G/TBT/N/EU/765  
14 December 2020  
(20-9016) Page: 1/3 
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 Comm ission  
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 [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):  Medicinal 
products and medical devices; Medical equipment (ICS 11.040), Pharmaceutics (ICS 
11.120)  
5. Title, number of pages and language(s) of the notified document:  Proposal for a 
Regulation of the European Parliament and of the Council on a reinforced role for the 
European Medicines Agency in crisis preparedness and management for medicinal 
products and medical devices (COM(2020) 725) (53 pa ge(s), in English)  
6. Description of content:  This draft Regulation provides for, within the European 
Medicines Agency, a framework for and the means to:  
(a)        prepare for and manage the impact of major events on medicinal products for 
human use and of public health emergencies on medicinal products for human use and 
on medical devices;  
(b)        monitor and report on shortages of medicinal products for human use and 
medical devices;  
(c)        provide advice on medicinal products for human use with the potential to address 
public health emergencies ('candidate medicines');  
(d)        provide support for the medical device expert panels designated in accordance 
with Commission Impleme nting Decision (EU) 2019/1396.  G/TBT/N/EU/765  
 
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  7. Objective and rationale, including the nature of urgent problems where 
applicable:  The general objectives of the proposal are to: 1. ensure a high level of human 
health protection by strengthening the Union's ability to m anage and respond to public 
health emergencies, which have an impact on medicinal products and medical devices; 
2. contribute to ensuring the smooth functioning of the EU internal market for such 
products during public health emergencies. The specific obje ctives of the proposal are to: 
1. monitor and mitigate potential and actual shortages of medicinal products and medical 
devices considered as critical in order to address a given public health emergency or, for 
medicinal products, other major events which may have a serious impact on public health; 
2. ensure timely development of high quality, safe and efficacious medicinal products with 
a particular focus on addressing a given public health emergency; 3. ensure smooth 
functioning of expert panels for the a ssessment of some high -risk medical devices and 
avail of essential advice in crisis preparedness and management with regard to the use 
of medical devices. The rationale for the proposal is based on the experience of the 
COVID -19 pandemic and the clear need  demonstrated for a strengthened framework for 
crisis preparedness and response to deal with future crises with an impact on medicinal 
products and medical devices.; Protection of human health or safety  
8. Relevant documents:   
The proposed Regulation will be a 'stand -alone' Regulation and will thus not revise or 
amend any current legislation on medicinal products, medical devices or the European 
Medicines Agency. It should be read in conjunction with Directive 2001/83/EC, Regula tion 
(EC) No 726/2004, Regulation (EU) 2017/745, Regulation (EU) 2017/746, and 
Commission Implementing Decision (EU) 2019/1396:  
Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 
on the Community code relating to medicin al products for human use  
https://eur -lex.europa.eu/legal -
content/EN/TXT/?uri=CELEX%3A32001L0083&qid=1606553610761  
Regulation (EC) No 726/2004 of the E uropean Parliament and of the Council of 31 March 
2004 laying down Community procedures for the authorisation and supervision of 
medicinal products for human and veterinary use and establishing a European Medicines 
Agency  
https://eur -lex.europa.eu/legal -
content/EN/TXT/?uri=CELEX%3A32004R0726&qid=1606553637213  
Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 
on medica l devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and 
Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 
93/42/EEC  
https://eur -lex.europa.eu/legal -
content/EN/TXT/?uri=CELEX%3A32017R0745&qid=1606553663620  
Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 
on in vitro diagnostic medical devices and repealing Directive 98/79/E C and Commission 
Decision 2010/227/EU  
https://eur -lex.europa.eu/legal -
content/EN/TXT/?uri=CELEX%3A32017R0746&qid=1606553780760  
Commission Implementing Decision (EU) 2019/1396 of 10 September 2019 laying down 
the rules for the application of Regulation (EU) 2017/745 of the European Parliament and 
of the Council as regards the designation of expert panels in the field of medical devices  
https://eur -lex.europa.eu/legal -
content/EN/TXT/?uri=CELEX%3A32019D1396&qid=1606553835020  
9. Proposed date of adoption:  2021 
Proposed date of entry into forc e: 20 days from publication in the Official Journal of 
the EU (with the exception of Article 28, the provisions shall apply on entry into force)  G/TBT/N/EU/765  
 
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  10. Final date for comments:  60 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 tex t is available on the EU -TBT Website: http://ec.europa.eu/growth/tools -
databases/tbt/en/  
https://members .wto.org/crnattachments/2020/TBT/EEC/20_7638_00_e.pdf