G/TBT/N/EU/212  
 
7 April 2014  
(14-2179)  Page: 1/2  
Committee on Technical 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 
Name and address (including telephon e 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: 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 [   ], 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): Active 
substances for medicinal products for human use. 
5. Title, number of pages and language(s) of the notified document: Draft 
Commission Delegated Regulation supplementing Directive 2001/83/EC of the European 
Parliament and of the Council with regard to principles and guidelines of good 
manufacturing practice for active substances for medicinal products for human use (11 pages, in English).  
6. Description of content:  This draft Commission Delegated Regulation addresses the EU 
principles and guidelines of good manufacturing practice for active substances for medicinal products for human use.  
This draft Delegated Regulation is largely based on the existing guidelines of good 
manufacturing practice (GMP) for active substances for medicinal products for human use published by the Commission in EudraLex - the rules governing medicinal products 
in the European Union, volume 4 . In practice, this draft Delegated Regulation will not 
modify the current EU standards of good manufacturing practice for active substances but will structure them into a legal fram ework to facilitate their enforcement.  
This is important in the context of the recent entry into force of the new EU rules on 
active substance importation (Articles 46b and 111b of Directive 2001/83/EC). Existing written confirmations certifying compliance with standards equivalent to those of the EU will not need to be reissued following the en try into force of this Delegated Regulation. 
Similarly, non-EU countries having been assessed as having manufacturing standards 
equivalent to those in the EU according to Article 111b of Directive 2001/83/EC will not need to be re-assessed following the entry into force of this Delegated Regulation. 
7. Objective and rationale, including the nature of urgent problems where 
applicable:  Protection of public health. G/TBT/N/EU/212 
 
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  8. Relevant documents:  Directive 2001/83/EC of the European Parliament and of the 
Council of 6 November 2001 on the Community code relating to medicinal products for 
human use (OJ L 311, 28.11.2001, p. 67) 
http://eur-
lex.europa.eu/LexUriServ/LexUriServ.do?uri=CONSLEG:2001L0083:20121116:EN:PDF  
Existing technical guidelines on the manufacturing of active substances published by the 
Commission in EudraLex - the rules governing medicina l products in the European Union, 
volume 4 . 
http://ec.europa.eu/health/documents/eudralex/vol-4/index_en.htm    
9. Proposed date of adoption:   
Proposed date of entry into force:    June 2014 The twentieth day following publication in the Official Journal of the EU 
10. Final date for comments: 60 days from notification 
11. Text available from:  National enquiry point [  ], or address, telephone and fax 
numbers, e-mail and web-site addresse s, if available of the other body:    
European Commission 
EU-TBT Enquiry Point 
Fax: + (32) 2 299 80 43 E-mail: eu-tbt@ec.europa.eu 
The text is available on the EU-TBT Website: http://ec.europa.eu/enterprise/tbt/  
 
http://members.wto.org/crnattach ments/2014/tbt/EEC/14_1791_00_e.pdf