Supplements manufactured in the EU and sold outside it
This is the part almost no manufacturer writes down, so brands find it out late and expensively. Inside the EU a supplement is not pre-approved at EU level: most Member States require a notification before sale. PharmaEurope already manufactures for brands selling into Europe, the Middle East, China, Africa and South America — association data lists Lebanon, Saudi Arabia and the UAE among the main markets, with turnover reported at €1.2 to 5.7 million for 2020–2024.
What comes with the order
- What we supply: the specification, the full ingredient and allergen declaration, the Certificate of Analysis for the batch and the site certificates with their numbers
- What the destination adds is local: a registration holder, a technical representative, sometimes pre-shipment inspection
- “Made in the EU” is a selling point, not a shortcut through registration
- Tell us the destination market at the enquiry stage — it can change the label, the pack and the documents
Three concerns exporting brands raise before ordering
“Can you register our product in our target market?”
Not from the factory. PharmaEurope does not act as the registration holder in the destination market: registration abroad is held by a locally established entity — an importer, registration holder or technical representative in that country. PharmaEurope supplies the specification, the analysis and the site certificates the filing is built on.
“Does an ‘EU-made’ stamp carry weight with a foreign regulator?”
Commercially yes, legally it is not a substitute. EU supplements are notified rather than assessed, so an EU origin isn’t evidence of prior review, and regulators outside the EU treat it that way — the certificate numbers behind the claim matter more than the words “EU-made.”
“We don’t even know what documents we need from a manufacturer for a foreign dossier.”
The product specification, the full ingredient and allergen declaration, the shelf-life statement, the Certificate of Analysis for the batch, and the site certificates with their numbers — ISO 22000 MSC-22-1384, GMP-FS-01, HACCP-01 and US FDA registration 13674831934.
Notified is not the same as approved, and the difference travels badly
In the European Union a food supplement is placed on the market by notifying a national authority; nobody assesses and approves the product first. That is efficient inside the single market and it is the source of the most expensive misunderstanding in export: a brand assumes an EU product has been vetted, and presents that to a regulator who works the other way round. Most markets outside the EU register the product itself, review the dossier and issue a number before a single unit may be sold.
The registration is held locally, and that is not a formality
Several markets require the holder of the registration to be established in the country. Morocco registers supplements through its own authority, Egypt works through a pharmacy channel with its own document legalisation chain, and Kenya requires a local technical representative alongside pre-shipment verification of conformity. None of this can be done by the factory, and any manufacturer who says otherwise is selling you something they cannot deliver. What the factory can do is supply a dossier that the local filing is actually built on, complete and consistent, the first time.
Decide the market before the label, not after
Ingredient limits, permitted claims, language requirements and pack sizes differ by destination, and a label designed for the EU rarely survives the move unchanged. Naming the market at the enquiry stage costs nothing; discovering it after ten thousand labels are printed costs the print run and the season.
Frequently asked questions
Can you register our product in a market outside the EU?
Not from the factory. PharmaEurope does not act as the registration holder in the destination market: registration abroad is held by a local entity: an importer, a registration holder or a technical representative established in that country. We supply the specification, the analysis and the site certificates the filing is built on.
Does a supplement need approval before sale in the EU?
No. Food supplements in the EU are not pre-approved at EU level: most Member States require a notification before sale. The company named on the label files a notification with its national authority before sale; in Spain that authority is AESAN. The composition and batch documentation come from us.
Which documents do you provide for an export dossier?
The product specification, the full ingredient and allergen declaration, the shelf-life statement, the Certificate of Analysis for the batch and the site certificates with their numbers: ISO 22000:2018 MSC-22-1384, GMP-FS-01, HACCP-01 and US FDA registration 13674831934.
Does “made in the EU” speed up registration abroad?
It helps commercially and it does not replace a local filing. Because EU supplements are notified rather than assessed, an EU origin is not evidence that a product has been reviewed, and regulators outside the EU treat it that way.
What are the delivery terms for an export order?
EXW Mārupe, Latvia by default: finished pallets are ready at the plant and your forwarder collects them, which keeps freight under your control and lets you consolidate with other suppliers. FCA or DAP can be quoted on request when you would rather we arrange the carrier. Customs export declarations for EU exit are prepared with the shipment; import clearance and registration remain on the destination side.
Which regions does PharmaEurope already manufacture for?
Europe, the Middle East, China, Africa and South America. The association profile behind this operation lists Lebanon, Saudi Arabia and the United Arab Emirates among its main markets, with turnover reported at €1.2 to 5.7 million across 2020–2024 on that same profile.
Does a supplement need approval before sale inside the EU?
No. Food supplements in the EU are not pre-approved at EU level: most Member States require a notification before sale — the company named on the label files the notification with its national authority before sale. PharmaEurope supplies the composition and the batch documentation that filing is built on, wherever the brand is registered.
What happens if a destination country doesn’t recognise EU notification at all?
The product is registered from the ground up under that country’s own rules, through a locally established representative — the same as any product entering that market for the first time. PharmaEurope’s documents are the evidence base for that filing, not a substitute for it.
More on who we manufacture for: all six kinds of buyer.
Where PharmaEurope’s side of the work ends
What PharmaEurope takes on, regardless of destination: the product itself, produced to the agreed specification, its Certificate of Analysis, and the site certificates with their numbers and expiry dates. What stays with the brand: the registration or notification in the destination country, filed through a locally established representative, importer or registration holder — because inside the EU that same filing is a notification, not an approval, and the principle carries over rather than changing at the border.
Get a quote for your quantity
Tell us the format, the active, the dose and how many units you need for the first run. You will get a price for that quantity and for a larger one, so you can see where the unit cost goes.