Private label supplements for Peru

Peru

Who registers food supplements in Peru

In Peru a food supplement is registered as a producto dietético with DIGEMID, the medicines directorate of the Ministry of Health, under D.S. 016-2011-SA. The applicant is a Peruvian laboratorio or droguería with a director técnico. Pharma Manufacture manufactures the product in Mārupe, Latvia, from 150 units of a ready-made tablet or capsule formula, and supplies the manufacturer’s documents for the file.

Some guides still send supplements to DIGESA. The Ministry of Health’s TUPA of 2026, like the earlier DIGEMID form TUPA 238, places them with DIGEMID, in the category productos dietéticos y edulcorantes.

Steps

Steps to your first shipment to Peru

1. A Peruvian laboratorio or droguería with a RUC and a director técnico agrees to be the applicant (Peruvian company).
2. You choose a ready-made formula or send your own; Pharma Manufacture returns formula options and a price, and the five manufacturer attachments listed below are assembled (you and Pharma Manufacture; first reply within 24 hours).
3. You and the applicant prepare the Spanish label draft for the primary and secondary pack (you and the applicant).
4. The applicant pays S/ 2,756.70 and files the application through VUCE (Peruvian applicant; DIGEMID has 30 working days, and no answer in time counts as a refusal that can be appealed).
5. DIGEMID issues the registro sanitario, valid 5 years (DIGEMID).
6. Pharma Manufacture makes the batch with the approved artwork (from 4 weeks, about 8 weeks for a typical run; it can be planned while the file is reviewed), and the importer clears it at Callao (Peruvian importer).

Fee and term from the TUPA of the Ministry of Health approved by Decreto Supremo 011-2026-SA (El Peruano, 21 July 2026), checked 30 October 2026; the rules for clearing each shipment were not checked.

What you pay. The applicant pays DIGEMID S/ 2,756.70 per product for the registration and S/ 2,660.30 for each renewal. In Latvia a certificate of free sale from LTRK costs EUR 50 + VAT or EUR 100 + VAT, if DIGEMID accepts it, and an apostille EUR 30 at a sworn notary. 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

DIGEMID sanitary registration: requirements for the manufacturer

The TUPA of the Ministry of Health approved in 2026 (Decreto Supremo 011-2026-SA) lists the registration as procedure N° 104 with seven attachments: five come from the manufacturer, two from the applicant. They are the same seven as on the earlier DIGEMID form TUPA 238.

In Latvia, certificates of free sale are issued to exporters by the Latvian Chamber of Commerce and Industry (LTRK), EUR 50 + VAT for members and EUR 100 + VAT for others; LTRK is a chamber of commerce, not a health authority. Latvian law allows the Food and Veterinary Service (PVD) to confirm compliance at the request of a food business that exports (Law on the Supervision of the Handling of Food, Section 21(2)(5)); a ready form of such a statement for supplements was not found on 30 October 2026. Which certificate DIGEMID accepts is DIGEMID’s decision, and an apostille on a Latvian public document is issued by any sworn notary for EUR 30.

Our GMP certificate GMP-FS-01 is issued by BM Certification SIA, an accredited certification body in Riga, against the Food Supplements Europe guide. It is a certificate of a certification body, not of a health authority, and its scope is tablets, capsules and powders.

Logistics

How to import supplements into Peru: Callao 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 Lima arrives at Callao.

The importer of record is on the Peruvian 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 DIGEMID registration and transit come on top of that.

Working with us

Supplement maquila for Peru: what the buyer gets

Frequently asked questions

Common questions about supplements for Peru

Who registers food supplements in Peru, DIGEMID or DIGESA?

DIGEMID. The Ministry of Health’s 2026 TUPA lists the registration of productos dietéticos y edulcorantes as procedure N° 104, S/ 2,756.70 and 30 working days, under D.S. 016-2011-SA, and the Peruvian applicant files it with the seven attachments listed.

Can supplements be imported into Peru?

Yes, once registered as dietetic products with DIGEMID. The applicant is a Peruvian laboratory or drugstore with a technical director, and import clearance stays on the Peruvian side. Pharma Manufacture manufactures in Latvia and supplies the manufacturer’s documents for the file.

Who applies for the registration in Peru?

A Peruvian laboratorio or droguería with a RUC and a director técnico. Pharma Manufacture manufactures the product and provides the manufacturer’s documents for that applicant’s file.

What does DIGEMID require for a sanitary registration?

Seven attachments under procedure N° 104 of the 2026 TUPA: from the manufacturer, the finished product specifications, a shelf-life justification, a certificate of free sale, a copy of the BPM or equivalent certificate and a letter with the composition; from the applicant, the Spanish label draft and the receipt of the S/ 2,756.70 fee.

Does DIGEMID accept your GMP certificate?

DIGEMID decides. The form asks for a BPM certificate or an equivalent from the authority of the country of origin. Pharma Manufacture holds GMP-FS-01, issued by an accredited certification body, with HACCP-01 and ISO 22000 MSC-22-1384, so the Peruvian applicant confirms with DIGEMID which document it accepts before the file is built.

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

The EU agreement has applied in Peru since 1 March 2013. Origin is proven with an EUR.1 or an origin statement, and your broker confirms the rate for the tariff line.

Can I register my own formula in Peru?

Yes. Pharma Manufacture has 350 ready-made formulas in the catalogue and also makes custom formulas. Either way the composition goes into the DIGEMID file through the Peruvian applicant.

What is the minimum order for Peru?

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

• Ministry of Health of Peru, TUPA approved by Decreto Supremo 011-2026-SA (El Peruano, 21 July 2026), procedures N° 104 and N° 106, digemid.minsa.gob.pe, checked 30 October 2026.
• DIGEMID, Ministry of Health of Peru, earlier form TUPA 238 “Inscripción en el Registro Sanitario de Productos Dietéticos y Edulcorantes”, digemid.minsa.gob.pe, checked 30 October 2026.
• European Commission, Access2Markets, “EU-Peru trade agreement” fact sheet (November 2023), trade.ec.europa.eu, 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.
• Saeima of Latvia, Law on the Supervision of the Handling of Food (Pārtikas aprites uzraudzības likums), Section 21(2)(5), likumi.lv, checked 30 October 2026.
• European Commission, Access2Markets, “EU-Colombia-Peru-Ecuador trade agreement”, trade.ec.europa.eu, checked 30 October 2026.