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30039000
3Medicaments (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

Other

Standard EU duty
0%
VAT
23%
Additional duties / sanctions
0 rules
Docs required
14 docs
Y106Y110Y1137P237P24E990+8
Preferences
ERGA OMNES 0%AD 0%CH 0%DZ 0%EH 0%FO 0%GB 0%IL 0%JO 0%LB 0%LOMB 0%MA 0%SM 0%SWITZ 0%SY 0%TN 0%TR 0%XC 0%XL 0%
Notes
TM904Preferences granted under the agreement between the European Union and Morocco in force from 19 July 2019.As of 3 October 2025, products originating in Western Sahara subject to controls by the customs authorities of the Kingdom of Morocco shall benefit from trade preferences under the terms of the new Agreement in the form of exchange of letters between the EU and Morocco, The European Union and the Kingdom of Morocco have agreed to allow those products to be identified by reference to the region of origin to be included in the proof of origin and as provided for in Protocol 4.In view of the application of these measures, the origin certificates codes U179 and U180 must be declared.The country code to be entered in the origin declaration when these proofs of origin are used is “EH”.
CD906The list of non-eligible locations and their postal codes is available at the following address: http://ec.europa.eu/taxation_customs/customs/technical-arrangement_postal-codes.pdf
CD500Eligibility to benefit from this preference is subject to the presentation of a proof of origin stating the community origin of the goods, in the context of the agreement between the European Union and the Swiss Confederation.
5

Binding Tariff Information

BTI classification examples

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mieszanina farmaceutycznaGRI 1GRI 6
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FRgold25-03399

Potassium bicarbonate bulk medicinal preparation

wodorowęglan potasuGRI 1GRI 5bGRI 6
IEgold026-BTI9

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DEgold844/24-1

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materiał roślinny (nasiona babki płesznik i ekstrakt senesu)GRI 1GRI 6

BTI (Binding Tariff Information) is an official EU customs decision confirming the classification of goods. Valid for 3 years, binding across all EU member states.

Scope of CN code 300390

CN code 300390 covers other medicaments consisting of two or more constituents mixed together for therapeutic or prophylactic uses, not put up in measured doses or in forms for retail sale, not classified under other subheadings of heading 3003. This is a residual heading covering bulk pharmaceutical preparations whose main active ingredients are not alkaloids, hormones, vitamins, or antibiotics – those are classified under the respective subheadings 300310 to 300360. Products under code 300390 include mixtures of active substances for further formulation, pharmaceutical premixes, medicine concentrates, and other multi-component preparations intended for the production of finished medicines. Single-substance products (containing only one active ingredient) do not fall under heading 3003 but are classified in the appropriate headings of Chapter 28 or 29.

Regulatory requirements and pharmaceutical oversight

Import of bulk medicines under CN code 300390 is governed by Directive 2001/83/EC on medicinal products for human use. The manufacturer must hold a GMP certificate confirming compliance with Good Manufacturing Practice principles, and the production site should be registered in the EudraGMDP database. The importer must hold an authorisation for manufacturing or importing medicinal products issued by the competent pharmaceutical supervisory authority. Multi-component preparations require documentation of the qualitative and quantitative composition of all active and excipient substances. The pharmacoepidemiological system requires comprehensive documentation enabling traceability of each batch throughout the supply chain. For medicines containing novel or innovative substances, additional requirements for preclinical and clinical safety assessment may apply.

Practical import guidance

At customs clearance for goods under CN code 300390, the importer should present the manufacturer's GMP certificate, a Certificate of Analysis (CoA) containing the full quantitative composition of the preparation, pharmacopoeial or manufacturer's internal specification, and documentation confirming the pharmaceutical intended use. Customs authorities may request additional clarification on preparation composition to confirm correct tariff classification – for multi-component medicines, it is essential to demonstrate that the product does not contain alkaloids, hormones, or antibiotics as main active substances, as these would require classification under subheadings 300310 to 300360. Duty rates and autonomous suspensions should be checked in TARIC or ISZTAR. Transport must comply with GDP requirements, taking into account specific temperature requirements specified by the manufacturer.

GMP requirements and drug registration

Importing pharmaceutical products under CN code 3003 90 (Other medicines not in doses) requires authorisation from the national medicines agency. All medicines placed on the EU market must hold a marketing authorisation issued by EMA (centralised procedure) or a national authority. Compliance with Good Manufacturing Practice (GMP) confirmed by a certificate is mandatory. Biological products require cold chain maintenance. Serialisation and authenticity verification (FMD 2011/62/EU) are mandatory for prescription medicines.

Frequently asked questions

When is a multi-component medicine classified under 300390 rather than 300310-300360?
Code 300390 applies when the preparation's main active substances do not include antibiotics, hormones, alkaloids, or vitamins – these have dedicated subheadings (300310-300360). If a preparation contains, for example, a combination of a non-opioid analgesic with an anti-inflammatory substance, classification falls under code 300390. The key is determining which active substances dominate the preparation's composition.
Are pharmaceutical premixes for medicine production classified under 300390?
Yes, provided the premix contains at least two substances mixed together for therapeutic purposes. The preparation must have a pharmaceutical rather than merely chemical character. Single-substance premixes are classified under Chapter 28 or 29 as chemical substances. Documentation should clearly indicate the pharmaceutical intended use and preparation composition.
Is a marketing authorisation required for importing bulk medicines?
Bulk medicines under code 300390 require a medicinal product import authorisation but do not always require an individual marketing authorisation (MA) if they are intended for further processing by a licensed manufacturer holding their own MA for the finished product. However, the importer must hold a manufacturing or import authorisation from the competent pharmaceutical inspectorate.
What permits are needed to import medicines CN 3003 90?
Importing medicines under CN code 3003 90 requires a marketing authorisation (national/EMA), import licence from the national medicines agency, manufacturer GMP certificate, and GDP documentation.