. /.   WORLD TRADE  
ORGANIZATION  G/TBT/N/FRA/83 
16 June 2008 
 (08-2800) 
Committee on Technical Barriers to Trade Original:  French 
  
 
 
NOTIFICATION 
 
The following notification is being circ ulated 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:  
Ministère de la santé, de la jeunesse et des sports 
(Ministry of Health, Youth Affairs and Sport) Direction générale de la santé  (Directorate-General for Health) 
Sous-direction de la politique des pratiques et des produits de santé 
(Sub-Directorate for Policy on Health Practices and Products) 
Bureau du médicament (Medicine Department) 
14, avenue Duquesne 
75 350 Paris 07 SP 
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):  
 Medicinal products for human use. 
5. Title, number of pages and language(s) of the notified document:   Projet de décret 
relatif à la collecte et l'élimination des médicaments non utilisés et modifiant le code de la 
santé publique (Draft decree concerning the collection and disposal of unused medicinal 
products and amending the Public H ealth Code (regulatory provisions)).  
6. Description of content:   The notified draft decree sets forth arrangements for the collection 
of unused medicinal products returned to pharm acies by patients, and specifies procedures 
for the disposal of such products. 
 The text describes procedures for the coll ection (provision of special containers, 
transportation) and disposal of unused medicina l products, the cost of which is borne by the 
pharmaceutical companies dealing in such prod ucts, in application of the principle of 
extended producer responsibility.  The text st ates that unused medicinal products must be 
disposed of by incineration and provides that companies may fulfil their obligations by 
joining an collective scheme approved by the government authorities, on the basis of a set 
of specifications, the terms of which may be clarified, if necessary, by Order. G/TBT/N/FRA/83 
Page 2  
 
  7. Objective and rationale, including the nature of urgent problems where applicable:  
 The purpose of the notified draft decree is  to provide a secure framework, from the 
point of view of public health and environmen tal protection, for the collection and disposal 
of unused medicinal products. 
 The introduction of special collection arra ngements is justified by the specific risks 
presented by medicinal product waste.  Such ri sks make it necessary to ensure that this 
waste is incinerated – currently the most secure method of disposal. 
 The arrangements rely on pharmacists, thus making it possible to fulfil certain 
health objectives, namely the provision of info rmation and the heightening of responsibility 
in respect of the consumption of medicinal products. 
8. Relevant documents:  
 Article L. 4211-2 of the Public Health Code 
 Article L. 541-10 of the Environment Code 
9. Proposed date of adoption:  
Proposed date of entry into force: }September/October 2008 
10. Final date for comments:   - 
11. Texts available from:  National enquiry point [  X ] or address, telephone and fax 
numbers, E-mail and web site addresses, if available, of other body:  
Point national d'information 
CINORTECH AFNOR 11 avenue Francis de Pressensé 93571 SAINT-DENIS – LA PLAINE cedex 
 
and  http://members.wto.org/crnatt achments/2008/tbt/fra/08_1638_00_f.pdf