Canada · Export from the EU · Mārupe, Latvia
Supplement manufacturer for Canada: private label products made in Europe for NPN holders
Private label tablets, capsules and dosed powders made in Latvia for brands and importers selling in Canada. In Canada they are likely natural health products (NHPs), Canada’s regulatory category for supplements: Health Canada targets 60 calendar days for a Class I product licence (NPN), 90 for Class II, and the new label rules, with English and French text, apply to every natural health product by 22 June 2028.
Pharma Manufacture in Mārupe, Latvia (EU), makes tablets, capsules and powders for brands selling in Canada. Your brand holds the NPN, your Canadian importer the site licence. Goods that meet the CETA rules of origin get the CETA preferential rate with an invoice origin declaration. Riga–Montreal: about two to four weeks by sea, 1–3 days by air; the forwarder confirms.
| Question | Answer for a product made by Pharma Manufacture |
|---|---|
| Who holds the NPN | Your brand as the applicant, with a representative in Canada if it is based abroad (NHPR s. 5) |
| Who imports | Your Canadian importer: it holds the site licence and is the importer of record with CBSA |
| Product licence review | Health Canada target: 60 calendar days for Class I, 90 for Class II |
| Customs duty | CETA preferential rate for goods that meet the CETA rules of origin; your broker confirms the tariff line |
| Proof of origin | Origin declaration on the invoice; up to €6,000 per consignment without registration, above that with a REX number |
| Production | From 4 weeks, about 8 weeks for a typical run |
| Transit | Booking-site estimates: sea freight Riga–Montreal about two to four weeks port to port, air 1–3 days door to door; your forwarder confirms |
| Labels | English and French (NHPR s. 87); the new label rules apply to every NHP by 22 June 2028 |
| Minimum order | From 150 units of a ready-made tablet or capsule formula |
NPN
product licence for every natural health product
16 Feb 2026
Foreign Site Reference Number process ended
EN + FR
labels in English and French; new label rules apply to all products by 22 June 2028
90 cm²
available surface area at or below which the Product Facts table can be exempt
Sourcing outside the US
Ordering from a European factory instead of the US: what changes for a Canadian brand
Ordering from a factory in the EU changes the trade agreement and the origin paperwork for a Canadian brand, not the Health Canada licences: the NPN and the site licence work the same way for any manufacturing site outside Canada. Pharma Manufacture makes the product in Mārupe, Latvia, and supplies the manufacturer’s documents; your brand and your importer hold the licences.
| Step | Ordering from Pharma Manufacture in the EU | Who does it |
|---|---|---|
| Product licence (NPN) | Same as for any site outside Canada; Health Canada target 60 calendar days for Class I, 90 for Class II | Your brand |
| Site licence | The importer’s site licence can cover the Mārupe site once the GMP evidence is filed; the FSRN process ended on 16 February 2026 | Your Canadian importer |
| Customs registration | Your importer registers with CBSA; your forwarder or broker confirms the steps | Your importer and its broker |
| Duty | CETA preferential rate for goods that meet the CETA rules of origin; supplements are generally classified in heading 21.06 | Your broker confirms the tariff line |
| Proof of origin | Origin declaration on the invoice; for a consignment up to €6,000 any exporter can make it, above that the exporter needs a REX number | The EU exporter writes it; your importer holds it at release |
| Factory documents | Certificate of Analysis for each batch, copies of GMP-FS-01, HACCP-01 and ISO 22000:2018 MSC-22-1384, site name and address | Pharma Manufacture |
| Labels | English and French (NHPR s. 87); the new label rules with the Product Facts table apply to every NHP by 22 June 2028 | The licence holder supplies the text and the NPN |
| Timing | Production from 4 weeks, about 8 weeks for a typical run; sea freight Riga–Montreal about two to four weeks and air 1–3 days by booking-site estimates, the forwarder confirms; licences come on top | Pharma Manufacture and your forwarder |
Why a Canadian brand may want a second supply route. Canada removed most of its counter-tariffs on US goods on 1 September 2025 and kept those on steel, aluminium and automobiles. After new US tariffs on Canadian goods in August 2026, Canada matched them with counter-tariffs of 15, 25 and 50 % from 8 September 2026 (Department of Finance Canada). For a Canadian brand, an EU manufacturer is a second supply route that spreads trade risk, not a tariff saving on supplements.
On 29–30 October 2026, at the 21st Canada–EU Summit in Montreal, Canada and the EU launched an Alliance for the Future and concluded a Canada–EU Digital Trade Agreement; the EU is Canada’s second-largest trading partner in goods and services (Office of the Prime Minister of Canada, 30 October 2026).
In an Abacus Data survey of 1,479 adults in September 2026, 77 % of Canadians said they intend to avoid American products. The survey covers products in general, not supplements.
First shipment
Steps to your first shipment to Canada
Two licences come before the first sale: the product licence held by your brand and the site licence held by your Canadian importer. The review times below are Health Canada’s service standards, targets rather than guarantees; Health Canada publishes the share of applications that meet them.
- Product licence (NPN)Your brand applies, with a representative in Canada if it is based abroad. Target: 60 calendar days for Class I, including compendial applications, 90 for Class II, and 30 days of screening plus 180 days of assessment for Class III.
- Site licenceYour Canadian importer holds it and files the GMP evidence for the Mārupe site. Target: 35, 65 or 95 working days, depending on the GMP evidence and the number of sites.
- Factory documentsPharma Manufacture sends the Certificate of Analysis, copies of its certificates and the site name and address for the site licence.
- English and French labelThe licence holder supplies the text and the NPN; every natural health product has to meet the new label rules by 22 June 2028.
- Production and shipmentPharma Manufacture makes the batch from 4 weeks, about 8 weeks for a typical run. Sea freight Riga–Montreal is estimated at about two to four weeks, air at 1–3 days; your forwarder confirms. Your importer is the importer of record, holds the CETA origin declaration at release and clears the goods with CBSA.
What you pay. Licence fees depend on Health Canada’s cost recovery proposal, which it will revisit; duty depends on the tariff line and on CETA origin.
| Cost | What applies |
|---|---|
| Product licence and site licence | Health Canada said on 24 November 2025 that the fees would not start on 1 December 2025; final fees will be published in the Canada Gazette, Part II, before they apply |
| Customs duty | Supplements are generally classified in heading 21.06; your broker confirms the tariff line, and the CETA preferential rate applies only to goods that meet the CETA rules of origin |
| Transport | Quoted by your forwarder for each shipment |
| Pharma Manufacture quote | Price per unit for your formula, form, pack and volume |
Canada
How to sell supplements in Canada: NPN, site licence and importer
In Canada tablets, capsules and dosed powders are likely natural health products (NHPs), Canada’s regulatory category for supplements, under the Natural Health Products Regulations, SOR/2003-196. Each product needs a product licence, shown on the label as the NPN, and is imported by a Canadian company holding a site licence. Pharma Manufacture manufactures in Mārupe, Latvia, from 150 units of a ready-made tablet or capsule formula, and supplies the manufacturer’s documents; the licences are held in Canada.
| Licence | Who holds it | Rule |
|---|---|---|
| Product licence (NPN) | The applicant, usually the brand | No NHP is sold without one (NHPR s. 4) |
| Site licence | The Canadian importer | Manufacturing, packaging, labelling or importing for sale |
| Foreign manufacturing site | Covered through site licensing, usually the importer’s site licence | The same GMP evidence goes through the site licensing pathway |
Classification
Which formats are natural health products and which are foods
Health Canada decides by format and use: food is eaten ad libitum, an NHP comes in a measured dose. A food or drink with added caffeine, vitamins, minerals or amino acids, in a listed category, is a supplemented food under the food rules.
| Our format | Canadian category | Basis |
|---|---|---|
| Tablets, hard capsules, softgels | NHP | Guidance, Table 1 |
| Protein powder (dry mix to be reconstituted) | Often a supplemented food; confirm per product | Protein dry mixes are named in Table 2 |
| Powder sachets with a dose and directions | Most likely NHP | Powders in dosed formats |
| Drops, syrups, effervescent tablets | Likely NHP | Not named; confirm per product |
| Caffeinated energy drink or drink mix | Supplemented food | Named in Table 2 |
| Drink cubes and shots | Borderline | Depends on dose and presentation |
The Supplemented Foods Regulations apply since 21 July 2022, with the new Supplemented Food Facts label required for all since 1 January 2026. For a borderline product the brand can ask Health Canada for a classification at smiu-ugdi@hc-sc.gc.ca.
Site licensing
What replaced the Foreign Site Reference Number (FSRN) in 2026?
Health Canada Bulletin No. 10 of 16 February 2026 ended the Foreign Site Reference Number: no new FSRNs, existing ones discontinued, and an FSRN no longer counts as GMP evidence. Sites that relied on an FSRN submit the same GMP evidence through the site licensing pathway, usually through the Canadian importer’s site licence. Foreign warehouses are no longer listed in site licences, though they still have to meet GMP. Older guides that still describe the FSRN are out of date on this point.
GMP
Evidence of GMP for a foreign manufacturing site
| Evidence filed for the site | Valid for (2015 guidance) | Condition |
|---|---|---|
| GMP certificate from the regulator of an MRA country or a PIC/S member | 3 years | Covers all NHP activities |
| NSF/ANSI 173, section 8 certificate | 3 years | Plus finished product testing and stability data |
| Quality Assurance Report | 1 year | Records of testing, release and stability |
Our GMP-FS-01, HACCP-01 and ISO 22000:2018 MSC-22-1384 certificates are issued by a certification body rather than a regulatory authority, so the importer chooses the evidence route with Health Canada.
Duty
Customs duty on EU-made supplements under CETA
CBSA Memorandum D10-14-30 places food supplements for general health and well-being in heading 21.06 rather than chapter 30; if the label states a therapeutic purpose, the broker may classify the product in chapter 30. The broker confirms the tariff line for each product. The CETA preferential rate applies only to goods that meet the CETA rules of origin.
The CETA rate is claimed with the exporter’s origin declaration on the invoice, described in the next section.
Proof of origin
How the CETA origin statement works
The CETA origin statement, officially the origin declaration, is one sentence the EU exporter writes on the invoice or another commercial document that describes the goods in enough detail; the text is set in Annex 2 of the CETA Protocol on Rules of Origin. The English version reads:
“The exporter of the products covered by this document (customs authorisation No …) declares that, except where otherwise clearly indicated, these products are of … preferential origin.”
The origin is entered as “Canada/EU”, followed by the place and date and the exporter’s signature and printed name. The customs authorisation or registration number is entered when an approved or registered exporter makes the declaration.
| Rule | What applies |
|---|---|
| Consignment up to €6,000 | Any exporter can make the declaration |
| Consignment above €6,000 | The exporter must be registered in the Registered Exporter System (REX) |
| Validity | 12 months from the date the exporter completed it |
| Several shipments of identical products | One declaration can state a period of up to 12 months, and every import has to fall within it |
| Language | Any official EU language; CBSA may ask for an English or French translation |
| At the Canadian border | Your importer has the declaration at release and presents it to CBSA on request (Memorandum D11-4-37) |
| Transport | The goods travel from the EU to Canada without further processing in a third country; storage, transhipment and splitting under customs supervision are allowed |
The declaration states the origin; whether a product qualifies depends on the CETA rule of origin for its tariff heading, checked for each formula before the declaration is made.
Logistics
Importer of record and shipping time from the EU to Canada
Your Canadian importer is the importer of record. Booking-site estimates put sea freight from Riga to Montreal at about two to four weeks port to port and air freight at 1–3 days door to door; your forwarder confirms the route and schedule.
The factory in Mārupe is two minutes from Riga International Airport and close to the Free Port of Riga.
Since the importer of record is on the Canadian side, 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.
Production takes from 4 weeks, about 8 weeks for a typical run from confirmed order and brief to despatch. The product licence, the site licence and transit come on top of that.
Label
Bilingual labels and the new label rules: 22 June 2028 deadline
Set label information must appear in English and French (NHPR s. 87). The front panel carries the brand, NPN, dosage form and net quantity; the outer label carries the Product Facts / Info-produit table, the licence holder or importer, the lot and the expiry date. Packs with 90 cm² or less of available surface area and products for one day of use or less can be exempt from the table (s. 93.5).
The new label rules, including the Product Facts table, came into force on 21 June 2025; every NHP has to comply by 22 June 2028. The text and the NPN come from the licence holder.
Documents
What Pharma Manufacture supplies for a Canadian file
| Document | Who provides it |
|---|---|
| Certificate of Analysis for each batch | Pharma Manufacture |
| Copies of GMP-FS-01, HACCP-01 and ISO 22000:2018 MSC-22-1384 | Pharma Manufacture |
| Site name and address for the site licence | Pharma Manufacture: SIA Pharma Market Solutions, Mārupe, Latvia |
Frequently asked questions
Common questions about private label supplements for Canada
Why would a Canadian brand source supplements from the EU?
Pharma Manufacture gives a Canadian brand a supply route outside the US, which spreads risk after Canada–US trade terms changed in September 2025 and again in September 2026. The Health Canada licences work the same way as for any site outside Canada; products are made in Mārupe, Latvia, and the CETA preferential rate applies when they meet the CETA rules of origin.
Do I need a Canadian importer, and who holds the site licence?
Yes. A site licence covers manufacturing, packaging, labelling or importing natural health products for sale. For a product made in Mārupe the Canadian importer holds it, the Mārupe site of Pharma Manufacture can be covered through it once the importer files the GMP evidence, and the importer is the importer of record with CBSA.
How do you get an NPN in Canada, and who holds it?
The applicant, usually your brand, applies for the product licence, holds the NPN shown on the label and names a representative in Canada if it is based abroad (NHPR s. 5). Pharma Manufacture supplies the manufacturer’s documents for the file.
How do I look up an NPN?
Search by NPN or product name in Health Canada’s Licensed Natural Health Products Database (LNHPD). For a product made by Pharma Manufacture, the NPN belongs to your brand as the product licence holder.
The database is at health-products.canada.ca/lnhpd-bdpsnh.
What duty applies to EU-made supplements in Canada?
The rate depends on the tariff line, which the customs broker confirms for each product; CBSA generally places supplements in heading 21.06. CETA preferential rates apply only to goods that meet the CETA rules of origin, claimed with the exporter’s origin declaration on the invoice.
How long does shipping from Latvia to Canada take?
Booking-site estimates put sea freight from Riga to Montreal at about two to four weeks port to port and air freight at 1–3 days door to door; your forwarder confirms the schedule. Pharma Manufacture production comes before that: from 4 weeks, about 8 weeks for a typical run.
What are the minimum order and lead time for Canada?
Pharma Manufacture starts from 150 units of a ready-made tablet or capsule formula. Production takes from 4 weeks, about 8 weeks for a typical run; the licences come on top of that time.
When must NHP labels meet the new rules?
The requirements came into force on 21 June 2025; every natural health product has to comply by 22 June 2028.
Are supplements regulated in Canada as NHPs or foods?
Both, depending on the product. Products in dosage formats not typical of foods (tablets, capsules, powders) are likely natural health products under SOR/2003-196. Some foods with added caffeine, amino acids or vitamins are supplemented foods, and Health Canada’s guidance lists protein dry mixes among the supplemented-food categories, so the category is decided per product.
What replaced the FSRN for foreign supplement manufacturers?
Since 16 February 2026 the same GMP evidence is submitted through the site licensing pathway, usually by the Canadian importer, and foreign warehouses are no longer listed in site licences (Bulletin No. 10).
Does Health Canada accept your GMP certificates?
Health Canada accepts set evidence, such as a regulator’s GMP certificate from an MRA or PIC/S country or a Quality Assurance Report. Ours come from a certification body, so the importer picks the route.
Are there Health Canada fees for NHP licences?
Health Canada said on 24 November 2025 that the fees would not start on 1 December 2025. It will revisit the cost recovery proposal, and final fees will be published in the Canada Gazette, Part II before they apply.
Sources
- Natural Health Products Regulations, SOR/2003-196, laws-lois.justice.gc.ca, checked 30 October 2026.
- Health Canada, Supplemented Foods Regulations guidance, canada.ca, checked 30 October 2026.
- Health Canada, Bulletin No. 10, 16 February 2026, canada.ca, checked 30 October 2026.
- Health Canada, Service standards for natural health product application reviews (product licences), canada.ca, checked 30 October 2026.
- Health Canada, Service standards for site licence applications, canada.ca, and site licensing bulletin of 15 October 2025, canada.ca, checked 30 October 2026.
- Health Canada, Site Licensing Guidance Document v3.0 (2015), canada.ca, checked 30 October 2026.
- Health Canada, Labelling of natural health products, canada.ca, checked 30 October 2026.
- Health Canada, Cost recovery for NHPs (24 November 2025), canada.ca, checked 30 October 2026.
- CBSA, Memorandum D10-14-30, cbsa-asfc.gc.ca, checked 30 October 2026.
- CBSA, Memorandum D11-4-37 (4 November 2021), origin declaration under CETA, cbsa-asfc.gc.ca, checked 1 November 2026.
- European Commission, Taxation and Customs Union, CETA Protocol on Rules of Origin, Annex 2, Text of the origin declaration, taxation-customs.ec.europa.eu, checked 1 November 2026.
- European Commission, Access2Markets, EU–Canada Comprehensive Economic and Trade Agreement (page version of 14 October 2026), trade.ec.europa.eu, checked 1 November 2026.
- Transit estimates, Riga to Montreal, from booking and reference sites (Fluent Cargo, Movehub), seen in search results on 1 November 2026.
- Department of Finance Canada, Canada’s response to U.S. tariffs (counter-tariffs removed 1 September 2025), canada.ca, checked 30 October 2026.
- Department of Finance Canada, countermeasures in response to U.S. tariffs, 25 August 2026, canada.ca, checked 30 October 2026.
- Office of the Prime Minister of Canada, Canada and the European Union announce new Alliance for the Future, 30 October 2026, pm.gc.ca, checked 1 November 2026.
- Global News, Abacus Data survey of 4–9 September 2026, published 2 October 2026, globalnews.ca, checked 30 October 2026.
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