EU market / Spain
Markets · SpainPrivate label supplement manufacturing for the Spanish market
Fabricación a terceros de complementos alimenticios · marca blanca
In Spain a food supplement (complemento alimenticio) needs a notification of first placing on the market, the notificación AESAN, filed through the AESAN electronic office by the business whose name and EU address are on the label; no approval is awaited. A company from another EU country files without a Spanish registration. PharmaEurope manufactures white and private label supplements in the European Union: ready-made capsules and tablets from 100 units, your own formula from 500 bottles, powders and sachets from 300 kg, production from 2 weeks on a ready-made formula and from 4 weeks on your own. Every batch ships with a specification and a Certificate of Analysis for the notification file.
In short: PharmaEurope makes the product and supplies the documents; your company files the notification and sells.
MOQ, production time and documents for the Spanish market
What a Spanish brand needs to know before the first order of complementos alimenticios marca blanca.
| Item | Detail |
|---|---|
| White label first run | From 100 units on ready-made capsules and tablets |
| Private label, your own formula | From 500 bottles per product for capsules and tablets |
| Powders and sachets | From 300 kg of finished blend |
| Effervescent tablets | Tubes of 20, low minimum order quoted per tube count |
| Production | From 2 weeks on a ready-made formula in all formats, from 4 weeks on your own formula |
| Label | Designed at the plant in the language you specify, or printed from your artwork |
| With every batch | Specification and Certificate of Analysis; copies of the ISO 22000, GMP and HACCP site certificates on request (scope: tablets, capsules and powders) |
| Approval before sale | None; a notification of first placing on the market |
| Contract party | PHARMA EUROPE SOLUTIONS 2023 SL, registered in Spain |
| Delivery | PharmaEurope already ships to Spain: standard EU delivery, arranged by PharmaEurope (DAP) or handed to your carrier (EXW or FCA) |
| Reply to an enquiry | Within 24 hours, Monday to Friday |
How does the AESAN notification for food supplements work?
It is a file made through the AESAN electronic office by the operator named on the label, with the label and proof of the fee. The table shows what your company needs for it.
| Question | Answer |
|---|---|
| Who files | The operator whose name and EU address are on the label |
| Your company has its registered office in Spain | Also needs registration in the Registro General Sanitario (RGSEAA), key 26 |
| Your company is in another EU country | Files without RGSEAA registration |
| Your company is outside the EU | An EU representative or distributor is named on the label and files |
| How | Only through the AESAN electronic office (sede electrónica), with a digital certificate or through a representative |
| What goes in the file | The form, all labels, lot marking under Real Decreto 1808/1991, proof of fee payment |
| One file or several | Each galenic form (tablets, capsules, drops) is a separate file with its own fee; flavours and pack sizes can share one file or be filed separately, so check with AESAN |
| Fee | A fee (tasa, form 791) is paid; check the current amount with AESAN |
| Already sold in another EU country | Under mutual recognition (Regulation (EU) 2019/515, Articles 34 and 36 TFEU), substances not harmonised at EU level need proof of prior lawful marketing in that country and the label used there |
What does PharmaEurope supply for the AESAN file?
PharmaEurope supplies the documents: the label artwork as a PDF, the product specification, the Certificate of Analysis for the batch and copies of the site certificates. Your company enters them in the notification and files it. If the product is already sold in another EU country, PharmaEurope also supplies the label files it designed for that country.
What must a food supplement label carry in Spain?
The particulars set by Articles 5 and 6 of Real Decreto 1487/2009, the lot marking under Real Decreto 1808/1991, and the name and EU address of the operator who files the notification. PharmaEurope designs the label at the plant or prints your artwork; your company, as the business named on it, approves the final text.
How does a private label supplement reach the Spanish shelf?
1. Formula and label
A ready-made formula or your own, with the label designed at the plant.
2. Production
From 2 weeks on a ready-made formula, from 4 weeks on your own, with the Certificate of Analysis.
3. Notificación
Your company files through the AESAN electronic office with the documents PharmaEurope supplies.
4. Delivery
PharmaEurope already ships to Spain: delivery arranged to your door (DAP), or handed to your carrier at the plant (EXW or FCA).
5. On sale
In shops, pharmacies or online, with your company as the business responsible for the product.
Questions about private label supplements for Spain
Do food supplements need approval before sale in Spain?
No. They need a notification of first placing on the market through the AESAN electronic office. PharmaEurope supplies the documents; your company files.
Who files the AESAN notification?
The operator whose name and EU address are on the label: your company, or for a company outside the EU, the EU representative or distributor named on the label. PharmaEurope supplies the documents for the file.
Is “fabricación a terceros” the same as “marca blanca”?
For supplements both terms are used for the same service: a manufacturer makes the product and your brand sells it. With PharmaEurope, white label means a ready-made formula from 100 units; private label means your own formula from 500 bottles.
Our company is not Spanish. Do we need a Spanish company?
Not if your company is in another EU country: it files without RGSEAA registration, which applies to companies with a registered office in Spain. A company outside the EU names an EU representative or distributor on the label. PharmaEurope supplies the same documents in either case.
Do capsules and tablets of the same product need separate notifications?
Yes. Each galenic form is a separate file with its own fee; flavours and pack sizes can share one file or be filed separately. Plan the forms with PharmaEurope at the quote.
How much does the notification cost?
A fee (tasa, form 791) is paid with each file; check the current amount with AESAN. PharmaEurope quotes the manufacturing, the label and the packaging.
What is the minimum order for Spain?
PharmaEurope makes ready-made capsules and tablets from 100 units, your own formula from 500 bottles per product, and powders and sachets from 300 kg of finished blend. The full table is on the minimum order quantities page.
How long does production take?
At PharmaEurope, from 2 weeks on a ready-made formula in all formats and from 4 weeks on your own formula. Transport comes on top.
Which company signs the contract?
PHARMA EUROPE SOLUTIONS 2023 SL, a company registered in Spain. Production takes place at the PharmaEurope plant in the European Union.
Which formats can PharmaEurope make for the Spanish market?
Capsules, tablets, softgels, effervescent tablets, powders, sachets, sports nutrition, syrups and vitamin oils. The full range is on the formats page, and ready-made products on the ready-made formulas page.
Can we get samples before ordering?
Yes. PharmaEurope sends samples of existing products to companies that are seriously considering an order, so you can see the product, the pack and the label before the first batch.
Sources
- AESAN, food supplements and Real Decreto 1487/2009: aesan.gob.es.
- AESAN, guide to the communication of food supplements, 6 October 2023: PDF.
- AESAN, help sheet on electronic filing of food supplement notifications, 25 September 2023: PDF.
- Real Decreto 1808/1991 on lot marking; Regulation (EU) 2019/515 on mutual recognition; Articles 34 and 36 TFEU, as referred to in the AESAN guide.
Checked on 30 October 2026. Procedures and fees change: confirm them with AESAN before you file.
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