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Re: biopharm post# 188425

Monday, 09/01/2014 8:53:35 AM

Monday, September 01, 2014 8:53:35 AM

Post# of 345694
Import Tax re: Bavituximab

page 32 of 148

Bavituximab
648904-28-3

http://www.usitc.gov/publications/332/pub4181.pdf

-----------------------------------------

PHARMACEUTICAL PRODUCTS RELIEF FROM CUSTOMS DUTY IS PROVIDED FOR
PHARMACEUTICAL PRODUCTS LISTED IN ANNEXES 3 TO 6
TO THE COMMON CUSTOMS TARIFF (SEE COMMISSION IMPLEMENTING REGULATION (EC) NO. 1001/2013 OF 4TH OCTOBER 2013, SECTION II, PARAGRAPH C, PAGE 17) SHOWN IN OFFICIAL JOURNAL L290, PUBLISHED 31ST OCTOBER 2013.

THIS REGULATION COMES INTO FORCE ON 1ST JANUARY 2014.
THE ANNEXES ARE REPRODUCED HEREIN, AS FOLLOWS:


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, 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

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.

....
..
..

found under the Annex 3 section "3002 10 91" which starts on pg 109 and looks like Bavituximab associated with this heading... cont'd and found "648904-28-3 bavituximab" on pg 111


http://www.uk-customs-tariff.com/content/contentlist/volume/vol1_pharma.pdf

---------------------------------------

30021030
Bavituximab (INN)

http://www.customs.gov.sg/nr/rdonlyres/10845b3e-7163-4de9-bfee-b361eefcefeb/0/agfullindex.pdf

"Bavituximab is a first-in-class phosphatidylserine (PS)-targeting monoclonal antibody that is the cornerstone of a broad clinical
pipeline."
-- Big Pharmas nightmare... unless they are fortunate enough to have The Bavi Edge!

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