G/TBT/N/CHE/231  
 
2 May 2018  
(18-2719) 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  
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 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 [   ], 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: products of chemical or bio logical origin which are intended to have or are 
presented as having a medicinal effect on the human or animal organism, in particular in 
the diagnosis, prevention or treatment of diseases, injuries and handicaps; blood and 
blood products are also consider ed to be medicinal products (relevant tariff items: 3002, 
3003, 3004).  
5. Title, number of pages and language(s) of the notified document: Draft revision of 
the Ordinance on Licensing in the Medicinal Products Sector, 41 pages, available in 
German, French  and Italian.  
6. Description of content: The Ordinance on Licensing in the Medicinal Products Sector 
(SR 812.212.1) is being currently revised due to numerous amendments relating to the 
ordinary revision of the Therapeutic Products Act (TPA) adopted by Parliament on 
18 March  2016 as well as to the approval and implementation of the Medicrime Convention 
adopted by Parliament on 29 September 2017.  
The following amendments of the abovementioned ordinance may be relevant for 
international trade:  
 more detaile d specifications with regard to the licence for the import, export and 
foreign trade of medicinal products  
 new licence for the activities of brokers  
 simplifications with regard to the individual import of immunological medicinal 
products or blood/blood pro ducts  
 new regulation concerning the import of unauthorised medicinal products in small 
quantities by private individuals and by health professionals  G/TBT/N/CHE/231  
 
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  7. Objective and rationale, including the nature of urgent problems where 
applicable: Protection of public  health, an optimal supply of medicinal products to the 
Swiss people  
8. Relevant documents:   
Draft revision of the Ordinance on Licensing in the Medicinal Products Sector:  
 German: https://www.admin.ch/ch/d/gg/pc/documents/2944/AMBV_Entwurf.pdf   
 French: https://www.admin.ch/ch/f/gg/pc/documents/2944/OAMed_projet.pdf   
 Italian: https://www.admin.ch/ch/i/gg/pc/documents/2944/  
OAMed_avamprogetto.pdf   
Ordinance on Licensing in the Medicinal Products Sector currently in force:  
 German: https://www.admin.ch/opc/de/classified -
compilation/20011780/index.html   
 French: https://www.admin.ch/opc/fr/classified -compilation/20011780/index.html   
 Italian: https://www.admin.ch/opc/it/classified -compilation/20011780/index.html   
9. Proposed date of  adoption: 21 November 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 addresses, if available, of other body: