G/TBT/N/EU/555  
 
13 March 2018  
(18-1519) 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 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/en/   
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 and medical devices  
5. Title, number of pages and language(s) of the notified document: Propos al for a 
Regulation of the European Parliament and of the Council on health technology assessment 
and amending Directive 2011/24/EU (COM(2018) 51 final) (49 page(s), in English; 
49 page(s), in French; 49 page(s), in Spanish)    
6. Description of content: This proposed Regulation concerns harmonised rules for carrying 
out the clinical assessment part of health technology assessment in EU Member States and 
introduces a system of joint assessments carried out at Union level for certain medicinal 
products and m edical devices.  
7. Objective and rationale, including the nature of urgent problems where 
applicable:  The objectives of the proposed Regulation are to ensure a better functioning 
of the EU's internal market and contribute to a high level of human health protection. This 
will be done through convergence in the way health technology assessment is done across  
EU Member States and by reducing the current duplication in assessments by EU Member 
States.  
8. Relevant documents:  The proposed Regulation would replace the current provisions on 
voluntary cooperation on health technology assessment between EU Member S tates set 
out in Article 15 of Directive 2011/24/EU.   
9. Proposed date of adoption: 2019 
Proposed date of entry into force:  20 days from publication in the Official Journal of the 
EU (The provisions shall apply from 3 years after the date of entry into f orce)  G/TBT/N/EU/555  
 
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  10. Final date for comments: 90 days from notification  
11. Texts available from: National enquiry point [  ] or address, telephone and fax 
numbers and email and website addresses, 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 EU -TBT Website: http://ec.europa.eu/ growth/tools -
databases/tbt/en/  
http://eur -lex.europa.eu/legal -
content/EN/TXT/?qid=1519739675367&uri=CELEX:52018PC0051  
https://members.wto.org/crnattachments/2018/TBT/EEC/18_1317_00_e.pdf  
https://members. wto.org/crnattachments/2018/TBT/EEC/18_1317_00_s.pdf  
https://members.wto.org/crnattachments/2018/TBT/EEC/18_1317_00_f.pdf