G/TBT/N/EU/420  
 
9 November 2016  
(16-6142) 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 a ddress (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: grow-eu-tbt@ec.europa.eu   
Website : http://ec.europa.eu/growth/tools -databases/tbt/   
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 notified document : Draft 
Implementing Regulation on the detailed arrangements for the Good Clinical Practice 
inspections procedures, including the qualification and training requirements for inspectors 
(9 pages, in English)   
6. Descrip tion of content : This draft Implementing Regulation on the detailed arrangements 
for Good Clinical Practice inspections procedures, including the qualification and training 
requirements for inspectors, provides for, inter alia : 
 requirements as regards the experience, training and qualifications for GCP 
inspectors;  
 rules on conflict of interest and impartiality for GCP inspectors;  
 empowerment of inspectors and applicable confidentiality requirements;  
 obligation for the Member States to adopt detailed procedu ral rules, inter alia, for 
the appointment of experts accompanying inspectors, arranging inspections in third 
countries;  
 principle of mutual recognition of inspections findings and obligation of cooperation.  
7. Objective and rationale , including the natur e of urgent problems where 
applicable : Protecti on of public health  
8. Relevant documents : Regulation (EU) 536/2014 of the European Parliament and the 
Council of 16 of April 2014 on the clinical trials on medicinal products for human use, and 
repealing Dir ective 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    G/TBT/N/EU/420  
 
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  9. Propo sed date of adoption : Mid January 2017  
Proposed date of entry into force : The twentieth day following publication in the Official 
Journal of the EU . The Regulation will be applicable when Regulation (EU) 536/2014 on 
clinical trials becomes applicable, what  is expected not earlier than beginning of 2018.  
10. Final date for comments : 60 days from notification  
11. Texts available from : National enquiry point  [X] or address, telephone and fax 
number s and e mail and website address es, if available , of other bod y: 
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/2016/TBT/EEC/16_4640_00_e.pdf