How to classify placebo and comparator products used in clinical trials if you are importing into or exporting out of the EU.
Before you start
This guide will help you to classify placebos and comparators used in clinical trials. If it does not cover your specific item in detail you can search for it in the Trade Tariff Tool.
This guide will:
- provide some or all of the commodity codes for particular items and types
- explain the differences between codes or headings affecting these items
- detail any exceptions or rules
You will still need to look up the full commodity code to use on your declaration using the Trade Tariff Tool. You can find out more about:
- using the trade tariff tool to find the full commodity code
- other ways to help you find a commodity to classify your goods
This guide will help you to classify products known as placebos and comparators. These are used in clinical comparative trials to test how effective a new drug is.
These products are classified according to:
- whether or not they’re defined as medicinal preparations
- their ingredients
- the way they’re made up - for example in measured doses like tablets or ampoules
These products are covered in the Trade Tariff at:
- Chapter 21 - for placebos containing ingredients that are food substances or have some nutritional value
- Chapter 30 - for comparator medicinal preparations for both humans and animals, read the guide on classifying pharmaceutical products
- Chapter 38 - for placebos made only of chemical ingredients
Not all placebos are covered in these chapters. Due to their make-up, some are covered elsewhere in the Trade Tariff.
It’s important for classification purposes to identify whether a product contains an active substance. If it does, it’s classed as a medicinal preparation. If you need a legally binding ruling you can apply for a Binding Tariff Information Ruling.
You’ll need to give the exact composition of the product you’re asking about to be sure of getting the right commodity code.
Quick reference table of heading codes
|Placebos - containing ingredients with nutritional value||2106|
|Placebos - packaged with medicinal preparations for retail sale||3004|
|Placebos - made from chemical ingredients only||3824|
|Placebos - intravenous solutions with a nutritional effect||3003|
|Placebos - intravenous solutions with a nutritional effect, for retail sale||3004|
|Comparator drugs - neither in measured doses nor packaged for retail sale||3003|
|Comparator drugs - in measured doses or packaged for retail sale||3004|
Definitions of placebos and comparators used for clinical trials
When you’re classifying placebos and comparators for the purposes of the Trade Tariff - in particular Chapter 30 - you may come across certain specific terms. Here are 4 examples.
A chemically defined substance, a chemically defined group of substances, such as alkaloids, polyphenols or anthocyanins, or a plant extract. Active substances must have medicinal properties to prevent or treat specific diseases and ailments, or their symptoms.
Drugs that are used in trials that compare new drugs with previously available ones. They contain active substances and are defined as medicinal preparations.
Preparations based on one or more active substances that have a therapeutic or prophylactic effect. In other words, that cure, treat or prevent diseases or ailments.
Products that do not contain active substances and so are not defined as medicinal preparations.
Classifying placebos with food ingredients
Placebos do not contain active substances and so, for the most part, they’re not classified in Chapter 30 as medicinal preparations. Instead they’re classified according to their contents.
If they contain food substances, or ingredients with nutritional value, no matter how little, then they’re covered in Chapter 21 under heading code 2106. This heading code covers ‘food preparations not elsewhere specified or included’ and would include, for example, tablets that contain a mix of food substances like sugar and starch. They could either be the only ingredients or they could be mixed with chemical items too.
There is an exception - placebos that are in the form of intravenous solutions that have a nutritional effect are classified in Chapter 30.
Classifying placebos with chemical ingredients
Placebos do not contain active substances, so they cannot be classified in Chapter 30 as medicinal preparations. They are classified according to their contents.
They often contain a mixture of chemical ingredients covered in Chapter 38 under heading 3824.
This heading code covers ‘products of the chemical or allied industries (including those consisting of mixtures of natural products), not elsewhere specified or included’. For example this heading code would cover tablets made up of mixtures of chemical products.
If any of the ingredients is a food substance, or a substance with nutritional value, then the product cannot be classified in Chapter 38. Instead it’s covered in Chapter 21 under heading code 2106.
Medicinal preparations of placebos and comparators used for clinical trials
Comparator drugs contain active substances and are defined as medicaments - or medicinal preparations. These are preparations used (either internally or externally) to treat or prevent human or animal diseases or ailments. They’re covered in Chapter 30 under heading codes 3003 and 3004, depending on how they’re supplied. They must have a therapeutic or prophylactic effect to be classified under either heading code.
Medicaments that are neither made up into measured doses, nor packaged for retail sale are covered under heading code 3003.
Heading code 3004 specifically covers medicaments that are:
- made up into measured doses - such as tablets, ampoules, syringes and capsules
- packaged for retail sale
It also covers placebos that are packaged together with medicinal preparations for retail sale - even though placebos are mainly covered in other chapters. This is because the active substances in the medicament part of the combined product (or set) satisfies the requirement that it should have a therapeutic or prophylactic effect.
Placebos that are in the form of intravenous solutions which have a nutritional effect are also included in Chapter 30, either under heading code 3003 or 3004, depending on how they’re presented.
Exclusions and difficult classifications
Placebos and comparators are classified in different chapters of the Trade Tariff, depending on their intended use, their ingredients and how they’re made up.
Products that contain active substances intended to treat, cure or prevent diseases and ailments are defined as medicaments and are covered in Chapter 30. Products that are made up of chemical ingredients are covered in Chapter 38. There are specific exclusions from each of these chapters.
Specific exclusions from Chapter 30
To be covered in Chapter 30 a product must contain active substances and prevent, cure or treat diseases and ailments. Placebos do not contain these active substances and so, with a few exceptions, are classified elsewhere.
Specific exclusions from Chapter 38
Placebos that are made up from a mixture of chemical ingredients are covered in Chapter 38 under heading code 3824. If any of the ingredients is considered to be food, or has any nutritional value, then the product is excluded from this heading code and covered in Chapter 21 under heading code 2106.
Nature of the product
Placebos and comparators are used in clinical trials to test how effective an alternative drug is, or to compare a new drug with an existing one.
An important difference between placebos and comparators is whether or not they contain active substances that would define them as medicaments. Medicaments, or medicinal preparations, are products that are meant for:
- therapeutic uses - they treat or cure a disease or ailment
- prophylactic uses - they prevent a disease or ailment from developing
Placebos do not contain active substances and so they’re likely to be covered in Chapter 21 or Chapter 38, depending on their ingredients. Products that do have therapeutic or prophylactic uses are covered in Chapter 30.
Use the online UK Trade Tariff tool to find the rest of your commodity code and other measures applying to imports and exports.
If you cannot find the information you need on this page, you can get more help to find the right commodity code for your goods.