Medicaments (excluding goods of heading 3002, 3005 or 3006) consisting of two or more constituents which have been mixed together for therapeutic or prophylactic uses, not put up in measured doses or in forms or packings for retail sale

Heading 3003 covers medicaments consisting of two or more constituents mixed together for therapeutic or prophylactic uses, not put up in measured doses nor in forms or packings for retail sale. This includes mixtures of active pharmaceutical ingredients used in pharmaceutical manufacturing, such as antibiotics, analgesics, and hormonal preparations. Duty rates range from 0% to 6.5%. Imports require a marketing authorization or import permit issued by the national pharmaceutical inspectorate. GMP compliance is mandatory, along with adherence to Directive 2001/83/EC on medicinal products for human use. Heading 3003 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 3003 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. Classification of goods under heading 3003 must follow the General Rules for the Interpretation (GRI) of the Combined Nomenclature. Rule 1 states that classification is determined primarily by the terms of the headings and the relevant section or chapter notes. The Explanatory Notes to the Harmonized System and the Combined Nomenclature clarify the scope of each heading and are essential references for importers and customs brokers.

Duty rates range from 0% to 6.5%. Imports require a marketing authorization or import permit issued by the national pharmaceutical inspectorate. GMP compliance is mandatory, along with adherence to Directive 2001/83/EC on medicinal products for human use. Duty rates from 0% to 6.5% — many pharmaceutical substances qualify for 0% duty under the WTO Pharmaceutical Agreement. Marketing authorization or import permit from the national pharmaceutical authority required. Products must comply with GMP — GMP certificate issued by the competent authority of the manufacturing country. Shipments are subject to quality controls and may require laboratory testing upon import. When importing goods under heading 3003 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 3003 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).

Heading 3003 covers medicaments (excl. 3002, 3005, 3006) consisting of two or more constituents, not in measured doses or retail packing. Medicines in doses or retail packs: 3004, not 3003. Single-substance medicines (unmeasured): 2937, 2941 or others. Key distinction: 3003 = medicinal mixtures in BULK (not dosed), 3004 = measured doses or retail packaging.