§ 1 Name, registered office, financial year

(1) The Association bears the name “DGRA - German Association for Regulatory Affairs” and is to be entered in the register of associations; after the registration, it will bear the suffix “e.V.”.

(2) The Association has its registered office in Bonn.

(3) The Association's financial year is the calendar year.

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§ 2 Purpose of the association

(1) The Association supports the academic training to become “Master of Drug Regulatory Affairs” (*). The Association promotes education and training in regulatory affairs.

(2) The Association pursues exclusively and directly charitable purposes within the meaning of the section “Tax-privileged purposes” of the German Tax Code.

The statutory purpose is realized in particular through the following measures:

regular events of education, training and qualification in the following special fields:

• Definition and task description of Regulatory Affairs,
• Information management,
• Pharmaceutical law,
• Quality management,
• Pharmaceutical-technical documentation,
• Pharmacological-toxicological documentation,
• Clinical documentation,
• National approvals (Germany),
• International approvals,
• Obtaining approvals,
• Pharmaceutical economics and health policy,
• Decision analytics;

Procurement, preparation and dissemination of scientific information relating to regulatory affairs;
Publication and discussion of these information via electronic media and other;
Communication with regulatory bodies at national and international level.

(3) The association is a non-profit organization; it does not primarily pursue its own economic purposes.

(4) The Association's funds may only be used for the purposes set out in the statutes. Members shall not receive any benefits from the Association's funds. No person may benefit from expenses that are unrelated to the purpose of the association or from disproportionately high remuneration.

(5) If the Association is dissolved or if its tax-privileged purposes cease to exist, the assets of the Association shall be transferred to the German Research Foundation (DFG), which shall use them directly and exclusively for the promotion of young scientists.

(6) Any resolution to amend the statutes must be submitted to the responsible tax office prior to its registration with the registration court.

(*) Formerly “Expert for Regulatory Affairs”, amended in the official announcement of the Rheinische-Friedrich-Wilhelms-Universität Bonn - Verkündungsblatt - of January 17, 2001.

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§ 3 Types of membership

(1) The members of the association are divided into ordinary, supporting and honorary members.

(2) Ordinary members are those who participate in the work of the Association in order to actively promote the objectives of the DGRA or who are active in the management of the Association. Supporting members support the association's activities primarily by paying a higher membership fee.

(3) Honorary members are persons who are appointed as such due to their special merits.

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§ 4 Acquisition of membership

(1) Natural persons of legal age and legal entities may become members of the Association. The Executive Board shall decide on the written application.

(2) The appointment as an honorary member is made by the general assembly with a majority of 2/3 of the voting members on the proposal of the advisory board. The appointment can be revoked in the same way.

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§ 5 Termination of membership

(1) The membership expires by death, by resignation, by deletion from the list of members or by exclusion from the association.

(2) Resignation shall be made by written declaration to the Executive Board. Resignation is only permitted at the end of a calendar year, subject to a notice period of 3 months.

(3) A member may be removed from the membership list by resolution of the Executive Board if, despite two reminders sent to the member's last known address, the member is in arrears with the payment of the membership fee. The removal may only be decided after 3 months have elapsed since the second reminder was sent and the membership fee debt has not been settled. The member must be informed of the deletion.

(4) A member may be expelled from the association by resolution of the Executive Board if they have severely violated the interests of the association. Before the resolution is passed, the member must be given the opportunity to comment within a reasonable period of time.

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§ 6 Membership fees

(1) Members are required to pay membership fees. The amount of the annual membership fee and its due date shall be determined by resolution of the General Assembly at the proposal of the Executive Board. A membership fee regulation may be issued in the same way.

(2) Honorary members are exempt from the obligation to pay membership fees.

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§ 7 Bodies of the association

The bodies of the Association are the Executive Board, the Advisory Board and the General Assembly.

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§ 8 The Executive Board

(1) The Executive Board of the Association consists of 5 persons, the Chairman, the Second Chairman, the Representative for Training and Further Education, the Treasurer and the Recording Secretary.

(2) The Association shall be represented in and out of court by 2 members of the Executive Board, including the Chairman or the Second Chairman.

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§ 9 Responsibilities of the Executive Board

(1) The Executive Board is responsible for the management of the Association. It is responsible for the affairs of the Association, unless they are assigned to another body of the Association by the statutes. It has the following tasks in particular:

• Preparing the General Assembly and drawing up the agenda;
• Convening the General Assembly;
• Implementing the resolutions of the General Assembly;
• Preparation of a budget for each financial year; bookkeeping, preparation of an annual report;
• Conclusion and termination of employment contracts;
• Passing resolutions on the admission, deletion and exclusion of members.

(2) The Executive Board is obliged to obtain the opinions of the Advisory Board in all important matters.

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§ 10 Term of office of the Executive Board

The Executive Board shall be elected by the General Assembly for a term of 4 years from the date of election; however, it shall remain in office until a new Executive Board is elected. Each member of the Executive Board shall be elected individually. Only ordinary members are eligible for election. If a member of the Executive Board resigns during their term of office, the Executive Board shall elect a replacement member for the remaining term of office of the resigning member.

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§ 11 Resolutions of the Executive Board

(1) The Executive Board generally passes its resolutions in Executive Board meetings, which are convened in writing or by fax by the Chairman or, in his absence, by the Second Chairman. A notice period of one week must be observed. No notification of the agenda is required. The Executive Board decides by a simple majority of votes. In the event of a tie, the Chairman or the person chairing the meeting shall have the casting vote.

(2) An Executive Board meeting is not required if all members of the Executive Board agree to a proposal or resolution in writing. The meeting of the Executive Board shall be chaired by the Chairman or, in his absence, by the Second Chairman. The resolutions of the Executive Board must be entered in a resolution book for evidence purposes and signed by the chairperson of the meeting. The record should contain the time and place of the Executive Board meeting, the names of the participants, the resolutions passed and the result of the vote.

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§ 12 Extended Executive Board

(1) The extended Executive Board consists of 2 cash auditors and, if appointed, a legal advisor.

(2) The legal advisor shall be appointed by the Executive Board as required.

(3) The two cash auditors are elected by the General Assembly at the proposal of the Executive Board.

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§ 13 The Advisory Board

(1) The members of the Advisory Board are appointed by resolution of the Executive Board with a 2/3 majority. All members have a right of nomination. At least 4 full members should be represented on the Advisory Board. Additional members may be nominated by the supporting members, whereby each supporting member may nominate one natural person.

(2) The Advisory Board has the task of advising the Executive Board on important association matters. It makes proposals for the appointment of honorary members (§ 4, 2).

(3) An Advisory Board meeting shall take place at least once per financial year. The Advisory Board shall be convened by the Chairman or his deputy with at least one week's notice. No notification of the agenda is required. The Advisory Board must be convened if at least four Advisory Board members request a meeting in writing from the Executive Board. If the request is not complied with within a period of two weeks, the Advisory Board members who have requested the convening of the Advisory Board from the Executive Board are entitled to convene the Advisory Board themselves.

(4) All members of the Executive Board have access to the meetings of the Advisory Board, including the right to discuss, but no voting rights. The members of the Executive Board shall be informed in writing prior to the meetings of the Advisory Board.

(5) The meetings of the Advisory Board shall be chaired by the Chairman (§ 8, 1) or, if he is unable to attend, by the Second Chairman. In other cases, the Advisory Board members present shall determine the chairperson of the meeting.

(6) The Advisory Board shall form its opinion by passing resolutions. Resolutions shall be passed by a majority of the valid votes cast.

(7) The resolutions of the Advisory Board shall be entered in a resolution book for evidence purposes and signed by the respective chairperson of the meeting. The members of the Association shall be informed of the essential content of the Advisory Board meeting in a suitable form.

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§ 14 The General Assembly

(1) Each member - including an honorary member - has one vote.

(2) The General Assembly of Members is exclusively responsible for the following matters:

• Approval of the budget prepared by the Executive Board for the next financial year; acceptance of the Executive Board's annual report; discharge of the Executive Board;
• Election and dismissal of the members of the Executive Board;
• Passing resolutions on amendments to the statutes and on the dissolution of the association and the amount of the membership fees and the membership fee regulations;
• Appointment of honorary members;
• Recommendations to the Executive Board.

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§ 15 Convening the General Assembly

The ordinary General Assembly shall take place at least once a year. It is convened by the Executive Board in writing, giving a period of 4 weeks' notice and stating the agenda. The notice period begins on the day following the dispatch of the invitation letter. The invitation letter is deemed to have been received by the member if it is sent to the last address provided to the association in writing by the member. The Executive Board sets the agenda.

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§ 16 Resolutions of the General Assembly

(1) The General Assembly shall be chaired by the Chairman or, if he is unable to attend, by the Second Chairman or another member of the Executive Board. If no member of the Executive Board is present, the meeting shall appoint the chairperson.

(2) The recording secretary shall keep the records of the meeting. In the event of his/her absence, the meeting shall appoint the recording secretary.

(3) The General Assembly is not open to the public. The chairman of the meeting may admit guests. The General Assembly shall decide on the admission of the press, radio and television.

(4) The General Assembly is quorate if it has been duly convened, regardless of the number of members present. This does not apply to resolutions amending the statutes and resolutions on the dissolution of the association; such resolutions require the presence of 1/10 of all association members. If there is no quorum, the Executive Board is obliged to bring about a written vote of all association members on the subject of the resolution within 4 weeks. In this written vote, the General Assembly shall in any case be deemed to have a quorum. This must be indicated in the invitation to the written vote.

(5) The resolutions of the General Assembly are passed by a simple majority of the valid votes cast, unless otherwise stipulated in the statutes or by mandatory law.

(6) A majority of 2/3 of the valid votes cast is required to amend the statutes and 3/4 of the valid votes cast is required to dissolve the association.

(7) An absolute majority of votes is required for the election of members of the Executive Board. Abstentions count as votes not cast. If none of the candidates achieves an absolute majority, a run-off election must be held immediately between the two candidates with the highest number of votes. In the run-off election, the candidate who receives the most votes is elected.

(8) Resolutions on the dissolution of the Association and amendments to the statutes can only be passed on the agenda.

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§ 17 Subsequent motions on agendas

Any member may submit a written request to the Executive Board no later than 1 week prior to the date of the General Assembly for additional matters to be added to the agenda at a later date. Motions relating to amendments to the statutes must be submitted to the Executive Board in writing no later than 2 weeks before the day of the General Assembly. The General Assembly decides on the inclusion of additional agenda items at the beginning of the meeting.

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§ 18 Extraordinary meetings of the General Assembly

An extraordinary General Assembly must be convened if the interests of the association require it or if 1/10 of all members request it in writing from the Executive Board, stating the purpose and reasons. The provisions governing the ordinary General Assembly of Members apply accordingly to the extraordinary General Assembly of Members. The notice period may be shortened to one week.

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§ 19 President

The Executive Board may appoint and dismiss an internationally recognized personality. The President advises the Executive Board in the conduct of its business and presents the Association to the outside world. The President is an honorary member of the Association.

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§ 20 Dissolution of the association

The dissolution of the Association can only be decided in a General Assembly of Members with a majority of 3/4 of the votes. Section 16 (4) applies to the quorum.

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