Notice Of Rules Of Procedure For The Board

Original Language Title: Bekendtgørelse om forretningsorden for Lægemiddelnævnet

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Overview (table of contents)



Annex 1



Their Declaration of interest statement for members of boards and councils, consultants etc. for Health Agency


The full text of the Ordinance on the rules of procedure for the Board

Under section 99 of the law on medicinal products, see. lovbekendtgørelse nr. 506 of 20. April 2013, fixed: § 1. Pharmaceutical Committee consists of a maximum of 15 members, of whom 2 must represent patient and consumer interests, see. the Danish Medicines Act section 96 (2). The members are appointed by the Minister for health and prevention for 4 years at a time, see. the Danish Medicines Act section 98 (1).

(2). The Minister for health and prevention among Committee members shall appoint a Chairman and a Vice-Chairman, see. the Danish Medicines Act section 98 (1).

(3). With the approval of the Minister for health and prevention can be reduced during the Pharmaceutical Committee Standing Committee, see. section 98 of the Danish Medicines Act, paragraph 4. For members of these Minister for health and prevention can appoint persons who are not members of the Committee referred to in article 6. section 98 of the Danish Medicines Act, paragraph 4.

§ 2. Pharmaceutical Committee advises the Board of health in matters relating to 1) the issuance, amendment, suspension or revocation of a marketing authorisation for medicinal products, 2) monitoring of side effects and other risks associated with the drugs, 3) balance of a medicinal product benefits against the risks of the drug, and 4) clinical trials of medicinal products referred to in article 6. the Danish Medicines Act section 96 (1).

(2). The Minister for health and prevention can drop additional tasks to the pharmaceutical Committee, see. the Danish Medicines Act section 98 (2).

(3). Pharmaceutical Committee may, in accordance with the needs and by prior arrangement with the health protection agency obtain expert opinions.

§ 3. Pharmaceutical Committee is assisted by a secretariat, which shall be made available by the National Board of health. The extent of the assistance of the Secretariat shall be determined by the Board of Health's Director.

§ 4. Pharmaceutical Committee operates in meetings, including Conference calls or similar, see. However, § 9. The Committee shall meet at least 3 times a year.

(2). The Committee meets on the Board agreed the meeting days. The Chairman may, if necessary, decide to hold extraordinary meetings.

(3). The President is preparing, in cooperation with the Secretariat, proceedings submission to the Board.

§ 5. The Chairman or the Secretariat, after the President's authorisation shall be convened in writing to the Committee's meetings, as far as possible with 8 days ' notice.

(2). Meeting requests must be accompanied by a draft agenda. Furthermore, where necessary made voucher material is available to the individual agenda items.

(3). The draft agenda shall be determined by the Chairman. For ordinary meetings, the agenda must contain at least the following points: 1) approval of the agenda.

2 Approval of the minutes from the previous meeting).

3) Capacity.

4) Chairperson's announcements.

5) Messages from the Secretariat.

6) cases for discussion and decision.

7) Possibly.

(4). Draft agenda published on the website of the National Board of Health's regulation. the Danish Medicines Act, section 72 (1) (8). 9, and paragraph 2.

§ 6. The meetings chaired by the President.

(2). The Committee is quorate when the President or the Vice President and a total of at least half of the Committee members are present.

(3). Even though the conditions laid down in paragraph 2 are not fulfilled, the decision taken, if the attendants estimates that the adjournment of a case will cause significant inconvenience for the or those proceedings or infringement of essential health considerations.

§ 7. Decision can be taken only on the topics listed on the agenda for decision, unless the Tribunal decides otherwise, in accordance with article 3. § 8.

§ 8. The Tribunal shall decide or approve by simple majority vote. There is a tied vote, the casting vote. In the President's absence is the Vice-President vote.

§ 9. The Secretariat may, in agreement with the President in special cases present a case in writing for the Board outside of a Committee meeting. A member may, however, require the matter dealt with at a meeting before making a decision.

(2). At the next ordinary Committee meeting after the written presentation of a case in accordance with paragraph 1, it shall inform the Chairman or the secretariat about the outcome of the case.

§ 10. Pharmaceutical Committee meetings are not public.

(2). Employees from the Secretariat and other staff members of the National Board of health may, to the extent the President decides it, participate in the meetings.

(3). The Tribunal can only hold meetings with special experts or others if it has previously been agreed with the National Board of health.

§ 11. There must be from each Committee meeting shall be taken into account a record.

(2). The minutes shall contain at least the information on the 1) the time and place of the meeting, 2) who have participated in the meeting, including who has been a reporter, 3) agenda for the meeting, 4) the decisions and 5) time and place of the next ordinary Committee meeting.

(3). Is a Committee member does not agree with a decision, the Member's position must be transferred to the record.

§ 12. Draft record is sent as soon as possible after the meeting and most recently in connection with the convening of the next regular meeting.

(2). Objections to the minutes must be submitted no later than at the next ordinary Committee meeting. Objections to the reproduction of the contents of a decision should however be immediately communicated to the Chairperson and the Secretariat.

(3). The approved minutes shall be signed by the Chairman or the Deputy Chairman, if this has led the meeting, see. section 14, paragraph 1.

(4). Report of proceedings accompanied by the decisions taken, the results of votes and explanations of votes, including minority opinions shall be published on the website of the National Board of Health's regulation. the Danish Medicines Act, section 72 (1) (8). 9, and paragraph 2.

§ 13. Committee members should, as far as possible, give notice to the Secretariat concerning absence.

§ 14. In the event of the President's absence, the Vice-President shall assume the President's duties.

(2). If the Chairman or the Deputy Chairman is absent, the Board decides by simple majority vote, who during the absence must perform the function as President.

§ 15. The members of the Pharmaceutical Committee must not have economic or other interests in the pharmaceutical industry which could affect their impartiality, see. the Danish Medicines Act § 102 (1).

(2). The Committee members before the first meeting after their appointment must fill out and sign a declaration of interest, see. the annex.

(3). Committee members should each year make a declaration of their financial interests in the pharmaceutical industry.

(4). If the facts referred to in their Declaration of interest statement, changes, on their own initiative, the Member must complete and sign a new declaration, which shall be annexed to the minutes of the next meeting.

(5). The Committee members ' Declaration of interest shall be published on the National Board of Health's website.

§ 16. A member of the pharmaceutical Committee may not take part in any proceedings if he or she has a personal interest in the outcome of the case, or if there exist circumstances which are apt to arouse doubts about the Member's impartiality, see. Management chapter 2.

§ 17. A member shall, before the commencement of any proceedings, inform the Board that he or she may be disqualified without prejudice. articles 15, paragraph 1, and 16.

(2). The Committee shall decide whether the Member can take part in a case. The Member concerned shall not take part in the proceedings and the decision of this question. The Board's decision must be recorded in the minutes.

(3). A member declared incapacitated, must leave the room during the examination of the case in which he or she is disqualified.

§ 18. The Committee members are bound by professional secrecy with regard to the information they gain knowledge of, in their capacity as a member of the Committee when the information by their nature are confidential, see. Executive Law § 27.

(2). Each Committee member shall ensure that the material to which the person is in possession of the Committee in connection with its function, is not disclosed to third parties. By a Committee member secession returned all confidential material, as the honourable Member is in possession of, and which the person is in possession of, in his capacity as Committee member.

§ 19. All Committee members must be given a copy of these rules of procedure.

(2). These rules of procedure shall be published on the website of the National Board of Health's regulation. the Danish Medicines Act, section 72 (1) (8). 9. section 20. The notice shall enter into force on the 24th. October 2013.

(2). Executive Order No. 1235 by 12. December 2005 on the rules of procedure for the Licensing Committee shall be repealed.

The Ministry of health and prevention, the 1. October 2013 Astrid Krag/Nina Moss



Annex 1



Their Declaration of interest statement for members of boards and councils, consultants etc. for Health Agency



1.0





Personal data







1.1





Name



 





1.2





Title



 





1.3





Site/company/institution



 





1.4





Board/Council




 

















2.0





These questions need to be answered if you assist the Health Agency dealing with cases in which there is or will be taken by administrative decision, see. Executive law § 2, paragraph 1, or if you otherwise assists the National Board of health with teaching, counseling, etc. If you assist the National Board of health with inspection of businesses, you must both answer the questions in section 2 and 3.







2.1





I own shares, shares, units or similar in one or more enterprises subject to Board of Health's supervision.





Yes



 





If Yes, which:









No



 





2.2





I sit on the Board of Directors, Executive Board or similar in one or more enterprises subject to Board of Health's supervision.





Yes



 





If Yes, which:









No



 





2.3





I have within the last 5 years, been employed in one or more enterprises subject to Board of Health's supervision.





Yes



 





If Yes, which:









No



 





2.4





I have within the last 5 years against payment performed tasks for one or more undertakings are governed by the National Board of Health's supervision.





Yes



 





If Yes, which:









No



 





2.5





I have a patent on one or more patents in areas that are subject to the Board of Health's authority.





Yes



 





If Yes, which:









No



 





2.6





My spouse, cohabitant or others in my household or in my immediate family is employed by a company that is subject to the National Board of Health's supervision.





Yes



 





If Yes, which:









No



 





2.7





Are you incidentally associated with companies related to the health sector in a way that may have an influence on your work for the health protection agency?





Yes



 





If Yes, which:









No



 





2.8





Receive your workplace financial contributions from companies that are subject to the National Board of Health's supervision?





Yes



 





If Yes, which:









No



 





2.9





Moreover, in the absence of circumstances that can arouse doubt your impartiality?





Yes



 





If Yes, which:









No



 

















3.0





These questions need to be answered if you assist the National Board of health with inspection of enterprises.

(Also remember to answer the questions in section 2.)







3.1





Do you have against payment performed tasks for pharmaceutical companies, medicovirksomheder or other companies in the area of health within the last 5 years?





Yes



 





If Yes, what are the companies:



(Please include if applicable reference list with description of tasks, etc.)







No



 





3.2





In the absence of circumstances that are particularly suitable to arouse doubt your impartiality in connection with the inspections, you will assist the National Board of health with?

You must explicitly indicate, for example if you have previously performed tasks for a company, you must inspect, although it appears from your reference list.





Yes



 





If Yes, what are the companies:









No



 

















4.0





These questions need to be answered if you shall assist the Board of health in connection with the conclusion of contractual or similar arrangements, as referred to in private law. Executive law § 2, paragraph 2.







4.1





Do you have personal or financial interests in companies that may become party to the contract or otherwise engage in a private law relationship with the health protection agency in connection with the task, which you shall assist the Board of health?





Yes



 





If Yes, please describe the stakeholders and businesses:









No



 









According to the best of my knowledge I have no additional extraneous interests which may affect my objective advice of the health protection agency. If my circumstances change after the making of this statement, complete and sign I as soon as possible hereafter a new declaration.



5.0





Signature, etc.







5.1





Place



 





5.2






Date



 





5.3





Signature