Chapter 1	The tasks and the composition of the medicinal product on the other,
Chapter 2	Preparation of the cases
Chapter 3	Detention of meeting and so on
Chapter 4	Decision, etc.
Chapter 5	Various provisions

Publication of the Rules of Procedure of the Medical Board of Medicinal Products

In accordance with section 56 (4), 2 and 5, in the Law of the Health Service, in accordance with the law on appeal and compensation access. Law Order no. 1113 of 7. The following shall be determined in November 2011 and after the debate with the Medical Board of Medicinal Products :

Chapter 1

The tasks and the composition of the medicinal product on the other,

§ 1. The Medical Board of Mediation Board is a complaint body for decisions of the Patient Insurance Association in cases of damages for medicinal products.

Paragraph 2. Damages, Ministry of Health and Prevention and others with the legal interest of the case may lodge a complaint for the Medical Board of Injuries in accordance with paragraph 1. 1.

§ 2. The Medical Board of Medicinal Products shall consist of a President and 8 crew members, cf. § 56, paragraph. 1, in the law on appeal and compensation access within the health care system.

Paragraph 2. The Board may, among its members, appoint a Vice-President to attend, in the absence of the President, to carry out the duties of the President following this notice.

Paragraph 3. In accordance with the recommendation of the authorities, etc. referred to in section 56 (3). 1, no. 2-7, in the law on appeal and compensation access in the healthcare system, a suppleant shall be appointed for each of the six groups for the medical emergency services.

Chapter 2

Preparation of the cases

§ 3. Complaints of the decisions referred to in Section 1 may be brought to the Medicines Board of Medicinal Products which have the final administrative decision, cf. § 57, paragraph. 1 in the Law on appeal and compensation access within the health care system.

Paragraph 2. The chairman or a Vice-President shall decide whether the complainant has a vested interest in the case and whether the deadline for the submission of the complaint has been complied with in accordance with the said procedure. § 57, paragraph. 2 in the Law on appeal and compensation access within the health care system. If the deadline is exceeded and there is no particular reason for this, the complaint may be rejected, cf. § 57, paragraph. 3 in the law on appeal and compensation access within the health care system.

§ 4. The availability of the patient shall provide the secretarial assistance for the Medical Board of Medicinal Products, cf. § 56, paragraph. 6, in the law of appeal and compensation access within the health care system.

Paragraph 2. The secretariat determines the order of processing of the complaints received.

Paragraph 3. The secretariat shall be responsible for the issue, the submission of the necessary expert opinion and the preparation of the draft decision.

Paragraph 4. Notification of replacement requirements according to the provisions in force for the compensation for medicinal products sent to the Patient omnitente shall be deemed to have been submitted to the appropriate authority at the time when they are received by the Patient Offer. The notification shall be forwarded immediately to the Patient Insurance, cf. § 60 a in the law of appeal and compensation access within the health care system.

§ 5. When a complaint is received, a confirmation to the complainant shall be sent to the complainant, with information on the expected procedure for proceedings.

Paragraph 2. The appeal shall be submitted before the submission of the Board of the Patient Insurance Association, which shall be submitted by the name of the case of the Patient Insurance Association, together with an opinion on the complaint lodged. The secretariat may fix a time limit for the submission of the opinion of the Patient Insurance in cases where special consideration is given to this.

Paragraph 3. Where special consideration is given to this, the President may, cf. § 57, paragraph. 1 in the law of the public health service, in accordance with the request of a complainent, the appeal shall be made to decide, in whole or in part, to have an opening effect on the payment of any compensation. The decision shall be taken within 14 days of receipt of the request.

Chapter 3

Detention of meeting and so on

§ 6. The Board shall exercise its activities in meetings, including telephone meetings or similar, cf. however, sections 10 and 11.

Paragraph 2. The names of the names shall be referred to by the secretariat at a reasonable notice. The summons shall be accompanied by an agenda of the cases to be dealt with at the meeting, a draft of the decision of the Board of the Board on each of the cases and the dossier necessary for the refusal to make a decision on each case.

§ 7. The chairman will have the appointment.

Paragraph 2. The Medical Board of Medicines shall be quorum when the President and at least one member from each of the law on appeal and compensation access in the health care system section 56 (3). 1, no. Two-seven, mentioned person groups are present.

§ 8. The juror's meetings aren't public.

Paragraph 2. The President of the Committee may, cf. § 56, paragraph. 2 in the Law on appeal and compensation access to health care, determine that special experts or others may participate without voting rights on matters of the jury.

Chapter 4

Decision, etc.

§ 9. Decisions of the jury shall be taken by the ballot. In voting, the President's voice is crucial.

Paragraph 2. The decisions of the jury shall be recorded in a decision-making protocol that is signed by the President.

Paragraph 3. In cases where a decision cannot be taken by unanimity, the members of the Member States may require their specific items to be recorded in the decision-making protocol. In such cases, the members of the jury may also insist on their specific points included in the decision itself, on the grounds of the position of the majority and the minority, and indicating the number of votes for the respective Member States ; the standpoints.

§ 10. The chairman may take a decision on behalf of the Board in matters which are not deemed to be unquestionable.

Paragraph 2. The following case categories are typically falling within the authorization of paragraph 1. 1 :

1) Cases that are only in the compensation calculation.

2) Cases where the damage falls outside the scope of the law.

3) Cases related to the request for the resumption of cases where there is no new and for the decision of the case, essential information.

4) Cases where the complaint has been lodged by a non-complainable person.

5) Cases related to complaints about access to information.

6) Cases where the conditions for the recognition of liability in accordance with the law are clearly recognised, and, incidentally, are not complicated.

7) Cases related to exceeding of appeal or limitation period after the law.

Paragraph 3. Decisions taken by the President, like decisions taken by the Board, could be brought before the court.

Paragraph 4. The other members of the other members may be informed of the decisions taken by the President.

§ 11. The Cases referred to by the chairman shall be eligible for written voting to be sent to the members of the jury with a recommendation on a decision. However, if a Member so requests, these matters must be discussed at a meeting.

§ 12. The following shall be of the following :

1) the decision of the Board shall amend or repeal the decision of the Patient Insurance Association,

2) that the board of the Board of the European Union shall be re-ruling the case of the Patient Insurance Association

3) that the board rejects the complaint, or

4) that the Board shall take a position on complaints concerning dossiers relating to cases dealt with in the Patient Insurance Association.

§ 13. The decisions of the jury shall be sent to the victims of injury, the medical and medical association, the medical board and, where appropriate, with a legitimate interest in the case.

Paragraph 2. The Ministry of the Interior and Health and the pharmaceutical manufacturer or the manufacturer or importer shall be informed of the decisions in which the Medical Board of Medicines has determined that injured claims are entitled to compensation and / or reimburseance.

Paragraph 3. The tender shall pay compensation and compensation in accordance with the decisions of the Patient Insurance and Medicinal Products Liamina.

Paragraph 4. The replacement shall be paid by the Patient Offer with a home meal in section 54 (5). 2 in the law on appeal and compensation access to health care and, on the basis of notice No, no. 428 of 9. May 2011 on the management of pharmacovigilance cases.

§ 14. The Medical Board of Medicinal Instructions is, in its establishment, independent of the instructions for the processing and decision of each case.

Paragraph 2. The decisions of the jury may not be brought to the second administrative authority, cf. § 57, paragraph. 1 in the Law on appeal and compensation access within the health care system.

§ 15. In a case that the Board has decided, new and for the decision of the case, substantial information, the Board may decide to review the matter for a review and decision. The same applies if there are significant errors in the case study.

Chapter 5

Various provisions

§ 16. The members of the medical and other person who are involved in the work of the Board shall be subject to the obligation of professional secrecy, cf. in the exercise of their activities. $27 administrative act.

§ 17. The members of medical officers are in the context of their work for the Board covered by the rules governing inhabilibility.

Paragraph 2. A Member of the Commission shall be obliged to inform the Board of Competency, which may lead to his incompatibility, like any other member of the jury who is familiar with such circumstances, has a duty to inform the Board of the Board.

Paragraph 3. A member of the Member's Member may not participate in the treatment of a specific case in the following situations :

1) whose members of the Member States have close personal relations with one of the parties to the case,

2) if the Member has participated in the treatment of the same case in another institution, such as the Legal Reader or the Patient Insurance Association, for example,

3) if injured at any time has been examined or examined by the member of the jury,

4) in the case of specific circumstances, which may be suitable to raise any doubt on the unwillingness of the person concerned.

Paragraph 4. If a member of the jury is in doubt about his capacity, the question can be discussed with the secretariat.

Paragraph 5. The Board will determine whether a member can participate in the processing of a case. The member shall not participate in the processing and decision of the question of the inhability of the person concerned. In the event of ballot, the President's voice is crucial.

§ 18. The Board shall deliver an annual report on its activities, which shall be sent to the Minister for Health and Prevention. The statement shall be prepared by the secretariat.

Paragraph 2. Decisions which are of fundamental importance and suitable guidance as guidance on the practice of the jury shall be published in anonymised and, where appropriate, summarised form.

§ 19. The announcement shall enter into force on 1. -February 2012.

Paragraph 2. At the same time, notice No 195 of 11. March 1997 on the Rules of Procedure for the Medical Board of Medicinal Products.