Buyer questions · Importing outside the EU

Which manufacturer documents do I need to import outside the EU?

Your importer or local applicant registers the product and clears it at the border; Pharma Manufacture supplies the manufacturer’s side of the file. That is a Certificate of Analysis for every batch and the GMP-FS-01, HACCP-01 and ISO 22000:2018 MSC-22-1384 certificates with their numbers and dates. Many importing countries add their own items, such as a certificate of free sale or a label in the local language.

The manufacturer’s file

Importing EU-made supplements: documents the manufacturer supplies

All three certificates cover the manufacturing and packaging of food supplements in tablets, capsules and powders. The products are made at the factory in Mārupe, Latvia, in the European Union.

Who registers the product in the importing country?

A company in that country. Registration, notification or an import permit is applied for by your importer, distributor or local applicant, and the authority deals with that company and decides on the file. Pharma Manufacture’s part is the manufacturer’s documents, in the form the applicant asks for. Agree with your applicant which documents the authority wants before the order is placed, because some of them have to be issued for a specific product and batch.

What importing countries ask the manufacturer for

Rules differ by country, and our market pages describe four of them with their official sources. In Kazakhstan a food supplement needs a state registration certificate (SGR) from the Ministry of Health, issued in 13 working days through the portal free of charge; in practice your importer or distributor files the application, and gov.kz has announced Data Matrix marking from 1 September 2026. In Uzbekistan your importer needs a Ministry of Health permit under Annex 63 to Resolution No. 86, reviewed in 10 working days, and the file includes a power of attorney from the manufacturer and the pack or its mock-up with information in Uzbek.

In Canada tablets, capsules and dosed powders are natural health products (NHPs), Canada’s regulatory category for supplements: the product licence is held by the applicant, and since Health Canada Bulletin No. 10 of 16 February 2026 the GMP evidence for a foreign factory goes through the site licensing pathway, usually through the Canadian importer’s site licence. Across South America the applicant is a local company, and Uruguay, Ecuador and Bolivia require a certificate of free sale from the country of origin, apostilled or consularised.

Frequently asked questions

Common questions about documents for importing outside the EU

Who registers the product in my country?

Your importer or local applicant applies for the registration or import permit, and Pharma Manufacture supplies the manufacturer’s documents for that file.

Does every batch come with a Certificate of Analysis?

Yes. Pharma Manufacture releases every batch with its Certificate of Analysis, and the batch number printed on the pack links each unit to it.

Which certificates go into the file?

GMP-FS-01 and HACCP-01, valid to 17 May 2027, and ISO 22000:2018 MSC-22-1384, valid to 7 January 2029, issued by BM Certification SIA, Riga. Pharma Manufacture publishes the numbers, dates and scans on its certificates page.

Where are the products made?

Pharma Manufacture makes them at its factory at “Kargo k-1”, Mārupe, Latvia, in the European Union.