. /.   WORLD TRADE  
ORGANIZATION  G/RO/W/138 
18 October 2010 
 (10-5387) 
Committee on Rules of Origin Original:   English 
 
 
 
SWITZERLAND’S COMMENTS ON DOCUMENT G/RO/W/111/REV. 5 
 
  The following communication, dated 15 October 2010, is being circulated at the request of the Delegation of Switzerland. 
 
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 Switzerland would like to address some issues rela ted to the proposed rules of origin in the 
Chemical - Pharmaceutical sector (Chapters 28 to 39).  
1. Structural issues related to HS Heading 30.02 
 
 Switzerland would like to reiterate the co mments submitted in its former communications 
(document G/RO/W/117 dated 11 April 2008 and G/RO/W/131 dated 8 October 2009), and bring 
forth additional information in response to a ques tion concerning the non-applicability of the rule of 
origin related to galenic forms of medicaments (ampoules, vials, etc.).   
 
 In our view, HS heading 30.02 presents a special case since both active substances and 
proportioned medicine forms are classified here.  Th e galenic form is the proportioned medicine form 
(put up in measured doses).  It allows a patient  to take a medicament in the correct dosage.   Thus, the 
current rule of origin for proportioned medicine fo rms is not appropriate for the reasons set forth 
below.  
 a. Active substances
 
 
 Active substances are classified in HS headi ng 30.02.  In accordance with Primary Rule 7 
(Biotechnological Processes) of Chapter 30, activ e substances can be biotechnologically processed.  
The rule of origin "change to the goods of this heading by biological or biotechnological processes" 
can be used.  
b. Galenic form, proportioned medicine form (ampoules, vials, etc.)
 
  Galenic forms are also classified in HS headi ng 30.02.  In HS heading 30.02 the rule CTH is 
not applicable for active substances of HS h eading 30.02 which are processed in galenic forms 
"Medicaments (excluding goods of headings 30.02, 30.05 or 30.06) …".  
 Example:  monoclonal anti-body: HS 3002.10;  ampoule with active substance monoclonal anti-body: 
HS 3002.10.    Thus CTH does not apply in this case.  The same is true for the rule CTSH. 
 G/RO/W/138 
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  2. Biotechnological processes 
 
 The ampoules used in the production of the galenic form are not biotechnologically manufactured.  The active substance is mixed with othe r auxiliary materials (excipients) which is then 
mixed together in the  ampoules.  The empty glass ampoule is filled in a germ-poor environment with 
special racking plants.  Staff is equipped with special protective clothing for germ-poor work. Mixing 
is thus to be considered a technical process. Sinc e the packing process is not origin conferring, the 
production of the  ampoule is considered the last substan tial processing operation (last substantial 
transformation).  Thus a biotechnological process does not take place.  Therefore, the rule for 
biotechnological processes is not applicable for proportioned medicine forms. 
 
3. Rule for goods of heading 30.02 – Swiss proposal 
 
 From a systematic point of view, medicine in the galenic form (put up in measured doses or packed for retail sale) in heading 30.02 should not have a different approach for establishing origin 
than medicine in galenic form (put up in measured doses or packed for retail sale) in heading 30.04.  
Throughout Chapter 30, the production of a galenic me dicine form (excluding me re pressing of tablets 
or by mere encapsulation) is origin conferring.  Th erefore, the rule of origin for heading 30.02 should 
be amended as follows:  "production of the measure d doses or in forms or packing for retail sale 
except by mere pressing of tablets or by mere encapsulation".  It is noted that no residual rule was proposed for 30.02. 
 
4. Chapter Residual rule - for goods of headings 30.02, 30.03 and 30.04 – Swiss proposal 
 
 We propose to amend the Chapter 30 residual rule as follows: 
 
 “Goods of headings 30.02, 30.03 and 30.04 produced by mixing or otherwise combining 
materials of different origins originate in the count ry that processed the materi als into dosage form or 
produced the therapeutic or prophylactic material s (disregarding solvents and other non-active 
additives) that predominate by weight, by volume or by the total value of materials.   
 
5. Chapter Residual rules for goods of Chapters 28 to 39 – Swiss proposal 
  Taking into account the points raised in the tw o last sentences of paragraph 6, we would also 
indicate that we still support the introduction of an alternative value criteria as appropriate in the 
Chapter Rules of the Chemical - Pharma ceutical sector (HS Chapters 28 - 39).  
 
 
 
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