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Notice Of Rules Of Procedure For The Board

Original Language Title: Bekendtgørelse om forretningsorden for Lægemiddelnævnet

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Table of Contents
Appendix 1 Hability declaration for members of board and board members, consultants, etc., for the Board of Health,

Publication of the Rules of Procedure for the Medicinal Board

Under Section 99, in the law on medicinal products, cf. Law Order no. 506 of 20. April 2013 :

§ 1. The Medical Board shall consist of a maximum of 15 members, two of whom shall represent the interests of patients and consumer interests, cf. Article 96 (3) of the medicinal product. 2. Members will be appointed by the Minister for Health and Prevention for 4 years at a time, cf. Article 98 (3) of the medicinal product. 1.

Paragraph 2. The Minister for Health and Prevention will appoint a President and a vice-president, cf. Article 98 (3) of the medicinal product. 1.

Paragraph 3. With the approval of the Minister for Health and Prevention, the Standing Committee shall be set up under the Medicinal Products Committee, cf. Article 98 (3) of the medicinal product. 4. To members of these, the Minister for Health and Prevention, the Minister for Health and Prevention, shall not be described as a member of the Board, cf. Article 98 (3) of the medicinal product. 4.

§ 2. Medical Board Counselor Board of Health in matters of

1) the issue, modification, suspension or revocation of marketing authorization for medicinal products,

2) the monitoring of adverse reactions and other risks to medicinal products ;

3) weighing up the benefits of a medicinal product to the risks of the medicinal product, and

4) clinical trials involving medicinal products, cf. Article 96 (3) of the medicinal product. 1.

Paragraph 2. The Ministry of Health and Prevention may refer further tasks to the Medicinal Board, cf. Article 98 (3) of the medicinal product. 2.

Paragraph 3. The medical board may, as appropriate, and after prior agreement with the Board of Health, make up the opinions of the experts in particular.

§ 3. The medical board shall be assisted by a secretariat made available by the Board of Health. The extent of the secretarial aid shall be determined by the director of the Health Board.

§ 4. The Medicinal Board shall exercise its activities at meetings, including telephone meetings or similar, cf. However, section 9. The Board shall meet at least 3 times a year.

Paragraph 2. The Board will be meeting at the board of the board approved meeting days. The chairman may decide, if necessary, to hold extraordinary meetings.

Paragraph 3. The chairman shall, in cooperation with the Secretariat, prepare for the submission of the Board.

§ 5. The chairman or the secretariat shall submit in writing to the Board of the Board in writing to the Board ' s meetings as far as possible on 8 days ' notice.

Paragraph 2. Meeting submissions must be accompanied by a draft agenda. In addition, documents shall be made available to each item on the agenda as appropriate.

Paragraph 3. Draft agenda shall be determined by the President. In the light of ordinary meetings, the daily scheme shall contain at least the following points :

1) Approval of the agenda.

2) Approval of the Minutes of the previous meeting.

3) Hability.

4) Messages from the President.

5) Messages from the secretariat.

6) Cases for discussion and decision.

7) Possible.

Paragraph 4. Draft agenda will be published on the Health Board's website, cf. Article 72 (3) of the medicinal product. 1, no. 9, and paragraph 1. 2.

§ 6. The meetings are led by the President.

Paragraph 2. The Board shall be quorum when the chairman or the Vice-President and, in all, at least half of the members of the Board shall be present.

Paragraph 3. Although the conditions laid down in paragraph 1 are 2 is not fulfilled, decisions may be taken if they consider that the postponement of a case will result in a significant disadvantage to the case or to the case concerned, or to disregard essential health considerations.

§ 7. Decision can only be taken on issues that are included in the agenda for decision unless the Board decides otherwise, cf. § 8.

§ 8. The Board shall make a decision or accept by simple ballot. If there is a vocal vote, the President's voice is crucial. In the absence of the President, the President-in-Office

§ 9. The secretariat may, in agreement with the President, submit a case in writing for the Board, in writing, in the case of a jury meeting. However, a Member may request the matter to be dealt with at a meeting before a decision is taken.

Paragraph 2. In the first order of the jury, after the written presentation of a case in accordance with paragraph 1. 1, shall inform the chairman or the secretariat of the outcome of the case.

§ 10. The meetings of the medical board are not public.

Paragraph 2. Employees of the Secretariat and other members of the Board of Health may, to the extent that the President decides, participate in the meetings.

Paragraph 3. The Board shall not be able to hold meetings with a specific expert or any other person whose prior agreement has been agreed with the Health Service.

§ 11. A summary shall be taken from each appointment.

Paragraph 2. The minutes shall contain at least the information on :

1) the time and place of the meeting ;

2) who has participated in the meeting, including who has been referred to,

3) the agenda of the meeting ;

4) decisions taken, and

5) the time and place of the earliest appointment of a jury.

Paragraph 3. If a juror does not agree with a decision, the Member's position must be taken to the rapporteur.

§ 12. Draft minutes to be sent as soon as possible after the meeting and within a call to the next ordinal meeting.

Paragraph 2. The objections to a record shall be made no later than at the earliest date of the appointment. However, objections to the determination of the content of a decision shall, however, be immediately notified to the President and the Secretariat.

Paragraph 3. The authorized rapporteur shall be signed by the chairman or vice-President, if this has led the meeting, cf. Section 14, paragraph 14. 1.

Paragraph 4. The rapporteur, accompanied by the decisions taken, the results of voting and the explanations of vote, including minority opinion, shall be published on the Health Board's website, cf. Article 72 (3) of the medicinal product. 1, no. 9, and paragraph 1. 2.

§ 13. The members of the Member States shall, as far as possible, notify the secretariat of the absence.

§ 14. In the absence of the chairman ' s absence, the Vice-President of the President shall

Paragraph 2. If the President or the Vice-President is absent, the next person shall decide by simple majority, who shall, under the absence, be responsible for the function of the President.

§ 15. The members of the Medicinal Products Board shall not have any economic or other interests in the pharmaceutical industry which may affect their impartiality, cf. Article 102 (1) of the medicinal product. 1.

Paragraph 2. The names of the members shall, before the first meeting of their replacement, complete and sign a habilitation declaration, cf. the Annex.

Paragraph 3. The members of the Member States must make a statement every year on their economic interests in the pharmaceutical industry.

Paragraph 4. If the facts referred to in the habilization declaration change, the member on his own initiative must fill and sign a new declaration attached to the minutes of the next sitting.

Paragraph 5. The authority declarations of the Member States shall be published on the Health Board ' s website.

§ 16. A member of the Medicinal Products Board shall not participate in the treatment of a case if they have an individual interest in the outcome of the case or, if any, circumstances which are suitable to raise doubts about the impartiality of the Member, cf. Chapter 2 of the Administrative Code.

§ 17. A member shall inform the Board that the person may be an inhacar before the examination of a case begins, cf. ~ § 15, paragraph 1. 1, and 16.

Paragraph 2. The Member will decide whether or not the member can participate in the processing of a case. The Member concerned shall not participate in the examination and the decision on this matter. The verdict shall be recorded in the name of the jury.

Paragraph 3. A member declared inhavan must leave the conference room during the examination of the case in which they are inhavan.

§ 18. The members of the Board shall be bound by professional secrecy in respect of information they are familiarsed with in their capacity as member of the Board when the information is classified as confidential in accordance with their character. $27 administrative act.

Paragraph 2. Each Member State shall ensure that, in the case of its operation in the Board, material that the person in question is in possession of in the name of its operation does not come from outside the board. In the event of an appointment of the Member State, all confidential material which the Member is in possession of and which the member is in possession of in his capacity as a member of the Member State shall be returned.

§ 19. All members of the jury shall have provided a copy of this Rules of Procedure.

Paragraph 2. This Rules of Procedure shall be published on the Health Board's website, cf. Article 72 (3) of the medicinal product. 1, no. 9.

20. The announcement shall enter into force on the 24th. October 2013.

Paragraph 2. Publication no. 1235 of 12. December 2005 on the Rules of Procedure of the Registration Board shall be repealed.

The Ministry of Health and Prevention, the 1. October 2013

Astrid Krag

/ Nina Moss

Appendix 1

Hability declaration for members of board and board members, consultants, etc., for the Board of Health,

1.0
Personal Information
1.1
Name
1.2
Title
1.3
Workspace / company / institution
1.4
Mention / Council

2.0
These questions must be answered if you are to assist the Health Services handling cases in which a management decision is taken or will be made. cf. section 2, stk.1, , or if you are able to assist the Health Services Committee with training, advice, etc. If you are able to assist the Health Services Inspection of Companies, you will have to answer both in sections 2 and 3.
2.1
I own shares, shares, shares, or similar activities in one or more establishments subject to the supervision of the Health Board.
Yeah.
If yes, which :
No.
2.2
I sit on the board, the management, or the like in one or more companies that are subject to the supervision of the Health Board.
Yeah.
If yes, which :
No.
2.3
In the last five years, I have been employed in one or more companies that have been subject to the supervision of health management.
Yeah.
If yes, which :
No.
2.4
I have, in the last five years, for the payment of tasks for one or more companies that have been subject to the supervision of health management.
Yeah.
If yes, which :
No.
2.5
I have a patent on one or more patents in areas subject to the authority of the Health Agency.
Yeah.
If yes, which :
No.
2.6
My spouse, the roommate or anyone else in my household, or in my immediate family, is employed in a company that is subject to the supervision of the Board of Health.
Yeah.
If yes, which :
No.
2.7
Are you, by the way, associated with the health care business, in a way that can affect your work for the Board of Health?
Yeah.
If yes, which :
No.
2.8
Do you accept your work as a financial contribution from companies that are subject to the supervision of health management?
Yeah.
If yes, which :
No.
2.9
Is there any other reason to doubt that your impartiality will be unmistakeable?
Yeah.
If yes, which :
No.

3.0
These questions need to be answered if you are to assist the Health Services Inspection of Companies.
(Remember also to answer the questions in paragraph 2.)
3.1
Do you have, against payment, tasks for pharmaceutical companies, media companies or other companies in the field of health in the last five years?
Yeah.
If yes, which undertakings :
(Attach, if applicable. referencing list e.l. with description of the tasks)
No.
3.2
In any case, there are circumstances which are particularly suitable for questioning your impartiality in relation to the inspections or inspections that you are to assist Health Services with?
For example, you must explicitly notify if you have previously performed tasks for a company that you need to inspect, even if it is shown in your reference list.
Yeah.
If yes, which undertakings :
No.

4.0
These questions must be answered if you are to assist the Board of Health in the award of contract or similar private law in accordance with the procedure laid down in the case of the Board of Directions. section 2 (2) of the management Act. 2.
4.1
Do you have any personal or financial interests in companies that can be contracted or otherwise enter into a private legal relationship with the Board of Health in the context of the task for which you are providing the Health Care Authority?
Yeah.
If yes, describe the stakeholders and businesses :
No.

In my best conviction, I have no further unimportant interests that could affect my objective consultation of the Health Service. If my relationships change after the completion of this statement, I shall complete and sign a new declaration as soon as possible.

5.0
Signature, etc.
5.1
Site
5.2
Date
5.3
Signature