Guidance: Classifying pharmaceutical products and placebos for import and export: Update

Pharmaceutical products are classified by:

• their purpose
• the way they’re made up – for example, in measured doses, such as tablets or ampoules
• whether or not they’re intended for retail sale

If a medicinal product contains an active substance, it’s considered to be a ‘medicinal preparation’, as classified in chapter 30.

When classifying pharmaceutical products for the purposes of chapter 30, the following terms and abbreviations may apply:

• active substance – a plant extract, chemically defined substance or group of substances, such as alkaloids, polyphenols or anthocyanins (must have the medicinal properties to prevent or treat diseases, ailments or their symptoms)
• diagnostic – identifying or determining the existence of a disease or ailment
• medicaments or medicinal preparations – preparations based on one or more active substance, used internally or externally to treat or prevent human or animal diseases or ailments
• prophylactic – preventing a disease or ailment from developing
• therapeutic – treating or curing a disease or ailment

Medicaments

Heading 3003 covers products that are made of two or more parts (or constituents) that make a medicinal preparation (mixed) for therapeutic or prophylactic uses. These products contain active substances and are used to treat or prevent diseases or ailments in humans and animals. They can be used internally or externally.

Products used to maintain general health and well-being are specifically excluded from heading 3003. For example, food supplements which are classified under heading 2106.

To be classified under heading 3003, vitamin and mineral-based medicines must contain a much higher level of these substances than is given in recommended daily allowances.

Medicaments which contain active substances for therapeutic or prophylactic uses will be excluded from heading 3003 if they’re:

• in measured doses or packaged for retail sale – products with these characteristics are classified under heading 3004 and can be mixed or unmixed
• products in measured doses, including:
  • tablets
  • capsules
  • ampoules
  • cachets
  • drops
  • capsules
  • transdermal administration systems, generally in the form of self-adhesive patches applied directly to the patient’s skin

Products packaged for retail sale include:

• certain medicinal preparations, such as penicillin and other antibiotics
• herbal and homeopathic medicinal preparations
• certain preparations containing vitamins, minerals, essential amino acids or fatty acids

These products must include certain information for consumers on their labels or packaging, or on the accompanying user directions. The instructions include:

• specific diseases, ailments or deficiencies (or their symptoms) the product is used to treat or prevent
• the concentration of active substances
• the dosage
• how to use the product

Comparators are products used in clinical trials to test how effective an alternative drug is, or to compare a new drug with an existing one. Comparators contain active substances and so are defined as medicinal preparations or medicaments. They’re usually classified under headings 3003 or 3004, depending on how they’re supplied.

Placebos

Placebos are used in clinical trials to test how effective an alternative drug is, or to compare a new drug with an existing one.

Nutritional value

If placebos contain food substances or ingredients with any nutritional value, they’re classified in heading 2106. For example, tablets that contain a mix of food substances (such as sugar and starch). The product may consist of these ingredients or food substances, or they may also include chemicals.

Placebos in the form of intravenous solutions with nutritional value are classified under headings 3003 or 3004.

Chemicals

Placebos often contain a mixture of chemical ingredients. Where there is no nutritional value, they are classified under heading 3824. For example, tablets made up only of chemical products.

Exclusions from chapter 38 are listed in legal note 1 to chapter 38.

Placebo exception

Although placebos are mainly classified in other chapters, heading 3004 does cover placebos that are packaged with medicinal preparations for retail sale. This is because the active substances in the medicament part of the combined product (or set) satisfies the requirement of therapeutic or prophylactic effect.

Mixed and unmixed products

When classifying pharmaceutical products under headings 3003 and 3004, and subheading 3006 30, you’ll need to know if they’re mixed or unmixed.

Unmixed products are:

• all items covered in chapters 28 and 29
• simple vegetable extracts which can be standardised or dissolved in any solution (covered under heading 1302)
• unmixed products that are dissolved in water

Mixed products are:

• colloidal solutions and suspensions, but not colloidal sulphur
• vegetable extracts produced by treating mixtures of vegetable materials
• salts and concentrates obtained by evaporating natural mineral waters

Pharmaceutical goods

Heading 3006 covers certain specific pharmaceutical products, including:

• sterile surgical catgut and similar sterile suture materials
• blood grouping reagents
• dental cements
• first aid kits

Combined products (or sets)

Some products are made by combining two or more separate elements (or constituents). Some or all of these constituents may be covered in section VI as products of the chemical or allied industries. They’re intended to be mixed together to produce products classified in section VI or VII. These combined products (or sets) are classified under the heading appropriate to the finished product, if the constituents are:

• put up in a way that confirms they’re to be used together, without first being repacked
• presented together
• complementary to one another, either because of their nature or because of the proportions in which they’re combined

Modified immunological products

Modified immunological products are classified under heading 3002, which covers:

• monoclonal antibodies (MABs)
• antibody fragments
• antibody conjugates
• antibody fragment conjugates

Intravenous nutritional preparations

Food and dietary supplements are not used to treat or prevent diseases or ailments. They’re generally classified in chapter 21 or 22. Nutritional preparations for intravenous administration by injection or drip into a vein are classified in chapter 30.

Items excluded from chapter 30

Exclusions are listed in legal note 1 to chapter 30.

Placebos are rarely classified in chapter 30, because they do not contain active substances.

Headings 3003 and 3004 exclude:

• goods classified under headings 3002, 3005 and 3006
• aqueous distillates and aqueous solutions of essential oils and preparations (classified under heading 3301), even if they have therapeutic or prophylactic properties
• medicated soaps (classified under heading 3401)
• insecticides, disinfectants and similar products (classified under heading 3808)

Heading 3004 also excludes:

• preparations put up as throat pastilles or cough drops (classified in heading 1704) – they consist mainly of:
  • sugars (whether with or without other foodstuffs, such as gelatin, starch or flour)
  • flavouring agents, including substances with medicinal properties (such as benzyl alcohol, menthol, eucalyptol, tolu balsam)
• snake or bee venom, which is not put up as a medicament (classified under heading 0511)
• preparations such as tablets, chewing gum or patches intended to help people stop smoking (classified under heading 2106 or 3824)

Other items that are specifically excluded from chapter 30 include:

• medicines that do not contain enough active substances to prevent or treat a disease or ailment (generally classified in chapter 21 or 22)
• herbal infusions or teas made from mixtures of plants or plant parts (classified as food preparations under heading 2106)
• food supplements designed to maintain general health or well-being, such as dietetic, diabetic or fortified foods, tonic drinks and mineral waters (generally classified in heading 2106, 2202, 2206 or 2208)
• body-building preparations (classified under various headings, for example, those based on milk powders and whey are classified under heading 1901)
• plasters for use in dentistry, heated to a high temperature (calcined) or finely ground (classified under heading 2520)
• water-based distillations or solutions of essential oils, suitable for medicinal use (classified under heading 3301)
• perfumes, cosmetics and toiletries (classified under headings 3303 to 3307, including when they have therapeutic or prophylactic characteristics)
• medicated soap and similar cleansing products (classified under heading 3401)
• dental plaster, wax and similar products (classified under heading 3407)
• blood albumin that is not prepared for therapeutic or prophylactic uses (classified under heading 3502)
• separate chemical elements or separate chemically defined compounds, not in measured doses or packaging intended for retail sale as medicaments (classified in chapter 28 or 29)

Find more information about food supplements and dietary preparations.

Find more information about vitamins and similar organic compounds that are separately defined.

More information

If this guidance does not cover your specific item in detail and you’re importing goods into Great Britain (England, Scotland and Wales), you can search for it in the Online Trade Tariff.

If you’re importing goods into Northern Ireland from outside the UK, and the EU and the goods are not ‘at risk’ of onward movement to the EU, you should also use the Online Trade Tariff.

If you’re importing goods into Northern Ireland from outside the UK and the EU, and the goods are at risk of onward movement to the EU, you should use the Northern Ireland (EU) Tariff.

If this guidance does cover your item, you’ll still need to find the full commodity code to use in your declaration on the appropriate tariff.

You can find more ways to help you find a commodity code by referring to the links given in this section.