| Legislation | Description of duty | §, para. | Form of fulfilment | Method of fulfilment | Frequency of performance (per year) | |
|---|---|---|---|---|---|---|
A provider in the field of medical genetics who does not meet the condition of an accredited laboratory and who intends to perform genetic laboratory tests in a laboratory which is his/her workplace, is obliged to notify the administrative authority which has granted the provider the authorisation to provide health services under the Health Services Act of the date from which he/she intends to start performing such tests no later than 14 days before the start of the performance of genetic laboratory tests. | Announcements | electronically: > data box in writing - postal service | 1 / year | |||
Application for authorisation to validate new procedures using a method that has not yet been established in clinical practice in a living human being. The application shall be submitted by the health service provider to the Ministry of Health. | Announcements other | electronically: > data box in writing - postal service | cannot be determined | |||
The provider verifying the non-established method is obliged to submit to the Ministry of Health (hereinafter referred to as "the Ministry") within the time limits set out in the authorisation for verification of the non-established method reports on the individual stages of verification; at the same time, this provider is obliged to submit to the Ministry a final report on the result of the verification within 30 days after the completion of the verification of the non-established method, in which it also assesses the non-established method in terms of its possibility of use in the provision of health services. | notification form not prescribed | electronically: > data box in writing - postal service | cannot be determined | |||
Obligation of the health service provider verifying the non-established method to notify the Ministry of Health without delay that a reasonable doubt has arisen on the part of the provider that the non-established method will not produce the expected result, or that its verification could lead to long-term or serious damage to the health of the patient on whom it is being verified, and for that reason the verification of the non-established method has been interrupted or stopped. | notification form not prescribed | electronically: > data box in writing - postal service | cannot be determined | |||
Obligation of the provider verifying a non-established method to immediately notify the Ministry of Health and the State Office for Nuclear Safety, if it has issued a binding consent opinion, of an adverse event (an adverse event is an adverse change in the patient's health condition resulting from the verification of a non-established method). | notification form not prescribed | electronically: > data box in writing - postal service | cannot be determined | |||
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