1. The Association called „Polish Society of Pharmacovigilance” hereinafter referred to as the “Society” is a voluntary, self-governing, sustainable society aimed at:

a. launching initiatives, activities and promoting behaviours that lead to implementation and development of principles of ethics and reliability in monitoring the safety of medicinal products, medical devices, food products, biocidal products, and cosmetic products (hereinafter understood as pharmacovigilance),

b. creating the atmosphere of trust and respect for institutions and individuals participating in pharmacovigilance system,

c. promoting the principles of pharmacovigilance and supporting its development,

d. framing the Society’s role as an expert and opinion-leading professionals center for pharmacovigilance,

e. building a forum for discussions and exchange of opinions among entities involved in pharmacovigilance as well as providing organizational and in-kind support for individuals and institutions who undertake such activities.

1. The seat of the Society is in Warsaw.

2. The Society’s activities pertain to the territory of the Republic of Poland.

3. The Society can act outside the borders of the Republic of Poland for the proper implementation of its objectives.

1. The Society pursues its objectives through:

a. comprehensive promotion of rules, standards, and methodology of pharmacovigilance in accordance with ethical principles and the legal regulations,

b. cooperation and mutual assistance of the Society members,

c. cooperation with both private and public institutions,

d. cooperation with individuals and institutions to collect the information and exchange of experience in pharmacovigilance,

e. advice, assistance, and training the members of the Society and other individuals as well as entities interested in pharmacovigilance monitoring system or implementation of the Society ‘sgoals as specified in §1,

f. performing activities that integrate members of the Society through cultural, entertainment, and social activities,

g. supporting the third-party initiatives to the extent consistent with the Society’s goals, including patronage and granting certifications,

h. carrying out educational, scientific, training, and research activities in pharmacovigilance.

2. The Society may institute other organizations within the bounds of the law to implement its statutory goals.

1. The activity of the Society is based on the social work of its members.

2. The Society may hire employees, including its members, to pursue the tasks entrusted to them.

1. The activity of the Society is based on the social work of its members.

2. Income from the economic activity may serve only to achieve the goals of the Society and may not be distributed among its members.

1. Every adult citizen of the Republic of Poland or a foreigner, including the one who is not resident of the Republic of Poland, who:

a. is a professional in pharmacovigilance,

b. submits a membership declaration, may become full member of the Society.

2. Legal entities may become supporting members.

3. Membership of the Society shall be acquired by a resolution through acceptance of the declaration by the Management Board in a simple majority vote.

1. Full members of the Society are required to:

a. contribute to the increasing role and importance of the Society by their attitude and actions,

b. preserve the good name of the Society,

c. strive for an appropriate public opinion that is related to the Society’s activities in the field of pharmacovigilance,

d. support and actively pursue goals of the Society,

e. obey generally applicable laws and provisions of the Society’s statute,

f. pay the membership fee regularly and on time.

2. Full member of the Society has the right to participate in the activities of the Society , in particular:

a. exercise their active and passive voting rights,

b. apply in all matters addressing the objectives and functioning of the Society ,

c. applying the Society’s recommendations for their activities within pharmacovigilance system,

d. use technical equipment, benefit from guidance and training, which the Society offers to its members,

e. exploit other opportunities provided to its members by the Society.

1. Legal entities may become supporting members by submitting a written declaration to the Society’s Management Board, which takes a decision thereon. The Supporting membership is granted in the same manner.

2. Supporting members agree with the Management Board the form and extent of their assistance to the Society.

3. Supporting members shall be obliged to comply with the rules applicable to full members of the Society that are listed in §7, section 1.

4. Supporting members benefit from the rights granted to full members that are listed in §7, section 2 b-e, unless the execution of these rights interferes with the objectives and functioning of the Society.

1. The person who has an outstanding contribution in pharmacovigilance in Poland, whose candidature has been submitted in writing by at least 5 full members of the Society may become an honorary member of the Society.

2. Honorary membership of the Society shall be acquired by a resolution through acceptance of the candidate by the Management Board in a simple majority vote.

3. Honorary members shall be obliged to comply with the rules applicable to full members of the Society that are listed in §7, section 1 a-e.

4. Honorary members benefit from the rights granted to full members that are listed in §7, section 2 c-e.

1. The withdrawal from the list of members of the Society , including the list of supporting and honorary members can be caused by:

a. written resignation of membership to the Management Board,

b. exclusion by resolution of the Management Board:

i. for activities contrary to the Statute and principles of the Society ,

ii. for an unjustified lack of participation in the Society’s activities,

iii. for delays in membership fee payment for three periods (not applicable to honorary members),

iv. upon the written motivated request of at least 10 members of the Society for the reasons set out under the points i and ii,

v. due to loss of the civil rights by an unappealable court judgment,

c. death of the member.

1. A resolution of the Management Board on the expulsion shall be served to a concerned member of the Society.

2. An excluded member can appeal the Management Board’s resolution on the expulsion to the General Assembly of Members. Such an appeal should be submitted to the Management Board within 21 days, starting from the day of delivery of the resolution on expulsion to the most recent address provided by a member.

3. The appeal shall be reviewed at the next General Assembly of Members, whose resolution on this matter is final. Until then, a member is suspended from the rights.

1. Authorities of the Society are:

a. General Assembly of Members,

b. Management Board,

c. Review Board,

d. Disciplinary Board.

2. The term of office of all elected authorities shall be 3 years.

3. Members of authorities are obliged to submit their resignations at the next General Assembly of Members upon expiry of the terms of office.

4. Each member of the elected authorities of the Society may be dismissed at any time.

5. The position of a member of the Management Board cannot be combined with the positions within the Disciplinary Board and the Review Board.

6. Only a full member of the Society may become a member of its elected authorities.

1. Resolutions of all the authorities of the Society are passed with a simple majority of votes with the required presence of at least half of the members entitled to vote unless for particular types of resolutions the statute provides otherwise.

2. The requirement to be present in at least half of the members does not apply to the General Assembly of Members unless for particular types of resolutions the statute provides otherwise.

1. The highest authority of the Society is the General Assembly of Members.

2. The Management Board shall convene the General Assembly of Members at least once every 3 years or more, upon the written substantiated request of at least half of the members of the Review Board or at least half of the full members of the Society . The Management Board shall inform all the members of its deadline, place, and agenda by sending invitations at least 14 calendar days before the date of the commencement of the session.

3. All members of the Society , including those in an advisory capacity, supporting and honorary members as well as invited guests, can participate in the General Assembly of Members.

4. The competence of the General Assembly of Members is the following:

a. verifying and approving statements of the Management Board and Review Board for the term of office,

b. adopting the rules of procedure on the deliberations of the General Assembly of Members,

c. granting discharge to the outgoing Management Board,

d. appointing and dismissing members of the Management Board, Review Board, and Disciplinary Board,

e. adopting amendments to the Statute,

f. adopting a resolution on the dissolution of the Society ,

g. processing of appeals against Society’s resolutions brought by members of the Society ; appeals shall be filed in writing via the Management Board within 30 days from the day of adopting the resolution by the Management Board. The appeal shall be considered at the next General Assembly of Members; the resolution of the Society shall remain in force until its consideration by the General Assembly of Members.

h. appointing and dismissing members of the Disciplinary Board, handling complaints of members of the Society filed against actions of the elected authorities of the Society.

5. Resolutions of the General Assembly of Members are passed by a simple majority of votes of members of the Society who participate in the deliberations.

6. Each member has one vote.

7. The General Assembly of Members is responsible for the adoption of resolutions that are non-reserved for other authorities of the Society.

1. The Management Board shall comprise five members elected by the General Assembly of Members to serve a specific function within the Management Board.

2. The Management Board shall comprise the President, two Vice-Presidents, Treasurer, and Secretary.

3. The competence of the Management Board is the following:

a. accepting new members of the Society,

b. the external representation of the Society and acting on its behalf,

c. management of the ongoing activity of the Society,

d. convening the General Assembly of Members,

e. setting rates of membership fees,

f. preparation and presentation of the annual activity report to the Review Board of the Society,

g. setting up of ad hoc committees established for particular cases, including their staff composition along with assigning specific functions to individuals within the committee.

1. The Review Board shall comprise three members elected by the General Assembly of Members to serve a specific function within the Review Board.

2. The Review Board shall comprise Chairman, Vice-Chairman, and Treasurer to serve a specific function within the Review Board.

3. The competence of the Review Board is the following:

a. ongoing review of the Management Board’s activity,

b. acceptance of the annual report submitted by the Management Board and in the event of non-acceptance, requesting to the Management Board for convening the General Assembly of Members in order to take the final decision,

c. submission of requests regarding the discharge procedure at the General Assembly of Members,

d. requesting to convene the General Assembly of Members.

1. The Disciplinary Board shall comprise three members of the Society elected by the General Assembly of Members.

2. Within the Disciplinary Board’s competence is handling any written complaint filed by a full member of the Association, regarding the compliance with the provisions of the Statute and resolutions of the Society’s authorities except resolutions regarding the expulsion of the Societys member.

3. The Disciplinary Board convenes upon the written request of the Society’s member and shall respond to it within no more than one month.

4. The Disciplinary Board shall close the proceedings by issuing its decision, which shall be served on parties in dispute.

5. The Disciplinary Board decisions shall be passed by a majority of 2/3 of votes.

6. Parties in dispute can appeal the Disciplinary Board’s resolution to the General Assembly of Members. Such an appeal should be submitted to the Management Board within 21 days, starting from the day of delivery of the resolution to parties in dispute. The appeal shall be reviewed at the next General Assembly of Members whose resolution on this matter is final.

1. In the event of a decrease in the number of the elected Association’s authorities during the term of office, the body composition shall be supplemented by co-optation. The co-optation shall be carried out by other members of the decreased body in the way of a resolution by a simple majority of votes. In the same manner, no more than half of the Society’s authorities shall be elected.

2. In the event of a decrease in the number of the elected Society’s authorities by half or more, the Management Board is obliged to convene the General Assembly of Members in order to supplement the composition of the body.

3. The term of office of the co-opted member of the Society’s authorities is terminated along with the end of cadency of acting authorities.

§19 1. Only three members of the Management Board collaborating are authorized to represent the Society outside, including contracting financial commitments and concluding contracts of employment.

1. The activity of the Society is based on the social work of its members.

2. The Society may hire employees, including its members, to pursue the tasks entrusted to them.

1. Any changes to the provisions of the Statute require adopting a resolution by the General Assembly of Members by an absolute majority of votes, with the presence of at least half of the members entitled to vote.

2. Request for amendment of the Statute shall be submitted by at least 5 Society members entitled to vote. The application must be accompanied by the proposed wording of the new or amended provisions of the Statute, together with a codified text of the new Statute.

3. A correctly submitted request shall be considered at the next General Assembly of Members.

1. The dissolution of the Society is based on a resolution of the General Assembly of Members or in other cases provided by the law. A resolution shall be determined by a majority of 2/3 of votes with a presence of at least half of the members entitled to vote.

2. By adopting a resolution on the dissolution of the Society , the General Assembly of Members shall specify the manner of its liquidation and the destination of the Society assets.

1. For any matters not governed by this Statute, special law on associations shall be applied.