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HS Code Description EU USTechnical Regulations Any Other Technical Regulations Any Other

290313 Chloroform (trichloromethane)

Marketing requirements for dangerous chemicals, pesticides and biocides The placing on the EU market of certain chemical products must comply with the marketing requirements laid down by the EU legislation designed to ensure a high level of protection of human health and the environment.The EU legislation establishes specific conditions for the following product categories: Dangerous substances, Dangerous preparations, Plant protection products, Biocidal products For ore See: mkt access database reqts\Marketing requirements for dangerous chemicals.docControl of trade in dangerous chemicalsImports of certain dangerous chemicals into the EU are banned or severely restricted and subject to control measures laid down in Regulation (EC) 304/2003, which implements the Rotterdam Convention on the Prior Informed Consent Procedure for certain hazardous chemicals and pesticides in international trade. These control measures are basedon a standardised system of exchange of information between exporting and importing countries which allows the latter to identify potential hazards and exclFor More See: mkt access database reqts\Control of tr

Tariff rates - 2007 (Conventional Rate of Duty in %): 5.5

General RegulationsGMP - Finished Products21 CFR, part 211(http://ecfr.gpoaccess.gov/cgi/t/text/text-idx?c=ecfr&sid=8a00a4b294cdc40b4a901c8a37735477&rgn=div5&view=text&node=21:4.0.1.1.10&idno=21) contains the minimum current good manufacturing practice for preparation of drug products for administration to humans or animals.Criteria for Bioavailability & Bioequivalence of drug products21 CFR, part 320(http://ecfr.gpoaccess.gov/cgi/t/text/text-idx?c=ecfr&sid=8a00a4b294cdc40b4a901c8a37735477&rgn=div5&view=text&node=21:5.0.1.1.7&idno=21) sets out the criteria for bioavailability and bioequivalence of drug products.Labeling - GeneralGeneral Labeling Provisions for drugs are to be found at 21 CFR, part 201, subpart A (http://ecfr.gpoaccess.gov/cgi/t/text/text-idx?c=ecfr&sid=a3c701da018770c6b52eb3a60fc9419e&rgn=div5&view=text&node=21:4.0.1.1.2&idno=21). It lists out the general labeling requirements that are to be met by manufacturers of all drugs including

1. Directions for use2. Name & place of business of manufacturer, packer or distributor3. Statement of ingredients4. National Drug Code Numbers5. Location of expiration date

Importation Requirements - Product Specific21 CFR, part 1312(http://ecfr.gpoaccess.gov/cgi/t/text/text-idx?c=ecfr&sid=8a00a4b294cdc40b4a901c8a37735477&rgn=div5&view=text&node=21:9.0.1.1.13&idno=21) sets out the procedures governing the importation, exportation, transshipment and intransit shipment of controlled substances pursuant.

290346 Bromochlorodifluoromethane, bromotrifluoromethane and dibromotetrafluoroethanes

Marketing requirements for dangerous chemicals, pesticides and biocides The placing on the EU market of certain chemical products must comply with the marketing requirements laid down by the EU legislation designed to ensure a high level of protection of human health and the environment.The EU legislation establishes specific conditions for the following product categories: Dangerous substances, Dangerous preparations, Plant protection products, Biocidal products For ore See: mkt access database reqts\Marketing requirements for dangerous chemicals.docOzone-Depleting Substances:Imports of products and equipment containing ozone-depleting substances (ODS) into the European Union are prohibited. This ban applies to imports from any country, whether or not party to the 1987 Montreal protocol on ODS.

Products liable to contain ODS are, for instance: fridges, freezers, air conditioning, fire protection and extinguishing equipment.

The complete list of these products can be found in Regulation 2037/2000/EC of the European Parliament and of the Council of 29 June 2000 on substances thatFor More See: mkt access database reqts\Ozone-depl




290542 Pentaerythritol Marketing requirements for dangerous chemicals, pesticides and biocides The placing on the EU market of certain chemical products must comply with the marketing requirements laid down by the EU legislation designed to ensure a high level of protection of human health and the environment.The EU legislation establishes specific conditions for the following product categories: Dangerous substances, Dangerous preparations, Plant protection products, Biocidal products For ore See: mkt access database reqts\Marketing requirements for dangerous chemicals.doc




290543 Mannitol Marketing requirements for dangerous chemicals, pesticides and biocides The placing on the EU market of certain chemical products must comply with the marketing requirements laid down by the EU legislation designed to ensure a high level of protection of human health and the environment.The EU legislation establishes specific conditions for the following product categories: Dangerous substances, Dangerous preparations, Plant protection products, Biocidal products For ore See: mkt access database reqts\Marketing requirements for dangerous chemicals.doc

Tariff rates - 2007 (Conventional Rate of Duty in %):9.6+125.8 Euro/100 kg/net



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290551 Ethchlorvynol Marketing requirements for dangerous chemicals, pesticides and biocides The placing on the EU market of certain chemical products must comply with the marketing requirements laid down by the EU legislation designed to ensure a high level of protection of human health and the environment.The EU legislation establishes specific conditions for the following product categories: Dangerous substances, Dangerous preparations, Plant protection products, Biocidal products For ore See: mkt access database reqts\Marketing requirements for dangerous chemicals.doc

Import requirements for medicinal active substancesActive substances intended to be used as raw materials in the manufacture of medicinal products can only be imported by registered authorised operators in the importing Member State. In order to be authorised, operators must meet certain specified requirements…..For More See: mkt access database reqts\Import requirements for medicinal active substances.docTariff rates - 2007 (Conventional Rate of Duty in %): Free



290911 Diethyl Ether Marketing requirements for dangerous chemicals, pesticides and biocides The placing on the EU market of certain chemical products must comply with the marketing requirements laid down by the EU legislation designed to ensure a high level of protection of human health and the environment.The EU legislation establishes specific conditions for the following product categories: Dangerous substances, Dangerous preparations, Plant protection products, Biocidal products For ore See: mkt access database reqts\Marketing requirements for dangerous chemicals.docControl of drug precursorsImports of certain chemical substances frequently used in the illicit manufacture of narcotic drugs and psychotropic substances (precursors) are subject to control requirements in order to prevent their illicit use. These requirements refer to Licensing and or registration of operators, Import documentation and labelling , Provision of information and Import authorisation These controls do not apply to medicinal products, pharmaceutical preparations, mixtures, natural produFor More See: mkt access database reqts\Control of d




Definition - Product Group Specific: 21 CFR, part 1300(http://ecfr.gpoaccess.gov/cgi/t/text/text-idx?c=ecfr&sid=8a00a4b294cdc40b4a901c8a37735477&rgn=div5&view=text&node=21:9.0.1.1.1&idno=21) sets out the definitions relating to controlled substances.Importation Requirements - Product Specific21 CFR, part 1312(http://ecfr.gpoaccess.gov/cgi/t/text/text-idx?c=ecfr&sid=8a00a4b294cdc40b4a901c8a37735477&rgn=div5&view=text&node=21:9.0.1.1.13&idno=21) sets out the procedures governing the importation, exportation, transshipment and intransit shipment of controlled substances pursuant.

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290960 Alcohol peroxides, ether peroxides, ketone peroxides and their halogenated, sulphonated, nitrated or nitrosated derivatives

Marketing requirements for dangerous chemicals, pesticides and biocides The placing on the EU market of certain chemical products must comply with the marketing requirements laid down by the EU legislation designed to ensure a high level of protection of human health and the environment.The EU legislation establishes specific conditions for the following product categories: Dangerous substances, Dangerous preparations, Plant protection products, Biocidal products For ore See: mkt access database reqts\Marketing requirements for dangerous chemicals.doc




291631 Benzoic Acid, Its Salts and Esters


Import requirements for medicinal active substancesActive substances intended to be used as raw materials in the manufacture of medicinal products can only be imported by registered authorised operators in the importing Member State. In order to be authorised, operators must meet certain specified requirements…..For More See: mkt access database reqts\Import requirements for medicinal active substances.docTariff rates - 2007 (Conventional Rate of Duty in %): 6.5



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291822 O-acetylsalicylic Acid, Its Salts and Esters





292146 Amfetamine (INN), benzfetamine (INN), dexamfetamine(INN), etilamfetamine (INN), fencamfamin (INN),lefetamine (INN), levamfetamine (INN), mefenorex (INN)and phentermine (INN); salts thereof





292214 Dextropropoxyphene (INN) and its salts





292231 Amfepramone (INN), methadone (INN) and normethadone(INN); salts thereof





292411 Meprobamate (INN) Marketing requirements for dangerous chemicals, pesticides and biocides The placing on the EU market of certain chemical products must comply with the marketing requirements laid down by the EU legislation designed to ensure a high level of protection of human health and the environment.The EU legislation establishes specific conditions for the following product categories: Dangerous substances, Dangerous preparations, Plant protection products, Biocidal products For ore See: mkt access database reqts\Marketing requirements for dangerous chemicals.doc




292424 Ethinamate (INN) Marketing requirements for dangerous chemicals, pesticides and biocides The placing on the EU market of certain chemical products must comply with the marketing requirements laid down by the EU legislation designed to ensure a high level of protection of human health and the environment.The EU legislation establishes specific conditions for the following product categories: Dangerous substances, Dangerous preparations, Plant protection products, Biocidal products For ore See: mkt access database reqts\Marketing requirements for dangerous chemicals.doc




292511 Saccharin and Its Salts Marketing requirements for dangerous chemicals, pesticides and biocides The placing on the EU market of certain chemical products must comply with the marketing requirements laid down by the EU legislation designed to ensure a high level of protection of human health and the environment.The EU legislation establishes specific conditions for the following product categories: Dangerous substances, Dangerous preparations, Plant protection products, Biocidal products For ore See: mkt access database reqts\Marketing requirements for dangerous chemicals.doc




293221 Coumarin, Methylcoumarins, Ethylcoumarins





293291 Isosafrole General RegulationsGMP - Finished Products21 CFR, part 211(http://ecfr.gpoaccess.gov/cgi/t/text/text-idx?c=ecfr&sid=8a00a4b294cdc40b4a901c8a37735477&rgn=div5&view=text&node=21:4.0.1.1.10&idno=21) contains the minimum current good manufacturing practice for preparation of drug products for administration to humans or animals.Criteria for Bioavailability & Bioequivalence of drug products21 CFR, part 320(http://ecfr.gpoaccess.gov/cgi/t/text/text-idx?c=ecfr&sid=8a00a4b294cdc40b4a901c8a37735477&rgn=div5&view=text&node=21:5.0.1.1.7&idno=21) sets out the criteria for bioavailability and bioequivalence of drug products.Labeling - GeneralGeneral Labeling Provisions for drugs are to be found at 21 CFR, part 201, subpart A (http://ecfr.gpoaccess.gov/cgi/t/text/text-idx?c=ecfr&sid=a3c701da018770c6b52eb3a60fc9419e&rgn=div5&view=text&node=21:4.0.1.1.2&idno=21). It lists out the general labeling requirements that are to be met by manufacturers of all drugs including


Definition - Product Group Specific: 21 CFR, part 1300.02(http://ecfr.gpoaccess.gov/cgi/t/text/text-idx?c=ecfr&sid=8a00a4b294cdc40b4a901c8a37735477&rgn=div5&view=text&node=21:9.0.1.1.1&idno=21#21:9.0.1.1.1.0.1.2) sets out the definitions relating to Listed Chemicals.Importation Requirements - Product Specific21 CFR, part 1312(http://ecfr.gpoaccess.gov/cgi/t/text/text-idx?c=ecfr&sid=8a00a4b294cdc40b4a901c8a37735477&rgn=div5&view=text&node=21:9.0.1.1.13&idno=21) sets out the procedures governing the importation, exportation, transshipment and intransit shipment of controlled substances pursuant.

293292 1-(1,3-Benzodioxol-5-yl)propan-2-one

Control of drug precursorsImports of certain chemical substances frequently used in the illicit manufacture of narcotic drugs and psychotropic substances (precursors) are subject to control requirements in order to prevent their illicit use. These requirements refer to Licensing and or registration of operators, Import documentation and labelling , Provision of information and Import authorisation These controls do not apply to medicinal products, pharmaceutical preparations, mixtures, natural products or other preparations containing scheduled substances in such a way that they cannot be easily used or extracted. For More See: mkt access database reqts\Control of drug precursors.doc




Definition - Product Group Specific: 21 CFR, part 1300.02(http://ecfr.gpoaccess.gov/cgi/t/text/text-idx?c=ecfr&sid=8a00a4b294cdc40b4a901c8a37735477&rgn=div5&view=text&node=21:9.0.1.1.1&idno=21#21:9.0.1.1.1.0.1.2) sets out the definitions relating to Listed Chemicals.Importation Requirements - Product Specific21 CFR, part 1312(http://ecfr.gpoaccess.gov/cgi/t/text/text-idx?c=ecfr&sid=8a00a4b294cdc40b4a901c8a37735477&rgn=div5&view=text&node=21:9.0.1.1.13&idno=21) sets out the procedures governing the importation, exportation, transshipment and intransit shipment of controlled substances pursuant.

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293321 Hydantoin and Its Derivatives





293333 Alfentanil (INN), anileridine (INN), bezitramide (INN), bromazepam (INN), difenoxin (INN), diphenoxylate (INN), dipipanone (INN), fentanyl (INN), ketobemidone (INN), methylphenidate (INN), pentazocine (INN), pethidine (INN), pethidine (INN) intermediate A, phencyclidine (INN) (PCP), phenoperidine (INN), pipradrol (INN), piritramide (INN), propiram (INN) and trimeperidine (INN); salts thereof





293353 Allobarbital (INN),

amobarbital (INN), barbital(INN), butalbital (INN), butobarbital, cyclobarbital (INN), methylphenobarbital (INN), pentobarbital (INN), phenobarbital (INN), secbutabarbital (INN), secobarbital (INN) and vinylbital (INN); salts thereof





293391 Alprazolam (INN), camazepam (INN), chlordiazepoxide(INN), clonazepam (INN), clorazepate, delorazepam (INN),diazepam (INN), estazolam (INN), ethyl loflazepate (INN),fludiazepam (INN), flunitrazepam (INN), flurazepam (INN),halazepam (INN), lorazepam (INN), lormetazepam (INN),mazindol (INN), medazepam (INN), midazolam (INN),nimetazepam (INN), nitrazepam (INN), nordazepam (INN),oxazepam (INN), pinazepam (INN), prazepam (INN),pyrovalerone (INN), temazepam (INN), tetrazepam (INN)and triazolam (INN); salts thereof






293610 UNMIXED PROVITAMINS Requirements for Food Supplements DIRECTIVE 2002/46/EC

Maximum amounts of vitamins and minerals present in food supplements per daily portion of consumption as recommended by the manufacturer shall be set

Contains requirements for labelling, presentation and advertising For More See: http://ec.europa.eu/food/food/labellingnutrition/supplements/index_en.htm

Tariff rates - 2007 (Conventional Rate of Duty in %): Free



293621 VITAMINS A AND THEIR DERIVATIVES

Marketing requirements for dangerous chemicals, pesticides and biocides The placing on the EU market of certain chemical products must comply with the marketing requirements laid down by the EU legislation designed to ensure a high level of protection of human health and the environment.The EU legislation establishes specific conditions for the following product categories: Dangerous substances, Dangerous preparations, Plant protection products, Biocidal products For ore See: mkt access database reqts\Marketing requirements for dangerous chemicals.docRequirements for Food Supplements DIRECTIVE 2002/46/EC






293622 VITAMIN B1 AND ITS DERIVATIVES








Marketing requirements for dangerous chemicals, pesticides and biocides The placing on the EU market of certain chemical products must comply with the marketing requirements laid down by the EU legislation designed to ensure a high level of protection of human health and the environment.The EU legislation establishes specific conditions for the following product categories: Dangerous substances, Dangerous preparations, Plant protection products, Biocidal products For ore See: mkt access database reqts\Marketing requirements for dangerous chemicals.doc Good Manufacturing Practice Medicinal Products for Human and Veterinary UseFor More See: mkt access database reqts\Control of drug precursors.docRequirements for Food Supplements DIRECTIVE 2002/46/EC






293624 D-OR DL-PANTOTHENIC ACID (VITAMIN B3 OR VITAMIN B5) AND ITS DERIVATIVES







293625 VITAMIN B6 & ITS DERIVATIVES














293627 VITAMIN C (ASCORBIC ACID) & ITS DRVTVS







293628 VITAMIN E AND ITS DERIVATIVES







293629 OTHER VITAMINS AND THEIR DERIVATIVES







293690 OTHER VITAMINS & PROVITAMINS INCLUDING NATURAL CONCENTRATES







293710 *PITUITARY(ANTRR)/ SIMILAR HORMONES & THEIR DERIVATIVES





293711 SOMATOTROPIN, ITS DERIVATIVES & STRUCTURAL ANALOGUES





293712 INSULIN AND ITS SALTS Marketing requirements for dangerous chemicals, pesticides and biocides The placing on the EU market of certain chemical products must comply with the marketing requirements laid down by the EU legislation designed to ensure a high level of protection of human health and the environment.The EU legislation establishes specific conditions for the following product categories: Dangerous substances, Dangerous preparations, Plant protection products, Biocidal products For ore See: mkt access database reqts\Marketing requirements for dangerous chemicals.doc




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293719 Steroidal hormones, their derivatives and structural analogues





293721 CORTISONE,HYDROCORTISONE,PREDNISONE (DEHYDROCORTISONE) AND FREDNISOLONE AND PREDNISOLONE (DEHYDROHYDROCORTISONE)





293722 Halogenated derivatives of corticosteroidal hormones





293723 Oestrogens and progestogens





293729 Catecholamine hormones, their derivatives and structuralanalogues





293731 EPINETHRINE Marketing requirements for dangerous chemicals, pesticides and biocides The placing on the EU market of certain chemical products must comply with the marketing requirements laid down by the EU legislation designed to ensure a high level of protection of human health and the environment.The EU legislation establishes specific conditions for the following product categories: Dangerous substances, Dangerous preparations, Plant protection products, Biocidal products For ore See: mkt access database reqts\Marketing requirements for dangerous chemicals.doc




293739 OTHER CATECHOLAMINE HORMONES THEIR DERIVATIVES & STRUCTURAL ANOLOGUES





293740 AMINO-ACID DERIVATIVES





293750 PROSTAGLANDINS, THROMBOXAMES& LEUKOTRIENES THEIR DERIVATIVES & STRUCTURAL ANOLOGUES





293790 OTHER HORMONES, NATURAL OR REPRODUCED BY SYNTHESIS USED AS HORMONES





293791 *INSULIN AND ITS SALTS Tariff rates - 2007 (Conventional Rate of Duty in %): Free



293792 *OESTROGENS AND PROGESTOGENS




293799 *OTHR HORMONES & THEIR DERIVATIVES;OTHER STEROIDS USED PRIMARILY AS HORMONES




293810 Rutoside (rutin) and its derivatives





293911 Concentrates of poppy straw; buprenorphine (INN), codeine, dihydrocodeine (INN), ethylmorphine, etorphine (INN), heroin, hydrocodone (INN), hydromorphone (INN), morphine, nicomorphine (INN), oxycodone (INN), oxymorphone (INN), pholcodine (INN), thebacon (INN) and thebaine; salts thereof





293919 Other Marketing requirements for dangerous chemicals, pesticides and biocides The placing on the EU market of certain chemical products must comply with the marketing requirements laid down by the EU legislation designed to ensure a high level of protection of human health and the environment.The EU legislation establishes specific conditions for the following product categories: Dangerous substances, Dangerous preparations, Plant protection products, Biocidal products For ore See: mkt access database reqts\Marketing requirements for dangerous chemicals.doc




293920 Alkaloids of cinchona and their derivatives; salts thereof





293930 Caffeine and its salts Marketing requirements for dangerous chemicals, pesticides and biocides The placing on the EU market of certain chemical products must comply with the marketing requirements laid down by the EU legislation designed to ensure a high level of protection of human health and the environment.The EU legislation establishes specific conditions for the following product categories: Dangerous substances, Dangerous preparations, Plant protection products, Biocidal products For ore See: mkt access database reqts\Marketing requirements for dangerous chemicals.doc




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293941 Ephedrine and its salts Marketing requirements for dangerous chemicals, pesticides and biocides The placing on the EU market of certain chemical products must comply with the marketing requirements laid down by the EU legislation designed to ensure a high level of protection of human health and the environment.The EU legislation establishes specific conditions for the following product categories: Dangerous substances, Dangerous preparations, Plant protection products, Biocidal products For ore See: mkt access database reqts\Marketing requirements for dangerous chemicals.docControl of trade in dangerous chemicalsImports of certain dangerous chemicals into the EU are banned or severely restricted and subject to control measures laid down in Regulation (EC) 304/2003, which implements the Rotterdam Convention on the Prior Informed Consent Procedure for certain hazardous chemicals and pesticides in international trade. These control measures are basedon a standardised system of exchange of information between exporting and importing countries which allows the latter to identify potential hazards and exclFor More See: mkt access database reqts\Control of tr




293942 Pseudoephedrine (INN) and its salts





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293943 Cathine (INN) and its salts Marketing requirements for dangerous chemicals, pesticides and biocides The placing on the EU market of certain chemical products must comply with the marketing requirements laid down by the EU legislation designed to ensure a high level of protection of human health and the environment.The EU legislation establishes specific conditions for the following product categories: Dangerous substances, Dangerous preparations, Plant protection products, Biocidal products For ore See: mkt access database reqts\Marketing requirements for dangerous chemicals.doc




293949 Other Marketing requirements for dangerous chemicals, pesticides and biocides The placing on the EU market of certain chemical products must comply with the marketing requirements laid down by the EU legislation designed to ensure a high level of protection of human health and the environment.The EU legislation establishes specific conditions for the following product categories: Dangerous substances, Dangerous preparations, Plant protection products, Biocidal products For ore See: mkt access database reqts\Marketing requirements for dangerous chemicals.docControl of trade in dangerous chemicalsImports of certain dangerous chemicals into the EU are banned or severely restricted and subject to control measures laid down in Regulation (EC) 304/2003, which implements the Rotterdam Convention on the Prior Informed Consent Procedure for certain hazardous chemicals and pesticides in international trade. These control measures are basedon a standardised system of exchange of information between exporting and importing countries which allows the latter to identify potential hazards and exclFor More See: mkt access database reqts\Control of tr




293951 Fenetylline (INN) and its salts









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293961 Ergometrine (INN) and its salts





293962 Ergotamine (INN) and its salts





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293963 Lysergic acid and its salts Marketing requirements for dangerous chemicals, pesticides and biocides The placing on the EU market of certain chemical products must comply with the marketing requirements laid down by the EU legislation designed to ensure a high level of protection of human health and the environment.The EU legislation establishes specific conditions for the following product categories: Dangerous substances, Dangerous preparations, Plant protection products, Biocidal products For ore See: mkt access database reqts\Marketing requirements for dangerous chemicals.docControl of drug precursorsImports of certain chemical substances frequently used in the illicit manufacture of narcotic drugs and psychotropic substances (precursors) are subject to control requirements in order to prevent their illicit use. These requirements refer to Licensing and or registration of operators, Import documentation and labelling , Provision of information and Import authorisation These controls do not apply to medicinal products, pharmaceutical preparations, mixtures, natural produFor More See: mkt access database reqts\Control of d









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293991 Cocaine, ecgonine, levometamfetamine, metamfetamine(INN), metamfetamine racemate; salts, esters andotherderivatives thereof





293999 Other Marketing requirements for dangerous chemicals, pesticides and biocides The placing on the EU market of certain chemical products must comply with the marketing requirements laid down by the EU legislation designed to ensure a high level of protection of human health and the environment.The EU legislation establishes specific conditions for the following product categories: Dangerous substances, Dangerous preparations, Plant protection products, Biocidal products For ore See: mkt access database reqts\Marketing requirements for dangerous chemicals.docControl of trade in dangerous chemicalsImports of certain dangerous chemicals into the EU are banned or severely restricted and subject to control measures laid down in Regulation (EC) 304/2003, which implements the Rotterdam Convention on the Prior Informed Consent Procedure for certain hazardous chemicals and pesticides in international trade. These control measures are basedon a standardised system of exchange of information between exporting and importing countries which allows the latter to identify potential hazards and exclFor More See: mkt access database reqts\Control of tr




294110 PENICILLINS & THEIR DERIVATIVES WITH A PENICILLANIC ACID STRUCTURE SALTS THEREOF





294120 STREPTOMYCINS & THEIR DERIVATIVES SALTS THEREOF





294130 TETRACYCLINES & THEIR DERIVATIVES SALTS THEREOF





294140 CHLORAMPHENICOL & ITS DERIVATIVES SALTS THEREOF





294150 ERTHROMYCIN & ITS DERIVATIVES SALTS THEREOF





294190 OTHER ANTIBIOTICS Marketing requirements for dangerous chemicals, pesticides and biocides The placing on the EU market of certain chemical products must comply with the marketing requirements laid down by the EU legislation designed to ensure a high level of protection of human health and the environment.The EU legislation establishes specific conditions for the following product categories: Dangerous substances, Dangerous preparations, Plant protection products, Biocidal products For ore See: mkt access database reqts\Marketing requirements for dangerous chemicals.doc




300110 Glands and Other Organs (Dried)

Guidelines for packagingRequirements for Labels, Legal status, packaging leaflet, presentation of medical product, http://ec.europa.eu/enterprise/pharmaceuticals/eudralex/vol-2/c/bluebox_03_2007.pdf

Introduction: How the EU promotes pharmaceutical trade and guarantees the quality, safety, and efficacy of medicinal products . It also explains the pharmacovigilance mechanisms and the electronic communications network in placeFor More See: http://ec.europa.eu/enterprise/pharmaceuticals/pharmacos/docs/brochure/pharmaeu.pdfTariff rates - 2007 (Conventional Rate of Duty in %): Free



300120 Extracts of Glands or Other Organs or of Their Secretions

CITES EU wildlife legislation, Regulation (EC) 338/1997 (OJ L-61 03/03/1997), based on the Convention on International Trade in Endangered Species of Wild Fauna and Flora (CITES), comprises a double-checking system involving export and import controls both at the country of origin and at EU level.For More See: mkt access database reqts\CITES.docGuidelines for packagingRequirements for Labels, Legal status, packaging leaflet, presentation of medical product, http://ec.europa.eu/enterprise/pharmaceuticals/eudralex/vol-2/c/bluebox_03_2007.pdf

Introduction: How the EU promotes pharmaceutical trade and guarantees the quality, safety, and efficacy of medicinal products . It also explains the pharmacovigilance mechanisms and the electronic communications network in placeFor More See: http://ec.europa.eu/enterprise/pharmaceuticals/pharmacos/docs/brochure/pharmaeu.pdfImport requirements for medicinal active substancesActive substances intended to be used as raw materials in the manufacture of medicinal products can only be imported by registered authorised operators in the importing Member State. In order to be authorised, operators must meet certain specified requirements…..For More See: mkt access database reqts\Import requirements for medicinal active substances.docTariff rates - 2007 (Conventional Rate of Duty in %): Free



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300190 Heparin, Its Salt, Other Animal Substances Prepared for Therapeutic Uses





300210 Antisera and Other Blood Fractions

Marketing requirements for dangerous chemicals, pesticides and biocides The placing on the EU market of certain chemical products must comply with the marketing requirements laid down by the EU legislation designed to ensure a high level of protection of human health and the environment.The EU legislation establishes specific conditions for the following product categories: Dangerous substances, Dangerous preparations, Plant protection products, Biocidal products For ore See: mkt access database reqts\Marketing requirements for dangerous chemicals.docHealth control of products of animal origin not intended for human consumptionImports into the EU of animal products not intended for human consumption must comply with general conditions of public and animal health designed to guarantee a high level of health and safety throughout the food and feed chains and to avoid the spread of infectious diseases that are dangerous to livestock or humans.The general health requirements applicable to these products are related to Country health approval, ApprFor More See: mkt access database reqts\Health contGuidelines for packagingRequirements for Labels, Legal status, packaging leaflhttp://ec.europa.eu/enterprise/pharmaceuticals/eudra




300220 Vaccines for Human Medicine





300230 Vaccines for veterinary medicine

Health control of products of animal origin not intended for human consumptionImports into the EU of animal products not intended for human consumption must comply with general conditions of public and animal health designed to guarantee a high level of health and safety throughout the food and feed chains and to avoid the spread of infectious diseases that are dangerous to livestock or humans.The general health requirements applicable to these products are related to Country health approval, Approved establishments, Health certificates and Health control For More See: mkt access database reqts\Health control of products of animal origin not intended for human consumptio1.doc


300231 Vaccines Against Foot and Mouth Disease




300239 Other Vaccines for Veterinary Medicine





300290 Human Blood, Animal Blood, Toxins, Microbial Culture, Similar Products





300310 Medicaments Containing Penicillines or Streptomycins or Their Derivatives

Good Manufacturing Practice Detailed guidelines of good manufacturing practice (GMP) for medicinal products, in accordance with principles laid down by two directives (Directive 2003/94/EC – medicinal products for human use, and Directive 91/412/EEC- veterinary). Used in assessing applications for manufacturing authorisations and as abasis for inspection of manufacturers of medicinal products.For More See: http://ec.europa.eu/enterprise/pharmaceuticals/eudralex/homev4.htmThe Paediatric Regulation A paediatric investigation plan is a development plan aimed at ensuring that the necessary data are obtained through studies in children, when it is safe to do so, to support the authorisation of the medicine for childrenFor More See: http://www.emea.europa.eu/htms/human/paediatrics/pips.htmGuidelines for packagingRequirements for Labels, Legal status, packaging leaflet, presentation of medical product, http://ec.europa.eu/enterprise/pharmaceuticals/eudralex/vol-2/c/bluebox_03_2007.pdf




300320 Medicaments Containing Other Antibiotics





300331 Medicaments Containing Insulin





300339 Medicaments Containing Other Hormones





300340 Medicaments Containing Alkaloids or Derivatives Thereof





a

e

F

300390 Other Medicaments Technical standards for in vitro diagnostic medical devices The placing of in vitro medical devices on the EU market is subject to the compliance with the essential requirements established by Directive 98/79/EC in order to ensure a high level of protection of the health and safety of patients, users and third parties and achieve the intended level of performance.For More See: mkt access database reqts\Technical standards for in vitro diagnostic medical devices.docGood Manufacturing Practice Detailed guidelines of good manufacturing practice (GMP) for medicinal products, in accordance with principles laid down by two directives (Directive 2003/94/EC – medicinal products for human use, and Directive 91/412/EEC- veterinary). Used in assessing applications for manufacturing authorisations and as abasis for inspection of manufacturers of medicinal products.For More See: http://ec.europa.eu/enterprise/pharmaceuticals/eudralex/homev4.htmThe Paediatric Regulation A paediatric investigation plan is a development plan For More See: http://www.emea.europa.eu/htms/humGuidelines for packagingRequirements for Labels, Legal status, packaging leaflhttp://ec.europa.eu/enterprise/pharmaceuticals/eudra




300410 Medicaments Containing Penicillines or Streptonycins (Put up in Packings)


Introduction: How the EU promotes pharmaceutical trade and guarantees the quality, safety, and efficacy of medicinal products . It also explains the pharmacovigilance mechanisms and the electronic communications network in placeFor More See: http://ec.europa.eu/enterprise/pharmaceuticals/pharmacos/docs/brochure/pharmaeu.pdfImport requirements for medicinal products for human useIn order to protect public health within EU, imports of medicinal products are subject to Importing authorization, Marketing authorization, Labelling and packaging provisions, Control of each batch and Pharmacovigilance system For More See: mkt access database reqts\Import requirements for medicinal products for human use.docImport requirements for veterinary medicinal productsIn order to protect public health within EU, imports of medicinal products are subject to Importing authorization, Marketing authorization, Labelling and packaging provisions, Control of each batch and Pharmacovigilance system For More See: mkt access database reqts\Import requirements for veterinary medicinal products.docTariff rates - 2007 (Conventional Rate of Duty in %):



F

F

300420 Medicaments Containing Other Antibiotics (Put up inPackings for Retail Sale





300431 Medicaments Containing Insulin (Put up in Packings for Retail Sale)





F

F

300432 Medicaments Containing Adrenal Cortex Hormones (Put up in Packings)





300439 Medicaments Containing Other Hormones (Put up in Packings for Retail Sale)





F

F

300440 Medicaments Containing Alkaloids or Derivatives Thereof (Put up in Packings)





300450 Medicaments Containing Vitamins or Other Products(Put up in Packings)





F

300490 Other Medicaments (Put up in Packings for Retail Sale)





Other Regulations on Pharmaceuticals

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