Decree No. 371 / 2025 Coll.
Decree amending Decree No. 376 / 2011 Coll., implementing certain provisions of the Act on Public Health Insurance, as amended
Valid
Order
Effective from 01.01.2026
Text versions:
01.01.2026
02.10.2025
371
DECLARATION
of 18 September 2025
amending Decree No. 376 / 2011 Coll., implementing certain provisions of the Public Health Insurance Act, as amended
The Ministry of Health shall determine pursuant to § 39a (4), § 39b (15), § 39c (11), § 39f (7), § 39g (4), § 39zc (7), § 39zg (5) and (8) and § 39zi (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., Act No. 371 / 2021 Coll.
Decree No. 376 / 2011 Coll., implementing certain provisions of the Act on Public Health Insurance, as amended by Decree No. 525 / 2021 Coll. and Decree No. 199 / 2024 Coll., is amended as follows:
1. In the introductory sentence, "3 'is replaced by" 4', "14 'is replaced by" 15', "§ 39d (6) and (7) and § 39f (7) 'is replaced by" § 39d (4), § 39f (7), § 39g (4), § 39zc (7), § 39zg (5) and (8) and § 39zi (2)' and "and Act No 298 / 2011 Coll. 'are replaced by", "Act No 298 / 2011 Coll.' and Act No 289 / 2025 Coll. '.
2. in Article 1 (a), the words "or food for special medical purposes" shall be deleted and the words "and non-categorised foods" shall be inserted after the words "(the preparation)."
3. In Article 1, the words "and non-categorised foodstuffs' shall be added at the end of the text in point (b).
4. in § 1 (c) and § 6, "4 to 6" is replaced by "5 to 7."
5. In Section 1, at the end of the text in point (d), the words "the product and the rules for excluding the manufacturer's foreign price as determined in accordance with Section 39zg (7) from the use for the determination of the maximum price for uncategorised food 'are added.
6. In Section 1, at the end of the text in point (e), the words "and the tolerance in the packaging size in search of the foreign price of the manufacturer of the non-categorised food pursuant to § 39zg (7) of the Act 'are added.
7. In Article 1 (f), the words "preparation and non-categorised foodstuffs' are inserted after the words" prices'.
8. In Article 1 (g), the words "importer or domestic producer 'are replaced by the words" producer or importer categorised'.
9. in Article 1 (j), the words "medicinal products' are replaced by the words" products';
10. in Paragraph 1 (l), the words' medicinal 'shall be deleted;
11. in Article 1, the words "and the method of verification of trade of the like product" shall be added at the end of the text in point (p).
12. in § 1 (x), the text "§ 39m" is replaced by "§ 39zi."
13. in § 1, at the end of point (x), the dot is replaced by a comma and the following points (y) and (z) are added:
"(y) criteria for the selection of the nearest therapeutically comparable food for special medical purposes under Section 39zg (7) (c) of the Act;
(z) the list of Member States of the European Union which publish information on food prices for special medical purposes. ';
14. in Article 2 (e), the words "importer or domestic producer" are replaced by the words "producer or importer categorised" and the words "for special medical purposes" are deleted;
15. In Article 3, at the end of the text of paragraph 1, the words "(the applicable course) 'shall be added.
16. in Article 3, the following paragraph 2 is inserted after paragraph 1:
"(2) If the applicable rate differs by more than 10% from the average of the quarterly foreign exchange market rates declared by the Czech National Bank for the six calendar quarters preceding the applicable rate, and at the same time for the product under consideration no more than 3 producer prices, the price to which such difference in the relevant rate relates shall be converted into the Czech currency by the average of the foreign exchange market rate declared by the Czech National Bank for the six calendar quarters preceding the relevant rate."
Paragraphs 2 and 3 shall become paragraphs 3 and 4.
17. In Article 7, the current text becomes paragraph 1 and the following paragraphs 2 and 3 are added:
"(2) If the Institute finds more than 3 producer prices for the product under consideration, it shall not use a price to calculate the manufacturer's maximum price that is linked to the applicable rate, which differs by more than 10% from the average of the quarterly foreign exchange market rates announced by the Czech National Bank for the six calendar quarters preceding the relevant rate. Paragraph 1 shall apply mutatis mutandis.
(3) The Institute shall exclude the identified foreign price of the manufacturer in a Member State of the European Union which has taken a flat measure affecting the price of the producer of the preparation (1) if the Institute has received official information on such a flat measure from the competent authority of the Member State concerned or from the Ministry of Health.
(1) Council Directive 89 / 105 / EEC of 21 December 1988 on the transparency of price-setting measures for medicinal products for human use and their inclusion in the scope of national health insurance systems. "
18. In Article 11, the following paragraph 2 is inserted after paragraph 1:
"(2) If the applicable rate differs by more than 10% from the average of the quarterly foreign exchange market rates announced by the Czech National Bank for the 6 calendar quarters preceding the relevant rate, the price to which such difference in the relevant rate relates shall be converted into the Czech currency by the average of the foreign exchange market rate declared by the Czech National Bank for the 6 calendar quarters preceding the relevant rate."
Paragraphs 2 and 3 shall become paragraphs 3 and 4.
19. In Section 12, the words "and the exclusion of the producer's foreign price 'are added.
20. In Paragraph 12, the following paragraph 4 is inserted after paragraph 3:
"(4) The Institute shall exclude the established foreign price of the manufacturer in a Member State of the European Union by analogy in accordance with Article 7 (3)."
Paragraph 4 shall become paragraph 5.
21. The following Sections 13a and 13b are inserted after Section 13, including the group title:
"Method of verifying trade of a similar product
(1) A similar product in the reference group containing the medicinal products covered by the prescription is considered to be traded on the market in the Czech Republic if the quantity of all similar products in the active substance according to § 39b (4) of the first and second sentences of the Act delivered for a given calendar month was at least 5% of the average monthly volume within all essentially therapeutically interchangeable medicinal products with the same active substance.
(2) The average monthly volume referred to in paragraph 1 shall be one twelfth of the sum of the data on the volume of deliveries over the last 12 consecutive calendar months.
(3) The Institute shall calculate the quantity referred to in paragraph 1 and the average monthly volume referred to in paragraph 2 as the number of defined daily doses in the package multiplied by the number of packages from the delivery volume reports referred to in Paragraph 77 (1) (f) of the Drug Act; If the defined daily dose is not determined, the Institute shall use the usual daily therapeutic dose and, if the usual daily therapeutic dose is not determined, the active substance shall be used in the unit of the pharmaceutical form.
(1) A similar product in a reference group containing only medicinal products paid as a separately charged medicinal product together with the relevant medical performance is considered to be traded on the market in the Czech Republic if the quantity of all similar medicinal products in the active substance according to § 39b (4) of the first and second sentences of the first and second laws supplied for the calendar month concerned was at least 2% of the average monthly volume within all essentially therapeutically interchangeable medicinal products with the same active substance.
(2) The average monthly volume referred to in paragraph 1 shall be one twelfth of the sum of the data on the volume of deliveries over the last 12 consecutive calendar months.
(3) The Institute shall calculate the quantity referred to in paragraph 1 and the average monthly volume referred to in paragraph 2 as the number of defined daily doses in the package multiplied by the number of packages from the delivery volume reports referred to in Article 33 (2) of the Medicines Act; If the defined daily dose is not determined, the Institute shall use the usual daily therapeutic dose, and if the usual daily therapeutic dose is not determined, the active substance shall be used in the unit of the pharmaceutical form. ';
22. Paragraph 15 (5) is deleted.
Paragraphs 6 to 8 shall become paragraphs 5 to 7.
23. In Article 15 (6), "6 'is replaced by" 5' and the word "in depth 'is inserted after the word" the following'.
24. in Article 16 (2), the words "In the public interest pursuant to Article 17 (2) of the Act, the Constitution may" be replaced by the words "If not for proceedings under § 39d or § 39da of the Act, the Institute may in the public interest under Article 17 (2) of the Act."
25. in Article 20 (1), the word "or" shall be added at the end of point (b).
26. in Article 20 (1) (c), the word "or" shall be replaced by a dot and point (d) shall be deleted;
27. in Article 20 (2), the words "according to the strength of the reference product" shall be inserted after the word "level."
28. In Paragraph 25 (2), the first sentence is added at the end of the text "; the submission of evidence demonstrating cost-effectiveness and budgetary impact is not required for the creditworthiness under Paragraph 31 '.
29. In Article 33 (4), the words "the medical insurance undertaking's medical examiner or, where appropriate, his authorised physician with the relevant specialised competence, with the designation of competence specified in the decision 'are replaced by the words" the health insurance undertaking'.
30. Part seven, including the title, reads:
FOOD FOR SPECIAL MEDICINAL PRODUCTS
Rules for notification of changes to notified prices of categorised foodstuffs
(1) The amendment of the announced prices of categorised foodstuffs pursuant to § 39za (7) and § 39zc (7) of the Act notifies the Institute's producer or importer electronically.
(2) The person referred to in § 39zc (1) of the Act may announce a reduction in the producer's price if this categorised food is actually marketed in the Czech market in the following period.
Conditions for reimbursement
Prescription restrictions
(1) If, in view of the effectiveness and safety of the non-categorised food or of the public interest, this is appropriate, the reimbursement of the non-categorised food shall be limited by the Institute to prescribe such non-categorised food by a doctor with specialised competence with the designation of competence specified in the Decision. The institute of non-categorised food with a prescription restriction in the decision shall indicate the symbol "L '; This also applies to the designation of categorised foods included in the reimbursement group in accordance with Annex 6 to the Act for publication in the list of covered foods for special medical purposes.
(2) Food for special medical purposes with a prescription restriction as referred to in paragraph 1, second sentence, may be prescribed by the health insurance undertaking only by a doctor with specialised competence with a designation of competence referred to in the prescription restriction which has a contract with the health insurance undertaking for the provision of the health care in question, or by another doctor authorised by it in writing, or by a doctor with specialised competence in the field of general medical practice, practical medicine for children and youth or pediatric medicine which has a contract with the health insurance undertaking for that specialist competence.
(3) If, in view of the effectiveness and safety of the non-categorised food, it is not appropriate to pass on its prescription to a doctor other than a doctor with specialised competence with the designation of competence referred to in paragraph 1, first sentence, the Institute shall indicate in the decision the non-categorised food with the symbol "E '; This also applies to the designation of categorised foods included in the reimbursement group in accordance with Annex 6 to the Act for publication in the list of covered foods for special medical purposes.
(4) If, in view of the effectiveness and safety of the non-categorised food or of the public interest, it is appropriate to make the reimbursement of the non-categorised food subject to approval by the health insurance undertaking, the Institute shall indicate in the decision the non-categorised food with the symbol "W '. If the Institute decides according to the first sentence, it shall also decide on the restriction provided for in Paragraph 45d.
Indicative restrictions
(1) If, in view of the efficiency and safety of the non-categorised food or the public interest, this is appropriate, the Institute shall make the reimbursement of the non-categorised food conditional on:
(a) the precise indication, including the initiation and termination of treatment and, where appropriate, the specific clinical condition of the patient; if the initiation and termination of treatment cannot be precisely defined, a periodic reassessment of the treatment success rate shall be established,
(b) use for listed patient groups characterised by a specific disease or clinical condition;
(c) failure, contraindication or lack of effectiveness of the previous line of therapy; or
(d) quantitative restrictions for the prescription of non-categorised food
(2) The non-categorised food referred to in paragraph 1 shall bear the symbol "P" in the decision; This also applies to the indication of a restriction on categorised foods included in the reimbursement group in accordance with Annex 6 to the Act for publication in the list of covered foods for special medical purposes. Food for special medical purposes with an indication restriction shall only be prescribed by the health care professional of the contractual medical establishment in accordance with the indication restriction.
Food for special medical purposes
(1) In the Decision, the Institute will indicate a non-categorised food whose use, in view of the public interest, is appropriate to concentrate in specialised centres under the "S" symbol of Paragraph 15 (10) of the Act.
(2) A non-categorised food labelled in accordance with paragraph 1 shall only be charged to a health insurance undertaking as a separately charged product by a specialised place of business, on the basis of a contract concluded between it and a health insurance undertaking; This also applies to the categorised food thus labelled, which is included in the reimbursement group as set out in Annex 6 to the Act.
Rules on maximum prices for non-categorised foodstuffs
Foreign exchange price conversion
(1) Food prices for special medical purposes in foreign currency are converted into Czech currency by the quarterly average of the foreign exchange market rate announced by the Czech National Bank for the calendar quarter preceding the calendar quarter in which the administrative procedure was opened.
(2) Each expiry of the entire 3 calendar quarters following the calendar quarter in which the administrative procedure was opened, the Institute of Food Price for Special Medical Purposes in Foreign Currency shall recalculate to the Czech currency, mutatis mutandis, the previous calendar quarter in accordance with paragraph 1.
(3) In the event of a decision or judgment of a court which repeals the decision of the Constitution and returns the case for reconsideration, the rates shall apply mutatis mutandis in accordance with paragraph 1 for the calendar quarter preceding the calendar quarter in which the renegotiation was initiated.
Producer price determination
(1) The period for establishing the producer's prices is 21 days from the date of initiation of the administrative procedure.
(2) In the case of a procedure under Paragraph 39zg (7) (b) of the Act, paragraph 1 shall not apply; a written agreement on the highest producer price pursuant to Article 39zg (7) (b) of the Act may be submitted within the time limit to comment on the grounds for a decision pursuant to Article 39g (5) of the Act.
(3) By the end of the entire 3 calendar quarters following the calendar quarter in which the administrative procedure was initiated, the Institute will re-establish producer prices within 21 days.
Assessment of availability
(1) The relevant period for assessing the availability of food for special medical purposes is the calendar quarter preceding the calendar quarter in which the administrative procedure was opened.
(2) By the end of the entire 3 calendar quarters following the calendar quarter in which the administrative procedure was opened, the Institute shall re-establish the availability for each previous calendar quarter.
The Member States of the European Union which publish information on food prices for special medical purposes are Finland, Ireland, Hungary, Germany, Poland, Slovakia and Spain (hereinafter referred to as the "countries of the reference food basket ').
Exclusion of the manufacturer's foreign price
Where the lowest price of the food under consideration for special medical purposes found in the country of the reference basket of foodstuffs or in other Member States of the European Union where the food under consideration is available on the basis of evidence submitted by the manufacturer or the importer of the food (hereinafter referred to as "the reference country '), is more than 20% lower than the average of the second and third observed lowest prices of that food for special medical purposes in other Member States of the European Union, this average or the highest price of the producer shall be used for the determination of the maximum price of the food under the written arrangements referred to in Article 39zg (7) (b) of the Act, if it is lower than that average.
Derogation in pack size
(1) If the food under consideration for special medical purposes is made available on the market in reference countries only in a package size different from that for the Czech market and the variation in the packaging size is not more than 10%, the manufacturer's foreign price shall be converted directly into the number of units of the pharmaceutical form of the food under consideration for special medical purposes intended for the Czech market.
(2) In the case where there is no food for special medical purposes on the market in the reference countries or with a variation in the packaging size of 10% or more, the food for special medical purposes may also be used in a different package size from that for the Czech market with a greater variation.
(3) Paragraph 2 shall not apply if the manufacturer or importer of the food under consideration for special medical purposes disagrees with the application of this procedure, not later than within a time limit to comment on the supporting documents for the decision.
Increase in the maximum price in the public interest
The maximum price of the manufacturer may be increased, at the request of the manufacturer or importer of the food for special medical purposes, in the public interest provided for in Article 17 (2) of the Act, with the agreement of all health insurance companies granted at the latest within the time limit to comment on the supporting documents for the decision.
The criteria for selecting the nearest therapeutically comparable food for special medical purposes for the purpose of applying § 39zg (7) (c) of the Act are as follows:
(a) the qualitative content of nutrients;
(b) route of administration with a distinction as to whether a food for special medical purposes is intended to be administered via a probe or without a probe;
(c) the quantitative nutrient content and calorie value; and
(d) the pack size.
Structure of the data, method and form of application for the maximum price and the level and conditions of reimbursement of non-categorised foodstuffs
(1) The request for the establishment of the maximum price and the amount and conditions of reimbursement and the attached documentation shall be made in electronic form in a format published by the Institute in a manner that allows remote access.
(2) The scope of the documentation submitted with the request to determine the level and conditions of reimbursement of the non-categorised food must correspond to the current knowledge of the food for special medical purposes and include all information concerning the food for special medical purposes, whether favourable or unfavourable to it. In particular, all relevant details concerning the efficacy, safety and comparison of the costs and benefits associated with the use of food for special medical purposes in normal clinical practice shall be provided.
(3) The applicant shall provide the information referred to in paragraph 2 in full, as well as a brief summary thereof, indicating the basic input parameters, the results found and their statistical evaluation.
(4) If the expert's expert opinion is included in the dossier or if such an expert opinion is requested by the Institute or the Ministry of Health, the author shall at the same time attach an affidavit to the opinion that he has studied all publicly available information concerning the efficacy and safety of the food for special medical purposes and that he has expressed his views on any relevant information that might affect the evaluated characteristics of the food for special medical purposes.
Provision of data on the volume of food for special medical purposes placed on the Czech market
(1) The manufacturer or importer of a food for special medical purposes shall provide the Institute with the data referred to in Section 39zi (2) of the Act by electronic notification for the preceding calendar month at the latest by the fifth day of the following calendar month. The manufacturer or importer of a food for special medical purposes shall provide the report even if he has not made any delivery of the food for special medical purposes in the relevant calendar month. If the manufacturer or importer has not launched the supply of food for special medical purposes on the market, he shall not report.
(2) The manufacturer or importer of a food for special medical purposes shall provide the report referred to in paragraph 1 through the Institute's communication interface accessible in a way that allows remote access in an open data format. Access data and unique identifier of the manufacturer or importer of the food for special medical purposes shall be assigned by the Institute to the manufacturer or importer of the food for special medical purposes upon request.
(3) Where the manufacturer or importer of a food for special medical purposes finds that it has entered incomplete or incorrect information in the report, he shall immediately send a correction to the Institute.
(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 manufacturer or importer of the food 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) information on whether food for special medical purposes has been delivered to a pharmacy, a health care facility, a person authorised to distribute medicinal products under the Drug Act or to another person;
(f) the food code for special medical purposes allocated by the Institute;
(g) the number of packages of food for special medical purposes. "
Efficacy
This Decree shall take effect on 1 January 2026.
Minister:
Prof. MUDr. Válek, CSc., MBA, EBIR, v. r.
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Regulation Information
| Citation | Decree No. 371 / 2025 Coll., amending Decree No. 376 / 2011 Coll., implementing certain provisions of the Act on Public Health Insurance, as amended |
|---|---|
| Regulation Type | Order |
| Author | - |
| Collection | Code of Laws |
| Date of Promulgation | 02.10.2025 |
|---|---|
| Effective from | 01.01.2026 |
| Effective until | - |
| Status | Valid |
The regulation text is for informational purposes only.
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