(consolidated version) (fn1)
- hereinafter referred to as "Laender" -
save of the if need be necessary approval of their legislative bodies, enter into the following Agreement on the Central Authority of the Laender for Health Protection Regarding Medicinal Products and Medical Devices:
The Land North Rhine-Westfalia establishes the Central Authority of the Laender for Health Protection Regarding Medicinal Products and Medical Devices (ZLG) in Bonn as a subordinate institution of the Ministry of Health of the Land North Rhine-Westfalia.
Responsibilities (fn 2)
(1) ) ZLG takes on the responsibility for tasks of the Laender in the field of medical devices and takes on a co-ordination function in the field of medicinal products.
(2) In the area of medical devices ZLG activities inter alia aim to keep and to improve the standard and quality and safety of medical devices in the Federal Republic of Germany in the framework and on the basis of Council Directive 93/42/EWG of 14 June 1993 on medical devices, Council Directive 90/385/EWG of 20 June 1990 for active implantable medical devices and the future EU-Directive for in-vitro-diagnostics, the medical device law as amended and its associated ordinances.
(3) In the field of medical devices ZLG executes Laender tasks concerning accreditation and notification. In particular ZLG has the following responsibilities:
- accreditation of testing laboratories and certifying bodies for quality assurance systems and non-active medical devices,
- accreditation of certifying bodies for personnel,
- accreditation in the field of in-vitro-diagnostics,
- cooperation in the accreditation of testing laboratories and certifying bodies for active medical devices,
- surveillance of the accredited bodies,
- development of regulations on the requirements to be followed in testing and certification,
- elaboration of expert’s reports on demand in individual cases and
- accreditation, notification and surveillance of conformity assessment bodies in the framework of Agreements of the European Community and third countries or organisations according to Art. 228 of the EG-Treaty (third country agreements).
(4) ZLG is offices for the exchange of experiences of the accredited bodies. It shall participate in the exchange of experiences on the level of the European Union and in consultations in connection with agreements with third countries and shall collaborate in confidence building measures and in working groups of the Joint Committees.
(5) ZLG is central co-ordination unit in the area of medicinal products. It is in particular responsible for co-ordination of
- the specialisation of inspectors, building a “pool” of specialists of the supervisory authorities, and the overall Laender collaboration of the supervisory authorities,
- the inclusion of external experts including experts in the criminal field on a national and international level,
- focal points of surveillance and comparative quality testing at the request of the EU, the EEA, the European Council and the Pharmaceutical Inspection Convention (PIC),
- national activities for surveillance of multi center clinical trials in the framework of the EU, the EEA and third countries,
- 5. the necessary measures to ensure the safety of medicinal products also regarding the cross-border trade of medicinal products, active ingredients and other ingredients of pharmacological effect,
- international surveillance activities in Germany,
- the use of external capacities for special testing,
- ring trials, also on the European level,
- the activities of the Laender official medicines control laboratories (OMCL),
- testing of medicinal products in the case of cross-border trade of medicinal products.
Through its activities the co-ordination unit supports the development of quality assurance in the fields of surveillance and testing of medicinal products. It shall evaluate the annual reports concerning surveillance and testing of medicinal products and work out a summary report. ZLG is empowered to accredit the official medicines control laboratories.
(6) The central co-ordination unit acts on behalf of the Laender or on its own initiative in agreement with the Laender. It shall collaborate with those involved in the above mentioned areas of responsibility.
(7) The Laender governments are empowered to assign additional responsibilities to ZLG by administrative agreements.
(1) For the purpose of advice of ZLG and as an instrument for participation of the Laender an Advisory Board shall be established.
(2) Each Land shall designate one member to the Advisory Board. Each member of the Advisory Board is nominated by the ministry which is responsible for health protection.
(3) The Advisory Board shall be informed on the activities of ZLG. For this purpose ZLG creates an annual report on 31 March of the current year by the latest covering the previous year. Upon special demand documents shall be made available to the Advisory Board in accordance with the regulations for data protection.
(4) The Advisory Board shall work out directives for the activities of ZLG. ZLG shall use these directives as a basis for its work.
(5) The draft budget as prepared by ZLG shall be pre-negotiated by the Advisory Board.
(6) Each member of the Advisory Board has one vote. The Advisory Board shall have a quorum, if at least half of its members are present. It reaches its decision by simple majority of the votes of the members present. The motion shall be rejected in the event of a tie.
(7) The federal ministries have a guest and speaking right as far as their responsibilities are touched.
(8) It shall be possible to reach a decision in writing, unless not more than three members object; subsection 6 shall apply accordingly.
(9) The Advisory Board elects from among its members a member to chair for the period of two years. Also by election a person shall be determined as deputy chairperson. The Advisory Board shall agree on standing orders.
(10) The Advisory Board meets at least annually for a regular meeting. Upon request of at least three members it must hold an extraordinary meeting. The chairing member calls and chairs the meetings and draws up the agenda.
Protocol Note to Art. 3 of the Agreement:
The Advisory Board shall in due course examine and deliver an opinion of recommendation to the Conference of the Ministers of Health (GMK) und Conference of Treasuries (FMK) when and under what conditions ZLG should be transferred by means of amendment of the agreement into the legal form of an institution of public law.
Sectoral Committees (fn 2)
At ZLG Sectoral Committees shall be formed. The Sectoral Committees have the responsibility to take part in the work on requirements to apply for testing laboratories, certification bodies and conformity assessment bodies. This includes also a comparison of third countries’ legislation and European legislation. Experts of the Laender and federal authorities as well as from the field of science, economy, physicians, dentists, pharmacists and hospitals and the associations of consumers may become members of the Sectoral Committees.
Financing (fn 2)
(1) For accreditation ZLG shall charge cost-effectively fees and expenses according to the law on administrative fees of North Rhine-Westfalia.
(2) In as much as ZLG carries out tasks above that, which cannot be specifically assigned to terms of the law on administrative fees and debtors, an estimated amount shall be determined and divided among the Laender in connection with the annual budget negotiations. The host Land shall be charged host Land quota at the outset being 10% of the financial need not covered by fees according to sentence 1. Beginning in the financial year 1994 the draft budget as pre-negotiated by the Advisory Board needs the consent of the treasuries of the Laender by a majority of two thirds of the votes. The host Land is obliged to implement the ZLG budget in the budget of North Rhine-Westfalia according to the decision of the treasuries of the Laender.
(3) The quorum among the Laender shall be determined according to their tax revenue by two thirds and according to the number of their inhabitants by one third. The tax revenue are increased or decreased by the amounts which the Laender receive by or pay to other Laender in connection with the general revenue equalisation. As tax revenue shall be deemed those tax revenues on which the tax equalisation of the Laender is based on. Decisive are the tax revenue for the financial year two years prior to the current financial year and the number of inhabitants as determined by the Federal Institute for Statistics on 30 June of the same year.
(4) The shares of the Laender are due in the course of each financial year on 31 May according to the amount as included in the budget. Amounts paid too much or less with respect to the financial amount according to the annual accounts shall be compensated in the financial year following the annual accounts.
Litigations related to this agreement shall be ruled by a court of arbitration. The arbitration agreement as appended is part of this agreement.
Final Provisions (fn 2)
(1) This agreement takes effect on the first day of the month following the month, in which the last notification of the contracting Laender, saying that the internal prerequisites for the agreement to come into effect are met, will be received by the Ministry of Health of the Land North Rhine-Westfalia.
(2) This agreement is valid for an indefinite period. It can be terminated by each Land at the end of the calendar year for a period of notice of one year by means of a written declaration addressed to the Ministry of Health of the Land North Rhine-Westfalia and in notifying all other Laender; this shall be possible for the first time on 31 December 1995.
(3) The terminating Land remains obliged to contribute to the financial need of ZLG as long and in as much as the financial need has been necessary due to the Land’s participation. Costs incurred after termination yet to be reckoned to the period of membership shall be beared proportionally by the terminating Land.
Berlin, 30 June 1994
Hans Otto Bräutigam
For Mecklenburg-Western Pomerania
For Lower Saxony
For North Rhine-Westfalia
fn 1 - GV. NW. 1994 p. 972, as amended by Agreement of 9 Feb 1999 (GV. NRW. p. 54).
fn 2 – Art. 2, 4 and 5 amended and Art. 7 omitted, article 8 became article 7, by Agreement of 9 Feb 1999 (GV. NRW. p. 54).
Annex to Art. 6
Arbitration Agreement On Litigations Regarding the Agreement On the Central Authority of the Laender For Health Protection Regarding Medicinal Products and Medical Devices
enter into the following arbitration agreement:
All litigations regarding the Agreement On the Central Authority of the Laender For Health Protection Regarding Medicinal Products and Medical Devices (ZLG) shall be subject to the decision of an arbitration court.
The regulations of the 10th book of the code of civil procedure shall apply for this procedure.
The arbitration court consists of the president of the supreme administration court of the Land North Rhine-Westfalia as chairing member and of two members of the Advisory Board being designated jointly by the arguing parties, which yet shall not belong to them. In case that due to the arguing situation the designation of one or both candidates is not possible the president determines one or two members of the supreme administration court of the Land North Rhine-Westfalia in drawing a lot from a list of judges prepared by presidial council. If the president of the supreme administration court of the Land North Rhine-Westfalia refuses to chair, he or she determines a chairing judge of the supreme administration court of the Land North Rhine-Westfalia in drawing a lot from a list prepared by the presidial council of the chairing judges as chairing member. For entry into the list the approval of the judges and the chair judges is necessary.