30039000
3›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
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.
Import control on REACHERGA OMNESR1907/06
Import control on REACH
ERGA OMNESR1907/06
Documents / references
Y106Y110Y113
Conditions
- B001Presentation of a certificate/licence/document: Y106— Import/export allowed after control
- B010Presentation of a certificate/licence/document: Y110— Import/export allowed after control
- B020Presentation of a certificate/licence/document: Y113— Import/export allowed after control
- B090Presentation of a certificate/licence/document: the condition is not fulfilled— Import/export not allowed after control
Notes
- CHM00009REACH - Annex XVII - Entry 9
- CD730A substance for which Annex XVII contains a restriction shall not be imported unless it complies with the conditions of that restriction.This shall not apply to the manufacture, placing on the market or use of a substance in scientific research and development. Annex XVII shall specify if the restriction shall not apply to product and process orientated research and development, as well as the maximum quantity exempted.The restrictions shall not apply to the use of substances in cosmetic products, as defined by Regulation (EC) No 1223/2009 of the European Parliament and of the Council of 30 November 2009 on cosmetic products (repealing the Directive 76/768/EEC), with regard to restrictions addressing the risks to human health within the scope of that regulation.(Article 67 points 1 and 2 of Regulation (EC) No 1907/2006).
The quality of solid fuelsERGA OMNESP1654/18
The quality of solid fuels
ERGA OMNESP1654/18
Documents / references
7P237P24
Conditions
- C001Presentation of a certificate/licence/document: 7P23— Entry into free circulation allowed
- C002Presentation of a certificate/licence/document: 7P24— Entry into free circulation allowed
- C003Presentation of a certificate/licence/document: the condition is not fulfilled— The entry into free circulation is not allowed
The quality of solid fuelsERGA OMNESP1654/18
The quality of solid fuels
ERGA OMNESP1654/18
Documents / references
7P237P24
Conditions
- C001Presentation of a certificate/licence/document: 7P23— Entry into free circulation allowed
- C002Presentation of a certificate/licence/document: 7P24— Entry into free circulation allowed
- C003Presentation of a certificate/licence/document: the condition is not fulfilled— The entry into free circulation is not allowed
The quality of solid fuelsERGA OMNESP1654/18
The quality of solid fuels
ERGA OMNESP1654/18
Documents / references
7P237P24
Conditions
- C001Presentation of a certificate/licence/document: 7P23— Entry into free circulation allowed
- C002Presentation of a certificate/licence/document: 7P24— Entry into free circulation allowed
- C003Presentation of a certificate/licence/document: the condition is not fulfilled— The entry into free circulation is not allowed
The quality of solid fuelsERGA OMNESP1654/18
The quality of solid fuels
ERGA OMNESP1654/18
Goods for torture and repression, export restrictionALLTC (excl. AD, AI, AL, AR, AU, AW, BA, BJ, BL, BM, BO, BQ, CA, CH, CO, CR, CV, CW, DJ, DO, EC, FK, FO, GA, GE, GI, GL, GS, GW, HN, IS, KG, LI, LR, MD, ME, MK, MN, MS, MX, MZ, NA, NC, NI, NO, NP, NZ, PA, PF, PH, PM, PY, RW, SC, SH, SM, ST, SX, TC, TF, TG, TL, TM, TR, UA, UY, UZ, VE, WF, XC, XL, XS, ZA)R0125/19
Goods for torture and repression, export restriction
ALLTC (excl. AD, AI, AL, AR, AU, AW, BA, BJ, BL, BM, BO, BQ, CA, CH, CO, CR, CV, CW, DJ, DO, EC, FK, FO, GA, GE, GI, GL, GS, GW, HN, IS, KG, LI, LR, MD, ME, MK, MN, MS, MX, MZ, NA, NC, NI, NO, NP, NZ, PA, PF, PH, PM, PY, RW, SC, SH, SM, ST, SX, TC, TF, TG, TL, TM, TR, UA, UY, UZ, VE, WF, XC, XL, XS, ZA)R0125/19
Documents / references
E990Y906
Conditions
- Y001Other conditions: E990— Import/export allowed after control
- Y002Other conditions: Y906— Import/export allowed after control
- Y003Other conditions: the condition is not fulfilled— Import/export not allowed after control
Notes
- CD789If the declared goods are described in the "TR" footnotes linked to the measure, an export authorisation is required.
- TR015Short and intermediate acting barbiturate anaesthetic agents including, but not limited to: (g) thiopental (CAS RN 76-75-5) (h) thiopental sodium salt (CAS RN 71-73-8), also known as thiopentone sodium
- TR014Short and intermediate acting barbiturate anaesthetic agents including, but not limited to: (a) amobarbital (CAS RN 57-43-2) (b) amobarbital sodium salt (CAS RN 64-43-7) (c) pentobarbital (CAS RN 76-74-4) (d) pentobarbital sodium salt (CAS 57-33-0) (e) secobarbital (CAS RN 76-73-3) (f) secobarbital sodium salt (CAS RN 309-43-3) This item also controls products containing one of the anaesthetic agents listed under short or intermediate acting barbiturate anaesthetic agents
Goods for torture and repression, export restrictionTRDESTR0125/19
Goods for torture and repression, export restriction
TRDESTR0125/19
Documents / references
C068E990Y906
Conditions
- Y001Other conditions: C068— Import/export allowed after control
- Y002Other conditions: E990— Import/export allowed after control
- Y003Other conditions: Y906— Import/export allowed after control
- Y004Other conditions: the condition is not fulfilled— Import/export not allowed after control
Notes
- CD789If the declared goods are described in the "TR" footnotes linked to the measure, an export authorisation is required.
- TR015Short and intermediate acting barbiturate anaesthetic agents including, but not limited to: (g) thiopental (CAS RN 76-75-5) (h) thiopental sodium salt (CAS RN 71-73-8), also known as thiopentone sodium
- TR014Short and intermediate acting barbiturate anaesthetic agents including, but not limited to: (a) amobarbital (CAS RN 57-43-2) (b) amobarbital sodium salt (CAS RN 64-43-7) (c) pentobarbital (CAS RN 76-74-4) (d) pentobarbital sodium salt (CAS 57-33-0) (e) secobarbital (CAS RN 76-73-3) (f) secobarbital sodium salt (CAS RN 309-43-3) This item also controls products containing one of the anaesthetic agents listed under short or intermediate acting barbiturate anaesthetic agents
Import controlUAR0692/14
Import control
UAR0692/14
Documents / references
N954U045U078U079Y997
Conditions
- Y001Other conditions: Y997— Import allowed
- Y002Other conditions: U078— Import allowed
- Y003Other conditions: U079— Import allowed
- Y005Other conditions: N954— Import allowed
- Y007Other conditions: U045— Import allowed
- Y009Other conditions: the condition is not fulfilled— Import is not allowed
Notes
- CD967I. According to Council Regulation (EU) No 692/2014, it shall be prohibited to import into European Union goods originating in Crimea or Sevastopol.The prohibition shall not apply in respect of goods originating in Crimea or Sevastopol which have been made available to the Ukrainian authorities for examination, for which compliance with the conditions conferring entitlement to preferential origin has been verified and for which a certificate of origin has been issued in accordance with the Association Agreement between the European Union and its Member States, of the one part, and Ukraine, of the other part.II. According to the Council Regulation (EU) 692/2014, the export of goods and technologies suited for use in the sectors of transport; telecommunications; energy; prospection, exploration and production of oil, gas and mineral resources is prohibited:(a) to any natural or legal person, entity or body in Crimea or Sevastopol, or(b) for use in Crimea or Sevastopol.
Import controlUAR0263/22
Import control
UAR0263/22
Documents / references
N954U045U078U079Y984
Conditions
- Y001Other conditions: Y984— Import/export allowed after control
- Y002Other conditions: N954— Import/export allowed after control
- Y005Other conditions: U045— Import/export allowed after control
- Y006Other conditions: U078— Import/export allowed after control
- Y007Other conditions: U079— Import/export allowed after control
- Y009Other conditions: the condition is not fulfilled— Import/export not allowed after control
Notes
- CD860According to Council Regulation (EU) 2022/263 (OJ L42I, p. 77):I. It shall be prohibited to import into the European Union goods originating in non-government controlled areas of the Donetsk, Kherson, Luhansk and Zaporizhzhia oblasts of Ukraine.The import prohibitions not apply in respect of: (a) the execution until 24 May 2022 of trade contracts concluded before 23 February 2022, or of ancillary contracts necessary for the execution of such contracts, provided that the natural or legal person, entity or body seeking to perform the contract has notified, at least 10 working days in advance, the activity or transaction to the competent authority of the Member State in which they are established; (b) goods originating in the specified territories which have been made available to the Ukrainian authorities for examination, for which compliance with the conditions conferring entitlement to preferential origin has been verified and for which a certificate of origin has been issued in accordance with the EU-Ukraine Association Agreement.II. It shall be prohibited to sell, supply, transfer or export goods and technology listed in Annex II to Council Regulation (EU) 2022/263: (a) to any natural or legal person, entity or body in the specified territories, or (b) for use in the specified territories. Annex II shall include certain goods and technologies suited for use in the following key sectors: (i) transport;(ii) telecommunications;(iii) energy; (iv) the prospecting, exploration and production of oil, gas and mineral resources. The prohibitions in point II above shall be without prejudice to the execution until 24 August 2022 of an obligation arising from a contract concluded before 23 February 2022, or from ancillary contracts necessary for the execution of such contracts, provided that the competent authority has been informed at least five working days in advance.
Value Added Tax (VAT)
V011Dietary foods for special medical purposes referred to in the Actof 25 August 2006 on food safety and nutrition
5%V020Medical devices, as defined by the Act on Medical Devices of 20 May 2010, (Journal of Laws of 2019, item 175, 447, 534), released for free circulation on the territory of the Republic of Poland
8%V021Medicinal products released for free circulation on the territory of the Republic of Poland according to the Pharmaceutical Act of 6 September 2001 (Journal of Laws of 2019, items 499, 399,959, 1495, 1542, 1556, 1590) and those for which permissions were issued by Council of European Union or by European Commission
8%V120For medical devices referred to in item 13 of Annex No. 3 to the Act in the wording applicable before the date of entry into force of the Act of 7 April 2022 on medical devices (Journal of Laws, item 974), the tax rate referred to in Art. 41 sec. 2 shall apply if, in accordance with: 1) Art. 120 sec. 4 of the regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC (Official Journal of the European Union L117 of 5 April 2017) or 2) Article 110 paragraph 4 of the regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU (Official Journal of the European Union L117 of 5 April 2017) – these products have been placed on the market and are still being made available on the market or put into use.
8%V999Other
23%Excise duty
X019Products having an actual alcoholic strength by volume exceeding 1,2% volume
8391 PLN / LPXX091Products of an actual alcoholic strength not exceeding 1,2% vol
wyroby nieobjęte akcyząCodes in the same group
300310Containing penicillins or derivatives thereof, with a penicillanic acid structure, or streptomycins or their derivatives300320Other, containing antibiotics300331Other, containing hormones or other products of heading|2937 - Containing insulin300339Other300341Other, containing alkaloids or derivatives thereof - Containing ephedrine or its salts300342Containing pseudoephedrine (INN) or its salts300343Containing norephedrine or its salts300349Other
5
Binding Tariff Information
BTI classification examples
IEgold4-BTI362
Spray dried pharmaceutical intermediate powder
mieszanina farmaceutycznaGRI 1GRI 6
IEgold5-BTI195
Diclofenac Sodium medicament in bulk pellets
substancja farmaceutyczna (Diclofenac Sodium)GRI 1GRI 6
FRgold25-03399
Potassium bicarbonate bulk medicinal preparation
wodorowęglan potasuGRI 1GRI 5bGRI 6
IEgold026-BTI9
Horse chestnut extract pellets in capsules
ekstrakt z kasztanowca (Aesculus hippocastanum)GRI 1GRI 6
DEgold844/24-1
Medicinal dragees: psyllium with senna extract
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.
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