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30
Tariff Chapter 30
Medicaments (excluding goods of heading 3002, 3005 or 3006) consisting of mixed or unmixed products for therapeutic or prophylactic uses, put up in measured doses (including those in the form of transdermal administration systems) or in forms or packings for retail sale
What does heading 3004 of the customs tariff cover?
Heading 3004 covers medicaments (excluding goods of heading 3002, 3005, or 3006) consisting of mixed or unmixed products, for therapeutic or prophylactic uses, put up in measured doses or in packings for retail sale. The duty rate is 0% for medicaments. Import requires a marketing authorization issued by the Office for Registration of Medicinal Products (URPL) or EMA. Good Manufacturing Practice (GMP) and Good Distribution Practice (GDP) requirements apply. Poland is one of the larger pharmaceutical markets in the EU, with a well-developed generic drug production sector. Import of innovative medicines is a significant trade item, and domestic pharmaceutical production is substantial. Heading 3004 is part of Chapter 30 (chemical industry products, pharmaceuticals and fertilizers) of the Combined Nomenclature (CN) used in the European Union. This classification is based on the Harmonized System (HS) developed by the World Customs Organization (WCO), which is used in over 200 countries worldwide. The EU Combined Nomenclature extends the HS with additional 8-digit subheadings, while the TARIC system adds 10-digit codes for identifying specific trade measures. Each 4-digit heading such as 3004 is subdivided into 6-digit (HS), 8-digit (CN) and 10-digit (TARIC) subheadings that specify the type of goods for the purpose of applying the correct duty rates, trade measures and regulatory requirements. Correct determination of the 10-digit code is essential for establishing the amount of customs duties and taxes, as well as required permits and certificates.
Duty rates and import requirements for heading 3004
The duty rate is 0% for medicaments. Import requires a marketing authorization issued by the Office for Registration of Medicinal Products (URPL) or EMA. Good Manufacturing Practice (GMP) and Good Distribution Practice (GDP) requirements apply. Import of innovative medicines is a significant trade item, and domestic pharmaceutical production is substantial. Duty rate is 0% - medicaments are duty-free. Marketing authorization required (URPL or EMA centralized procedure). Importer must hold pharmaceutical wholesale license and meet GDP requirements. Medicines require proper storage and transport conditions (cold chain) and serialization. When importing goods under heading 3004 into the European Union, attention must be paid to applicable duty rates, which depend on the specific subheading (8- or 10-digit code) and the country of origin. MFN (Most Favoured Nation) duty rates apply to imports from countries with which the EU does not have preferential trade agreements. Current rates can be checked in the EU TARIC database on the European Commission website. Import of goods under heading 3004 may benefit from preferential duty rates under Free Trade Agreements (FTAs) concluded by the EU with third countries, the Generalised Scheme of Preferences (GSP) for developing countries, or autonomous tariff suspensions. Claiming preferences requires presentation of appropriate proof of origin (EUR.1 certificate, origin declaration, REX certificate or statement on origin under the registered exporter system).
Classification of goods under heading 3004 - key considerations
Heading 3004 covers medicaments in measured doses or retail packaging. Tablets, capsules, ampoules, syrups, ointments: 3004. Bulk medicines (not dosed): 3003. Medicated dressings: 3005. Vaccines: 3002. Dietary supplements (no medicinal substances): 2106. Key distinction: 3004 = finished medicines in doses/retail packs. Common error: vitamin tablets may be 3004 (medicinal) or 2106 (dietary supplements).
Frequently asked questions
What are the EU customs duty rates for importing medicaments?
Import of medicaments (heading 3004) into the EU is subject to a 0% duty rate. Medicaments - both mixed and unmixed, for therapeutic or prophylactic uses, in measured doses or retail packings - are duty-free. This applies to both prescription and over-the-counter medicines. Classification under heading 3004 requires the product to be intended for therapeutic use and put up for retail sale. Pharmaceutical raw materials may fall under different tariff headings with potentially different rates. Current duty rates should be verified in the European Commission's TARIC database. Classification follows the Combined Nomenclature (CN) of the European Union.
What documents and permits are required to import medicaments into the EU?
Importing medicaments requires a marketing authorisation issued by the national medicines agency (e.g., URPL) or the European Medicines Agency (EMA). Compliance with Good Manufacturing Practice (GMP) and Good Distribution Practice (GDP) must be confirmed. An import licence and wholesale distribution authorisation are required. Controlled substances need additional permits. Labelling must comply with Directive 2001/83/EC on medicinal products. Batch testing certificates are mandatory. This applies to goods classified under heading 3004 of the Combined Nomenclature. Current duty rates should be verified in the European Commission's TARIC database. Classification follows the Combined Nomenclature (CN) of the European Union.
What practical considerations apply when importing medicaments into the EU?
Despite the zero duty rate, medicament imports are subject to some of the strictest regulations. Each medicine requires an individual marketing authorisation. The supply chain must meet GDP requirements for temperature, humidity, and batch traceability. The Falsified Medicines Directive (FMD) requires pack serialisation to combat counterfeiting. Biological and innovative medicines require centralised EMA registration. Narcotic substances are subject to additional controls and import quotas. This applies to goods classified under heading 3004 of the Combined Nomenclature. Current duty rates should be verified in the European Commission's TARIC database. Classification follows the Combined Nomenclature (CN) of the European Union.
Useful tools & resources
Customs calculators
Duty & VAT CalculatorCalculate customs duty and VAT for "Medicaments (excluding goods of heading 3002, 3005 or 3006) consisting of mixed or unmixed products for therapeutic or prophylactic uses, put up in measured doses (including those in the form of transdermal administration systems) or in forms or packings for retail sale" and see the full import cost.Import Profitability CalculatorCheck the import profitability of "Medicaments (excluding goods of heading 3002, 3005 or 3006) consisting of mixed or unmixed products for therapeutic or prophylactic uses, put up in measured doses (including those in the form of transdermal administration systems) or in forms or packings for retail sale" with all costs included.
Related glossary terms