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30043900
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
22 docs
C057C079C082Y120Y121Y123+16
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

DEgold883/25-1

Estradiol hormone transdermal patch

mieszanina chemiczna z estradiolemGRI 1GRI 6
DEgold068/24-1

Misoprostol tablets for ulcer treatment

substancja czynna farmaceutyczna (Misoprostol)GRI 1GRI 6
DKgold-0857801

GLP-1 analogue injection pen for diabetes

analog GLP-1 (glukagonopodobny peptyd-1)GRI 1GRI 3bGRI 6
DKgold-1851044

Disposable insulin injection pen

aktywna substancja farmaceutyczna (analog hormonu)GRI 1GRI 3bGRI 6
DKgold-1867925

Oral diabetes medication tablets

substancja czynna (analog hormonu)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.

Classification scope of CN code 300439

CN code 300439 covers other medicines containing hormones or other products of heading 2937, put up in measured doses or in forms for retail sale, excluding medicines containing insulin (code 300431). Products classified here are finished medicinal products containing steroid hormones (oestrogens, progestogens, androgens, corticosteroids), thyroid hormones (levothyroxine, liothyronine), pituitary hormones (somatotropin, oxytocin), parathyroid hormones, and their synthetic analogues and derivatives. Pharmaceutical forms include tablets, capsules, transdermal patches, gels, creams, injection solutions, subcutaneous implants, and nasal delivery systems. Products must be packaged in doses or retail forms - hormonal preparations in bulk form are classified under code 300259.

Pharmaceutical regulations and trade control

Importing hormonal medicines into the EU requires a marketing authorisation (MA) issued by the EMA or a national regulatory authority under Directive 2001/83/EC. Prescription hormonal medicines are subject to mandatory serialisation under Directive 2011/62/EU. The manufacturer must hold a GMP certificate and the distributor a GDP certificate. Special requirements apply to medicines containing sex hormones - hormonal contraception and hormone replacement therapy are subject to enhanced pharmacovigilance requirements including Periodic Safety Update Reports (PSURs) and Risk Management Plans. Anabolic steroids may be subject to additional restrictions as substances with abuse potential. Medicines containing growth hormone (somatotropin) require the centralised EMA registration procedure as biotechnological medicines.

Practical guidance for importers

At customs clearance of hormonal medicines under CN code 300439, the marketing authorisation, manufacturer's GMP certificate, Certificate of Analysis (CoA), and packaging serialisation documentation must be presented. Many hormonal medicines require cold chain transport (2 to 8 degrees Celsius), particularly biological preparations such as somatotropin. Transdermal patches and hormonal gels may require protection from elevated temperatures and light. Duty rates should be checked in TARIC or ISZTAR - numerous hormonal medicines benefit from autonomous duty suspensions. The importer should verify that the product does not contain substances banned in the EU (e.g. diethylstilboestrol has been withdrawn from the market) and that it meets current labelling requirements under Directive 2001/83/EC, including the patient information leaflet in the local language.

GMP requirements and drug registration

Importing pharmaceutical products under CN code 3004 39 (Other hormonal 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.

Frequently asked questions

Are oral contraceptive pills classified under code 300439?
Yes. Oral contraceptives containing hormones (oestrogens, progestogens, or their combinations), packaged in doses for retail sale, are classified under CN code 300439. This applies to both monophasic and multiphasic tablets, as well as progestogen-only preparations (mini-pills). Contraceptive patches and vaginal rings are also covered by this classification.
Do corticosteroid medicines require special import permits?
Medicines containing cortisone and other corticosteroids do not require special narcotic permits, as they are not controlled substances under UN conventions. However, they are subject to standard pharmaceutical requirements: marketing authorisation, manufacturer's GMP certificate, and GDP principles in distribution. Import requires holding a pharmaceutical wholesale distribution authorisation.
How to distinguish hormonal medicine classification between codes 300431 and 300439?
Code 300431 is exclusively for medicines containing insulin. All other hormonal medicines packaged in retail doses - containing oestrogens, progestogens, corticosteroids, thyroid hormones, somatotropin, and other hormones - are classified under code 300439. The sole distinguishing criterion is the type of hormone: insulin versus all other hormones.
What permits are needed to import medicines CN 3004 39?
Importing medicines under CN code 3004 39 requires a marketing authorisation (national/EMA), import licence from the national medicines agency, manufacturer GMP certificate, and GDP documentation.

Useful tools & resources

Customs calculators
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Related glossary terms
Customs DutyCustoms ValueMFN Rate