G/TBT/N/EU/874  
28 February 2022  
(22-1870) 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 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/tb t/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):  
Pharmaceutics (ICS 11.120)  
5. Title, number of pages and language(s) of the notified document:  Proposal for a 
Directive of the European Parliament and of the Council amending Directives 2001/20/EC 
and 2001/83/EC as regards derogations from certain obliga tions concerning certain 
medicinal products for human use made available in the United Kingdom in respect of 
Northern Ireland, as well as in Cyprus, Ireland and Malta (COM(2021) 997 final) (17 
page(s), in English)  
6. Description of content:  To ensure lega l certainty and predictability the notified draft 
measure provides for permanent derogations from EU pharmaceutical law to ensure the 
continued long -term supply of and access to medicines from Great Britain to Northern 
Ireland ("NI"). In addition, it provi des for three -year derogations to address outstanding 
supply concerns for Cyprus ("CY"), Malta ("MT") and Ireland ("IE"). Upon fulfilment of 
certain conditions as applicable, amendments to Directives 2001/20 and 2001/83 would 
allow imports of medicines wit hout EU manufacturing and import authorisation from parts 
of the United Kingdom other than Northern Ireland. In addition,  amendments to Directive 
2001/83 would allow the following:  
• For NI + CY/MT/IE  
o localisation of regulatory functions in parts of the United Kingdom other 
than Northern Ireland;  
o exports of medicines to parts of the United Kingdom other than 
Northern Ireland and subsequently into NI/CY/MT/IE without the need 
to repeat batch testing if already carried out in the EU;  G/TBT/N/EU/874  
 
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  o quality control tes ting carried out in parts of the United Kingdom other 
than Northern Ireland;  
• for CY/MT  
o the placing on the CY/MT market of a medicinal product based on an 
authorisation by a competent authority in parts of the United Kingdom 
other than Northern Ireland.  
• For NI  
o the supply to patients in NI of innovative medicines at the same time as 
any other patients in other parts of the United Kingdom other than 
Northern Ireland;  
o the marketing authorisation applicant to choose between the mutual 
recognition/decentralised  procedures and the national authorisation 
procedure in respect of NI.  
7. Objective and rationale, including the nature of urgent problems where 
applicable:  The objectives of the measure are to ensure the protection of human health 
and in particular, to prevent shortages of medicines and ensure an adequate level of 
public health protection in Northern Ireland, Cyprus, Ireland and Malta.; Protection of 
human h ealth or safety  
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 https://eur -lex.europa.eu/legal -
content/EN/TXT/?uri=CELEX%3A02001L0083 -20210526  
• Directive 2001/20/EC of the European Parliament and of the Council of 4 April 
2001 on the approximation of the laws, regulations and administrative 
provisions of the Member States relating to the implementation of good clinical 
practice in the conduct of c linical trials on medicinal products for human use 
https://eur -lex.europa.eu/legal -content/EN/TXT/?uri=CELEX%3A02001L0020 -
20090807  
9. Proposed date of adoption : 1st quarter 2022  
Proposed date of entry into force:  1st or 2nd quarter 2022 with retroactive application 
from 1 January 2022  
10. Final date for comments:  30 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/  
 
EUR-Lex - 52021PC09 97 - EN - EUR-Lex (europa.eu)  
https://members.wto.org/crnattachments/2022/TBT/EEC/22_1848_00_e.pdf