LegalizeVerdrag tussen het Koninkrijk der Nederlanden en het Europees Geneesmiddelenbureau betreffende de vestiging van het Europees Geneesmiddelenbureau
The Kingdom of the Netherlands
and
the European Medicines Agency,
Having regard to the Treaty on the European Union, in particular Protocol No 7 on the Privileges and Immunities of the European Union annexed to the Treaty on the European Union (hereinafter “the Protocol”), the Treaty on the Functioning of the European Union and the Treaty establishing the European Atomic Energy Community;
Having regard to Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Community procedures for the authorization and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency;
Having regard to the decision of the Member States in the margins of the General Affairs Council meeting of 20 November 2017 to relocate the seat of the European Medicines Agency in Amsterdam, the Netherlands;
Whereas Article 74 of Regulation (EC) No. 726/2004 provides that the Protocol shall apply to the Agency and to its staff;
Whereas Article 75 of Regulation (EC) No 726/2004 provides that the Staff Regulations of officials of the European Union, the Conditions of Employment of Other Servants of the European Union and the rules adopted jointly by the institutions of the European Union for the purposes of the application of those Staff Regulations and Conditions of Employment shall apply to the staff of the Agency;
Whereas further administrative provisions must be agreed for the implementation of the Protocol, in particular to lay down conditions concerning the privileges, immunities, facilities, and services of and related to the Agency and its staff in the territory of the Kingdom of the Netherlands as necessary for the fulfilment of the purposes of the Agency;
Have agreed as follows:
Article 1. Definitions
- a). “Agreement” means this Agreement between the Kingdom of the Netherlands and the European Medicines Agency on the hosting of the European Medicines Agency and any future amendments to the Agreement;
- b). “host State” means the Kingdom of the Netherlands;
- c). “the Agency” means the European Medicines Agency established by 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, and subsequent amendments;
- d). “Staff Regulations and the CEOS” means the Staff Regulations of Officials of the European Union and the Conditions of Employment of the Other Servants of the European Union, laid down by Council Regulation (EEC, Euratom, ECSC) No 259/68;
- e). “Parties” means the Agency and the host State;
- f). “Vienna Convention” means the Vienna Convention on Diplomatic Relations of 18 April 1961;
- g). “Head of the Agency” means the Executive Director of the Agency;
- h). “staff” or “staff member” means personnel employed by the Agency, subject to the Staff Regulations and the CEOS, including the Head of the Agency;
- i). “seconded national experts” means personnel employed by an EU/EEA national, regional or local public administration or a public intergovernmental organisation and seconded to the Agency. A seconded national expert shall in no case fall under the definition of staff of the Agency;
- j). “trainee” means any person working at the Agency for apprentice purposes. A trainee shall in no case fall under the definition of staff of the Agency or seconded national experts;
- k). “members of the household” means:
- (i). a spouse of a staff member, irrespective of his/her nationality and/or sex;
- (ii). a stable non-marital partner of a staff member, under the conditions laid down in Article 1(2)(c) of Annex VII to the Staff Regulations and the CEOS, irrespective of his/her nationality and/or sex;
- (iii). any dependent child as defined in Article 2(2) of Annex VII to the Staff Regulations and the CEOS;
- (iv). any person whom a staff member has a legal responsibility to maintain and whose maintenance involves heavy expenditure under the conditions set out in Article 2(4) of Annex VII to the Staff Regulations and the CEOS;
- l). “premises” means buildings, parts of buildings and areas, including installations and facilities of the headquarters made available to, maintained, occupied or used by the Agency in the host State in connection with its functions and purposes;
- m). “property” means all property (be it material, real, or intellectual), assets, and funds belonging to the Agency or held, administered or otherwise used by the Agency in connection with its functions and purposes;
- n). “Ministry of Foreign Affairs” means the Ministry of Foreign Affairs of the host State;
- o). “competent authorities” means national, provincial, municipal and other official authorities under the laws, regulations and customs of the host State;
- p). “Protocol” means Protocol No 7 on the Privileges and Immunities of the European Union annexed to the Treaty on the European Union, the Treaty on the Functioning of the European Union and the Treaty establishing the European Atomic Energy Community.
Article 2. Object and Purpose
This Agreement shall implement the Protocol and regulate other matters relating to or arising out of the establishment and the proper and continuous functioning of the Agency in the host State. It shall, inter alia, create conditions conducive to the stability and independence of the Agency and facilitate its smooth and efficient functioning.
Article 3. Legal status and legal personality
According to Article 71 of Regulation (EC) No 726/2004, the Agency shall have legal personality. The Agency shall possess in the host State the most extensive legal capacity accorded to legal persons under the laws of the host State. This shall, in particular, include the capacity:
- a). to acquire and dispose of movable and immovable property;
- b). to enter into contracts and other types of agreements, including agreement to operate bank accounts and engage in other banking and financial transactions;
- c). to employ persons;
- d). to participate in legal proceedings; and
- e). to take other legal action in connection with its functions and purposes.
Article 4. Premises
The Agency shall have its seat in Amsterdam, the Netherlands.
Following consultations between the Agency and the Ministry of Foreign Affairs, the locations of the premises, in addition to the temporary and definitive headquarters of the Agency as referred to in paragraph 4 and 5 of this Article, require approval of the Ministry of Foreign Affairs, which approval will not be unreasonably withheld.
The host State supports the establishment of the Agency in Amsterdam by providing a suitable location in Amsterdam.
The definitive headquarter of the Agency will be in the building located at Domenico Scarlattilaan 6, Amsterdam, in the Zuidas district of Amsterdam. The use of the premises by the Agency shall be governed by a Lease Agreement with the Ministry of the Interior and Kingdom Relations, legally represented by the State Secretary, represented in this matter by the Director General of the Central Government Real Estate Agency (CGREA).
The Agency shall be temporarily hosted by the Dutch Government at the Spark building in the Sloterdijk area of Amsterdam and shall use these temporary premises in accordance with the terms and conditions separately agreed upon by the Parties. Upon request of EMA to use additional buildings or parts thereof in connection with its functions and purposes, during the period that EMA is hosted at the Spark building, the host State will ensure that the competent authorities are informed of the applicability of this Agreement to these buildings or parts thereof.
The Agency may display such signs, plaques, flags, and emblems on the premises as it deems appropriate.
The Agency shall be exclusively entitled to display its emblem on the premises of the Agency and on its means of transport.
Article 5. Application of the Protocol
The Protocol shall apply to the Agency and the staff members.
Members of the household of staff shall enjoy the privileges and immunities as set forth in this Agreement.
All references in the Protocol to the European Union shall be understood as references to the Agency, for the purposes of this Agreement. All references in the Protocol to officials and other servants of the European Union should be understood as references to staff of the Agency, for the purposes of this Agreement.
Article 6. Inviolability of the premises
The premises shall be inviolable. They shall be exempt from search, requisition, confiscation, expropriation or any form of seizure. The competent authorities shall ensure that the Agency is not dispossessed and/or deprived of all or any part of its premises without its express consent.
The competent authorities shall not enter the premises to perform any official duty, except with the express consent, or at the request of the Head of the Agency, or a staff member designated by him or her. The service of judicial and extrajudicial documents at the premises of the Agency and of any other procedural instruments relating to a cause of action against the Agency shall not constitute a breach of inviolability.
The property and assets of the Agency shall be inviolable. Any administrative or legal measure of enforcement, whether by executive, administrative, judicial or legislative action may only be taken with the authorisation of the Court of Justice of the European Union.
The execution of judicial measures concerning the seizure of private property of staff cannot be enforced on the premises except with the consent of, and in accordance with the conditions approved by the Head of the Agency, or a staff member designated by him or her.
The archives of the Agency as well as all documents and data belonging to the Agency or held by it, wherever located, shall be inviolable.
In case of fire or other emergency requiring prompt protective action, or in the event that the competent authorities have reasonable cause to believe that such an emergency has occurred or is about to occur on the premises that requires protective action, the consent of the Head of the Agency, or a staff member designated by him or her, to any necessary entry into the premises shall be presumed if neither of them can be contacted in time.
Subject to paragraphs 1, 2, 3 and 4 of this Article, the competent authorities shall take the necessary action to protect the premises against fire or other emergency which could constitute a danger for public health and safety.
The Agency shall prevent its premises from being used as a refuge by persons who are avoiding arrest or the proper administration of justice under any law of the host State.
Article 7. Security and protection of the premises and their vicinity
The host State shall exercise due diligence to ensure that the security and tranquillity of the premises are not impaired by any person or group(s) of persons attempting unauthorized entry into or onto the premises or creating disturbances in the immediate vicinity. As may be required for this purpose, the host State shall provide adequate police protection on the boundaries and in the vicinity of the Agency premises.
In accordance with Article 8, paragraph 1, the Agency may adopt internal rules and procedures necessary to ensure security and maintenance of good order inside the premises. The Agency may, in particular, refuse access to its premises or expel any person considered undesirable from its premises.
The Agency may appoint security guards and bodyguards to protect its premises, staff and visitors, in accordance with the laws and regulations of the host State.
Article 8. Law and authority on the premises
The premises shall be under the control and authority of the Agency as provided for in this Agreement.
Except as otherwise provided in this Agreement and/or in the applicable European Union legal framework, the laws and regulations of the host State shall apply on the premises. The Agency shall promptly inform the host State of any newly adopted European Union regulations and rules which would apply to the premises.
Article 9. Public services for the premises
The competent authorities will take appropriate steps to ensure, upon the request of the Head of the Agency, or a staff member designated by him or her, on fair and equitable conditions, the public services needed by the Agency such as, but not limited to, postal, telephone, telegraphic services, any means of communication, electricity/energy, water, gas, sewage, collection of waste, fire protection, local transportation and cleaning of public streets, including snow removal.
In cases where the services referred to in paragraph 1 of this Article are made available to the Agency by the competent authorities, or where the prices thereof are under their control, the rates for such services shall not exceed the lowest comparable rates accorded to essential agencies and organs of the host State.
In case of any interruption or threatened interruption of any such services, the Agency shall be accorded the priority given to essential agencies and organs of the host State, and the host State shall take steps accordingly to ensure that the work of the Agency is not prejudiced.
Upon request of the competent authorities, the Head of the Agency, or a staff member designated by him or her, shall make suitable arrangements to enable duly authorized representatives of the appropriate public services to inspect, repair, maintain, reconstruct and relocate utilities, conduits, mains and sewers on the premises under conditions which shall not unreasonably disturb the carrying out of the functions of the Agency.
Underground constructions may be undertaken by the competent authorities on the premises only after consultation with the Head of the Agency, or a staff member designated by him or her, and under conditions which shall not disturb the carrying out of the functions of the Agency.
Article 10. Official Communications
The host State shall permit and protect unrestricted official communication related to the operation of the Agency.
The official communications and transmission of all the documents related to the operation of the Agency shall be treated in a manner equivalent to that accorded by the host State to diplomatic missions.
Article 11. Absence of restrictions for financial assets
The Agency may purchase, receive, convert and hold any kind of funds, currency, cash or securities. It may use or dispose of them freely for any official activity and hold accounts in any currency to the extent required to meet its obligations, in accordance with the applicable EU legislation.
Article 12. Funds, assets, and other property
The Agency, its funds, assets and other property of the Agency, wherever located and by whomsoever held, shall enjoy immunity from every form of legal proceedings in the host State.
De raadpleging van dit document komt niet in de plaats van het lezen van het oorspronkelijke Staatsblad of de Staatscourant. Wij aanvaarden geen aansprakelijkheid voor eventuele onnauwkeurigheden die voortvloeien uit de omzetting van het origineel naar dit formaat.