in Ecuador?

Ecuador has applied the EU agreement since 1 January 2017. Origin is proven with an EUR.1 or an origin statement, and your customs broker confirms the rate for the tariff line.

What is the minimum order for Ecuador?

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

• ARCSA, gob.ec, “Inscripción de notificación sanitaria de suplementos alimenticios de fabricación nacional o extranjera” (page updated 1 January 2026), gob.ec/arcsa, 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.