PHARMACEUTICAL REGULATORY AFFAIRS ASSOCIATION CONSTITUTION

1. NAME

The name of the association shall be THE SOUTHERN AFRICAN PHARMACEUTICAL REGULATORY AFFAIRS ASSOCIATION (SAPRAA).


ADDRESS

P O Box 2909
Randburg
2125

2. OBJECTIVES

The objectives of SAPRAA shall be the following:


2.1 To promote professionalism amongst regulatory personnel in Southern Africa.

2.2 To communicate with the Regulatory Authorities and the Pharmaceutical Industry (in South Africa and neighbouring countries) on matters affecting the regulation of medicines.

2.3 To establish and maintain contact with registration personnel in the general field of pharmaceutical, veterinary and agricultural matters, medical devices and any other areas concerned.

2.4 To arrange informative meetings with speakers who will be leaders in their area to promote the development of professionalism in the regulatory field.

3. FEES


3.1 Meeting fees will be charged to cover the expense of the meetings and general running costs of the association.

3.2 The Committee shall administer the funds of the Association.

3.3 The Committee shall serve members at minimal cost.

3.4 SAPRAA is a non-profit association. All funds generated from meeting fees are to be used solely for the furtherance of the objectives of the association as outlined in point 2 above. Any monies invested on behalf of the association may not be distributed to any person or SAPRAA member. In the event of the liquidation or winding-up of the Association, any assets remaining after the satisfaction of all the liabilities, will be transferred to another society or association with similar objectives to those of SAPRAA

4. MEMBERSHIP

Any person having a professional regulatory position or interest in regulatory issues pertaining to the health care field and other relevant areas may be enrolled as a member.

5. REGISTER OF MEMBERS

The name, address and contact details of every member shall be entered on a list, which will be administered by the SAPRAA secretary.

6. RIGHTS OF MEMBERS

Members shall have the right to participate in any discussion on any matter affecting his/her interests at any meetings of the Association. Members will always retain the right to communicate directly with the Chairperson of the committee or committee members regarding problem areas experienced with regulatory affairs. This right refers to general problems and no confidential information of any company in the industry may be revealed.

7. DURATION OF MEMBERSHIP

The membership shall run until such time as the member notifies the secretary to remove their name from the SAPRAA list.

8. ALTERATIONS TO THE CONSTITUTION

Alterations to this constitution shall only be made at a General Meeting by two thirds of the members present voting in favour thereof.

9. ANNUAL GENERAL MEETING

The Annual General Meeting (AGM) shall be held not later than March of each year, to carry out such business as may appear on the agenda of such a meeting and in particular the following:


9.1 To read and confirm the minutes of the previous Annual General Meeting, and of any Special General Meetings which may have been held during the year under review.

9.2 To receive the report of the Committee covering the activities of the Committee for the same period.

9.3 To receive the report of the Treasurer of the statement of revenue and expenditure for the same period.

9.4 To consider any other general business.

10. SPECIAL GENERAL MEETINGS

10.1 The Chairperson may at any time convene a Special General Meeting and shall call a Special General Meeting (SGM) if petitioned to do so by not less than twenty (20) members.

10.2 Notice of at least one week of any SGM, specifying the place, date and hour of the meeting, and in the case of special business the general nature of that business shall be given to members at the address and/or telephone number appearing in the Register of Members. Non receipt of the notice by any member shall not invalidate the proceedings at the SGM. Members not able to attend such a meeting may proxiform their vote to the Chairperson.

11. ELECTION AND COMPOSITION OF THE COMMITTEE

The election of the Committee shall take place at the Annual General Meeting and shall be deemed to be elected for a period of two years. The Committee shall be constituted as follows:


Chairperson
Vice-Chairperson
Secretary
Treasurer
3 supporting members

Additional supporting SAPRAA members may be co-opted to serve on the Committee.

12. DUTIES OF THE COMMITTEE

The duties and power of the Committee shall be:


12.1 CHAIRPERSON:


To preside at all meetings.
To sign the minutes after adoption.
To represent the association and to make any public announcements on behalf of the association.
To convene all meetings when necessary.
To instruct the secretary to issue notices of meetings in due time.
To institute and/or direct the activities of the association, e.g. to comment on any other regulation or policy document.
To attend all meetings with the Regulatory Authorities.
To nominate committee members to countersign cheques with the Treasurer.

12.2 VICE-CHAIRPERSON


To deputise and act for the Chairperson in the performance of any duties when the Chairperson is absent or unable to act and further to perform such duties as the Chairperson may delegate to him/her.


12.3 SECRETARY


To attend to all correspondence.
To keep an accurate record of the proceedings of the meetings of the Committee and of general meetings.
To have in safe-keeping all the written records of the association.
To advise the Chairperson as to the requirements of this constitution.
To maintain an accurate and up-to-date list of all members.
To perform such other duties as are delegated by the Chairperson.

12.4 TREASURER


To receive all monies payable to the association and to pay the same into the banking account of the association as soon as possible thereafter.
To keep a proper record of the financial transactions of the association, and to issue and obtain proper documents for the receipt and payment of monies respectively.
To countersign cheques.
To prepare an annual financial statement.
To arrange for the financial records of the association to be checked by an independent accountant at the end of each financial year.
To ensure that all financial obligations are met.

12.5 DELEGATION OF DUTIES

Any of the above duties may be delegated to another Committee member with the approval of the Committee.

13. FILLING OF VACANCIES

Should the Chairperson, Vice-Chairperson, Secretary, Treasurer or supporting members cease to be a member before the expiry of their term of office, the Committee shall have the power to co-opt and elect some other member to hold office for the unexpired portion of his/her term of office.

Should any member be absent from any three (3) consecutive committee meetings without reasonable excuse, the Committee shall be empowered to declare the position vacant. Due notice will be sent to the member so removed from office.


14. VOTING AT MEETINGS

14.1 In the event of equality of voting, the Chairperson shall have a casting vote.

14.2 Any resolution involving alteration, amendment or addition to this Constitution shall be carried by the vote of two-thirds of the members present at a General Meeting as provided in Section 8 of this Constitution.

14.3 Voting at all meetings shall be by a show of hands or by ballot. Members not able to attend such a meeting may proxiform their vote to the Chairperson where relevant.

15. CONDUCT OF MEETINGS

In the absence of the Chairperson or Vice-Chairperson from any meetings, a Chairperson shall be nominated by the Committee.

The proceedings at all meetings shall be regulated by the Chairperson whose ruling on all questions and points of order shall be final.

16. MISCELLANEOUS


16.1 The financial year shall be from the 1st March to the last day of February of the following year.
16.2 Names, addresses, and telephone numbers of Committee members must be circulated to members within thirty (30) days of election.