Buyer questions · Your country’s market

Are supplements regulated in Europe, and who files the notification?

Yes, food supplements are regulated under common EU rules in every member state, and where a country requires a notification, the brand or its local applicant files it. Pharma Manufacture makes the product in Mārupe, Latvia, inside the EU, and supplies the manufacturer’s documents the filing needs, from the Certificate of Analysis of each batch to its three certificates, GMP, HACCP and ISO 22000. Notification rules are set and run by each country’s own regulator, so the country of sale should be named before the formula and the label are fixed.

A dose or a label that suits one member state can need adjusting for another, and that is cheaper to find out before artwork goes to print than after.

Who does what

Your side and the factory’s side of a launch

Who files the notification in my country?

The business that places the product on that market, which in private label is your company or the importer acting for you. It is the name on the label, and it carries the obligations under Regulation (EU) No 1169/2011 and Regulation (EC) No 1924/2006. Our part is the manufacturer’s documents that go into its file.

The legal basis is Article 10 of Directive 2002/46/EC: a member state may require the manufacturer or the person placing the product on its market to notify the competent authority, by sending a model of the label used for the product.

Are supplements regulated in the EU? What is common, what changes

The common base is the same everywhere in the union: hygiene under Regulation (EC) No 852/2004, food information under Regulation (EU) No 1169/2011, claims under Regulation (EC) No 1924/2006, with the list of authorised health claims in Regulation (EU) No 432/2012. What differs is the procedure: whether a notification is needed, what goes into it, and the national rules the authority checks a formula and a label against.

That is why the country belongs in your first message to us. A launch in three countries is three procedures, each run by its own authority, and the formula and label that go to print should already fit all three.

Frequently asked questions

Common questions about EU supplement regulation and notification

Who files the notification, and what does Pharma Manufacture supply?

The brand or its local applicant files it in the country of sale, and Pharma Manufacture supplies the manufacturer’s documents for that file.

Why name the country before the label is designed?

Because a dose or a label that is fine in one country can need changes in another, and a change after printing means new artwork and new packaging.

Does each EU country need its own notification?

Each country applies its own procedure through its own regulator, so selling in several member states usually means one filing per country where a notification is required, each made by the brand or its local applicant.

Which EU rules regulate supplements in every member state?

Pharma Manufacture produces to Regulation (EC) No 852/2004 on hygiene, Regulation (EU) No 1169/2011 on food information and Regulation (EC) No 1924/2006 on claims, with Directive 2002/46/EC as the base for food supplements.