Quick answer: CN code and import compliance
Conditional answer: a finished medicinal product for therapeutic or prophylactic use, in measured doses or retail packaging, normally falls in CN 3004 90 00 unless a named active-ingredient subheading applies. Bulk medicaments may fall in 3003, vaccines and biologics in 3002, dressings in 3005, specified pharmaceutical goods in 3006, and pure active substances in Chapters 28 or 29. Import from a third country requires more than customs release: a valid Union or national marketing authorisation, an authorised EEA importer/manufacturing site, GMP compliance and Qualified Person certification are normally required.
| Imported state | Candidate CN | Decisive fact |
|---|---|---|
| Finished measured-dose medicine | 3004 90 00 | Active substance, dose and presentation |
| Bulk medicament | 3003 | Not in measured doses/retail packs |
| Vaccine or biological product | 3002 | Biological identity |
| Pure active substance | Chapter 28/29 | Chemical identity and purity |
Chapter 30 classification boundaries
Classification follows GIR 1, the legal notes to Chapter 30 and GIR 6. The file must identify every active substance and salt, strength, excipients where relevant, dosage form, route, indication, retail presentation and regulatory status. Food supplements, cosmetics with medicinal claims, medical-device combinations and veterinary medicines require separate analysis. A marketing-authorisation number is not a tariff code, and a tariff opinion from a non-EU country does not determine the CN. Binding Tariff Information is appropriate for recurring uncertain products.
Customs duty, origin and import VAT
Import VAT is national: common medicine rates include Germany 19%, France 2.1% or 10% depending on reimbursement, Spain 4%, Italy 10%, Poland 8% and Netherlands 9%, subject to the exact legal category. Preferential duty requires qualifying origin and valid proof; country of dispatch is not enough. Customs value, assists, royalties and Incoterms must be reviewed. TARIC may also show sanctions, licensing or trade-defense measures, which are separate from pharmaceutical authorisation.
Marketing authorisation
A medicinal product may be placed on the market only under a valid marketing authorisation issued through the centralised, decentralised, mutual-recognition or national procedure. The authorised name, strength, pharmaceutical form, manufacturing sites, specifications, package and product information must match the imported batch. A licence from the exporting country does not replace EU/EEA authorisation. Named-patient, shortage, compassionate-use and clinical-trial pathways are narrow exceptions controlled by national authorities.
Manufacturing and import authorisation
Directive 2001/83/EC Article 40 requires authorisation for manufacture and third-country import. The physical importer and the site responsible for batch certification must hold the correct Manufacturing and Import Authorisation scope and be recorded in EudraGMDP where applicable. Wholesale distribution requires a WDA and GDP compliance. An ordinary customs broker or logistics warehouse cannot become the pharmaceutical importer simply by appearing on the customs declaration.
QP batch certification and GMP
For third-country products, each batch must be tested as required and certified by a Qualified Person under Article 51 before EEA market release, subject only to applicable mutual-recognition arrangements. The QP checks the marketing-authorisation dossier, GMP status, manufacturing and testing chain, deviations and transport conditions. Vaccines and plasma-derived products may additionally require Official Control Authority Batch Release. Customs release, physical import and QP batch release are distinct events.
Safety features and distribution
Prescription medicines within scope need the unique identifier and anti-tampering device required by Directive 2011/62/EU and Delegated Regulation 2016/161, with verification and decommissioning through the medicines-verification system. Labels and package leaflets must use the authorised national language(s). GDP, temperature mapping, serial-number handling, pharmacovigilance, shortage reporting and recall procedures continue after import. Online supply is permitted only through lawfully authorised channels.
Controlled and exceptional medicines
Narcotic and psychotropic substances require separate national and international import authorisations and quota controls. Investigational medicinal products follow Regulation 536/2014 and clinical-trial authorisation. Unauthorised medicines for named patients or shortages require the competent national route and cannot be distributed as ordinary authorised products. Radiopharmaceuticals, blood products, advanced therapies and veterinary medicines have additional regimes.
Customs and compliance file
The compliance file should link invoice, packing list, transport, customs value and origin, CN/TARIC reasoning, marketing authorisation, MIA/WDA, GMP evidence, QP declaration, batch COA, temperature data, serialisation and approved label. A precise description is: “Human medicinal product, [dosage form], [active substance/salt] ... mg per unit, ... units per pack, MA number ..., batch ..., CN candidate 3004 90 00, origin ...”. Never declare only “pharmaceuticals.”
Official EU sources
Official sources checked 12 September 2026: European Commission TARIC, Directive 2001/83/EC, EMA pre-authorisation guidance and European Commission falsified-medicines rules. The importer must recheck the current TARIC measure, national authorisation and tax treatment on the import date.
Limits of this guidance
This is conditional general guidance, not BTI, a marketing authorisation or a batch-release decision. A final opinion requires the full formula, active substance and salt, strength, dosage form, route, indication, packaging, authorisation file, manufacturing sites, origin and import date. The declarant, MA holder, importer, QP and distributor retain their separate legal responsibilities.