  
  
G/TBT/N/CHE/284  
18 December 2023  
(23-8663) 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  
Division of Biomedicine  
Therapeutic Products Law Section  
Schwarzenburgstrasse 157  
3003 Bern  
Switzerland  
Tel. +41 58 463 51 54  
HMR@bag.admin.ch  
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  
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 [  ], 3.2 [  ], 7.2 [  ], 
other :  
4. Products covered (HS or CCCN where applicable, otherwise national tariff 
heading. ICS numbers may be provided in addition, where applicable):  
PHARMACEUTICAL PRODUCTS (HS code(s): 30); Generalities. Terminology. 
Standardization. Documentation (ICS code(s): 01); Natural and applied sciences (ICS 
code(s): 07); Health care technology (ICS code(s): 11)  
5. Title, number of pages and language(s) of the notified document:  Revision of the 
Federal Act on Medicinal Products and Medical Devices (Therapeutic Products A ct, TPA); 
(25 page(s), in Italian), (25 page(s), in German), (25 page(s), in French)  
6. Description of content:  The Therapeutic Products Act, which has been in force since 
2002, is currently being revised . Topics which are affected:  
• Advanced therapy medi cinal products (ATMPs)  
• Digitalisation in the prescription, dispensing and use of therapeutic products  
• Veterinary medicinal products  
Swiss law is harmonised with EU law in order to reduce technical barriers to trade. The 
proposed changes are intended to bri ng greater clarity and certainty to the authorisation 
of advanced therapy medicinal products (ATMPs). In the area of veterinary medicinal G/TBT/N/CHE/284  
 
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  products, a legal basis is created to prohibit the use of certain antimicrobial medicinal 
products (prevention of anti biotic resistance), to authorise innovative therapies and to 
permit authorisations to be valid for an unlimited period.  
7. Objective and rationale, including the nature of urgent problems where 
applicable:  Protection of human health or safety; Protection of animal or plant life or 
health; Harmonization; Reducing trade barriers and facilitating trade  
8. Relevant documents:   
Swiss Federal Act on Medicinal Products and Medical Devices  
Overview revision with links to regulatory impact assessments  
Regulation (EU) 2019/6 of the European Parliament and of the Council of 11 December 
2018 on veterinary medicinal products  
Regulation (EU) 2019/4 of the European Parliament and of the Council of 11 December 
2018 on the manufacture, placing on the market and use of medicated feed  
Regulation (EC) No 1394/2007 of the European Parliament and of the Council of 13 
November 2007 on advanced therapy medicinal products  
9. Proposed date of adoption:  To be determined  
Proposed date of entry into force:  To be determined  
10. Final date for comments:  22 March 2024  
11. Texts available from:  National enquiry point [X] or address, telephone and fax 
numbers and email and website addresses, if available , of other body:   
Swiss Information Center for Technical Rules (switec)  
Sulzerallee 70  
8404 Winterthur  
Tel: +(41) 52 224 54 55 Fax: +(41) 52 224 54 75  
Email: switec@snv.ch  
https://fedlex.data.admin.ch/eli/dl/proj/2023/72/cons_1  
https://members.wto.org/crnattachments/2023/TBT/CHE/23_14702_00_f.pdf  
 