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 Act, 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 medicinal 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 bring greater clarity and certainty to the authorisation of advanced therapy medicinal products (ATMPs). In the area of veterinary medicinal products, a legal basis is created to prohibit the use of certain antimicrobial medicinal products (prevention of antibiotic 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://members.wto.org/crnattachments/2023/TBT/CHE/23_14702_00_f.pdf