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.

Active substance - 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.

Comparators - Drugs that are used in trials that compare new drugs with previously available ones. They contain active substances and are defined as medicinal preparations.

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.

Placebos - 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.

Intravenous solutions - 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.

Quick reference table of heading codes – Item (heading): 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).

This post is a resume of 

"Guidance - Classifying placebos and comparators for import and export" 

that is found at www.gov.uk/guidance/classifying-placebos-and-comparators. 

Source: HM Revenue & Customs, 2017