G/TBT/N/EU/306  
 
12 August 2015  
(15-4124)  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: grow-eu-tbt@ec.europa.eu   
Website: http://ec.europa.eu/growth/tools-databases/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 applic able, otherwise national tariff heading. 
ICS numbers may be provided in  addition, wher e applicable): Medicinal products for 
human use 
5. Title, number of pages and langua ge(s) of the notified document: Draft Commission 
Delegated Regulation supplementing Directiv e 2001/83/EC of the European Parliament and 
of the Council by laying down detailed rules for the safety features appearing on the outer 
packaging of medicinal products for human use (34 pages of main document + 5 pages of Annexes, in English) 
6. Description of content: This draft Commission Delegated Regulation sets out the detailed 
rules for the implementation of obligatory safety features (a unique identifier and an anti-tampering device) to prevent the entry of falsified medicines in the legal supply chain 
in the Union. 
The delegated act provides for, inter alia:   The harmonised structure and content of th e unique identifier as well as its carrier, 
across the EU. 
 The setting up of an “end-to-end” system for the verification of the authenticity of 
the safety features complemented by risk-based checks at wholesaler level. In 
practice, the safety features placed on a medicine pack by the manufacturer are 
systematically verified for authenticity at  the end of the supply chain, before that 
pack is dispensed to a patient (e.g.: by ph armacies or hospitals). The authenticity of 
medicines at higher risk of falsification is additionally verified in the middle of the 
supply chain by wholesalers. 
 The setting up, management and supervision of a repositories system where 
legitimate unique identifiers are stored. The repositories system is to be set up and 
managed by stakeholders, under the supervision of Member States competent 
authorities. The repositories system is quer ied in order to verify the authenticity of 
the medicinal product. G/TBT/N/EU/306 
 
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  7. Objective and rationale, including the nature of urgent problems where 
applicable: Protection of public health 
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   
9. Proposed date of adoption: Mid-October 2015 
Proposed date of entry into force: The twentieth day following publication in the Official 
Journal of the EU (application date: 3 years after publication) 
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 text is available on the Website: http://ec.europa.eu/growth/tools-databases/tbt/   
https://members. wto.org/crnattachments/2015/TBT/EEC/15_3123_00_e.pdf   
https://members. wto.org/crnattachments/2015/TBT/EEC/15_3123_01_e.pdf