Decree No. 334 / 2023 Coll.
Decree amending Decree No. 306 / 2012 Coll., on the conditions for the prevention and spread of infectious diseases and on the health requirements for the operation of health facilities and social care institutions, as amended by Decree No. 244 / 2017 Coll.
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334
DECLARATION
of 10 November 2023
amending Decree No. 306 / 2012 Coll., on the conditions for the prevention and spread of infectious diseases and on sanitary requirements for the operation of health facilities and social care institutions, as amended by Decree No. 244 / 2017 Coll.
According to Article 108 (1) of the Act No. 258 / 2000 Coll., on the Protection of Public Health and on the amendment of certain related laws, as amended by Act No. 110 / 2007 Coll., Act No. 151 / 2011 Coll., Act No. 375 / 2011 Coll. and Act No. 267 / 2015 Coll., ("the Act '), Act No. 222 / 2006 Coll., Act No. 110 / 2007 Coll., Act No. 151 / 2011 Coll., Act No. 375 / 2011 Coll., and Act No. 267 / 2015 Coll. (b.), (" Act'), § 16 (2), § 17 (1) and § 72 (1) (a):
Decree No. 306 / 2012 Coll., on conditions for the prevention and spread of infectious diseases and on health requirements for the operation of health care establishments and social care institutions, as amended by Decree No. 244 / 2017 Coll., is amended as follows:
1. In the title of the decree, the words "social care institutions' are replaced by the words" selected social services establishments'.
2. In Section 1 (1) of the Introductory Part of the provision, the words "Infectious diseases are classified 'are replaced by the words" Cases of infectious diseases are classified'.
3. In Article 1 (1), at the end of the text in point (c), the words "or diagnostic criteria, as the case may be, or an infectious disease with a non-symptomatic course satisfying only laboratory criteria 'shall be added.
4. In Article 1 (2) (a), the words "new 'are deleted and the words" or other mycobacteriosis' are inserted after the words "tuberculosis'.
5. in Article 1 (2) (a), (c) and (e), the words "electronically or" shall be inserted after the words "submit," and the words "to the extent that the particulars listed in Annex 6 to this Decree" shall be added;
6. In Article 1 (2) (b), the words "electronically or 'shall be inserted after the words" mycobacteriosis', the words "to the extent that the information set out in Annex 6 to this Regulation 'and the part of the sentence after the semicolon shall be replaced by the words" a person disinfected in the group of active tuberculosis shall be reported mutatis mutandis, the finding that a natural person disinfected in that group does not have active tuberculosis or mycobacteriosis, or the reassignment of such person into the group of inactive tuberculosis'.
7. In Article 1 (2) (d), the words "on the form" Reporting of a positive result of a mycobacteriological examination "'shall be replaced by the words" electronically, to the extent that the particulars listed in Annex 6 to this Decree ";
8. in Paragraph 1 (2) (e), the word "Lymphogranuloma" shall be replaced by the word "Lymphogranuloma," the word "Granuloma" shall be replaced by the word "granuloma," and the words "and STDs caused by viral acanthoma agents" shall be deleted;
9. in Paragraph 1 (2), point (f) is deleted;
Point (g) shall be renumbered as point (f).
(10) In Article 1 (2) (f), the words "directly electronically in the register of the current health status of natural persons who have been infected with an infectious disease and natural persons suspected of being infected, or" shall be inserted after the word "submitted."
11. in Paragraph 1 (2), the period at the end of point (f) shall be replaced by the words "to the extent specified in Annex 6 to this Order,"
12. at the end of paragraph 2, the following points (g) and (h) are added:
"(g) acute respiratory infections (ARI) and influenza-like diseases (ILI) shall be administered each week in an anonymised form, commandealed by the territorial units and age groups concerned or transmitted electronically to the register of the current health status of individuals who have become infected with the disease and individuals suspected of being infected,
(h) on severe acute respiratory diseases (SARI), the provider of acute bed care shall provide intensive or acute bed care to the standard electronically to the extent necessary, directly to the register of the current health status of individuals who have been infected with infectious diseases and individuals suspected of being infected. "
13. in Article 1 (3), the words "administered by the person providing care" shall be replaced by the words "providing health services without delay" and the words "in a secure format" shall be inserted after the word "type."
14. in Article 1 (4), the words "by fax or" shall be deleted and the words "in secure format" shall be inserted after the words "by post."
15. in Paragraph 1 (5), the first sentence, "by fax" shall be deleted and the second sentence shall be deleted;
16. Footnote 1 reads as follows:
"(1) Commission Implementing Decision (EU) 2018 / 945 of 22 June 2018 on communicable diseases and related specific health problems which must be covered by epidemiological surveillance and the relevant case definitions.";
17. in Article 2, the word "fax" shall be deleted and the words "electronic signature" shall be replaced by the words "secure format."
18.
List of infectious diseases where isolation is ordered in health care facilities and diseases whose treatment is compulsory
(Articles 45 (3) and 70 (1) of the Law)
The list of infectious diseases provided for in Section 70 (1) of the Act is set out in Annex 2 to this Decree. In the event of the occurrence of the infectious diseases referred to in points 1 to 15 of Annex 2 to this Regulation, isolation and treatment in the infectious ward or, where appropriate, the separation of tuberculosis from the hospital's bedside care facility shall always be ordered. ';
19. in Article 4 (b), the words "A or E" and the words "at the workplace, at home or at the place of residence" shall be inserted after the words "hepatitis";
20. in Article 5 (1) (b), including footnote 8:
"(b) sterile medical devices and diagnostic medical devices in vitro8 (hereinafter referred to as" medical devices ") and disposable gloves shall be used for the collection of the biological material, and for only one natural person under investigation; the permeability and resistance of gloves shall be consistent with their use and the risk of biological agents;
8) Act No. 375 / 2022 Coll., on in vitro medical devices and diagnostic medical devices. Regulation (EU) 2017 / 745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001 / 83 / EC, Regulation (EC) No 178 / 2022 and Regulation (EC) No 1223 / 2009 and repealing Council Directives 90 / 385 / EEC and 93 / 42 / EEC, as amended. ';
21. in Article 5 (1) (e), the words "declared for the transport of samples falling within category UN3373" shall be inserted after the words "the product."
22. in Article 5 (2), the words "where appropriate, the number of the insured person or the date of birth, if the number of the insured person is not assigned, the telephone number, if the natural person or his legal representative is available, nationality, sex, departmental identifier of the patient, if assigned, and," the words "or, in the case of an electronic form of the certificate referred to in Section 54a of the Health Services Act," and the words "clinical diagnosis" shall be replaced by the words "diagnosis code according to the current version of the International Classification of Diseases (MKN)."
23. In Article 5, at the end of the text of paragraph 3, the words "electronically directly to the register of the current health status of natural persons who have been infected with an infectious disease and natural persons suspected of being infected, in the event of danger of delay by telephone 'shall be added.
24. in Article 5 (4), the words "testing for human immunodeficiency virus," "and" shall be deleted and the words "for HIV" shall be inserted after the words "laboratory";
25.
26. In Section 7, the words "social care institutions' are replaced by the words" selected social services establishments'.
27. in the first sentence of Article 7 (2), the words "doctor" shall be replaced by the words "person who," the words "social care institution" shall be replaced by the words "selected social services establishment," and at the end of the text of the first sentence the words "and the data recorded in the epidemiological history" shall be added.
28. In the last sentence of Article 7 (2), the words "For children hereafter 'are replaced by the words" Further' and the words "and others' are inserted after the words" Regular '.
29. in Article 7 (3) (b), the words "cord blood" shall be deleted and the words "cord blood" shall be inserted after the words "newborn."
30. in Article 7 (3) (d):
"(d) all persons who have completed the fifteenth year of age and are admitted to the dermatoenerological department for diagnosis or suspicion of syphilis,"
31. in Article 7 (3) (e), the words "aged 15 to 65" shall be replaced by the words "completed the 15th year of age," and the word "venerological" shall be replaced by "dermatoenerological."
32. Paragraph 7 (4) reads as follows:
"(4) When a person with a history of active and previous intravenous drug use is admitted to the care of the provider of bed care services or long-term outpatient care, an examination of the basic markers of viral hepatitis C will be carried out in persons who have not been proven to have been vaccinated, including markers of viral hepatitis A and B. This person is actively offered an examination for HIV infection. If reactivity is detected when testing antibodies against viral hepatitis C, the laboratory shall perform or ensure the completion of an HCV RNA amplification test from the same blood sample. '
33. in Article 7 (5), the word "adequate" shall be inserted after the word "to do";
34. In Article 7, at the end of paragraph 6, the sentence "Where a natural person is found to be colonised by highly resistant bacteria, the provider of health or social services shall ensure a barrier treatment."
35. in Articles 7 (7), 9 (8) and 10 (1), the words "social care institutions" are replaced by the words "selected social services establishments."
36. in Article 7 (7), the words "including the collection and testing of biological material, if necessary as part of the treatment," shall be inserted after the word "treatment."
37. in Article 7 (7) and Annex 3 (t), the words "in social services" shall be replaced by the words "in selected social services establishments."
38. in Paragraph 9 (2), the words "In social care institutions" shall be replaced by the words "In selected social services establishments."
39. in Paragraph 9 (3), the words "or the client of the selected social services facility (hereinafter referred to as" the client ")" shall be inserted after the words "the patient."
40. In Article 9 (4), the first sentence is replaced by the following: "The linen used shall be immediately placed in dedicated packages and classified, if necessary, only in a room designated for that purpose with natural or forced ventilation."
41. in Article 9 (5), the word "one-off" shall be inserted after the word "or" one-off. "
42. In Article 9 (5) and (7), in Annex 3 (c), (e), (g) and (l) and in Annex 5 (C) (6), the words "or client" shall be inserted after the word "patient."
43. In Paragraph 9 (6), the word "working" shall be inserted after the word "protective."
44. in Article 9 (7), the words "and selected social services establishments" shall be inserted after the word "establishments" and the words "or the client" shall be added at the end of paragraph 7;
45. In Article 9, the following paragraph 8 is inserted after paragraph 7:
"(8) In the case of laundry, a body different from the health or social service provider, the health or social service provider shall act under the contract for the provision of laundry services and the operating rules of the health or social service provider. ';
Paragraph 8 shall become paragraph 9.
46. At the end of the title of Section 10, the words "health care establishments and selected social services establishments' are added.
47.Paragraph 10 (1) reads as follows:
"(1) Cleaning of all areas of health care facilities and selected social services facilities is carried out daily on a wet basis, if necessary more frequently. This cleaning method shall be consistent with the nature of the operation of the floor covering. In the operating and intervention halls where procedures are performed that violate the integrity of the skin or mucous membranes, cleaning is performed before and after the start of the operation programme. In acute bed care intensive workplaces, cleaning is performed three times a day, in rooms where the biological material is collected, at least once a day according to the operating time. The frequency of cleaning at other workplaces is adapted to the nature of the operation and is determined in the operating order. In the event of a cleaning operation carried out by an entity different from the provider of health services or the selected social services facility, the authorised official shall proceed according to the contract and the disinfectant or cleaning order. ';
48. in Paragraph 10 (2):
"(2) In the workplaces of bed, overnight and outpatient care, in the operating and intervention rooms, in the laboratories and where biological material is collected and performed to interfere with the integrity of the skin or mucous membranes, in toilets and in bathrooms, normal cleaning products and disinfectants with a virucidal effect are used according to the risk of transmission of infectious agents and the risk of developing and spreading health-related infections; disinfectants with a wider spectrum of efficacy are used in workplaces with an infection agent requiring a given efficacy. Normal cleaning products may be used when cleaning other premises. '
49.Paragraph 10 (4) reads:
"(4) For contamination of the surfaces with biological material, immediate decontamination of the stained site shall be carried out in particular by covering the cellulose wadding or by a disposable towel moistened with a disinfectant solution with a virusic effect or by filling with absorption granules with disinfectant effect. The contaminated site shall be cleaned as usual after the exposure period of the disinfectant. Used beds and mattresses shall be disinfected in the room or in the centre of the beds with a disinfectant having a virucidal effect after each release of the patient or client. '
50. Paragraph 10 (5), including footnotes 2, 3, 4, 5 and 12, reads as follows:
"(5) The waste shall be sorted at the place of origin, the hazardous waste shall be stored in labelled, separated, covered, closed, impermeable and mechanically resistant packaging, as far as possible, without the need for further handling of waste. Sharp waste shall be stored in labelled packaging which shall comply with the requirements of other legislation2). Hazardous waste shall not be stored in paper packaging. Hazardous waste arising from patients' or clients' beds is removed from the room immediately, and from the workplace continuously, at least every 24 hours. The concentration of this waste shall be carried out according to the operating rules of the installation in containers intended to comply with the requirements of another legislation2). The concentration of hazardous infectious and anatomical waste before its final treatment shall be possible for a maximum of 3 days in a restricted enclosure, or for a period of 1 month in a freezer or refrigerated compartment at a temperature of not more than 8 ° C. Highly infectious waste, which is highly likely to contain group 3 or 4 biological agents within the meaning of other legislation3), 12), must be adapted immediately following its formation in a facility with validated decontamination technology with a proven verifiable effective2). In the case of modifications to decontamination, the procedure shall be followed in accordance with another legislation2). The handling of parts of the body and organs shall be carried out in accordance with another legislation4). Recording, transport and transfer of waste to waste facilities shall be carried out in accordance with other legislations5). In the handling of hazardous waste in means of transport by the medical emergency service provider, the medical transport service provider and the patient transport provider of emergency care and the health care provider that provides medical care during the visiting service and the provision of medical services outside the medical facility shall apply the procedure set out in this paragraph mutatis mutandis.
2) Decree No. 273 / 2021 Coll., on Details of Waste Management, as amended.
3) Decree No. 432 / 2003 Coll., laying down the conditions for the classification of works into categories, the limit values for biological exposure test indicators, the conditions for the collection of biological material for carrying out biological exposure tests and the formalities for reporting of work with asbestos and biological agents, as amended.
4) Act No. 372 / 2011 Coll., on Health Services and Conditions of Provision (Health Services Act), as amended.
5) Act No. 541 / 2020 Coll., on Waste, as amended.
12) Government Regulation No. 361 / 2007 Coll., laying down conditions for the protection of health at work, as amended. '
51. In the first sentence of Article 10 (6), the words "and selected social services facilities' are inserted after the words" premises'.
52. In the second sentence of Article 10 (6), the words "and selected social services facilities' and the words" and 'are replaced by the words "or'.
53. In the second sentence of Article 10 (7), the words "a product with a viral effect 'shall be inserted after the words" disinfection'.
54. In the third sentence of Article 10 (7), the words "at least with a virucidal effect 'are replaced by the words" with a wide range of disinfectants, at least with a virucidal, bactericidal, tuberculoidal and fungicidal effect'.
55. In Annex No 1, the words "if a mass occurrence occurs in a hospital or a selected social services establishment 'shall be added at the end of the text of point 1.
56. A comma shall be added to Annex 1 at the end of points 2 and 3.
57. In Annex 1, point 3, the text "091 'is replaced by the text" O91'.
58. Annex 2, including the title:
"Annex No 2 to Decree No. 306 / 2012 Coll.
List of infectious diseases where isolation is ordered in the hospital or medical institution's bed departments and diseases which are compulsory
1. anthrax
2. Haematological Fever
3. Cholera
4. CNS infection interpersonal
5. MERS, SARS, infections caused by highly pathogenic avian influenza viruses and febrile conditions of undetected aetiology with a positive travel history
6. Plague
7. Parathyphus
8. Portable polio
9. Ricketsiosis
10. Trains
11. Pulmonary form of tuberculosis, bacteriologically proven in a situation where controlled treatment and isolation are not possible outside the health care facility. The regulation of isolation is decided by the lung doctor of the hospital.
12. Typhoid
13. Viral hepatitis A
14. Diphtheria
15. Other emerging and emerging infectious diseases according to European Union / European Centre for Disease Prevention and Control and the World Health Organisation
16. Granuloma inguinale (Donovan)
17. Gonorrhea
18. Lymphogranuloma venereum
19. Monkey pox
20. Pertussis in acute stage
21.
22. Syphilis in stage I and stage II
23. Syphilis latens reviews
24. Pulmonary form of tuberculosis, bacteriologically proven in a situation where controlled treatment and isolation are possible outside the health care facility of the bed care. Pulmonary form of tuberculosis, bacteriologically unverified. An extrapulmonary form of tuberculosis.
25. Disease caused by Shiga toxin-producing E. coli
26. Ulcus molle
27. Amebic dysentery
28. Bacillary dysentery
29. Viral hepatitis B, C, D and E. "
59. In the title of Annex 3, the words "to a healthcare establishment 'are replaced by the words" in a healthcare establishment' and the words "social care institution 'are replaced by the words" clients of the selected social services establishment'.
60. in Annex 3 (a) and (s), the words "social care institutions" shall be replaced by the words "selected social services establishments."
61. In the first sentence of Annex 3 (h), the words "patients must be employed by health care professionals" shall be replaced by the words "patients or clients must be employed by the health service provider or the operator of the selected social services facility."
62. In Annex 3 (h), second sentence, "patients" is replaced by "patients or clients."
63. In the second sentence of Annex 3 (i), the words "or client" shall be inserted after the words "Colonization of the patient," the words "client" shall be inserted after the words "reception," and the words "social care institution" shall be replaced by the words "selected social services establishment."
64. In Annex 4, Section II.I, paragraph 1 (c), "A0 'is replaced by" A0'.
65. In Annex 4, Section II.I, paragraph 2 (b), the word "protective" and the text "100%" shall be replaced by "100%."
66. In Annex 4, Section II.III (a), the sentence "All types of such instruments are classified by the manufacturer in Class IIb medical devices." is deleted.
67. In Annex 4, Section III, paragraph 1, the words "microbiologically physiological 'are replaced by the words" physiologically microbial'.
68. in Annex 4, Section IV.II (4) (e), the word "certificate" is replaced by "declaration of conformity."
69. In Annex 4, Section IV. III at the end of the text in point 6.2.2, the words "checking its tightness before each sterilisation cycle 'are added.
70. In Annex 4, Section IV. The words "checking its tightness before each sterilisation cycle 'shall be deleted.
71. In Annex 4, Section IV. point 6.2.4 is replaced by the text "NPEL ';
72. In Annex 4, Section IV. In Article IV (2), the words "medical aid packaged" shall be replaced by the words "medical device packaged."
73.In Annex 4, Section IV.IX (2) (b) (1), "medical articles" is replaced by "medical devices."
74. In the heading of Annex 5, the words "social welfare institutions' are replaced by the words" selected social services establishments'.
75. In Annex 5, Part B, the words "or selected social services facilities' shall be inserted after the words" from health care establishments'.
76. In Annex 5 (C) (1), the words "or the operator of the selected social services facility 'shall be inserted after the word" services'.
77. In Annex 5 (E) (2), the words "or selected social services facilities' shall be inserted after the words" equipment '.
78. The following Annex 6 is added, including the title:
"Annex No 6 to Decree No. 306 / 2012 Coll.
Scope of reports of suspicion, occurrence or death of infectious disease
A. Reporting of tuberculosis and other mycobacteriosis
1. Compulsory reporting of tuberculosis and other mycobacteriosis according to § 1 (2) (a) shall include:
(a) identification of the reporting health service provider, including identification of the treating physician;
(b) identification of the reported person (patient) within the scope of the name or, where applicable, the name, surname, sex, birth number, insured person number or date of birth, unless the insured person's number is assigned, the patient's departmental identifier, if the address of the registered person's place of residence is assigned in the Czech Republic, country of origin, date of entry into the Czech Republic, type of residence, type of health insurance,
(c) diagnosis and method of detection of tuberculosis or other mycobacteriosis, date of report, type of report, if relevant, then indication of diagnosis abroad, prior diagnosis and treatment, inclusion in the dispensarisation,
(d) the date of the first positive collection, the results of the diagnosis tests, including microscopic, culturing, histological, X-ray and molecular genetic methods;
(e) result of HIV, tuberculin test, IGRA test,
(f) data on aetiological agents, associated diseases and conditions,
(g) the date and manner of initiating antituberculosis treatment,
(h) death data, death date, diagnosis, cause of death, anti-tuberculosis resistance in the deceased.
2. The control report of tuberculosis and other mycobacteriosis referred to in Article 1 (2) (b) shall contain:
(a) identification of the reporting health service provider, including identification of the treating physician;
(b) identification of the disenfranchising health service provider;
(c) identification of the reported person (s) within the scope of the name or, where applicable, the name, surname, sex, birth number, insured person's number or date of birth, unless the insured person's number is assigned, the hospital identifier of the patient, if assigned and the address of the resident person in the Czech Republic,
(d) the date of reporting, diagnosis, case definition, data on dispenserisation, data on aetiological agents and resistance;
(e) hospitalisation and treatment data, including evaluation of antituberculosis treatment;
(f) data on possible death, date of death, diagnosis, cause of death.
3. The data change report referred to in Article 1 (2) (c) shall contain:
(a) the identification of the reported person (s) within the scope of the name or, where applicable, the name, surname, sex, birth number, insured person number or date of birth, unless the insured person's number is assigned, the departmental identifier of the patient, if assigned, both original and new if changed;
(b) the original and new address of the person declared to be present in the Czech Republic,
(c) identification of the original and new dispensing health service provider;
(d) the date of amendment.
4. The report of the positive result of the mycobacteriological examination referred to in Article 1 (2) (d) shall contain:
(a) the identification of the reported person (s) within the scope of the name or, where applicable, the name, surname, sex, birth number, insured person's number or date of birth, unless the insured person's number is assigned, the departmental identifier of the patient, if assigned and the address of the resident person in the Czech Republic;
(b) identification of the laboratory and the applicant health service provider, reason for the examination;
(c) date of collection, number of the laboratory report;
(d) the material, methods of examination and their results;
(e) data on test results for susceptibility to antituberculosis.
B. Reporting of STDs
The report of STDs referred to in Article 1 (2) (e) shall include:
(a) identification of the reporting health service provider, including identification of the treating physician;
(b) the identification of the reported person (s) within the scope of the name or, where applicable, the name, surname, sex, birth number, insured person's number or date of birth, unless the insured person's number is assigned, the departmental identifier of the patient, if assigned and the address of the place of residence of the reported person in the Czech Republic, nationality, country of origin,
(c) data on economic activity, educational attainment, ethnicity, family status, coexistence;
(d) data on transmission, country of disease, disease occurrence, disease detection,
(e) data on sexual and other risks, HIV status,
(f) pregnancy and birth, country of birth and nationality of the mother in congenital infections;
(g) date of first visit, date of examination, date of commencement of treatment,
(h) diagnosis, method of confirmation of diagnosis, data on possible combination with other sexually transmitted diseases;
(i) treatment and its results, identified antibiotic resistance,
(j) data on the source and contact of the patient, statistical classification of the disease.
C. Reporting of other infectious diseases subject to reporting
Reporting of other infectious diseases under § 1 (2) (f) shall include:
(a) identification of the reporting health service provider, including identification of the treating physician;
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Regulation Information
| Citation | Decree No. 334 / 2023 Coll., amending Decree No. 306 / 2012 Coll., on conditions for the prevention and spread of infectious diseases and on sanitary requirements for the operation of health care establishments and social care institutions, as amended by Decree No. 244 / 2017 Coll. |
|---|---|
| Regulation Type | Order |
| Author | - |
| Collection | Code of Laws |
| Date of Promulgation | 21.11.2023 |
|---|---|
| Effective from | 01.01.2024 |
| Effective until | - |
| Status | Valid |
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