Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL amending Regulation (EC) No 726/2004 as regards the location of the seat of the European Medicines Agency
Date: 2017-11-29
Institutions: Directorate-General for Health and Food Safety, European Commission
Subjects: European Medicines Agency, European Union membership, United Kingdom, offshoring, operation of the Institutions

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   EUROPEAN COMMISSION  Brussels, 29.11.2017 COM(2017) 735 final 2017/0328 (COD)  Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL amending Regulation (EC) No 726/2004 as regards the location of the seat of the European Medicines Agency  (Text with EEA relevance)  
 
EXPLANATORY MEMORANDUM 

1. 

CONTEXT OF THE PROPOSAL 

Reasons for and objectives of the proposal 

The  European  Medicines  Agency  has  been  established  by  Regulation  (EEC)  No  2309/93, 
which has been replaced by Regulation (EC) No 726/20041. In accordance with Article 1 of 
Decision of 29 October 1993 taken by common agreement between the representatives of the 
governments of the Member States, meeting at Head of State and Government level, on the 
location of the seats of certain bodies and departments of the European Communities and of 
Europol2, the European Medicines Agency has its seat in London, United Kingdom. 

On 29 March 2017 the United Kingdom notified to the European Council its intention to leave 
the Union, pursuant to Article 50 of the Treaty on European Union.  

On  20  November  2017,  the  27  remaining  Member  States,  in  the  margins  of  the  General 
Affairs  Council  (Art.  50),  selected  Amsterdam,  the  Netherlands,  as  the  new  seat  of  the 
European Medicines Agency.  

2. 

• 

LEGAL BASIS, SUBSIDIARITY AND PROPORTIONALITY 

Legal basis 

The  act  to  be  amended  being  based  on  Articles  114  and  168(4)(c)  of  the  Treaty  on  the 
Functioning  of  the  European  Union  ("TFEU"),  the  amending  act  should  be  founded  on  that 
basis.  

• 

Choice of the instrument 

This  proposal  seeks  the  amendment  of  Regulation  (EC)  No  726/2004.  The  corresponding 
amendment is therefore proposed as an amending Regulation. 

• 

Subsidiarity and Proportionality   

The issue of the location of the seat of the Agency falls within the exclusive competence of 
the Union. The measure is proportionate to the purpose of the proposed Regulation, namely to 
confirm the new seat of the Agency within Regulation (EC) No 726/2004. 

4. 

BUDGETARY IMPLICATIONS 

The  relocation  of  the  European  Medicines  Agency  will  have  budgetary  implications,  in 
particular in view of the costs related to the early termination of its current rental contract in 
London as a consequence of the withdrawal, the costs related to the move itself and the costs 
related  to  the  installation  in  the  new  premises  in  Amsterdam.  As  set  out  in  the  negotiation 
directives of the Council of 22 May 2017 for the negotiation of an agreement with the United 
Kingdom  setting  out  the  arrangements  for  its  withdrawal  from  the  European  Union,  the 
United Kingdom should fully cover the specific costs related to the withdrawal process, such 
as the relocation of the agencies based in the United Kingdom. 

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Regulation (EC) No 726/2004 of the European 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 (OJ L 136, 30.4.2004, p. 1). 
OJ C 323, 30.11.1993, p. 1. 

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Some  of  the  relocation  costs  may  have  to  be  pre-financed  by  the  EU  budget,  prior  to  the 
financial  settlement.  In  this  respect, the  Commission  will  assess  possible  additional  funding 
needs  to  be channelled through  the  EU  budget  in  cooperation  with the European  Medicines 
Agency.  As  necessary,  the  Commission  will  present  relevant  proposals  to  the  European 
Parliament and the Council in the context of the annual budgetary procedure for 2019, and if 
necessary for 2018. This concerns for instance the costs related to the move itself. In addition, 
the costs related to the installation in the new premises will also be presented in the context of 
the  building  procedure  set  out  in  Article  203  of  the  Financial  Regulation3,  which  requires 
prior  approval  from  the  European  Parliament  and  the  Council  before  contracts  related  to 
building projects are concluded. This procedure is expected to be launched as soon as possible 
(at the latest in early 2018).  

.  

3 
Regulation (EU, Euratom) No 966/2012 of the European Parliament and of the Council of 25 October 
2012 on the financial rules applicable to the general budget of the Union and repealing Council Regulation (EC, 
Euratom) No 1605/2002 (OJ L 298, 26.10.2012, p. 1). 

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2017/0328 (COD) 

Proposal for a 

REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL 

amending Regulation (EC) No 726/2004 as regards the location of the seat of the 
European Medicines Agency 

(Text with EEA relevance) 

THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION, 

Having  regard  to  the  Treaty  on  the  Functioning  of  the  European  Union,  and  in  particular 
Article 114 and article 168(4)(c) thereof, 

Having regard to the proposal from the European Commission, 

After transmission of the draft legislative act to the national parliaments, 
Having regard to the opinion of the European Economic and Social Committee4,  
Having regard to the opinion of the Committee of the Regions5, 

Acting in accordance with the ordinary legislative procedure, 

Whereas: 

(1) 

(2) 

(3) 

(4) 

(5) 

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In the context of the United Kingdom's notification on 29 March 2017 of its intention 
to leave the Union, pursuant to Article 50 of the Treaty on European Union, the other 
27  Member  States,  meeting  in  the  margins  of  the  General  Affairs  Council 
(‘Article 50’), selected Amsterdam, the Netherlands, as the new seat of the European 
Medicines Agency. 

Having  regard  to  Article  50(3)  of  the  Treaty  on  European  Union,  the  European 
Medicines  Agency  should  take  its  new  seat  as  from  the  date  on  which  the  Treaties 
cease  to  apply  to  the  United  Kingdom  or  from  30  March  2019,  whichever  is  the 
earlier. 

To  ensure  the  proper  functioning  of  the  European  Medicines  Agency  in  its  new 
location,  a  headquarters  agreement  should  be  concluded  before  the  European 
Medicines Agency takes up its new seat. 

To  give  the  European  Medicines  Agency  sufficient  time  to  relocate,  this  Regulation 
should enter into force as a matter of urgency. 
Regulation (EC) No 726/2004 of the European Parliament and of the Council6 should 
therefore be amended accordingly, 

OJ C , , p. . 
OJ C , , p. . 

Regulation (EC) No 726/2004 of the European 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 (OJ L 136, 30.4.2004, p. 1). 

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HAVE ADOPTED THIS REGULATION: 

In Regulation (EC) No 726/2004, the following Article 71a is inserted: 

“Article 71a 

Article 1 

The Agency shall have its seat in Amsterdam, the Netherlands.” 

Article 2 

This Regulation shall enter into force on the day of its publication in the Official Journal of 
the European Union. 

This Regulation shall apply from the date on which the Treaties cease to apply to the United 
Kingdom or from 30 March 2019, whichever is the earlier.  

This Regulation shall be binding in its entirety and directly applicable in all Member States. 

Done at Brussels, 

For the European Parliament 
The President 

For the Council 
The President 

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