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3›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

Other

Standard EU duty
0%
VAT
23%
Additional duties / sanctions
0 rules
Docs required
31 docs
C400Y900C057C079C082Y120+25
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.
CloseMRN — potwierdzenie wywozu z każdego portu UE
5

Binding Tariff Information

BTI classification examples

SKgold5/24/112

Medical nitrous oxide gas in pressurized bottles

linenGRI 1GRI 5bGRI 6
ESgold24REN805

70° denatured alcohol disinfectant for skin

alkohol denaturowany 70°GRI 1GRI 6
ESgold24REN807

Hydrogen peroxide skin disinfectant liquid

linenGRI 1GRI 6
IEgold4-BTI286

Hard gelatin capsules with diclofenac/omeprazole pellets

żelatynaGRI 1GRI 6
ESgold5SOL1501

Antibacterial gel-cream for wound treatment

silverGRI 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 300490

CN code 300490 covers other medicaments consisting of two or more constituents mixed together, for therapeutic or prophylactic uses, put up in measured doses or in forms for retail sale, not classified under subheadings 300410 to 300450. This is the broadest residual heading within heading 3004, covering finished medicines whose main active substances are not antibiotics, hormones, alkaloids, or vitamins. Products classified here include analgesics (paracetamol, ibuprofen, acetylsalicylic acid in combination preparations), anti-inflammatory medicines, cardiovascular medicines, neurological medicines, dermatological medicines, and many other therapeutic categories. Pharmaceutical forms include tablets, capsules, ointments, creams, gels, injection solutions, aerosols, patches, and therapeutic systems. This heading also covers single-substance medicines packaged in retail doses.

Regulatory requirements and pharmaceutical oversight

Importing medicines under CN code 300490 into the EU is subject to the full regulatory requirements of Directive 2001/83/EC. Each imported medicine must hold a marketing authorisation (MA) valid in the destination country. The manufacturer must hold a GMP certificate, and production must take place at facilities registered in the EudraGMDP database. The Falsified Medicines Directive 2011/62/EU requires serialisation of prescription medicine packaging comprising a unique identifier and anti-tampering device. The importer must hold a pharmaceutical wholesale distribution authorisation and comply with GDP requirements for storage and distribution. The pharmacoepidemiological system requires maintaining adverse reaction registries and fulfilling pharmacovigilance obligations. For generic medicines, proof of bioequivalence with the reference medicine is required.

Practical import guidance

Customs clearance of medicines under CN code 300490 requires presentation of the marketing authorisation, manufacturer's GMP certificate, Certificate of Analysis (CoA), serialisation documentation, and confirmation that labelling complies with Directive 2001/83/EC. Given the enormous diversity of products classified under this code, customs authorities may request detailed composition information to verify classification correctness - particularly to demonstrate that the product does not contain antibiotics, hormones, alkaloids, or vitamins as main active substances. Transport conditions depend on product specifics, ranging from controlled room temperature to cold chain. Duty rates and autonomous duty suspensions should be checked in TARIC or ISZTAR. The importer should ensure that the product bears complete labelling in the local language, including a patient information leaflet.

GMP requirements and drug registration

Importing pharmaceutical products under CN code 3004 90 (Other medicines 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. Customs clearance requires Good Distribution Practice (GDP) documentation.

Frequently asked questions

Are single-substance medicines (e.g. paracetamol tablets alone) classified under code 300490?
Yes. Heading 3004 covers both combination and single-substance medicines packaged in doses for retail sale, provided the active substance is not an antibiotic, hormone, alkaloid, or vitamin. Paracetamol in retail-packaged tablets is classified under code 300490. The criterion is the presentation form - in doses or retail packaging.
What requirements apply to importing generic medicines into the EU?
Generic medicines imported into the EU must hold a marketing authorisation (MA) obtained by demonstrating bioequivalence with the reference medicine. A manufacturer's GMP certificate, Certificate of Analysis (CoA), and serialisation compliance for prescription medicines are required. The registration process for generics is simplified compared to innovative medicines, but manufacturing and distribution quality requirements are identical.
Is a prescription dermatological ointment classified under code 300490?
Yes, provided the main active substance is not a hormone (such as a corticosteroid), antibiotic, or alkaloid. Ointments with corticosteroids are classified under code 300439 (hormonal medicines), and those with antibiotics under code 300420. Ointments with non-steroidal anti-inflammatory substances or other active substances are classified under code 300490.
What permits are needed to import medicines CN 3004 90?
Importing medicines under CN code 3004 90 requires a marketing authorisation (national/EMA), import licence from the national medicines agency, manufacturer GMP certificate, and GDP documentation.

Useful tools & resources

Customs calculators
Duty & VAT CalculatorCalculate customs duty and VAT for "Other" and see the full import cost.Import Profitability CalculatorCheck the import profitability of "Other" with all costs included.
Related glossary terms
Customs DutyCustoms ValueMFN Rate