Medicine import checks for the EU and US: authorisations and registrations

Last updated: 17 October 2026. Rules differ by product type and country. Confirm each point with the competent authority or a regulatory specialist.

A medicine shipment involves more than a commercial invoice. In the EU, importing from a third country needs an authorisation and a batch certification. In the US, foreign establishments register with FDA before their drugs are imported and list each drug. This guide lists what each side asks for and the records that have to match.

EU: authorisation to import.

Directive 2001/83/EC, the EU code for human medicines, says in Article 40 that manufacturing authorisation is also required for imports coming from third countries into a Member State. The Member State records the authorisation in the Union database. The text of Article 40 as hosted by legislation.gov.uk reflects the 2011 amendment, so check the current consolidated text on EUR-Lex before you rely on a detail.

EU: qualified person and batch certification.

Article 51 sets the duties of the qualified person:

• For a product from a third country, each production batch undergoes a full qualitative analysis in a Member State, a quantitative analysis of at least all the active substances, and the other tests needed to ensure quality under the marketing authorisation.
• The qualified person can be relieved of those controls when the EU has an arrangement with the exporting country for equivalent manufacturing standards and for the controls to be carried out there.
• For products intended for the EU market, the safety features must be affixed to the packaging.
• The qualified person certifies in a register or equivalent document that each batch meets Article 51. The record is kept up to date and retained for the period the Member State sets, and at least five years.

The Commission's EU GMP guidelines (EudraLex Volume 4) include Annex 16 on certification by a qualified person and batch release, in operation since 15 April 2016, and Annex 21 on importation of medicinal products. Check Annex 21 directly for its current status.

US: establishment registration and drug listing.

21 CFR Part 207 sets these rules:

• Manufacturers, repackers, relabelers and salvagers must register each foreign establishment whose drugs are imported or offered for import (21 CFR 207.17). A foreign establishment registers before its drugs are imported or offered for import (21 CFR 207.21(b)).
• A foreign registrant designates a single US agent who resides or maintains a place of business in the US. The agent may not be a mailbox, answering machine or service (21 CFR 207.69(b)).
• Registrants list each drug they make, repack, relabel or salvage for commercial distribution (21 CFR 207.41). Initial listing is due within three days after initial registration (21 CFR 207.45).
• Each listed drug needs a unique National Drug Code, with labeler, product and package segments (21 CFR 207.33). A new code is required when information such as the drug name, active ingredients, strength or dosage form changes (21 CFR 207.35).
• Registrants review and update registration information every year between 1 October and 31 December, and certify when nothing has changed (21 CFR 207.29(b)). A change of name, address or official contact is due within 30 days (21 CFR 207.29(a)).
• Registration and listing do not mean FDA approval or legal marketing (21 CFR 207.77).

Mismatches to look for.

1. The manufacturing site differs between documents. The name or address on the label, the invoice, the certificate and the registration record are not the same.
2. The importer has no authorisation, or the authorisation does not cover the product or the site.
3. The batch has no certification record in the qualified person's register when the importer is asked.
4. The batch number or expiry date differs between the label, the certificate of analysis and the shipping documents.
5. A foreign establishment is not registered, or the annual update was missed in the 1 October to 31 December window.
6. The US agent details are out of date.
7. The NDC on the label differs from the listing after a change in name, strength or dosage form.
8. The product name, strength or dosage form differs between the label, the listing and the invoice.

Checks to run before a batch ships.

1. Confirm the importer's authorisation for the destination and that it names the product and the site.
2. Compare the manufacturing site's name and address across the label, the certificate, the invoice and the registration.
3. Compare batch numbers, expiry dates, strengths and dosage forms across the label, the certificate of analysis and the shipping documents.
4. For the EU, confirm that the batch certification record exists and who holds it.
5. For the US, confirm that each foreign establishment is registered, that the annual update is current, that the US agent is correct and that each drug is listed with the NDC shown on the label.
6. Keep a dated record of each check, and repeat it whenever a site, authorisation, strength or label changes.

Common questions.

Does importing a medicine into the EU need an authorisation?

Directive 2001/83/EC, Article 40, says manufacturing authorisation is also required for imports from third countries into a Member State.

What must a foreign establishment do before its drugs are imported into the US?

Register with FDA before its drugs are imported or offered for import, designate a US agent and list each drug (21 CFR Part 207).

Does FDA registration mean the drug is approved?

No. 21 CFR 207.77 says registration and listing do not mean FDA approval or legal marketing.

Sources.

• European Union, Directive 2001/83/EC on medicinal products for human use
• legislation.gov.uk, Directive 2001/83/EC, Article 40 (text as hosted there)
• legislation.gov.uk, Directive 2001/83/EC, Article 51 (text as hosted there)
• European Commission, EudraLex Volume 4, EU GMP guidelines
• eCFR, 21 CFR Part 207, registration and listing

This guide is information, not legal or regulatory advice. Medicines are tightly regulated and rules differ by product type and country. Confirm each point with the competent authority or a regulatory specialist.