WORLD TRADE
ORGANIZATIONG/TBT/N/CHE/5
13 June 2001
(01-2919)
Committee on Technical Barriers to Trade Original:  English
NOTIFICATION
The following notification is being circulated in accordance with Article 10.6.
1. Member to Agreement notifying:   SWITZERLAND
If applicable, name of local government involved (Articles 3.2 and 7.2):           
2. Agency responsible:   Federal Office of Public Health
Name and address (including telephone and fax numbers, e-mail and web-site
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
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
5. Title, number of pages and language(s) of the notified document:   Ordinance on
Authorizations in Relation to Medicinal Products
6. Description of content:   The ordinance regulates both the requirements and obligations that
must be fulfilled by a company dealing with  medicinal products and the control of this
company by the competent health authorities.  The following require authorizations:
manufacture, wholesale trade, import and export of medicinal products, commerce withmedicinal products abroad and the taking of blood for transfusions or for the production of
medicinal products.  In the first chapter of the ordinance, its scope and important concepts
are defined.  Chapter 2 regulates separately the requirements for the granting of various
types of establishment authorizations.  Th e third chapter regulates the authorization
processes.  The authorization for the individual import of a particular medicinal product  is
regulated in Chapter 4.  Details of the enforcement of the ordinance are to be found in
Chapter 5.  Lastly, Chapter 6 contains the concluding regulations
7. Objective and rationale, including the na ture of urgent problems where applicable:   
In order to protect the health of humans the ordinance ensures that marketed medicines and
medicinal products are of a high quality, safety and efficacy and will be used correctly
8. Relevant documents:   Federal Medicines Act, FF 2000  5689
http://www.admin.ch/ch/f/ff/2000/5689.pdf .
9. Proposed date of adoption:  Autumn 2001
Proposed date of entry into force:  1 January 2002
10. Final date for comments:   31 July 2001
11. Texts available from:  National enquiry point [ X] or address, telephone and fax
numbers, e-mail and web-site addresses, if available of the other body:           