G/TBT/N/CHE/223  
 
24 July 2017  
(17-4065) Page: 1/2 
Committee on Technical Barriers to Trade  Original: English  
 
  NOTIFICATION  
The following notification is being circulated in accordance with Article 10.6  
 
1. Notifying Member : SWITZERLAND   
If applicable, name of local government involved  (Article 3.2 and 7.2) :  
2. Agency responsible:  Swissmedic - Swiss Agency for Th erapeutic Products  
Name and address (including telephone and fax numbers , email and website 
addresses, if available) of agency or authority designated to handle comments 
regarding the notification  shall be indicated if different from above :  
State Secretar iat for Economic Affairs SECO  
Holzikofenweg 36, 3003 Berne  
tbt@seco.admin.ch , www.seco.admin.ch   
3. Notified under Article 2.9.2 [ X], 2.10.1 [  ], 5.6.2 [ X], 5.7.1 [  ], other : 
4. Products covered (HS or CCCN where applicable, otherwise national tariff heading. 
ICS numbers may be provided in addition, where applicable):  Medicinal products  
5. Title, number of pages  and language(s)  of the notified document:  Draft Ordinance on 
Complementary and Herbal Medicinal Products (KPAV) (36 pages and additional annexes, 
available in German, French and Italian)    
6. Description of content:  With the recent revision of the Therapeutic Products Act (TPA, 
Stage 2), the legislative body is impr oving, amongst other things, the popu lation' s access 
to medicinal products. Due to this recent legislative changes and based on the adapted 
Art. 14 and 15 of the TPA, the ordinance describes the requirements for simpler access 
opportunities for various med icinal products used in complementary medicine. For several 
herbal, homeopathic and anthroposophic medicinal products as well as for some 
traditionally used Asiatic medicines the documentation requirements are reduced. For 
certain categories (with a low sc ientific risk profile), the marketing authorization procedure 
is reduced to a simple notification process. In separate annexes of the ordinance, the 
active substances allowed as components of those medicinal products are listed.  
7. Objective and rationale , including the nature of urgent problems where applicable: 
Availability and security of medicinal products  
8. Relevant documents:   
 Draft Ordinance on Complementary and Herbal Medicinal Products (KPAV) incl. 
Annexe  1 to 9 (see attachment)  
 Ordinance on Com plementary and Herbal Medicinal Products  
French: ( https://www.admin.ch/opc/fr/classified -compilation/20051631/index.html )  
German: ( https://www.admin.ch/opc/de/classified -compilation/20051631/index.html )  
Italian: ( https://www.admin.ch/opc/it/classifie d-compilation/20051631/index.html )  G/TBT/N/CHE/223  
 
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   Latest revision of the Therapeutic Products Act, TPA (not yet in force):  
French: ( https://www.admin.ch/opc/fr/official -compilation/2017/2745. pdf)  
German: ( https://www.admin.ch/opc/de/official -compilation/2017/2745.pdf )  
Italian: ( https:// www.admin.ch/opc/it/official -compilation/2017/2745.pdf )   
9. Proposed date of adoption: September 2018  
Proposed date of entry into force: 1 January 2019  
10. Final date for comments:  60 days from notification  
11. Texts available from: National enquiry p oint [X] or address, telephone and fax 
numbers and email and website addresses, if available, of other body:   
https://members.wto.org/crnattachments/2017/TBT/CH E/17_3363_00_f.pdf  
https://members.wto.org/crnattachments/2017/TBT/CHE/17_3363_00_x1.pdf  
https://members.wto.org/crnattachments/2017/TBT/CHE/17_3363_00_x2.pdf