. /.WORLD TRADE
ORGANIZATIONG/TBT/N/FRA/21
14 March 2003
(03-1491)
Committee on Technical Barriers to Trade Original:  French
NOTIFICATION
The following notification is being circulated in accordance with Article 10.6.
1. Member to Agreement notifying:  FRANCE
If applicable, name of local government involved (Articles 3.2 and 7.2):
2. Agency responsible:
Interministerial Director for Standards
SQUALPI
64-70 Allée de Bercy
Télédoc 811 – 75574Paris Cedex 12
Tel.: 01 53 44 97 04
Fax: 01 53 44 98 88
E-mail: suzanne.piau@industrie.gouv.fr or syrte@industrie.gouv.fr
Ministry of Health, the Family and Disabled Persons
Directorate-General of Health
Office of Health Products of Human Origin
8, avenue de Ségur - 75700 PARIS
Name and address (including telephone and fax numbers and 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:
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):  Ancillary therapeutic
products (ATP): products coming into contact with organs, tissues, cells or products of
human or animal origin during storage, preparation, processing, treatment or transportation
before use in human therapy, and any product coming into contact with embryos in the
sphere of medically-assisted reproduction.
5. Title, number of pages and language(s) of the notified document:  Draft Decree on
Marketing Authorization Requirements for  Ancillary Therapeutic Products and Amending
the Public Health Code (3 pages).G/TBT/N/FRA/21
Page 2
6. Description of content:   The Decree of the Council of State ( Conseil d'Etat )  refers to the
marketing authorization procedure for ATPs,  in accordance with Article L.1263-2, and the
procedures whereby manufacturers and importers have to inform the French Health
Products Safety Agency (Afssaps) of any unexpected or undesirable effects linked to ATPs,pursuant to Article L.1263-4.
7. Objective and rationale, including the na ture of urgent problems where applicable: 
The aim of the rules established under the draft decree and decision  (marketing
authorization procedures by the French Health Products Safety Agency and necessary
technical requirements) is to ensure the quality and safety of these products.  It seemed
essential for the French authorities to provide a regulatory framework - based very largely
on the existing controls applying to medicines - for ATPs of chemical or organic origin that
come into contact with human products intended for transplantation or embryos for
implantation, in order to guarantee their safety and therapeutic effectiveness.
8. Relevant documents:
The Articles of the Public Health Code upon which the decree and the decision are based:
Article L.1263-1 to L.1263-4.
9. Proposed date of adoption:  June 2003
Proposed date of entry into force:
10. Final date for comments:  End of May 2003
11. Texts available from:  National enquiry point [   X ] or address, telephone and fax
numbers and E-mail and Web site addresses, if available, of other body:
National Enquiry Point
CINORTECH
AFNOR11, avenue Francis de Pressensé
93571 Saint-Denis La Plaine Cedex
France