30043900
3›Medicaments (ausgenommen goods der Position 3002, 3005 or 3006) consisting of mixed or unmixed Erzeugnisse for therapeutisch or prophylaktisch uses, in abgemessenen Dosen (einschließlich those in Form von transdermal administration systems) or in forms or packings für den Einzelverkauf
Medicaments (ausgenommen goods der Position 3002, 3005 or 3006) consisting of mixed or unmixed Erzeugnisse for therapeutisch or prophylaktisch uses, in abgemessenen Dosen (einschließlich those in Form von transdermal administration systems) or in forms or packings für den Einzelverkauf, andere, containing Hormone or andere Erzeugnisse der Position 2937, andere
EU-Regelzollsatz
0%
MwSt.
19%
Zusatzzölle / Sanktionen
0 Regeln
Erforderliche Dokumente
22 Dok.
C057C079C082Y120Y121Y123+16
Praferenzen
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%
Hinweise
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 of fluorinated greenhouse gasesERGA OMNESR0573/24
Import control of fluorinated greenhouse gases
ERGA OMNESR0573/24
Dokumente / Referenzen
C057C079C082Y120Y121Y123Y160Y162Y163Y166Y179
Bedingungen
- YA001Other conditions: Y123- Import/export allowed after control
- YA005Other conditions: Y160- Import/export allowed after control
- YA010Other conditions: Y162- Import/export allowed after control
- YA090Other conditions: the condition is not fulfilled- Import/export not allowed after control
- YB001Other conditions: C057- Import/export allowed after control
- YB005Other conditions: C079- Import/export allowed after control
- YB010Other conditions: C082- Import/export allowed after control
- YB015Other conditions: Y120- Import/export allowed after control
- YB020Other conditions: Y160- Import/export allowed after control
- YB030Other conditions: Y179- Import/export allowed after control
- YB090Other conditions: the condition is not fulfilled- Import/export not allowed after control
- YC001Other conditions: Y166- Import/export allowed after control
- YC005Other conditions: Y160- Import/export allowed after control
- YC090Other conditions: the condition is not fulfilled- Import/export not allowed after control
- YD001Other conditions: Y163- Import/export allowed after control
- YD005Other conditions: Y160- Import/export allowed after control
- YD090Other conditions: the condition is not fulfilled- Import/export not allowed after control
- YE001Other conditions: Y121- Import/export allowed after control
- YE005Other conditions: Y160- Import/export allowed after control
- YE090Other conditions: the condition is not fulfilled- Import/export not allowed after control
Hinweise
- CD807https://climate.ec.europa.eu/system/files/2024-12/guidance%20customs%20F-gas%20labelling%20medicinal%20products.pdf
- CD917By virtue of Article 4(6) of Regulation (EU) 2024/573, the placing on the market of fluorinated greenhouse gases shall be prohibited, unless importers provide evidence that any trifluoromethane, produced as a by-product during the production process of the fluorinated greenhouse gases has been destroyed or recovered for subsequent use, using best available techniques.By virtue of Article 11.1. of Regulation (EU) 2024/573, the placing on the market of products and equipment, including parts thereof, listed in Annex IV, with an exemption for military equipment, shall be prohibited from the date specified in that Annex.By virtue of Article 11.1 sub paragraph 2 (a)(b), (c) of Regulation (I) 2024/573, the placing on the market of parts of products and equipment required for repair and servicing of existing equipment listed in Annex IV shall be allowed. By virtue of Article 11.3. of Regulation (EU) 2024/573, the placing on the market of non-refillable containers for fluorinated greenhouse gases listed in Annex I and in Section 1 of Annex II, empty, or fully or partially filled, shall be prohibited.By virtue of Article 11.4 of Regulation (EU) 2024/573, undertakings which place on the market refillable containers for fluorinated greenhouse gases shall produce a declaration of conformity that includes evidence confirming that there are binding arrangements in place for the return of those containers for the purpose of refilling, in particular identifying the relevant actors, their obligatory commitments and the relevant logistical arrangements.By virtue of Article 12 of Regulation (EU) 2024/573, the following products and equipment that contain fluorinated greenhouse gases or whose functioning relies upon those gases shall only be placed on the market if they are labelled as:(a) refrigeration equipment ;(b)air-conditioning equipment ; (c)heat pumps ;(d)fire protection equipment ; (e)electrical switchgear ;(f)aerosol dispenser that contain fluorinated greenhouse gases, including metered dose inhalers;(g)all fluorinated greenhouse gas containers ;(h)fluorinated greenhouse gas-based solvents ; or(i)organic Rankine cycles.By virtue of Article 16 of Regulation (EU) 2024/573, the placing on the market of hydrofluorocarbons shall be allowed only to the extent that importers have been allocated quota by the Commission as set out in Article 17.By virtue of Article 19.1 of Regulation (EU) 2024/573, refrigeration and air-conditioning equipment, heat pumps and metered dose inhalers pre-charged with substances listed in Section 1 of Annex I shall not be placed on the market unless those substances with which the products or equipment have been pre-charged are accounted for within the quota system.By virtue of Article 19.2 of Regulation (EU) 2024/573, the placing on the market of goods falling under the provisions of Article 19.1 shall be subject to the presentation of a declaration of conformity.By virtue of Article 19.6 of Regulation (EU) 2024/573, undertakings that placed on the market less than 10 tonnes of CO2 equivalent of hydrofluorocarbons, per year, contained in the products or equipment referred to in Article 19.1 shall be exempted from the provisions of Article 19. By virtue of Article 20.4 of Regulation (EU) 2024/573, the undertakings shall have a valid registration in the F-gas Portal prior to carrying out any of the activities listed in points (a) to (g).By virtue of Article 23.3 (a) of Regulation (EU) 2024/573, the F-gas Portal registration identification number shall be declared.The information listed in Article 23.3(a) to (d) of Regulation (EU) 2024/573 shall be provided to customs authorities, where relevant, in the customs declaration.
Import control on REACHERGA OMNESR1907/06
Import control on REACH
ERGA OMNESR1907/06
Dokumente / Referenzen
Y106Y110Y113
Bedingungen
- 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
Hinweise
- 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
Dokumente / Referenzen
7P237P24
Bedingungen
- 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
Dokumente / Referenzen
7P237P24
Bedingungen
- 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
Dokumente / Referenzen
7P237P24
Bedingungen
- 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
Export control of fluorinated greenhouse gasesALLTCR0573/24
Export control of fluorinated greenhouse gases
ALLTCR0573/24
Dokumente / Referenzen
Y121Y123Y160Y163
Bedingungen
- Y001Other conditions: Y123- Import/export allowed after control
- Y010Other conditions: Y160- Import/export allowed after control
- Y090Other conditions: the condition is not fulfilled- Import/export not allowed after control
- YB001Other conditions: Y121- Import/export allowed after control
- YB010Other conditions: Y160- Import/export allowed after control
- YB090Other conditions: the condition is not fulfilled- Import/export not allowed after control
- YC001Other conditions: Y163- Import/export allowed after control
- YC010Other conditions: Y160- Import/export allowed after control
- YC090Other conditions: the condition is not fulfilled- Import/export not allowed after control
Hinweise
- CD918By virtue of Article 22 (1) of Regulation (EU) 2024/573 export of fluorinated greenhouse gases, and products and equipment containing those gases or whose functioning relies upon those gases shall be subject to the presentation of a valid licence to customs authorities issued by the Commission pursuant to Article 20(4) and (5).By virtue of Article 20(5) a valid registration in the F-Gas Portal at the moment of export constitutes a licence required under Article 22.By virtue of Article 22 (1), second paragraph, the provisions from Article 22 (1) do not apply to products and equipment that are personal effects.By virtue of Article 11(3) export of non-refillable containers for fluorinated greenhouse gases listed in Annex I and in Section 1 of Annex II empty, or fully or partially filled, shall be prohibited. Such containers may only be stored or transported for subsequent disposal. The containers for laboratory or analytical uses of fluorinated greenhouse gases are excluded from export prohibition (Article 11(3)).By virtue of Article 12.9. of Regulation (EU) 2024/573 containers containing fluorinated greenhouse gases listed in Annex I and intended for direct export shall be labelled with an indication that the contents of the container are for direct export only.The information listed in Article 23.3(a) to (d) of Regulation (EU) 2024/573 shall be provided to customs authorities, where relevant, in the customs declaration.By virtue of article 22.5 of Reg. (EU) 573/2024 each undertaking with an establishment within the Union shall take all necessary measures to ensure that the export of refrigeration and air-conditioning equipment and of heat pumps, does not violate import restrictions that the importing state has notified under the Protocol.
Import controlUAR0692/14
Import control
UAR0692/14
Dokumente / Referenzen
N954U045U078U079Y997
Bedingungen
- 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
Hinweise
- 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
Dokumente / Referenzen
N954U045U078U079Y984
Bedingungen
- 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
Hinweise
- 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.
Mehrwertsteuer (MwSt.)
V011Dietary foods for special medical purposes referred to in the Actof 25 August 2006 on food safety and nutrition
19%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
19%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
19%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.
19%V999Other
19%Verbrauchsteuer
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 derselben Gruppe
300410Medicaments (ausgenommen goods der Position 3002, 3005 or 3006) consisting of mixed or unmixed Erzeugnisse for therapeutisch or prophylaktisch uses, in abgemessenen Dosen (einschließlich those in Form von transdermal administration systems) or in forms or packings für den Einzelverkauf, containing penicillins or Derivate thereof, with a penicillanic Säure structure, or streptomycins or their Derivate300420Medicaments (ausgenommen goods der Position 3002, 3005 or 3006) consisting of mixed or unmixed Erzeugnisse for therapeutisch or prophylaktisch uses, in abgemessenen Dosen (einschließlich those in Form von transdermal administration systems) or in forms or packings für den Einzelverkauf, andere, containing Antibiotika300431Medicaments (ausgenommen goods der Position 3002, 3005 or 3006) consisting of mixed or unmixed Erzeugnisse for therapeutisch or prophylaktisch uses, in abgemessenen Dosen (einschließlich those in Form von transdermal administration systems) or in forms or packings für den Einzelverkauf, andere, containing Hormone or andere Erzeugnisse der Position 2937, containing insulin300432Medicaments (ausgenommen goods der Position 3002, 3005 or 3006) consisting of mixed or unmixed Erzeugnisse for therapeutisch or prophylaktisch uses, in abgemessenen Dosen (einschließlich those in Form von transdermal administration systems) or in forms or packings für den Einzelverkauf, andere, containing Hormone or andere Erzeugnisse der Position 2937, containing corticosteroid Hormone, their Derivate or structural analogues300441Medicaments (ausgenommen goods der Position 3002, 3005 or 3006) consisting of mixed or unmixed Erzeugnisse for therapeutisch or prophylaktisch uses, in abgemessenen Dosen (einschließlich those in Form von transdermal administration systems) or in forms or packings für den Einzelverkauf, andere, containing Alkaloide or Derivate thereof, containing ephedrine or its Salze300442Medicaments (ausgenommen goods der Position 3002, 3005 or 3006) consisting of mixed or unmixed Erzeugnisse for therapeutisch or prophylaktisch uses, in abgemessenen Dosen (einschließlich those in Form von transdermal administration systems) or in forms or packings für den Einzelverkauf, andere, containing Alkaloide or Derivate thereof, containing pseudoephedrine (INN) or its Salze300443Medicaments (ausgenommen goods der Position 3002, 3005 or 3006) consisting of mixed or unmixed Erzeugnisse for therapeutisch or prophylaktisch uses, in abgemessenen Dosen (einschließlich those in Form von transdermal administration systems) or in forms or packings für den Einzelverkauf, andere, containing Alkaloide or Derivate thereof, containing norephedrine or its Salze300449Medicaments (ausgenommen goods der Position 3002, 3005 or 3006) consisting of mixed or unmixed Erzeugnisse for therapeutisch or prophylaktisch uses, in abgemessenen Dosen (einschließlich those in Form von transdermal administration systems) or in forms or packings für den Einzelverkauf, andere, containing Alkaloide or Derivate thereof, andere
5
Verbindliche Zolltarifauskunft
vZTA Klassifizierungsbeispiele
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
Die vZTA ist eine amtliche Entscheidung der EU-Zollbehörde zur Einreihung von Waren. Sie gilt 3 Jahre und ist in allen EU-Mitgliedstaaten verbindlich.
Umfang der Einreihung unter KN-Code 300439
Der KN-Code 300439 umfasst andere Arzneimittel, die Hormone oder andere Erzeugnisse der Position 2937 enthalten, in Dosierungen oder in Aufmachungen für den Einzelverkauf, ausgenommen insulinhaltige Arzneimittel (Code 300431). Hierunter fallen fertige Arzneimittel mit Steroidhormonen (Östrogene, Gestagene, Androgene, Kortikosteroide), Schilddrüsenhormonen (Levothyroxin, Liothyronin), Hypophysenhormonen (Somatotropin, Oxytocin), Nebenschilddrüsenhormonen sowie deren synthetischen Analoga und Derivaten. Darreichungsformen umfassen Tabletten, Kapseln, transdermale Pflaster, Gele, Cremes, Injektionslösungen, subkutane Implantate und nasale Applikationssysteme. Produkte müssen in Dosierungen oder Einzelhandelsformen vorliegen - Hormonpräparate in Bulk-Form werden unter Code 300259 eingereiht.
Pharmazeutische Vorschriften und Handelskontrolle
Die Einfuhr von Hormonarzneimitteln in die EU erfordert eine Genehmigung für das Inverkehrbringen (MA) der EMA oder einer nationalen Zulassungsbehörde gemäß Richtlinie 2001/83/EG. Verschreibungspflichtige Hormonarzneimittel unterliegen der obligatorischen Serialisierung gemäß Richtlinie 2011/62/EU. Der Hersteller muss ein GMP-Zertifikat und der Vertriebshändler ein GDP-Zertifikat besitzen. Besondere Anforderungen gelten für Arzneimittel mit Sexualhormonen - hormonale Kontrazeption und Hormonersatztherapie unterliegen verschärften Pharmakovigilanz-Anforderungen einschließlich Periodischer Sicherheitsberichte (PSUR) und Risikomanagementplänen. Anabole Steroide können zusätzlichen Beschränkungen als Substanzen mit Missbrauchspotenzial unterliegen. Arzneimittel mit Wachstumshormon (Somatotropin) erfordern das zentralisierte EMA-Zulassungsverfahren.
Praktische Hinweise für Importeure
Bei der Zollabfertigung von Hormonarzneimitteln unter KN-Code 300439 sind die Genehmigung für das Inverkehrbringen, das GMP-Zertifikat, das Analysezertifikat (CoA) und die Serialisierungsdokumentation vorzulegen. Viele Hormonarzneimittel erfordern Kühlkettentransport (2-8 Grad Celsius), insbesondere biologische Präparate wie Somatotropin. Transdermale Pflaster und Hormongele können Schutz vor erhöhten Temperaturen und Licht erfordern. Zollsätze sind im TARIC oder ISZTAR zu prüfen - zahlreiche Hormonarzneimittel profitieren von autonomen Zollaussetzungen. Der Importeur sollte prüfen, ob das Produkt keine in der EU verbotenen Substanzen enthält (z. B. Diethylstilbestrol wurde vom Markt genommen) und die aktuellen Kennzeichnungsanforderungen gemäß Richtlinie 2001/83/EG einschließlich der Gebrauchsinformation in der Landessprache erfüllt.
GMP-Anforderungen und Arzneimittelzulassung
Die Einfuhr pharmazeutischer Produkte unter KN-Code 3004 39 (Andere Hormonarzneimittel in Dosen) erfordert eine Genehmigung der zuständigen Arzneimittelbehörde. Alle auf dem EU-Markt in Verkehr gebrachten Arzneimittel müssen eine Zulassung der EMA (zentralisiertes Verfahren) oder einer nationalen Behörde besitzen. Die Einhaltung der Guten Herstellungspraxis (GMP) muss durch ein Zertifikat bestätigt werden. Biologische Produkte erfordern die Aufrechterhaltung der Kühlkette. Serialisierung und Echtheitsprüfung (FMD 2011/62/EU) sind für verschreibungspflichtige Arzneimittel obligatorisch.
Häufig gestellte Fragen
Werden orale Kontrazeptiva unter Code 300439 eingereiht?
Ja. Orale Kontrazeptiva mit Hormonen (Östrogene, Gestagene oder deren Kombinationen), in Dosierungen für den Einzelverkauf verpackt, werden unter KN-Code 300439 eingereiht. Dies gilt sowohl für monophasische als auch multiphasische Tabletten sowie für reine Gestagen-Präparate (Minipillen). Kontrazeptive Pflaster und Vaginalringe fallen ebenfalls unter diese Einreihung.
Erfordern Kortikosteroid-Arzneimittel besondere Einfuhrgenehmigungen?
Arzneimittel mit Kortison und anderen Kortikosteroiden erfordern keine besonderen Betäubungsmittelgenehmigungen, da sie keine kontrollierten Substanzen gemäß den UN-Übereinkommen sind. Sie unterliegen jedoch den pharmazeutischen Standardanforderungen: Genehmigung für das Inverkehrbringen, GMP-Zertifikat des Herstellers und GDP-Grundsätze im Vertrieb. Die Einfuhr erfordert eine pharmazeutische Großhandelsvertriebsgenehmigung.
Wie unterscheidet man die Einreihung von Hormonarzneimitteln zwischen Code 300431 und 300439?
Code 300431 ist ausschließlich für insulinhaltige Arzneimittel vorgesehen. Alle anderen Hormonarzneimittel in Einzelhandelsdosierungen - mit Östrogenen, Gestagenen, Kortikosteroiden, Schilddrüsenhormonen, Somatotropin und anderen Hormonen - werden unter Code 300439 eingereiht. Das einzige Unterscheidungskriterium ist die Hormonart: Insulin gegenüber allen anderen Hormonen.
Welche Genehmigungen braucht man für Arzneimittel KN 3004 39?
Für die Einfuhr von Arzneimitteln unter KN-Code 3004 39 sind eine Zulassung (nationale Behörde/EMA), eine Einfuhrgenehmigung, ein GMP-Zertifikat des Herstellers und GDP-Dokumentation erforderlich.
Nützliche Tools & Ressourcen
Zollrechner
Zoll- & MwSt.-RechnerBerechnen Sie Zoll und MwSt. für „Medicaments (ausgenommen goods der Position 3002, 3005 or 3006) consisting of mixed or unmixed Erzeugnisse for therapeutisch or prophylaktisch uses, in abgemessenen Dosen (einschließlich those in Form von transdermal administration systems) or in forms or packings für den Einzelverkauf, andere, containing Hormone or andere Erzeugnisse der Position 2937, andere“ und sehen Sie die gesamten Importkosten.Import-RentabilitätsrechnerPrüfen Sie die Rentabilität des Imports von „Medicaments (ausgenommen goods der Position 3002, 3005 or 3006) consisting of mixed or unmixed Erzeugnisse for therapeutisch or prophylaktisch uses, in abgemessenen Dosen (einschließlich those in Form von transdermal administration systems) or in forms or packings für den Einzelverkauf, andere, containing Hormone or andere Erzeugnisse der Position 2937, andere“ unter Berücksichtigung aller Kosten.
Verwandte Begriffe