Normative Documents STATUTE OF THE ASSOCIATION FOR GOOD CLINICAL PRACTICE (GCP) AND CLINICAL RESEARCH DEVELOPMENT Adopted at the Constituent Meeting held in Sofia on April 25th, 2002, next Constituent Meeting on May 30th, 2002, General Assembly on December 3rd, 2003, General Assembly on July 30th, 2004 and Last General Assembly on July 20th, 2005
I. GENERAL Status Art. 1. (1) This non-profit association, namely the ASSOCIATION FOR GOOD CLINICAL PRACTICE (GCP) AND CLINICAL RESEARCH DEVELOPMENT (hereinafter the “Association”) is a non-party, voluntary and independent organisation of people sharing the same ideas, which shall conduct its activities in accordance with the Constitution and the laws of the Republic of Bulgaria and this Statute.
(2) The Association shall be a legal entity separate from its members, established in accordance with the provisions of the Non-Profit Legal Entities Act, this Statute and the Resolution of the Constituent Meeting held in Sofia on April 25th, 2002.
(3) For its obligations the Association shall be liable with its assets.
(4) The members of the Association shall bear no liability for the Association’s obligations. Name Art. 2. (1) The name of the Association shall be Association for Good Clinical Practice (GCP) and Clinical Research Development.
(2) The Association’s name as well as its domicile, address, the Court which the Association is registered with, the Court registration number and the statistical registration number (BULSTAT) must be shown on the Association’s documents and correspondence.
(3) The names of the Association’s branches shall be formed by adding the word “branch” and the name of the city, town or village where the branch has its domicile. The name of the branch may include an indication of its activities. Domicile and registered office Art. 3. The Association shall be domiciled in the city of Sofia and its registered office shall be situated at apt. 22, No. 131 Odrin Street, Sofia. Term Art. 4. The Association’s existence shall not be limited by any term of time or other terminating condition. Definition of activity Art. 5. The Association shall be a non-profit legal entity engaged in activity to the public interest, i.e. training of medical personnel for participation in research and development projects on the territory of the Republic of Bulgaria as well as on the territories of other countries where the Association has activities either according to contracts with other organizations or by its regestered branch ensuring ICH GCP compliance in the medical field. The Association is also involved in activities such as Ethic review of the conducted clinical trials via sharing information, discussions and scientific-educational activities. Major objectives of the Association: Art. 6. The major objectives of the Association shall be:
1. Development of programmes for familiarisation of medical doctors and nurses with the rules for performance of research and development (R&D) activities in compliance with the international requirements of Good Clinical Practice in the medical field.
2.Improvement of the medical institutions’ work quality in relation with their participation in international R&D projects;
3.Ensuring the rights of all patients as regards the ethical standards embodied in the so called Good Clinical Practice (GCP);
4.Support and participation by all lawful means in enhancing the legislation, which governs the ethical standards in the provision of medical services. The means for attainment the Association’s objectives: Art. 7. The means, by which the Association shall be attaining its objectives, shall be:
Organisation of workshops and other meetings to popularise the Association’s tasks and objectives and for training of medical personnel to the requirements of Good Clinical Practice;
Analyses, summaries and popularisation of the results from the participation of the Association and its representatives in international R&D projects;
Contacts with the competent authorities to ensure their assistance in the creation of a favourable environment for participation of Bulgarian medical personnel in international projects; Solicitation of international experts to lecture at the training courses to be organised by the Association;
Carrying out of international exchange, activities and cooperation in studying international practices and experience as regards R&D projects the field of clinical medicine;
Membership in national or international organisations with similar or alike tasks and objectives;
Publication of newsletters with information materials.
Synchronizing of the active regulation on the territory of the countries in which the Association has activities with the permission of the law. II. MEMBERSHIP Members’ rights and obligations: Art. 8. (1) Membership in the Association shall be voluntary. Both individuals and legal entities may become members of the Association.
(2) A member of this Association may be any legal entity that shares the Association’s objectives and the means for attainment thereof, submits to and fulfills its Statute.
(3) A member of this Association may be any individual having completed full legal age, who shares the Association’s objectives and the means for attainment thereof, submits to and fulfills its Statute.
(4) Members of the Association are:
Regular Members
Associated Members
Honorable Members
The associated and honorable members shall have powers and obligations equal to those of the regular members save that at the Association’s General Meetings they may only have an advisory vote. The Managing Board accepts the rules for accepting candidates for definite kind of membership.
Art. 9. Each member of the Association shall have the right to:
1. take part in the Association’s activities and in the proceedings of the General Meeting;
2. be elected to the Association’s managing bodies;
3. exercise control on the affairs of the Association and on the work of its managing bodies;
4. be kept informed of the Association’s activities;
5. benefit from the Association’s assets and the results of its activities.
Art. 10. Each member of the Association shall be obligated to:
1. pay a monthly membership fee;
2. abide by the Association’s Statute and work towards attainment of its objectives;
3. work towards increasing the Association’s assets and its public reputation.
Art. 11. The members’ rights and obligations shall not be transferable and shall not pass onto others upon a member’s death or termination of membership. The exercising of a member’s rights may be assigned to others by a notarised power of attorney to that effect. Acquisition of membership Art. 12. Members shall be acceded to the Association by resolution of the General Meeting. The candidates ought to lodge a written application with the Management Board or send an application via Internet, the Management Board ought to review such application within one month and present it to the next ordinary or annual General Meeting. Accidence of members shall be voted on a show of hands and shall require an ordinary majority. Termination of membership Art. 13. (1) A member’s membership shall be terminated:
1. by unilateral resignation submitted to the Association in writing ;
2. upon the member’s death or placement under interdiction;
3. upon the dissolution or winding up of a member who is a legal entity;
4. where the member is expelled by the General Meeting acting upon a proposal of the Management Board.
(2) The resolution to expel a member shall be taken by the Management Board of the Association in the case of willful misconduct that renders further membership incompatible. A resolution expelling a member may be appealed before the Association’s General Meeting. III. ASSETS Assets Art. 14. The Association’s assets shall comprise of ownership titles and other rights on fixed and short-term assets, claims and rights depending on the applicable legislation. Sources of the Association’s assets Art. 15. (1) All members of this Association are and shall be obligated to pay membership fee. The annual membership fee amount shall be determined by the Association’s General Meeting and shall be paid in the beginning of each calendar year. The deadline for payment of membership fees shall be March 30th of the going year.
(2) The Association, in the face of its Management Board, may receive donations from individuals or from legal entities and may enter into sponsorship contracts and to participate in international GCP programs. Compensation of loss Art. 16. Upon any loss appearing on the Association’s annual balance sheet the General Meeting may decide to compensate such loss by additional contributions from the Association’s members. A resolution to that effect shall be taken by ordinary majority of the attending members. IV. MANAGEMENT The Association’s bodies Art. 17. The Association’s bodies shall be the General Meeting and the Management Board. General Meeting Art. 18. The General Meeting shall be the Association’s supreme body comprising all of its members. The members of the Association may attend the General Meeting either in person or by proxy. Only the Regular Members have a voting right. Representative powers Art. 19. (1) Those members, who are legal entities, shall be represented at the General Meeting by their legal representatives or a proxy authorised by the latter to that effect.
(2) The proxy of a legal entity or an individual may only be an individual.
(3) The instruments appointing a proxy must expressly refer to participation in the Association’s General Meeting and may be issued for a limited or unlimited number of sessions of the General Meeting.
(4) A proxy may not represent more than three members at the General Meeting. Competency of the General Meeting Art. 20. The General Meeting shall have the powers to:
amend and supplement the Association’s Statute;
adopt any other bylaws;
reorganise and dissolve the Association;
accede and expel members;
elect and remove members of the Management Board and determine their emoluments;
deal with the Company’s assets; resolve on acquisition, disposal or imposition of encumbrances on the Association’s real assets or establishment of special rights thereupon, or their leasing out for any period longer than a year as well as on the acquisition, management and dealing with the other assets of the Association subject to the provisions of this Statute;
appoint and remove the Association’s auditors;
appoint the Association’s liquidators in the case of its dissolution, save if declared bankrupt;
rule on appeals against resolutions of the Management Board for termination of membership;
adopt resolutions on establishment or liquidation of branches;
adopt resolutions on participation in other organisations;
adopt the general guidelines and programmes as regards the Association’s activities;
approve the Association’s budget;
resolve on whether membership fee shall be due and on the amount of any membership due;
approve the report on the activity of the Management Board;
repeal any resolution of the Management Board that may be inconsistent with the provisions of the law and this Statute;
exempt the members of the Management Board from liability;
determine the terms and conditions under which the Association’s activity shall be conducted, including the one to the general benefit. Proceedings at the General Meeting Art. 21. (1) The General Meeting shall be held at least once in every year – an ordinary General Meeting.
(2) The General Meeting may at all times be convened by the Management Board – an extraordinary General Meeting. Convocation of the General Meeting Art. 22. (1) The General Meeting shall be convened by the Management Board. It may be convened upon demand of one-third of the Association’s members.
(2) In case that the Management Board fails to serve notice of the General Meeting within one month following the demand therefor, the General Meeting shall be convened by the Court per the Association’s domicile upon written demand of the members concerned or their appointee.
(3) The convocation shall be made by a notice published in the State Gazette and posted on the notice board in the building where the Association’s management is situated.
(4) Said notice shall specify the agenda and the issues proposed to be discussed at the meeting, draft resolutions thereto, the date, time and place of the General Meeting and the initiator(s) convening it.
(5) The time between from the publication of the notice and the opening of the General Meeting may not be less than a month. Entitlement to obtain information Art. 23. Each member has the right to be informed about Association’s activities and about the current meetings aiming to obtain the Associations’ objectives and aims. List of attendees Art. 24. (1) A list of all attending members or their proxies shall be made at each session of the General Meeting. The members or their proxies shall certify their attendance by their signature and shall produce proof of their identity. Said list ought to be endorsed by the Chairman and the Secretary of the General Meeting.
(2) The list as per the foregoing paragraph (1) shall include all members that have announced their presence before the meeting proceeds to the first vote following establishment of quorum. Quorum Art. 25. The General Meeting may proceed to business if such number of members shall have appeared that represent more than half of all members. Where a quorum is not present the Management Board shall adjourn the meeting to one hour later at the same place and under the same agenda, and such adjourned meeting shall be valid notwithstanding the number of members attending it. Entitlement to vote Art. 26. Each member shall be entitled to one vote. Conflict of interest Art. 27. No member or member’s proxy shall be entitled to vote on matters relating to:
1. lodgment of claims against such member;
2. undertaking of action or waiver of action for enforcement of such member’s liability to the Association.
3. the member as such or his/her spouse, descendants or ascendants, without limitation, or lateral relatives, up to and including fourth order lateral relatives, or spousal relatives, up to and including second order spousal relatives. Majority Art. 28. (1) The General Meeting’s resolutions shall be adopted by a majority of the attending members.
(2) The resolutions under Art. 20(1) and Art. 20(3) shall require a majority of two thirds of the attending members, and the resolutions under Art. 20 (6) and (19) shall require the absolute majority of all members. Resolutions Art. 29. (1) The General Meeting may not adopt resolutions pertaining to any issues that were not specified in the notice of the meeting, except if all members are present at the meeting in person or by proxy and none of them objects to such issues being discussed at the meeting in question.
(2) All resolutions of the General Meeting shall be with immediate effect subject to any adjournment thereof or subject to any legal requirement for publication. Minutes Art. 30. (1) Minutes be made at each session of the General Meeting and such minutes shall be bound in a Minute Book especially kept for this purpose.
(2) The minutes of the General Meeting shall be signed by Chairman and the Secretary of the meeting, and by the vote tellers (if ones were elected at the General Meeting in question). The list of attendees and all documents related with the convocation of the General Meeting shall be attached to the minutes of the General Meeting they pertain to.
(3) Each member, who has attended the General Meeting, shall be entitled to require and verify that all resolutions are properly reflected in the minutes. The Management Board Art. 31. (1) The Association shall be managed and represented by the Management Board.
(2) The members of the Management Board shall be elected for a term of 5 (five) years.
(3) The Management Board shall be made of 3 (three) to 7 (seven) members, which must be members of the Association
(4) A member of the Management Board may also be a legal entity, provided that such entity is a member of the Association, whereas at the Board’s meetings it shall be represented by its legal representative or by another individual expressly authorised by the latter to that effect;
(5) The term in office of the first Management Board, which according to the Minutes of the Constituent Meeting is made of three members, shall be three years.
(6) The members of the Management Board may be reelected without limitation.
Art. 32. (1) The members of the Management Board, or the individuals representing the legal entities, which are members of the Board, must satisfy the following conditions:
1. They must be permanently residing within the country;
2. They must be persons having appropriate qualification and experience;
3. They must not be convicted to imprisonment for a premeditated crime of general nature. Rights and obligations of the Management Board Art. 33. (1) The members of the Management Board shall exercise their functions as internally allocated among them in a protocol made to that effect.
(2) The members of the Management Board shall be obligated to fulfill their obligations in the Association’s interest and shall safeguard its secrets notwithstanding any termination of their term in office.
(3) The Management Board shall adopt its procedural rules and shall elect, among its members, a Chairman who shall represent the Association before third parties. The first Chairman shall be elected by the Constituent Meeting. The Chairman shall oversee compliance with this Statute and shall sign all documents, which bind the Association financially.
(4) The Management Board shall have regular meetings at least once in every six months in order to discuss the Association’s condition and development.
(5) Each member of the Management Board may requisition that the Chairman convenes a meeting to discuss a particular matter.
(6) The Management Board shall arrange for the keeping and safeguarding of the Association’s assets.
(7) The Management Board shall prepare and submit to the General Meeting reports on the Association’s activities on a once a year basis.
(8) The Management Board shall prepare and submit to the General Meeting proposals on the Association’s budget.
(9) The Management Board shall arrange for the fulfillment of the General Meeting’s resolutions.
(10) The Management Board may set up groups or commissions if so required for the fulfillment of particular assignments or projects as well as engage experts in various fields in order to ensure such fulfillment.
(11) The Management Board shall establish and maintain contacts with state, public, scientific, corporate or other bodies and organisations as well as individuals.
(12) The Management Board may discuss and resolve any other matters save those, which are reserved for the General Meeting. Quorum and majority Art. 34. (1) Resolutions may be taken provided that more than half of the members of the Management Board are present in person or by a proxy to be appointed among the other Board members. An attending member may not represent more than one absent member.
(2) The Board’s resolutions shall be taken by ordinary majority save resolutions on the matters envisaged in Art. 34(8) and 34(9) hereof, which resolutions ought to be taken by an absolute majority.
(3) The Management Board may also take resolutions in the absence of any of its members provided that all members have been advised of this method of voting and none of them has objected thereto. A person shall be deemed to be present if such person has a two-way telephone or other connection ensuring his/her proper identification and enabling him/her to take part in the discussions and in the taking of resolutions. Any vote so cast shall be reflected in the minutes by the Chairman of the meeting.
(4) In addition to the cases expressly envisaged in this Statute, the unanimous consent of the Management Board shall be required for adoption of resolutions pertaining to:
1. any substantial change in the Association’s activities;
2. any substantial organisational change;
3. long-term cooperation, which is material to the Association, and termination of any such cooperation;
4. resolutions proposing to the General Meeting to establish branches and theirs closure. The Chairman of the Management Board Art. 36. (1) The Management Board shall assign the Association’s management to a Chairman. The Chairman may be replaced at any time. The Chairman shall at all times be under the obligation to immediately report to the Management Board all occurrences that are material to the Association.
(2) The Chairman shall be entitled to execute all actions and deals related with the Association’s activities, to represent the Association and to authorise others for the accomplishment of particular actions. The Chairman may not dispose of or encumber the Association’s real properties save if expressly authorised to that effect by the Management Board.
(3) The Chairman shall:
1. arrange for the fulfillment of the resolutions taken by the Management Board;
2. organise the Association’s activities, manage the day-to-day activities of the Associations, ensure the keeping and safeguarding of its assets;
3. sign contracts of employment with the Association’s employees other than those whose appointment is reserved for the Management Board;
4. represent the Association and perform the functions assigned to him/her by the Management Board;
5. immediately advise the Management Board of all significant circumstances affecting the Association’s activities. Emoluments of the members of the Management Board Art. 39. (1) The members of the Management Board shall be entitled to annual emoluments the amount of which shall be determined by the General Meeting. V. ANNUAL CLOSING Documents comprised in the annual closing Art. 37. Each year by the end of February the Management Board shall prepare, in respect of the previous year, an annual financial statement and a report on the activity, which shall be submitted to the General Meeting. Contents of the report on the activity Art. 38. The report on the activity shall describe how the Association’s activities were conducted and the Association’s condition, and shall also provide explanations to the annual financial statement Mandatory reports Art. 40. In conformance with the provisions of the Accounting Act, the Association shall prepare its reports complying with the principles of fairness, truthfulness and timeliness. Dividends Art. 41. The Association shall not distribute any profits. The Association’s Books Art. 42. (1) Minutes shall be kept at each General Meeting and at each meeting of the Management Board, which shall reflect the discussions made, the proposals raised and the resolutions taken thereat. Said minutes shall be certified by the signatures of the Chairman of the relevant body and of the Secretary of the meeting and shall be bound into special books. The members of the Management Board may familiarise themselves with the contents of the Minute Books and obtain duplicates or excerpts of the minutes.
(2) The Association shall keep a Book of its members reflecting each member’s name and address and, in the case of legal entities and unipersonal companies, details of the persons representing them. VI. DISSOLUTION AND LIQUIDATION Grounds for dissolution: Grounds for dissolution:
Art. 43. The Association shall be dissolved:
1. by resolution of the General Meeting;
2. if declared bankrupt;
3. by resolution of the District Court per the Association’s domicile in the events envisaged in the Non-Profit Legal Entities Act.
VII. LIQUIDATION Art. 44. (1) Liquidation shall be carried out in the event of the Association’s dissolution, except in those cases when the Association shall be reorganised.
(2) The liquidation shall be carried by the Association’s Management Board. The Board ought to take all actions foreseen in the Commercial Act as regards the Association’s liquidation, turning its assets to cash and satisfaction of its creditors.
(3) The assets remaining after satisfaction of the creditors shall be distributed in equal portions among the members at the time being of the Association.
(4) All persons that have acquired assets as per the foregoing Paragraph (3) shall be liable for the Association’s obligations up to the amount of assets so received. VIII. TRANSITIONAL AND FINAL PROVISIONS Art. 45. This Statute may be amended in the manner provided for in the Non-Profit Legal Entities Act.
Art. 46. The construction and enforcement of the provisions of this Statute shall be governed by the provisions of Bulgaria’s common civil law and the provisions of the Non-Profit Legal Entities Act.
This Statue was adopted unanimously by all constituents attending the Constituent Meeting of the Association for Good Clinical Practice (GCP) and Clinical Research Development in Bulgaria held in Sofia on April 25th, 2002, in witness whereof they affixed their handwritten signatures: THE CONSTITUENTS: 1. Milen Nikolaev Vrabevski
2. Stefan Zhekov Popov
3. Ivaylo Vladimirov Tsanev
4. Dimitar Andreas Engibarov
5. Tsvetomila Stefanova Zhecheva
6. Galina Nikolaeva Koleva
7. Monika Stoyanova Atanasova
8. Maria Marinova Bodurova
9. Galina Stepanova Maximova
10. Tihomir Radomirov Daskalov ____ I, the undersigned Vladimir Spassov Tzanov, do certify that my Bulgarian to English translation of the herewith document, namely Statute of the Association for Good Clinical Practice (GCP) and Clinical Trials Development in Bulgaria, said translation consisting of 12 (twelve) pages, is true and correct.
Translator: Vladimir Spassov Tzanov, Personal number 6009293528
© 2002 AGCPCRD
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