Commission Implementing Regulation (EU) No 927/2012Show full title

C. Pharmaceutical products

1.

Relief from customs duty is provided for pharmaceutical products of the following categories:

(1)

pharmaceutical substances which are covered by the CAS RN (chemical abstracts service registry numbers) and the international non-proprietary names (INNs) listed in Annex 3;

(2)

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 HS-subheadings as the relevant INN;

(3)

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;

(4)

pharmaceutical intermediates, i.e. 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:

(1)

INNs cover only those substances described in the lists of recommended and proposed INNs published by the World Health Organisation (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;

(2)

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;

(3)

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:

example: alanine methyl ester, hydrochloride;

(4)

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:

example: oxprenoate potassium (INN): duty-free

oxprenoate sodium: not duty-free.