G/TBT/N/EU/445  
 
19 January 2017   
(17-0354) Page: 1/2 
Committee on Techni cal Barriers to Trade  Original : English  
 
  NOTIFICATION  
The following notification is being circulated in accordance with Article 10.6  
 
1. Notifying Member : EUROPEAN UNION  
If applicable, name of local government involved  (Article 3.2 and 7.2) : 
2. Agency responsible:  
European Commission  
EU-TBT Enqu iry Point  
Fax: +(32) 2 299 80 43  
E-mail: grow-eu-tbt@ec.europa.eu   
Website : http://ec.europa.eu/growth/tools -databases/tbt/   
Name and address (i ncluding 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 : 
3. Notified under Article 2.9.2 [  ], 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 n otified document : Draft Commission 
Directive supplementing Directive 2001/83/EC of the European Parliament and of the Council 
as regards the principles and guidelines of good manufacturing practice for medicinal 
products for human use (9 pages + Annex 3 pa ges, in English)  
6. Description of content : This draft Commission Directive on principles and guidelines of 
good manufacturing practice for medicinal products for human use provides for, inter alia 
requirements regarding : 
 Personnel  
 Premises and equipment  
 Documentation  
 Production  
 Quality control  
 Outsourced operations  
 Complaints and product recall  
This draft Commission Directive will also repeal Directive 2003/94/EC laying down the 
principles and guidelines of good manufacturing practice in respect of medici nal products 
for human use and investigational medicinal products for human use. Good manufacturing 
practice for investigational medicinal products will be laid down in a new Commission 
Delegated Regulation.  
7. Objective and rationale , including the natur e of urgent problems where 
applicable : Protection of public health  G/TBT/N/EU/445  
 
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  8. Relevant documents :  
Directive 2001/83/EC of the European Parliament and of the Council of 6 of 
November  2001 on the Community code relating to medicinal products for human use  
(OJ  L 3 11, 28.11.2001, p. 67 : http://eur -lex.europa.eu/legal -
content/EN/TXT/?qid=1467722279026&uri=CELEX:02001L0083 -20121116  
9. Proposed date of adopti on: End of March 2017  
Proposed date of entry into force : The twentieth day following publication in the Official 
Journal of the EU. It is currently expected that the measures will become applicable in 
October 2018.  
10. Final date for comments : 60 days fro m notification  
11. Texts available from : National enquiry point  [ ] or address, telephone and fax 
number s and e mail and website address es, if available , of other body:  
European Commission  
EU-TBT Enquiry Point  
Fax: + (32) 2 299 80 43  
E-mail: grow-eu-tbt@ec.europa.eu   
The text is available on the Website : http://ec.europa.eu/growth/tools -databases/tbt/   
https://members.wto.org/crnattachments/2017/TBT/EEC/17_0358_00_e.pdf   
https://members.wto.org/crnattachments/2017/TBT/EEC/17_0358_01 _e.pdf