. /.WORLD TRADE
ORGANIZATIONG/TBT/N/FRA/22
14 March 2003
(03-1505)
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 – 75574
PARIS Cedex 12
Tel.: 01 53 44 97 04
Fax: 01 53 44 98 88E-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 thesphere of medically-assisted reproduction.
5. Title, number of pages and language(s) of the notified document:  Draft Order on the
Rules of Good Practice for Manufacturing, Tr eating, Storing, Importing, Transporting and
Distributing ATPs (19 pages).
6. Description of content:   The order sets rules of good practice by specifying basic
requirements in terms of staff, premises, equipment, procedures and documentation to
guarantee the quality of these products.  It comprises four parts on:  quality control;  the
preparation of ATPs; their storage, distribution and transportation; and import, respectively.G/TBT/N/FRA/22
Page 2
7. Objective and rationale, including the na ture of urgent problems where applicable:
The aim of the rules established under the draft order 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 fortransplantation 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: 1 January 2004 (the order will enter into force six
months after publication)
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
 AFNOR
11, avenue Francis de Pressensé
93571 SAINT-DENIS LA PLAINE Cedex
FRANCE