Decree No. 525 / 2021 Coll.
Decree amending Decree No. 376 / 2011 Coll., implementing certain provisions of the Act on Public Health Insurance
Valid
Order
Effective from 01.01.2022
Text versions:
01.01.2022
31.12.2021
525
DECLARATION
of 23 December 2021
amending Decree No. 376 / 2011 Coll., implementing certain provisions of the Public Health Insurance Act
According to § 39a (3), § 39b (15), § 39c (11), § 39d (4), § 39f (7) and § 39m (2) of Act No. 48 / 1997 Coll., on Public Health Insurance and on the amendment and addition of certain related laws, as amended by Act No. 261 / 2007 Coll., Act No. 298 / 2011 Coll., Act No. 369 / 2011 Coll. and Act No. 371 / 2021 Coll. ("Act '):
Decree No. 376 / 2011 Coll. implementing certain provisions of the Public Health Insurance Act is amended as follows:
1. in Article 1 (f), "3" is replaced by "2."
2. In Article 1 (l), "highly innovative 'is replaced by" medicinal'.
3. in Paragraph 1 (v):
"(v) the basic structure of the data provided by the specialised workplace under Section 39d (4) of the Act in connection with the use of a highly innovative medicinal product and the results of this treatment,"
4. In Section 1, point (w) is deleted.
The current point (x) shall be renumbered as point (w).
5. In Article 1, at the end of point (w), the dot is replaced by a comma and the following point (x) is added:
"(x) the structure, method, form and time interval of the reporting pursuant to Paragraph 39m (2) of the Act."
6. in Article 2, point (f) is deleted;
Points (g) and (h) shall be renumbered as points (f) and (g).
7. In Paragraph 4 (1), "period 'is deleted.
8. In Article 4 (3), the last sentence is deleted.
9. In Paragraph 8 (1), the words "examined 'and" or in another Member State of the European Union' are inserted after the words "If '.
10. In Article 8 (2), the words "if the marketing authorisation holder of the product concerned or at least one health insurance undertaking does not agree to this procedure at the latest within the time limit for its comments, the grounds for the decision 'shall be deleted.
11. in Article 8, the following paragraph 3 is added:
"(3) Paragraph 2 shall not apply if the marketing authorisation holder of the product concerned disagrees with the application of this procedure at the latest within the time limit to comment on the supporting documents for the decision. ';
12. in Article 9, "3" is replaced by "2."
13. in § 10 (1) of the introductory part of the provision, the words "under § 39m (1) (a) of the Act" shall be deleted.
14. in Paragraph 10 (1), point (a) is deleted;
Points (b) and (c) shall become points (a) and (b).
15. in Paragraph 10 (2), "(c)" is replaced by "(b)";
16. in Paragraph 12 (1), the word "period" shall be deleted;
17. in Article 12 (3), the last sentence is deleted;
18. In Paragraph 16 (1) of the Introductory Part of the provision, "3 'is replaced by" 2'.
19. in Paragraph 16 (2), "3" is replaced by "2."
20. In Article 17 (1), the words "in the reference group under consideration 'shall be deleted after the words" in the reference group under consideration' and the words "in the reference group under review 'shall be inserted after the words" in the reference group under consideration'.
21. In the first sentence of Paragraph 20 (2), the words "after a unit of pharmaceutical form" shall be inserted after the words "the same."
22. in Article 20 (3), the words "highly innovative products with remuneration calculated in accordance with Article 44 (1) and" shall be deleted.
23. In Section 21, the word "packaging 'is replaced by" reimbursement' and the words "with the nearest number of units of the pharmaceutical form 'are replaced by" proposed by the applicant'.
24. In the first sentence of Paragraph 25 (2), the words "and budgetary implications' shall be inserted after the word" effectiveness'.
25. In Section 31 of the introductory part of the provision, "3 'is replaced by" 2'.
Article 26 (40) and (41) shall be deleted.
27. In Paragraph 42, paragraphs 1 and 2 are deleted and paragraph 3 is deleted.
28. The heading of § 43 reads: "The basic structure of the data provided by the specialised workplace under § 39d (4) of the Act."
29. in Paragraph 43, the introductory part of the provision reads:
"Specialised workplaces shall transmit to the persons referred to in § 39d (4) of the Act the data referred to in § 39d (4) of the Act in the following structure: '.
30. Article 44 shall be deleted, including the title.
31. In the heading of Part Six, the words "HIGH AND SIGNIFICANT 'shall be inserted after the words" PRICES A'.
32. In Paragraph 45 (1), the words "above and conditions' shall be inserted after the words" or '.
33. In the first sentence of Paragraph 45 (2), the words "above and subject to conditions' shall be inserted after the word" determination ', and at the end of the paragraph, the sentence "In the case of an application submitted under Paragraph 39da of the Law, the applicant shall also submit the information necessary for carrying out the assessment under Paragraph 39da (3) of the Act.'.
34. In Section 45 (3) of the introductory part of the provision, the words "(a) 'shall be inserted after the words" paragraph 6'.
35. the following Part Seven is inserted after Part Six:
PROVISION OF FOOD INDUSTRY DATA FOR SPECIAL MEDICAL PURPOSES APPLICABLE TO THE CZECH MARKET
(1) The importer or the domestic food manufacturer for special medical purposes provides the Institute with the data referred to in Section 39m (2) of the Act by electronic notification for the previous calendar month at the latest by the 10th day of the following calendar month.
(2) The importer or domestic food manufacturer for special medical purposes shall provide the report referred to in paragraph 1 via the communication interface of the Institute. Access data and unique identifier of the importer or domestic food manufacturer for special medical purposes shall be assigned by the Institute to the importer or domestic food manufacturer for special medical purposes upon request. The communication interface is created in the form of a web application interface and is published by the Institute on the Institute's website, including its technical documentation.
(3) An update of the report already provided pursuant to paragraph 1 may be made by an importer or a domestic food manufacturer for special medical purposes between the 10th and 20th day of the calendar month. After the 20th day of the month, the content of the report cannot be changed. Where an importer or a domestic food manufacturer for special medical purposes finds, retrospectively after the 20th day of the calendar month, that he has provided incomplete or incorrect information in the report, he shall immediately send the Institute a corrective report.
(4) The report referred to in paragraph 1 and the corrective report referred to in paragraph 3 shall contain:
(a) the identification code of the importer or domestic food manufacturer for special medical purposes assigned by the Institute;
(b) the calendar month and year for which the report is sent;
(c) the unique message identifier assigned by the Institute;
(d) an identifier indicating food supply reports for special medical purposes;
(e) the identification of the person who has been supplied with the food for special medical purposes in accordance with Section 39m (2) of the Act;
(f) the food code for special medical purposes allocated by the Institute;
(g) the number of packages of food for special medical purposes. "
Part seven shall be renumbered part eight.
Efficacy
This Decree shall take effect on the day following that of its publication.
Minister:
Prof. MUDr. Válek, CSc., MBA, EBIR, v. r.
Contents
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Regulation Information
| Citation | Decree No. 525 / 2021 Coll., amending Decree No. 376 / 2011 Coll., implementing certain provisions of the Public Health Insurance Act |
|---|---|
| Regulation Type | Order |
| Author | - |
| Collection | Code of Laws |
| Date of Promulgation | 31.12.2021 |
|---|---|
| Effective from | 01.01.2022 |
| Effective until | - |
| Status | Valid |
The regulation text is for informational purposes only.
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