. /.   WORLD TRADE  
ORGANIZATION  G/TBT/N/FRA/80 
9 May 2008 
 (08-2194) 
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 mise en place d’un dispositif de sécurisation du conditionnement extérieur du médicament et modifiant le code de la  santé publique (dispositions réglementaires) (Draft 
decree concerning the affixing of a security f eature to the outer packaging of medicinal 
products and amending the Public Hea lth Code (regulatory provisions)). 
6. Description of content:   The notified draft decree requires that a security feature be affixed 
to the outer packaging of medicinal products lis ted by the Director-General of the French 
Health Product Safety Agency as non-prescription medicines that may be obtained over the 
counter in pharmacies. 
 The text states that the pharmacist in charge of the pharmaceutical establishment 
responsible for affixing the security feature must  make a declaration to  the Director-General 
of the French Health Product Safety Agency  certifying this procedure and specifying the 
security feature used.  Where the establishment is located in another State that is party to the 
European Economic Area Agreem ent, the declaration must be  made by the qualified person 
referred to in Article 48 of Directive 2001/83/EC of the European Parliament and of the Council.G/TBT/N/FRA/80 
Page 2  
 
  7. Objective and rationale, including the nature of urgent problems where applicable:    
 The draft decree is applicable in the context of patients being given over-the-
counter access in pharmacies to certain medici nal products which do not require a medical 
prescription and which are therefore freely available. 
 The purpose of affixing a security feature to  the outer packaging of such medicinal 
products is to enable the patient or pharmacist  to ensure that the packaging has not been 
tampered with.  This measure thus responds to  health security concerns by minimizing the 
potential risk of malicious practices, main taining patient confidence and ensuring the 
specificity of medicinal products, within the context of new over-the-counter access 
arrangements in pharmacies. 
8. Relevant documents:  
9. Proposed date of adoption: 
Proposed date of entry into force: }- 
10. Final date for comments:   End of July 
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:  
CINORTECH-AFNOR 
11 avenue Francis de Pressensé 
93571 Saint Denis La Plaine Cedex  http://members.wto.org/crnatt achments/2008/tbt/fra/08_1272_00_f.pdf