G/TBT/N/EU/444  
 
19 Jan uary 2017  
(17-0353) 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  
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 (in cluding 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 no tified document : Draft Commission 
Delegated Regulation supplementing Regulation (EU) No 536/2014 of the European 
Parliament and Council by specifying principles of and guidelines for good manufacturing 
practice for investigational medicinal products for hu man use and arrangements for 
inspections (16 pages + Annex 3 pages, in English).  
6. Description of content : This draft Delegated Regulation laying down principles and 
guidelines of good manufacturing practice for investigational medicinal products for hum an 
use and arrangements for inspections, provides for, inter alia:  
 Requirements as regards personnel, premises and equipment, documentation, 
production, quality control, responsibilities of the qualified person, outsourced 
operations, complaints, product r ecall and emergency unblinding  
 Inspection arrangements, e.g. unannounced inspections, requirement to draft an 
inspection report, granting of GMP certificates and submission to the Eudra  GMDP of 
such certificates and mutual recognition of inspection conclus ions 
 Rules on conflict of interest and impartiality for GMP inspectors  
 Inspectors' empowerment and competence.  
7. Objective and rationale , including the nature of urgent problems where 
applicable : Protection of public health  G/TBT/N/EU/444  
 
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  8. Relevant documents : Regula tion (EU) 536/2014 of the European Parliament and of the 
Council of 16 of April 2014 on the clinical trials on medicinal products for human use, and 
repealing Directive 2001/20/EC (OJ L 158, 27.05.2014, p.1) : http://eur -
lex.europa.eu/legal -content/EN/TXT/?uri=uriserv%3AOJ.L_.2014.158.01.0001.01.ENG  
9. Proposed date of adoption : End of March 2017  
Proposed date of entry into force : The twentieth day fol lowing publication in the Official 
Journal of the EU. It is currently expected that the measure wi ll become applicable in 
October  2018.  
10. Final date for comments : 60 days from 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_0357_00_e.pdf   
https://members.wto.org/crnattachments/2017/TBT/EEC/17_0357_01_e.pdf