G/TBT/N/CHE/222  
 
24 July 2017  
(17-4064) 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 
the Simplified Authorization Procedure and the Notification Procedure for Medicinal 
Products (VAZV) (18 pages, incl. additional annexes, available in German, French and 
Italian)    
6. Description of content:  Partial revision of the Ordinance on the Simplifi ed Authorization 
Procedure and the Notification Procedure for Medicinal Products (VAZV). The VAZV 
contains the essential implementing provisions for the Articles 14 and 15 of the 
Therapeutic Products Act (TPA). The VAZV includes rules regarding admission a nd 
simplified authorization of medicinal products as so -called orphan drugs (important drugs 
for rare diseases: Art. 14 para. 1 let. f TPA). It also outlines rules on the simplified 
authorization procedure for medicinal products with known active pharmaceu tical 
ingredients, hospital exemptions, and drugs manufactured by using a formula recognized 
by the Swiss Federal Agency for Therapeutic Products.  
Major proposed revisions are as follows:  
To introduce minor adjustments to the criteria for the designation o f a medicinal product 
as an orphan medicinal product and to the rules of withdrawal of orphan designations;  
To implement new and simplified access opportunities for certain medicinal product 
categories (especially medicinal products approved in an EU or EF TA country, medicinal 
products with traditional use and medicinal products already approved in a canton).  
To introduce adjustments regarding conditional marketing authorizations (especially 
requirements for the application, imposing of specific [scientific ally based] obligations and 
renewal of a conditional marketing authorization).  
To simplify the regulation on the notification procedure for medicinal products for certain 
small pet animals not intended to produce food for human consumption.  G/TBT/N/CHE/222  
 
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  7. Objective a nd rationale , including the nature of urgent problems where applicable: 
Availability and security of medicinal products  
8. Relevant documents:   
 Draft Ordinance on the Simplified Authorization Procedure and the Notification 
Procedure for Medicinal Products  (VAZV) (see attachment)  
 Ordinance on the Simplified Authorization Procedure and the Notification Procedure  
French: ( https://www.admin.ch/opc/fr/classified -compilation/20 051634/index.html )  
German: ( https://www.admin.ch/opc/de/classified -compilation/20051634/index.html )  
Italian: ( https://www.admin.ch/opc/it/classified -compilation/20051634/index.html )  
 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 da ys from notification  
11. Texts available from : National enquiry point  [X] or address, telephone and fax 
number s and e mail and website address es, if available , of other body:   
https://members.wto.org/crnattachments/2017/TBT/CHE/17_3362_00_f.pdf  
https://members.wto.org/crnattachments/2017/TBT/CHE/17_3362_00_x1.pdf  
https://members.wto.org/crnattachments/2017/TBT/CHE/17_3362_00_x2.pdf