{
  "url": "https://openlegislation.uk/eu-regulation-2010-1238/annex-II",
  "json_url": "https://openlegislation.uk/eu-regulation-2010-1238/annex-II.json",
  "legislation": "eur/2010/1238",
  "legislation_title": "Regulation (EU) No 1238/2010 of the European Parliament and of the Council of 15 December 2010 amending Annex I to Council Regulation (EEC) No 2658/87 as regards the provision of duty-free treatment for specified pharmaceutical active ingredients bearing an ‘international non-proprietary name’ (INN) from the World Health Organization and specified products used for the manufacture of finished pharmaceuticals",
  "legislation_url": "https://openlegislation.uk/eu-regulation-2010-1238",
  "path": "annex/II",
  "kind": "annex",
  "number": "II",
  "heading": "List of prefixes and suffixes which, in combination with the INNs of Annex 3 to Annex I to Regulation (EEC) No 2658/87, 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 six-digit HS subheading as the corresponding INN",
  "text": "The references to ‘International Nonproprietary Names (INN) for pharmaceutical substances, names for radicals and groups, comprehensive list 2004’ are replaced by ‘International Nonproprietary Names (INN) for pharmaceutical substances, names for radicals, groups and others, comprehensive list 2007’.\nThe following prefixes or suffixes are added to the list included in Annex 4 to Annex I to Regulation (EEC) No 2658/87:\nPreferred prefix or suffix\nSynonym\nSystematic name when different\nalanetil (INNRG)\n[(S)-1-ethoxy-1-oxo-propan-2-yl]amino (INNCN)\nalaninate (INNRG)\nL-alaninate (INNCN)\nalapivoxil (INNRG)\nL-alanyl, [(2,2-dimethylpropanoyl)oxy]metyl (INNCN)\naldifitox (INNRG)\n(4-iminobutane-1,4-diyl)sulfanediyl[(3RS)-2,5-dioxopyrrolidine-1,3-diyl]-1,3-phenylenecarbonyl and forming an N-benzoyl derivative of a primary amine group of diphtheria [550-L-phenylalanine]toxin from Corynebacterium diphtheriae-(26-560)-peptide (INNCN)\nbesudotox (INNRG)\nL-lysyl-L-alanyl-L-serylglycylglycine (linker) fusion protein with des-(365-380)-[Asn364,Val407,Ser515,Gln590,Gln606,Arg613]exotoxin A (Pseudomonas aeruginosa)-(251-613)-peptide (toxin with region IA and first 16 residues of region IB deleted) (INNCN)\nceribate (INNRG)\nrac-2,3-dihydroxypropyl carbonate (ester) (INNCN)\ncipecilate (INNRG)\ncyclohexanecarboxylate (ester), cyclopropanecarboxylate (ester) (INNCN)\ndalanated (INNRG)\ndes-B30-alanine (INNCN)\nenacarbil (INNRG)\n{rac-1-[(2-methylpropanoyl)oxy]ethoxy}carbonyl (INNCN)\nestafenatox (INNRG)\nglycylglycyl-L-proline (linker) fusion protein with enterotoxin type A (Staphylococcus aureus)-(1-33)-peptidyl-L-seryl[Ser36,Ser37,Glu38,Lys39,Ala41,Thr46,Thr71,Ala72,Ser75,Glu76,Glu78,Ser80,Ser81,Thr214,Ser217,Thr219,Ser220,Ser222,Ser224]enterotoxin type E (Staphylococcus aureus)-(32-230)-peptide (synthetic superantigen SEA/E-120) (INNCN)\netexilate (INNRG)\nethyl, (hexyloxy)carbonyl\nfosamil (INNRG)\nphosphono (INNCN)\nglucuronide (INNRG)\nβ-D-glucopyranosiduronic acid [oside] (INNCN)\nmedocaril (INNRG)\n[(5-methyl-2-oxo-1,3-dioxol-4-yl)methoxy]carbonyl (INNCN)\npaptox (INNRG)\nprotein PAP (Phytolacca americana antiviral) (INNCN)\nplacarbil (INNRG)\n(R)-2-methyl-1-[(2-methylpropanoyl)oxy]propoxy}carbonyl) (INNCN)\nThe systematic name of the following prefix or suffix is amended as follows:\nPreferred prefix or suffix\nSynonym\nSystematic name when different\naritox (INNRG)\nricin A chain (INNCN)",
  "extent": "E+W+S+N.I.",
  "status": null,
  "version": "current",
  "annotations": [],
  "outstanding_effects": [],
  "provenance": {
    "source": "legislation.gov.uk",
    "source_url": "https://www.legislation.gov.uk/eur/2010/1238/annex/II",
    "retrieved_at": "2026-11-01T14:50:24.898101+00:00"
  },
  "licence": "Open Government Licence v3.0",
  "licence_url": "https://www.nationalarchives.gov.uk/doc/open-government-licence/version/3/",
  "attribution": "Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives."
}