G/TBT/N/CHE/220  
 
24 July 2017  
(17-4062) 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:  Federal Office of Public Health FOPH  
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 Secretariat for Econom ic 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 
Medicinal Produ cts (VAM) (40 pages incl. additional annexes, available in German, French 
and Italian)    
6. Description of content:  The revision contains e.g. the new requirements for the 
application for a market authorization which have been introduced with the latest r evision 
of the TPA (Therapeutic Products Act) adopted on 18 March 2016.  
Major proposed elements are:  
On the basis of the latest revision of the TPA a new instrument, paediatric investigation 
plan, and its regulatory details will be implemented in accordanc e with the European 
Regulation on medicinal products for paediatric use (Regulation (EC) No 1901/2006 of the 
European Parliament and of the Council of 12 December 2006 on medicinal products for 
paediatric use and amending Regulation (EEC) No 1768/92, Direc tive 2001/20/EC, 
Directive 2001/83/EC and Regulation (EC) No 726/2004).  
Regulations concerning pharmacovigilance planning with implementing details are also a 
new element. Furthermore, the requirements for a market authorization will be simplified 
for cert ain categories of medicinal products (especially medicinal products approved in an 
EU or EFTA country, medicinal products with "traditional use" and medicinal products 
already approved in a canton, as well as various medicinal products used in 
complementar y medicine). Additional alterations concern the simplification of the 
examination process with regard to a medicinal product already authorized in a country 
with comparable control of medicinal products and the alignment of the requirements for 
variations and changes of the market authorizations of medicinal products with the EU 
requirements (EU Variation Regulation).  
The draft contains further regulations, which are, however, not subject of notification.  G/TBT/N/CHE/220  
 
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  7. Objective and rationale , including the nature of  urgent problems where applicable: 
Availability and security of medicinal products  
8. Relevant documents:   
 Draft Ordinance on Medicinal Products, incl. additional annexes (VAM) (see 
attachment).  
 Ordinance on Medicinal Products  
French: ( https://www.admin.ch/opc/fr/classified -compilation/20011787/index.html )  
German: ( https://www.admin.ch /opc/de/classified -compilation/20011787/index.html )  
Italian : (https://www.admin.ch/opc/it/classified -compilation/20011787/index.html )  
 Latest revision of the Therapeut ic 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. Propose d 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 point [X] or address, telephone and fax 
numbers and email and website a ddresses, if available, of other body:   
https://members.wto.org/crnattachments/2017/TBT/CHE/17_3360_00_f.pdf  
https://members.wto.org/crnattachments/2017/TBT/CHE/17_3360_00_x1.pdf  
https://members.wto.org/crnattachments/20 17/TBT/CHE/17_3360_00_x2.pdf