Explanatory notes
Updated 31 December 2018
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This publication is available at https://www.gov.uk/government/publications/uk-trade-tariff-customs-duty-relief-on-pharmaceutical-products/explanatory-notes
1. Pharmaceutical products
Relief from customs duty is provided for pharmaceutical products of the following categories:
- pharmaceutical substances which are covered by the Chemical Abstracts Service reference numbers (CAS RN) and the international non-proprietary names (INNs) listed in Annex 3
- salts, esters and hydrates of INNs, which are described by combining INNS of Annex 3 with prefixes or suffixes of Annex 4, provided such products are classifiable in the same 6 digit Harmonised System (HS) subheadings as the relevant INN
- salts, esters and hydrates of INNs, which are listed in Annex 5 and which are not classifiable in the same 6 digit HS-subheadings as the corresponding INNs
- pharmaceutical intermediates, ie compounds used in the manufacture of finished pharmaceutical products which are covered by the CAS RN and the chemical names, listed in Annex 6
2. Special cases
INNs cover only those substances described in the lists of recommended and proposed INNs published by the World Health Organization (WHO). Where the number of substances covered by an INN is less than that covered by the CAS RN, only those substances covered by the INN will be subject to duty free treatment;
Where a product of Annex 3 or Annex 6 is identified by a CAS RN corresponding to a specific isomer, only that isomer may qualify for duty free treatment;
Double derivatives (salts, esters and hydrates) of INNs identified by a combination of an INN of Annex 3 with a prefix or suffix of Annex 4 qualify for duty free treatment, provided they are classifiable in the same 6 digit HS-subheading as the relevant INN (for example, alanine methyl ester, hydrochloride).
Where an INN of Annex 3 is a salt (or an ester), no other salt (or ester) of the acid corresponding to the INN may qualify for duty free treatment. For example:
- oxprenoate potassium (INN) - duty free
- oxprenoate sodium - not duty free
3. Annex 3
Annex 3 is a list of international non-proprietary names (INNs), provided for pharmaceutical substances by the WHO, which are free of duty.
4. Annex 4
Annex 4 is a list of prefixes and suffixes which, in combination with the international non-proprietary names (INNs) of annex 3, describe the salts, esters or hydrates of INNs; these salts, esters and hydrates are free of duty, on condition that they are classifiable in the same 6-digit HS-subheading as the corresponding INN.
Prefixes and suffixes can be combined (for example, hydrochloride phosphate). They can be preceded by a multiplying prefix such as bi, bis, di, hemi, hepta, hexa, mono, penta, sesqui, tetra, tri, tris, … (for example, diacetate). Synonyms and systematic names can also be used, in the same way.
INN means international non-proprietary names for pharmaceutical substances, WHO.
INNRG means INNs for pharmaceutical substances, names for radicals, groups and others, comprehensive list 2007.
INNCN means chemical or systematic name listed in INNs for pharmaceutical substances, names for radicals, groups and others, comprehensive list 2007.
5. Annex 5
Salts, esters and hydrates of international non-proprietary names (INNs), which are not classified in the same HS-heading as the corresponding INNs and which are free of duty.
6. Annex 6
Annex 6 is a list of pharmaceutical intermediates, ie compounds used for the manufacture of finished pharmaceutical products, which are free of duty.