. /.  WORLD TRADE  
ORGANIZATION   
G/TBT/N/EU/29 
26 March 2012  
 (12-1602) 
Committee on Technical Barriers to Trade Original:   English 
  
 
NOTIFICATION 
 
The following notification is being circ ulated in accordance with Article 10.6 
 
1. Notifying Member:  EUROPEAN UNION  
If applicable, name of local governme nt involved (Article 3.2 and 7.2):     
2. Agency responsible:  European Commission 
Name and address (including telephone and fax numbers, email and website 
addresses, if available) of agency or authority designated to handle comments 
regarding the notification shall be indicated if different from above :   
European Commission EU-TBT Enquiry Point Fax:  +(32) 2 299 80 43 E-mail:  mailto:eu-tbt@ec.europa.eu  
Website:  http://ec.europa.eu/enterprise/tbt/   
3. Notified under Article 2.9.2 [X], 2.10.1 [   ], 5.6.2 [X], 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:  Draft Commission 
Implementing Regulation on the performance of pharmacovigilance activities provided for in 
Regulation (EC) No 726/2004 and Directiv e 2001/83/EC (35 pages, in English). 
6. Description of content:  This draft Commission Implementing Regulation sets uniform 
conditions for certain aspects of pharmacovig ilance activities for medicinal products for 
human use. This includes amongst other things  the content of the pharmacovigilance system 
master file (a succinct and comprehensive desc ription of the pharmacovi gilance system of the 
marketing authorisation holder); format and content of risk manage ment plans (detailed 
description of the risk manage ment system used by the mark eting authorisation holder for a 
specific product) and the use of internationally  agreed terminology, formats and standards for 
the performance of pharma covigilance activities.  
7. Objective and rationale, including the na ture of urgent problems where applicable:  
Protection of human health and safety (high st andards of quality and safety of medicinal 
products).  G/TBT/N/EU/29 
Page 2  
 
  8. Relevant documents:   Regulation (EC) No 726/2004 of the European Parliament and of the 
Council of 31 March 2004 laying down Community procedures for the authorisation and 
supervision of medicinal products  for human and veterinary use and establishing a European 
Medicines Agency (OJ L 136, 30.4.2004, p. 1 - 33): 
http://eur-lex.europa.eu/LexUriServ/L exUriServ.do?uri=OJ :L:2004:136:0001:0033:EN:PDF  
Directive 2001/83/EC of the European Parliame nt and of the Council of 6 November 2001 on 
the Community code relating to medicinal pr oducts for human use (OJ L 311, 28.11.2001, p. 
67-128): 
http://eur-lex.europa.eu/LexUriServ/L exUriServ.do?uri=OJ :L:2001:311:0067:0128:EN:PDF  
9. Proposed date of adoption:   
Proposed date of entry into force:    May 2012 
20 days from publication in  the Official Journal 
of the EU.  It shall apply from 2 July 2012. However, Articles 28 to 37 shall apply 6 months after entry into force. 
10. Final date for comments:  30 days from date of notification 
11. Text available from:  National enquiry point [X], or address, telephone and fax 
numbers, e-mail and web-site addres ses, if available of the other body:    
European Commission 
EU-TBT Enquiry Point Fax:  + (32) 2 299 80 43 E-mail:  mailto:eu-tbt@ec.europa.eu  
The text is available on the EU-TBT Website :  http://ec.europa.eu/enterprise/tbt/