Procedures for Approving Medical Technologies to be Used in Medical Treatment and the Procedures for Introducing New Medical Technologies

Issued pursuant to
Section 9, Paragraph one and
Section 35 of the Medical Treatment Law
[3 November 2009]

I. General Provisions

1. This Regulation prescribes the procedures for approving medical technologies to be used in medical treatment (hereinafter - the medical technologies) and the procedures for introducing new medical technologies.

2. Medical technologies shall be assessed and approved by the National Health Service (hereinafter - the Service), except for:

2.1. medicinal products used in conformity with the type of use indicated in the package leaflet of the medicinal products and approved in accordance with the laws and regulations regarding the registration of medicinal products;

2.2. medical devices used according to the type of use indicated in the package leaflet and approved in accordance with the laws and regulations regarding the registration of medical devices.

[24 January 2017]

II. Submission of Documents for the Approval of a Medical Technology

3. In order to approve a medical technology, a medical treatment institution or a professional organisation of medical practitioners (hereinafter - the applicant) shall complete and submit to the Service an application for the approval of a medical technology.

[3 November 2009; 27 January 2015; 24 January 2017]

4. The applicant shall append the following documents to the application:

4.1. [27 January 2015];

4.2. the detailed description of the method of the medical technology to be approved;

4.3. the justification for the necessity of introducing the medical technology to be approved by indicating the purpose for the use of the medical technology and the anticipated results;

4.4. the summary of the results of the clinical trials attesting the effectiveness of the medical technology to be approved (except for the methods used for a forensic medical expert-examination, forensic psychiatric expert-examination, and narcologic expert-examination);

4.5. the justification for the resources necessary to ensure the operation of the medical technology to be approved:

4.5.1. information on medical practitioners, their general qualification and additional qualification required for the use of the relevant medical technology;

4.5.2. information on other medical technologies required for the use of the medical technology (characterising conditions and conditions for use), including on medicinal products and medical devices by appending the documents attesting such information;

4.5.3. information on the premises where the specific medical technology will be used and the technical equipment of the relevant premises;

4.5.4. [27 January 2015].

[27 January 2015; 24 January 2017]

5. The documents referred to in Paragraphs 3 and 4 of this Regulation shall be submitted by the applicant in the official language or the original language by appending a certified translation in accordance with the laws and regulations regarding the procedures for the certification of document translations in the official language. If the documents referred to in Paragraphs 3 and 4 of this Regulation are not drawn up in accordance with the laws and regulations regarding the drawing up of electronic documents, such documents shall be submitted in paper format by sending also the electronic version thereof to the Service. The documents attesting the information referred to in Sub-paragraph 4.5.2 of this Regulation may be drawn up and submitted only electronically.

[27 January 2015]

III. Assessment of a Medical Technology

6. The Service shall examine whether all necessary documents have been submitted within three working days following the day on which the documents referred to in Paragraphs 3 and 4 of this Regulation were submitted.

[3 November 2009; 27 January 2015]

7. If it is established that all documents referred to in Paragraphs 3 and 4 of this Regulation have not been submitted, the Service shall immediately request the missing documents. If within 30 days after sending the request the applicant does not submit the missing documents, the director of the Service shall take a decision to refuse to approve the medical technology.

[3 November 2009; 27 January 2015]

8. After receipt and examination of the documents referred to in Paragraphs 3 and 4 of this Regulation, the Service is entitled to request the applicant to submit additional information, also opinions of the State Agency of Medicines, Latvian Association of Physicians and professional organisations of medical practitioners regarding the medical technology to be approved.

[3 November 2009; 27 January 2015]

9. The Service shall assess the medical technology by taking into account the aspects of safety, effects, effectiveness, professional ethics, and the economic justification for use.

[3 November 2009; 27 January 2015]

10. [27 January 2015]

11. In order to assess the medical technology, the Service shall evaluate and summarise the information submitted by the applicant and shall also obtain scientific evidence for the medical technology to be assessed. The Service shall evaluate the quality of the collected evidence.

[3 November 2009; 27 January 2015]

12. The collected scientific evidence shall be divided into the following levels of evidence:

12.1. A Level - strong evidence obtained in multiple high-quality and good quality studies (meta-analysis);

12.2. Level B - average evidence attested by a systematic report on separate high-quality control or group (cohort) studies or by a report on well-organised separate or group (cohort) studies with low-risk likelihood of a lack of impartiality, contingencies or insignificant incidental occurrence of correlation;

12.3. Level C - limited evidence, individual control or group (cohort) studies with high-risk likelihood of a lack of impartiality, contingencies or very significant incidental occurrence of correlation;

12.4. Level D - insufficient evidence, impossible to use the analysis of evidence, one or multiple reports on individual cases or personal opinion of experts.

13. [27 January 2015]

14. [27 January 2015]

15. After compilation of all data obtained in the course of assessment the medical technology, the Service shall draw up the report on the assessment of the medical technology and submit it for review to the Commission for the Evaluation of Medical Technologies (hereinafter - the Commission). The procedure for the operation of the Commission and its personnel shall be approved by the director of the Service. Five representatives of the Service and one representative of the Health Inspectorate and the State Agency of Medicines shall be included within the composition of the Commission. The Commission has the right to invite specialists and experts of the relevant sector with advisory rights that do not represent the applicant.

[27 January 2015]

15.¹ A member, specialist or expert of the Commission shall not participate in the assessment of the medical technology if there is a conflict of interests or due to commercial or other reasons that could influence the impartiality of the process of assessing the medical technology. Members of the Commission and invited specialists, and experts do not have the right to disclose any information to third parties which has become known to them as a result of participating in the assessment of the medical technology.

[27 January 2015]

16. The Commission shall review the report on the assessment of the medical technology and provide an opinion to the director of the Service regarding the approval of the medical technology or regarding the refusal to approve the medical technology by taking into account the criteria referred to in Paragraphs 17 and 18 of this Regulation.

[3 November 2009; 27 January 2015]

IV. Approval of a Medical Technology

17. The director of the Service shall take the decision on the approval of the medical technology, if the effectiveness, safety, positive impact of the technology on the quality of life of a patient was proven during the assessment of the medical technology. The Service shall register the approved medical technology in the database of medical technologies used in medical treatment.

[3 November 2009; 27 January 2015]

17.¹ Upon evaluating the methods used in a forensic medical expert-examination, forensic psychiatry expert-examination, and narcology expert-examination, the director of the Service shall take the decision to approve the method if the effectiveness thereof was proven during the evaluation of the method. The Service shall register the name of the approved method used in a forensic medical expert-examination, forensic psychiatry expert-examination, and narcology expert-examination in the database of medical technologies used in medical treatment. The Service shall not register the description of the method used in a forensic medical expert-examination, forensic psychiatry expert-examination, and narcology expert-examination in the database of medical technologies used in medical treatment and issue it therefrom because it is classified as restricted access information.

[24 January 2017]

18. The director of the Service shall refuse to approve the medical technology if:

18.1. false information or documents have been submitted regarding the medical technology to be approved;

18.2. the submitted documents do not comply with the requirements laid down in the laws and regulations regarding the drawing up of documents;

18.3. effectiveness, safety, positive impact of the medical technology on the quality of life of a patient was not proven during the assessment of the medical technology.

[3 November 2009; 27 January 2015]

19. The decision to approve the medical technology or the decision to refuse to approve the medical technology shall be sent or issued by the Service to the applicant within five working days following the day on which the relevant decision was taken in accordance with the procedures laid down in the Law on Notification.

[27 January 2015]

20. The decision to approve the medical technology or the decision to refuse to approve the medical technology may be contested before the Ministry of Health in accordance with the procedures laid down in the Administrative Procedure Law. The decision of the Ministry of Health may be appealed before a court in accordance with the procedures laid down in the Administrative Procedure Law.

[27 January 2015]

V. Reviewing and Supplementing an Approved Medical Technology

21. The applicant has the right to propose to the Service to supplement a previously approved medical technology.

[3 November 2009; 27 January 2015]

22. In order to review and supplement the approved medical technology, the applicant shall submit an application to the Service regarding reviewing and supplementing the medical technology.

[3 November 2009; 27 January 2015]

23. The applicant shall append the following documents to the application referred to in Paragraph 22 of this Regulation:

23.1. detailed description of the method of the medical technology to be approved;

23.2. the statement of reasons for the necessity to review and supplement the medical technology wherein the summary of the results of the clinical trials regarding the safety, effects, effectiveness, and positive impact of the medical technology on the quality of life of a patient is specified, and documents attesting such information.

[27 January 2015]

24. The documents referred to in Paragraphs 22 and 23 of this Regulation shall be submitted by the applicant in the official language or the original language by appending a certified translation in accordance with the laws and regulations regarding the procedures for the certification of document translations in the official language. If the documents referred to in Paragraphs 22 and 23 of this Regulation are not drawn up in accordance with the laws and regulations regarding the drawing up of electronic documents, such documents shall be submitted in paper format by sending also the electronic version thereof to the Service. The documents attesting the information referred to in Sub-paragraph 23.2 of this Regulation can be drawn up and submitted only electronically.

[27 January 2015]

VI. Evaluation of the Proposal for Reviewing and Supplementing an Approved Medical Technology

25. The Service shall examine whether all necessary documents have been submitted within three working days following the day on which the documents referred to in Paragraphs 22 and 23 of this Regulation were submitted.

[3 November 2009; 27 January 2015]

26. If it is established that all the documents referred to in Paragraphs 22 and 23 of this Regulation have not been submitted, the Service shall immediately request the missing documents. If the applicant does not submit the missing documents within 30 days after sending the request, the director of the Service shall take the decision to refuse to supplement the medical technology.

[3 November 2009; 27 January 2015]

27. After receipt of the documents referred to in Paragraphs 22 and 23 of this Regulation, the Service is entitled to request the applicant to submit the necessary additional information, also opinions of the State Agency of Medicines, Latvian Association of Physicians and professional organisations of medical practitioners.

[3 November 2009; 27 January 2015]

28. The Service shall evaluate the proposal for reviewing and supplementing the medical technology and shall draw up a report regarding the assessment of the medical technology. The report shall be submitted for review to the Commission.

[3 November 2009; 27 January 2015]

29. The Commission shall review the report referred to in Paragraph 28 of this Regulation and shall provide an opinion to the director of the Service regarding the supplementing the medical technology or regarding the refusal to supplement the medical technology by taking into account the criteria referred to in Paragraphs 30 and 31 of this Regulation.

[3 November 2009; 27 January 2015]

VII. Approval of a Reviewed and Supplemented Medical Technology

30. The director of the Service shall take the decision to supplement the medical technology if the effectiveness, safety, positive impact of the technology on the quality of life of a patient were proven during the assessment of the medical technology. The Service shall register the supplemented medical technology in the database of medical technologies used in medical treatment.

[3 November 2009; 27 January 2015]

30.¹ When assessing the methods used in a forensic medical expert-examination, forensic psychiatry expert-examination, and narcology expert-examination, the director of the Service shall take the decision to supplement the method if the effectiveness thereof was proven during the assessment of the method. The Service shall not register the supplemented description of the method used in a forensic medical expert-examination, forensic psychiatry expert-examination, and narcology expert-examination in the database of medical technologies used in medical treatment and issue it therefrom because it is classified as restricted access information.

[24 January 2017]

31. The director of the Service shall refuse to supplement the medical technology in the following cases:

31.1. false information or documents have been provided regarding the medical technology;

31.2. the submitted documents do not comply with the requirements laid down in the laws and regulations regarding the drawing up of documents;

31.3. effectiveness, safety, positive impact of the medical technology on the quality of life of a patient were not proven during the assessment of the medical technology.

[3 November 2009; 27 January 2015]

32. The decision to supplement the medical technology or the decision to refuse to supplement the medical technology shall be sent or issued by the Service to the applicant within five working days following the day on which the relevant decision was taken in accordance with the procedures laid down in the Law on Notification.

[27 January 2015]

33. The decision to supplement the medical technology or the decision to refuse to supplement the medical technology may be contested before the Ministry of Health in accordance with the procedures laid down in the Administrative Procedure Law. The decision of the Ministry of Health may be appealed before a court in accordance with the procedures laid down in the Administrative Procedure Law.

[27 January 2015]

VIII. Revocation of the Approval of a Medical Technology

34. The Health Inspectorate, medical treatment institutions or professional organisations of medical practitioners have the right to propose the revocation of the approval of the medical technology in accordance with the procedures laid down in this Regulation.

[27 January 2015; 24 January 2017]

35. [27 January 2015]

36. In order to revoke the approval of the medical technology, the institutions referred to in Paragraph 34 of this Regulation shall submit an application to the Service regarding the revocation of the approval of the medical technology.

[3 November 2009; 27 January 2015; 24 January 2017]

37. The statement of reasons for the necessity of the revocation of the approval of the medical technology and documents attesting the relevant information shall be appended to the application referred to in Paragraph 36 of this Regulation.

[27 January 2015]

38. The documents referred to in Paragraphs 36 and 37 of this Regulation shall be submitted by the applicant in the official language or the original language by appending a certified translation in accordance with the laws and regulations regarding the procedures for the certification of document translations in the official language. If the documents referred to in Paragraphs 36 and 37 of this Regulation are not drawn up in accordance with the laws and regulations regarding the drawing up of electronic documents, such documents shall be submitted in paper format also sending the electronic version thereof to the Service. The documents attesting the information referred to in Paragraph 37 of this Regulation may be drawn up and submitted only electronically.

[27 January 2015]

IX. Evaluation of the Proposal for the Revocation of the Approval of a Medical Technology

39. The Service shall examine whether all necessary documents have been submitted and whether they comply with the requirements laid down in this Regulation within three working days following the receipt of the documents referred to in Paragraphs 36 and 37 of this Regulation.

[3 November 2009; 27 January 2015]

40. If it is established that all the documents referred to in Paragraphs 36 and 37 of this Regulation have not been submitted, the Service shall immediately request the missing documents. If the applicant does not submit the missing documents within 30 days after sending the request, the director of the Service shall take the decision to refuse to revoke the approval of the medical technology.

[3 November 2009; 27 January 2015]

41. After receipt of the documents referred to in Paragraphs 36 and 37 of this Regulation, the Service is entitled to request the applicant to provide the necessary additional information, also opinions of the State Agency of Medicines, Latvian Association of Physicians and professional organisations of medical practitioners.

[3 November 2009; 27 January 2015]

42. After evaluation of the proposal for the revocation of the approval of the medical technology, the Service shall draw up a report regarding the assessment of the medical technology. The report shall be submitted for review to the Commission.

[3 November 2009; 27 January 2015]

43. The Commission shall review the report referred to in Paragraph 42 of this Regulation and provide an opinion to the director of the Service regarding the revocation of the approval of the medical technology or the refusal to revoke the approval of the medical technology by taking into account the criteria referred to in Paragraphs 44 and 45 of this Regulation.

[3 November 2009; 27 January 2015]

X. Revocation of the Approval of a Medical Technology

44. The director of the Service shall revoke the approval of the medical technology and the Service shall delete the relevant medical technology from the database of medical technologies used in medical treatment if data stating that the relevant medical technology is not effective, safe or it has a negative impact on the quality of life of a patient have been obtained as a result of the evaluation of the proposal for the revocation of the approval of the medical technology.

[3 November 2009; 27 January 2015]

45. The director of the Service shall refuse to revoke the approval of the medical technology in the following cases:

45.1. false information or documents have been submitted regarding the medical technology;

45.2. the submitted documents do not comply with the requirements laid down in the laws and regulations regarding the drawing up of documents;

45.3. data attesting that the medical technology is effective, safe and without negative impact on the quality of life of a patient have been obtained as a result of the assessment of the proposal for the revocation of the approval of the medical technology.

[3 November 2009; 27 January 2015]

46. The decision to revoke the approval of the medical technology or the decision to refuse to revoke the approval of the medical technology shall be sent or issued to the applicant within five working days following the day on which the relevant decision was taken in accordance with the procedures laid down in the Law on Notification.

[27 January 2015]

47. The decision to revoke the approval of the medical technology or the decision to refuse to revoke the approval of the medical technology may be contested before the Ministry of Health in accordance with the procedures laid down in the Administrative Procedure Law. The decision of the Ministry of Health may be appealed before a court in accordance with the procedures laid down in the Administrative Procedure Law.

[27 January 2015]

XI. Introduction of New Medical Technologies

48. The head of the medical treatment institution shall be responsible for the introduction and use of a new medical technology at the medical treatment institution.

49. Upon introducing a new medical technology at the medical treatment institution, the head of the medical treatment institution shall inform the Service thereon in writing.

[3 November 2009; 27 January 2015]

50. The medical treatment institution which has introduced a new medical technology shall compile and not later than 18 months after the introduction of the medical technology submit a report to the Service regarding the results of the use of the new medical technology during the first year (except for the methods used for a forensic medical expert-examination, forensic psychiatric expert-examination, and narcologic expert-examination).

[3 November 2009; 27 January 2015; 24 January 2017]

XII. Closing Provision

51. Medical technologies which have been approved and registered in the database of medical technologies that are used in medical treatment until the day of the coming into force of this Regulation shall be regarded as approved medical technologies until taking the decision to revoke the approval of the medical technology.

Prime Minister A. Kalvītis

Minister for Health G. Bērziņš

Translation © 2018 Valsts valodas centrs (State Language Centre)