Date: 2018-11-16Category: Not ApplicableState: Union GovernmentCountry: Europe
Regulation (EU) 2018/1718 of the European Parliament and of the Council of 14 November 2018 amending Regulation (EC) No 726/2004 as regards the location of the seat of the European Medicines Agency (Text with EEA relevance)
Executive Summary:
Regulation EU 2018/1718 amends Regulation EC No 726/2004, relocating the European Medicines Agency (the Agency) seat to Amsterdam, the Netherlands, following the United Kingdom's intention to withdraw from the Union. The Agency should take its new seat as of 30 March 2019. The regulation emphasizes the need for a headquarters agreement between the Agency and the Netherlands and requires the Netherlands to provide progress reports on the relocation.
Key Points / Main Content:
Relocation of the European Medicines Agency:
* The European Medicines Agency (the Agency) shall have its seat in Amsterdam, the Netherlands.
Timeline and Reporting:
* The Netherlands must ensure the Agency can move to a temporary location by 1 January 2019.
* The Netherlands must ensure the Agency can move to a permanent location by 16 November 2019.
* The Netherlands must submit written progress reports to the European Parliament and the Council on the adaptations to the temporary premises and on the construction of the permanent building by 17 February 2019, and every three months thereafter, until the Agency has moved to its permanent location.
Enforcement and Effective Date:
* The Regulation entered into force upon publication in the Official Journal of the European Union.
* The Regulation applies from 30 March 2019.
Impact Analysis:
European Medicines Agency:
* Impact: Must relocate its seat to Amsterdam, Netherlands, by the specified deadlines, focusing on core tasks during the relocation process.
* Action Required: Prepare for and execute the relocation of its operations to Amsterdam.
Netherlands Authorities:
* Impact: Responsible for ensuring the Agency can move to both temporary and permanent locations within the stipulated timeframes and for providing regular progress reports.
* Action Required: Take all necessary measures to adapt the temporary premises and construct the permanent building for the Agency, and submit written reports to the European Parliament and the Council. Conclude a headquarters agreement with the Agency.
European Parliament and Council:
* Impact: Will receive progress reports from the Netherlands regarding the Agency's relocation.
* Action Required: Review the progress reports submitted by the Netherlands.
European Commission:
* Impact: To monitor the overall relocation process of the Agency to its new seat and assist that process within the limits of its competences.
* Action Required: Monitor and assist the relocation process.
Key Entities Referenced
European Parliament: One of the two legislative branches of the European Union
Council of the European Union: One of the two legislative branches of the European Union, consisting of government ministers from each member state.
European Medicines Agency: A decentralised agency of the European Union responsible for the scientific evaluation, supervision and safety monitoring of medicines in the EU.
Amsterdam, the Netherlands: The new seat of the European Medicines Agency following the United Kingdom's withdrawal from the European Union.
Regulation EC No 726/2004: A regulation of the European Parliament and of the Council laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency.
Treaty on the Functioning of the European Union: One of the primary treaties of the European Union, detailing the organisation and functioning of the Union.
United Kingdom: Refers to the United Kingdoms notification on 29 March 2017 of its intention to withdraw from the Union pursuant to Article 50 of the Treaty on European Union
European Commission: The executive branch of the European Union, responsible for proposing legislation, implementing decisions, and managing the EU's budget.
16.11.2018 EN Official Journal of the European Union L 291/3
REGULATION (EU) 2018/1718 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL
of 14 November 2018
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 point (c) of
Article 168(4) 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 Committee (1),
After consulting the Committee of the Regions,
Acting in accordance with the ordinary legislative procedure (2),
Whereas:
(1) In the context of the United Kingdom’s notification on 29 March 2017 of its intention to withdraw from the Union
pursuant to Article 50 of the Treaty on European Union (‘TEU’), the other 27 Member States, meeting on
20 November 2017 in the margins of the Council, selected Amsterdam, the Netherlands, as the new seat of the
European Medicines Agency (‘the Agency’).
(2) Having regard to Article 50(3) TEU, the Agency should take its new seat as of 30 March 2019.
(3) To ensure the proper functioning of the Agency in its new location, a headquarters agreement should be concluded
between the Agency and the Netherlands before the Agency takes up its new seat.
(4) It is to be welcomed that the authorities of the Netherlands are making efforts to ensure the operational
effectiveness, continuity and uninterrupted functioning of the Agency during and after the relocation. Nevertheless,
given the extraordinary situation, the Agency may have to temporarily focus on its core tasks and prioritise other
activities according to their impact on public health and the Agency’s ability to function.
(5) The Commission should monitor the overall relocation process of the Agency to its new seat and assist that process
within the limits of its competences.
(6) To give the Agency sufficient time to relocate, this Regulation should enter into force as a matter of urgency.
(7) Regulation (EC) No 726/2004 of the European Parliament and of the Council (3) should therefore be amended
accordingly,
(1) OJ C 197, 8.6.2018, p. 71.
(2) Position of the European Parliament of 25 October 2018 (not yet published in the Official Journal) and decision of the Council of
9 November 2018.
(3) 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).L 291/4 EN Official Journal of the European Union 16.11.2018
HAVE ADOPTED THIS REGULATION:
Article 1
The following Article is inserted in Regulation (EC) No 726/2004:
‘Article 71a
The Agency shall have its seat in Amsterdam, the Netherlands.
The competent authorities of the Netherlands shall take all necessary measures to ensure that the Agency is able to
move to its temporary location no later than 1 January 2019 and that it is able to move to its permanent location no
later than 16 November 2019.
The competent authorities of the Netherlands shall submit a written report to the European Parliament and the
Council on the progress on the adaptations to the temporary premises and on the construction of the permanent
building by 17 February 2019, and every three months thereafter, until the Agency has moved to its permanent
location.’.
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 30 March 2019.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Strasbourg, 14 November 2018.
For the European Parliament For the Council
The President The President
A. TAJANI K. EDTSTADLER