Hierarchy

06Section VI — PRODUCTS OF THE CHEMICAL OR ALLIED INDUSTRIES

3003000000Medicaments (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

3003310000Other, containing hormones or other products of heading|2937

3003310000Containing insulin

3003390000Other

Duties & Measures

Third Country Duty0.000 %

Base rate (erga omnes)

Applies to all third countries without preferential agreement

0.000 %

Preferential rates(19)

Preferential rates - 19 Origin
Origin	Savings	Trade agreement	Details
EU-Switzerland agreement: re-imported goods1007 0.000 %	—	—	2
Preferential origin in accordance with the Agreement in the form of an Exchange of Letters between the European Union and the Kingdom of Morocco on the amendment of Protocols 1 and 4 to the Euro-Mediterranean Agreement establishing an association between the European Communities and their Member States, of the one part, and the Kingdom of Morocco, of the other part.2000 0.000 %	—	—
OCTs2080 0.000 %Overseas Association Decision	—	Overseas Association Decision
Andorra 0.000 %EU-Andorra Customs Union	—	EU-Andorra Customs Union
Switzerland 0.000 %EU-Switzerland Bilateral Agreements	—	EU-Switzerland Bilateral Agreements
Algeria 0.000 %EU-Algeria Association Agreement	—	EU-Algeria Association Agreement
Faroe Islands 0.000 %EU-Faroe Islands FTA	—	EU-Faroe Islands FTA
United Kingdom 0.000 %EU-UK Trade and Cooperation Agreement	—	EU-UK Trade and Cooperation Agreement

Low-value consignment customs duty(2)

inherited from 3000000000

ERGA OMNES

3.000 EURRegulation 0382/262026-07-01

TM01066From 1 July 2026 until 1 July 2028, a customs duty of EUR 3 per item in a consignment the intrinsic value of which does not exceed a total of EUR 150 shall apply instead of the relief eliminated pursuant to Article 1 of this Regulation, where: (a) the importation of the goods is exempt from VAT in accordance with Article 143(1), point (ca), of Directive 2006/112/EC; or (b) the goods are in a postal consignment as defined in Article 1, point (24), of Delegated Regulation (EU) 2015/2446.

ERGA OMNES

3.000 EUR4Regulation 0382/262026-11-01

4 certificate(s) required

C127Other certificates

Merchant product identifier

C128Other certificates

Non-standardised manufacturer product identifier

C129Other certificates

Standardised manufacturer product identifier

Y081Particular provisions

No standardised manufacturer product identifier for the declared product exists

Import not allowed

Import control(2)

inherited from 3000000000

Ukraine

Regulation 0692/142026-06-24

EU-Ukraine DCFTA(since 2016)

3 certificate(s) required

Y997Particular provisions

Goods not originating from or destined to Crimea or Sevastopol (Articles 2 and 2b.1 of Council Regulation (EU) No 692/2014)

N864UN/EDIFACT certificate

Invoice declaration or origin declaration made out by any exporter on invoice or any other commercial document

N954UN/EDIFACT certificate

Movement certificate EUR.1

Import not allowed

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.

Ukraine

Regulation 0263/222026-06-24

EU-Ukraine DCFTA(since 2016)

3 certificate(s) required

Y984Particular provisions

Goods not originating from or not destined for the non-government controlled areas of Ukraine in the oblasts of Donetsk, Kherson, Luhansk and Zaporizhzhia

N954UN/EDIFACT certificate

Movement certificate EUR.1

N864UN/EDIFACT certificate

Invoice declaration or origin declaration made out by any exporter on invoice or any other commercial document

Import/export not allowed after control

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.

Import control -REACH(1)

inherited from 3000000000

ERGA OMNES

Regulation 1907/062023-02-10

3 certificate(s) required

Y106Particular provisions

Compliance with the REACH restrictions defined in Column 2 of Annex XVII of Regulation (EC) No 1907/2006

Y110Particular provisions

Exemption from REACH restrictions by virtue of Article 67(1) and 67(2) of Regulation (EC) No 1907/2006

Y113Particular provisions

Substance/mixture not subjected to the provisions of Regulation (EC) No 1907/2006 (Annex XVII)

Import/export not allowed after control

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).

CHM00009REACH - Annex XVII - Entry 9

Start date: 1972-01-01

Description & Classification

Common misclassifications

3003390000: Medicaments contain hormones or other products of heading 2937, but do not contain insulin.

Classification tips

Medicaments contain insulin.

Typical uses

For therapeutic or prophylactic uses

Sample products

Medicaments consisting of mixed constituents, for therapeutic or prophylactic uses, not put up in measured doses or for retail sale, containing insulin

Regulatory notes

NENC3003

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

Chapter noteChapter 30 — Pharmaceutical products

1. This chapter does not cover: (a) foods or beverages (such as dietetic, diabetic or fortified foods, food supplements, tonic beverages and mineral waters), other than nutritional preparations for intravenous administration (Section IV); (b) preparations such as tablets, chewing gum or patches which are intended to help smokers stop smoking (heading 2106 or 3824); (c) plasters specially calcined or finely ground for use in dentistry (heading 2520); (d) aqueous distillates or aqueous solutions of essential oils, suitable for medicinal uses (heading 3301); (e) preparations of headings 3303 to 3307, even if they have therapeutic or prophylactic properties; (f) soap or other products of heading 3401 containing added medicaments; (g) preparations with a basis of plaster for use in dentistry (heading 3407); (h) albumin not prepared for therapeutic or prophylactic uses (heading 3502). 2. For the purposes of heading 3002, 'immunological products' applies when such products are used directly on patients for therapeutic or prophylactic purposes, including monoclonal antibodies (MAbs), antibody fragments, antibody conjugates and antibody fragment conjugates. 3. For the purposes of headings 3003 and 3004, the following are to be treated as: (a) 'unmixed products': unmixed products dissolved in water; all goods of Chapters 28 or 29; and simple vegetable extracts of heading 1302, merely standardised or dissolved in any solvent; (b) 'mixed products': colloidal solutions and suspensions; mixtures obtained from extraction of vegetable substances or of animal substances; and products of Note 3(a) to which substances have been added. 4. Heading 3006 applies only to: sterile surgical catgut and similar sterile suture materials; sterile laminaria and sterile laminaria tents; sterile absorbable surgical or dental haemostatics; opacifying preparations for X-ray examinations and diagnostic reagents designed to be administered to the patient; blood-grouping reagents; dental cements and other dental fillings; bone reconstruction cements; first-aid boxes and kits; chemical contraceptive preparations based on hormones, on other products of heading 2937 or on spermicides; gel preparations designed to be used in human or veterinary medicine as a lubricant for parts of the body for surgical operations or physical examinations or as a coupling agent between the body and medical instruments; pharmaceutical waste.

Non-preferential origin

tariff_shift

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.

CTH

tariff_shift

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.

CTH

Residual rule

Where the country of origin cannot be determined by application of the prima ry rules and the other

Annex 22-01 DA 2015/2446

FAQ

What is the EU customs duty for Containing insulin (3003310000)?

The third country duty (erga omnes) for Containing insulin is 0.000 %. This rate applies to imports from countries without a preferential trade agreement with the EU.

Are there tariff preferences for Containing insulin (3003310000)?

Yes, 16 tariff preferences are available for this code. Preferential rates apply to imports from countries with a trade agreement with the EU.

Are import controls required for Containing insulin (3003310000)?

Yes, 3 import control measure(s) apply to this code (e.g. CITES, REACH, sanitary controls, etc.).

What products are classified under code 3003310000?

TARIC code 3003310000 (Containing insulin) covers the following products: Medicaments consisting of mixed constituents, for therapeutic or prophylactic uses, not put up in measured doses or for retail sale, containing insulin, Insulin-containing medicaments of mixed constituents, not put up in measured doses or for retail sale.

How to correctly classify a product under code 3003310000?

Help

Need help?

Ask a question about this code or find a tariff classification expert.

Hierarchy

06Section VI — PRODUCTS OF THE CHEMICAL OR ALLIED INDUSTRIES

3000000000PHARMACEUTICAL PRODUCTS

3003310000Other, containing hormones or other products of heading|2937

3003310000Containing insulin

3003390000Other

Duties & Measures

Third Country Duty0.000 %

Base rate (erga omnes)

Applies to all third countries without preferential agreement

0.000 %

Preferential rates(19)

Preferential rates - 19 Origin
Origin	Savings	Trade agreement	Details
EU-Switzerland agreement: re-imported goods1007 0.000 %	—	—	2
Preferential origin in accordance with the Agreement in the form of an Exchange of Letters between the European Union and the Kingdom of Morocco on the amendment of Protocols 1 and 4 to the Euro-Mediterranean Agreement establishing an association between the European Communities and their Member States, of the one part, and the Kingdom of Morocco, of the other part.2000 0.000 %	—	—
OCTs2080 0.000 %Overseas Association Decision	—	Overseas Association Decision
Andorra 0.000 %EU-Andorra Customs Union	—	EU-Andorra Customs Union
Switzerland 0.000 %EU-Switzerland Bilateral Agreements	—	EU-Switzerland Bilateral Agreements
Algeria 0.000 %EU-Algeria Association Agreement	—	EU-Algeria Association Agreement
Faroe Islands 0.000 %EU-Faroe Islands FTA	—	EU-Faroe Islands FTA
United Kingdom 0.000 %EU-UK Trade and Cooperation Agreement	—	EU-UK Trade and Cooperation Agreement

Low-value consignment customs duty(2)

inherited from 3000000000

ERGA OMNES

3.000 EURRegulation 0382/262026-07-01

ERGA OMNES

3.000 EUR4Regulation 0382/262026-11-01

4 certificate(s) required

C127Other certificates

Merchant product identifier

C128Other certificates

Non-standardised manufacturer product identifier

C129Other certificates

Standardised manufacturer product identifier

Y081Particular provisions

No standardised manufacturer product identifier for the declared product exists

Import not allowed

Import control(2)

inherited from 3000000000

Ukraine

Regulation 0692/142026-06-24

EU-Ukraine DCFTA(since 2016)

3 certificate(s) required

Y997Particular provisions

Goods not originating from or destined to Crimea or Sevastopol (Articles 2 and 2b.1 of Council Regulation (EU) No 692/2014)

N864UN/EDIFACT certificate

Invoice declaration or origin declaration made out by any exporter on invoice or any other commercial document

N954UN/EDIFACT certificate

Movement certificate EUR.1

Import not allowed

Ukraine

Regulation 0263/222026-06-24

EU-Ukraine DCFTA(since 2016)

3 certificate(s) required

Y984Particular provisions

Goods not originating from or not destined for the non-government controlled areas of Ukraine in the oblasts of Donetsk, Kherson, Luhansk and Zaporizhzhia

N954UN/EDIFACT certificate

Movement certificate EUR.1

N864UN/EDIFACT certificate

Invoice declaration or origin declaration made out by any exporter on invoice or any other commercial document

Import/export not allowed after control

Import control -REACH(1)

inherited from 3000000000

ERGA OMNES

Regulation 1907/062023-02-10

3 certificate(s) required

Y106Particular provisions

Compliance with the REACH restrictions defined in Column 2 of Annex XVII of Regulation (EC) No 1907/2006

Y110Particular provisions

Exemption from REACH restrictions by virtue of Article 67(1) and 67(2) of Regulation (EC) No 1907/2006

Y113Particular provisions

Substance/mixture not subjected to the provisions of Regulation (EC) No 1907/2006 (Annex XVII)

Import/export not allowed after control

CHM00009REACH - Annex XVII - Entry 9

Start date: 1972-01-01

Trade Statistics

Description & Classification

Common misclassifications

3003390000: Medicaments contain hormones or other products of heading 2937, but do not contain insulin.

Classification tips

Medicaments contain insulin.

Typical uses

For therapeutic or prophylactic uses

Sample products

Medicaments consisting of mixed constituents, for therapeutic or prophylactic uses, not put up in measured doses or for retail sale, containing insulin

CJEU Case Law

C-941/19

10 Mar 2021

Samohýl group a.s. v Generální ředitelství cel

On those grounds, the Court (Ninth Chamber) hereby rules: The Combined Nomenclature set out in Annex I to Council Regulation (EEC) No 2658/87 of 23 July 1987 on the tariff and statistical nomenclature and on the Common Customs Tariff, in the version resulting from Commission Implementing Regulation (EU) No 1101/2014 of 16 October 2014, must be interpreted as meaning that a product consisting of a solution intended for cats, which must be applied by local cutaneous route (spot-on) by means of pipettes (0.5ml) and which contains the active substance fipronil (50 mg per pipette), and excipients, such as butylated hydroxyanisole E 320, butylated hydroxytoluene E 321, benzyl alcohol and diethylene glycol monoethyl ether, comes within tariff heading 3808 of the CN, as an ‘insecticide’, subject to the assessment by the referring court of all the facts at its disposal. [Signatures] ( *1 ) Language of the case: Czech.

Regulatory notes

NENC3003

Chapter noteChapter 30 — Pharmaceutical products

Non-preferential origin

tariff_shift

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.

CTH

tariff_shift

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.

CTH

Residual rule

Where the country of origin cannot be determined by application of the prima ry rules and the other

Annex 22-01 DA 2015/2446

FAQ

What is the EU customs duty for Containing insulin (3003310000)?

The third country duty (erga omnes) for Containing insulin is 0.000 %. This rate applies to imports from countries without a preferential trade agreement with the EU.

Are there tariff preferences for Containing insulin (3003310000)?

Yes, 16 tariff preferences are available for this code. Preferential rates apply to imports from countries with a trade agreement with the EU.

Are import controls required for Containing insulin (3003310000)?

Yes, 3 import control measure(s) apply to this code (e.g. CITES, REACH, sanitary controls, etc.).

What products are classified under code 3003310000?

How to correctly classify a product under code 3003310000?

Help

Need help?

Ask a question about this code or find a tariff classification expert.

Synonyms

insulin-containing medicaments, non-dose insulin preparation, bulk insulin-containing medicament

Materials

Containing insulin

Keywords

insulin-containing medicaments · non-dose insulin preparation · bulk insulin-containing medicament · Containing insulin · For therapeutic or prophylactic uses · Not put up in measured doses or in forms or packings for retail sale

Section noteNotes to Section VI — Products of the chemical or allied industries

1. (A) Products (other than radioactive ores) answering to a description in heading 2844 or 2845 are to be classified in those headings and in no other heading of the Nomenclature. (B) Subject to paragraph (A) above, products answering to a description in heading 2843, 2846 or 2852 are to be classified in those headings and in no other heading of this Section. 2. Subject to Note 1 above, products classifiable in heading 3004, 3005, 3006, 3212, 3303, 3304, 3305, 3306, 3307, 3506, 3707 or 3808 by reason of being put up in measured doses or for retail sale are to be classified in those headings and in no other heading of the Nomenclature. 3. Goods put up in sets consisting of two or more separate constituents, some or all of which fall in this Section and are intended to be mixed together to obtain a product of Section VI or VII, are to be classified in the heading appropriate to that product, provided that the constituents are: (a) having regard to the manner in which they are put up, clearly identifiable as being intended for use together without first being repacked; (b) presented together; and (c) identifiable, whether by their nature or by the relative proportions in which they are present, as being complementary one to another.

What are the non-preferential origin rules for Containing insulin (3003310000)?

Non-preferential origin rules for Containing insulin are defined in Annex 22-01 of the UCC Delegated Act. These rules determine the country of origin for MFN duty rates, trade policy measures, and origin marking.

Trade Statistics

Imports

€0

Exports

€0

Balance

€0

Import €/kg

€133.69/kg

Export €/kg

€101.24/kg

Market concentration (HHI)

8,121

Concentrated

Trade value (2022–2025)

Import sources

Third-country sourcing partners

#	Partner	Value (EUR)	kg	€/kg	Share
1	🇺🇸 United States	€26.1M	213Kt	€122.42/kg	89.5%
2	🇨🇳 China	€3.0M	4Kt	€805.15/kg	10.4%
3	🇬🇧 United Kingdom	€11K	52	€213.60/kg	0.0%
4	🇮🇳 India	€2K	47	€48.94/kg	0.0%
5	🇳🇴 Norway	€2K	56	€36.13/kg	0.0%
6	🇧🇩 Bangladesh	€1K	894	€1.58/kg	0.0%

Export markets

Third-country target markets

#	Partner	Value (EUR)	kg	€/kg	Share
1	🇬🇧 United Kingdom	€1.1M	10Kt	€109.16/kg	53.8%
2	🇾🇪 YE	€369K	5Kt	€76.82/kg	18.6%
3	🇧🇩 Bangladesh	€166K	8	€20.8K/kg	8.4%
4	🇳🇨 NC	€163K	374	€436.75/kg	8.2%
5	🇵🇫 PF	€118K	317	€371.80/kg	5.9%
6	🇲🇾 Malaysia	€83K	67	€1.2K/kg	4.2%
7	🇺🇸 United States	€11K	59	€183.58/kg	0.5%
8	🇵🇲 PM	€5K	49	€97.06/kg	0.2%
9	🇨🇦 Canada	€145	-	-	0.0%

EU Member States

EU ImportersEU Exporters

View full analysis

Imports

€0

Exports

€0

Balance

€0

Import €/kg

€133.69/kg

Export €/kg

€101.24/kg

Market concentration (HHI)

8,121

Concentrated

Trade value (2022–2025)

Import sources

Third-country sourcing partners

#	Partner	Value (EUR)	kg	€/kg	Share
1	🇺🇸 United States	€26.1M	213Kt	€122.42/kg	89.5%
2	🇨🇳 China	€3.0M	4Kt	€805.15/kg	10.4%
3	🇬🇧 United Kingdom	€11K	52	€213.60/kg	0.0%
4	🇮🇳 India	€2K	47	€48.94/kg	0.0%
5	🇳🇴 Norway	€2K	56	€36.13/kg	0.0%
6	🇧🇩 Bangladesh	€1K	894	€1.58/kg	0.0%

Export markets

Third-country target markets

#	Partner	Value (EUR)	kg	€/kg	Share
1	🇬🇧 United Kingdom	€1.1M	10Kt	€109.16/kg	53.8%
2	🇾🇪 YE	€369K	5Kt	€76.82/kg	18.6%
3	🇧🇩 Bangladesh	€166K	8	€20.8K/kg	8.4%
4	🇳🇨 NC	€163K	374	€436.75/kg	8.2%
5	🇵🇫 PF	€118K	317	€371.80/kg	5.9%
6	🇲🇾 Malaysia	€83K	67	€1.2K/kg	4.2%
7	🇺🇸 United States	€11K	59	€183.58/kg	0.5%
8	🇵🇲 PM	€5K	49	€97.06/kg	0.2%
9	🇨🇦 Canada	€145	-	-	0.0%

EU Member States

EU ImportersEU Exporters

View full analysis