Classifying placebos and comparators for import and export
- HM Revenue & Customs
- Part of:
- Classification of goods and International freight industry and businesses making customs declarations
- First published:
- 3 August 2012
- Last updated:
- 19 April 2016, see all updates
How to classify placebo and comparator products used in clinical trials when using the Tariff.
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 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, see 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 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.
Find commodity codes and other measures applying to imports and exports by accessing our online UK Trade Tariff tool.
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 Tariff - in particular Chapter 30 - you may come across certain specific terms. Some examples are listed below.
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 don’t contain active substances and so aren’t defined as medicinal preparations.
Classifying placebos with food ingredients
Placebos don’t 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 though - 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 don’t contain active substances and so they can’t be classified in Chapter 30 as medicinal preparations. Instead they’re classified according to their contents.
If they’re made purely from chemical ingredients, then they’re covered in Chapter 38. Because they commonly contain a mixture of ingredients they’re normally covered under heading code 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.
However, if any of the ingredients is a food substance, or a substance with nutritional value, then the product can’t 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 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 however 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 don’t 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. But 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 don’t 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.
Harmonised System Explanatory Notes (HSENs)
HSENs give useful guidance on the scope of Tariff chapters, headings and subheadings. When you’re classifying placebos and comparators you may find the following HSENs helpful.
HSENs to heading code 3003 (page 569)
HSENs Chapter note 1(b) to Chapter 38 (page VI-38-1)
HSENs to heading code 3824 (page VI-3824-1 to VI-3824-8)
You can buy the HSENs on the World Customs Organization website
The free on-line UK Trade Tariff is available for your use to look up classification codes. This offers easy access to tariff information by providing commodity code and duty rate listings together with a search engine to facilitate enquiries and allow self-service to commodity code information.
If after visiting this site you are unable to self-assess your products, you can request additional support by sending a request by email to email@example.com.
You’ll need to send a separate email for each item you’re asking about. So HMRC can answer your query, make sure you include details about:
- what the product is
- what it’s made of - if it’s made of more than one material, explain the breakdown of the materials
- what it’s used for
- how the product works
- how it’s presented and packaged
You’ll also need to provide extra information for:
- footwear – include the type (shoe, boot, slipper etc), upper material, outer sole material, heel height and purpose (eg, men’s or woman’s)
- food – include full composition details by percentage weight of all the ingredients, and the method of manufacture or process undergone eg, fresh, frozen, dried, further prepared/preserved etc
- chemicals – include the Chemical Abstracts Service Number, whether the product is a liquid, powder or solid, and include the percentage ingredients
- textiles – include the material composition, how it is constructed (knitted/woven) and the name of fabric
- vehicles – include the age, engine type (petrol or diesel) and engine size, and whether the vehicle is:
- new or used
- over 30 years old
- in its original condition
- for everyday use
You’ll then be sent an email from a classification officer providing you with non-legally binding classification advice based on the information you have supplied.
Published: 3 August 2012
Updated: 19 April 2016
- Paragraph 'Harmonised System Explanatory Notes to heading code 3003 (page 569) amended.
- The further information section has been updated to show the change of contact details.
- First published.
From: HM Revenue & Customs