G/TBT/N/CHE/221  
 
24 July 2017  
(17-4063) 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 Authorization of Medicinal Products (AMZV) (37 pages incl. additional annexes, 
available in German, French and Italian)    
6. Description of content:  Partial revision of the Ordinance on the Authorization of Medicinal 
Products (AMZV). In the AMZV the Sw iss Agency for Therapeutic Products describes in 
detail the information and documentation that must be provided as part of an application 
for a marketing authorization. The ordinance applies both to human and to veterinary 
medicines outlining the elements of the authorization that need to be supported by 
scientific evidence. It also describes the requirements for labelling and package inserts.  
Major proposed revisions are as follows:  
To incorporate the new requirements for the application for a marketing au thorization 
which have been introduced with the latest revision of the TPA (Therapeutic Products Act) 
adopted on 18 March 2016 (paediatric investigation plan, pharmacovigilance plan).  
To introduce a legal basis for a new process to label medicinal products  that are being 
monitored particularly closely by regulatory authorities.  
To introduce adjustments to the rules on the grouping of variations to medicinal products.  
To separate the requirements for the labelling and for the design of the Summary of 
Product  Characteristics (SmPC) and package leaflet of medicinal products for human and 
veterinary use and to regroup all requirements for veterinary medicinal products in a 
single new annex.  
To harmonize the requirements for the declaration of active substances a nd 
pharmaceutical excipients of medicinal products for human and veterinary use with the 
corresponding provisions of the European Excipients -Guideline (CPMP/463/00 Final, 
July 2003).  G/TBT/N/CHE/221  
 
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  7. Objective and rationale , including the nature of urgent problems wher e applicable: 
Availability and security of medicinal products  
8. Relevant documents:   
 Draft Ordinance on the Authorization of Medicinal Products (AMZV) incl. annexes 1 to 7 
(see attachment)  
 Ordinance on the Authorization of Medicinal Products (AMZV)  
Frenc h: (https://www.admin.ch/opc/fr/classified -compilation/20011693/index.html )  
German: ( https://www.admin.ch/opc/de/classified -compilation/20011693/index.html )  
Italian: ( https://www.admin.ch/opc/it/classified -compilation/20011693/index.html )  
 Latest re vision of the TPA (not yet in force): available in  
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 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_3361_00_f.pdf  
https://members.wto.org/crnattachments/2017/TBT/CHE/17_3361_00_x1.pdf  
https://members.wto.org/crnatta chments/2017/TBT/CHE/17_3361_00_x2.pdf