Act No. 456 / 2023 Coll.
Act amending Act No. 378 / 2007 Coll., on Medicines and on Amendments to Certain Related Acts (Law on Medicines), as amended, and Act No. 48 / 1997 Coll., on Public Health Insurance and on Amendment and Addition of Certain Related Acts, as amended
Valid
Law
Effective from 01.01.2024
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456
THE LAW
of 20 December 2023
amending Act No. 378 / 2007 Coll., on Medicines and on Amendments to Certain Related Acts (Law on Medicines), as amended, and Act No. 48 / 1997 Coll., on Public Health Insurance, and amending and supplementing certain Related Acts, as amended
Parliament has decided on this law of the Czech Republic:
Amendment to the Drug Act
Act No. 378 / 2007 Coll., Act No. 141 / 2009 Coll., Act No. 281 / 2009 Coll., Act No. 291 / 2009 Coll., Act No. 75 / 2011 Coll., Act No. 375 / 2011 Coll., Act No. 50 / 2013 Coll., Act No. 70 / 2013 Coll., Act No. 250 / 2014 Coll., Act No. 251 / 2017 Coll., Act No. 80 / 2015 Coll., Act No. 44 / 2019 Coll., Act No. 65 / 2017 Coll., Act No. 66 / 2017 Coll., Act No. 183 / 2017 Coll.
1. In Article 11, at the end of point (s), the dot is replaced by a comma and the following points (t) to (v) are added:
"(t) issue measures of a general nature in accordance with § 77e (2) to include the medicinal product for human use in the system of reserve stocks,
(u) issue measures of a general nature pursuant to Article 77g (1) imposing an obligation to release stocks of a medicinal product for human use included in the reserve supply system for distribution to operators authorised to supply pursuant to Article 82 (2);
(v) issue measures of a general nature in accordance with Article 112c, which may, in the event of a threat to the availability of a medicinal product relevant to the provision of health services, adjust the conditions for its distribution, prescription and supply. ';
2. In Paragraph 13, at the end of paragraph 2, the dot is replaced by a comma and the following point (q) is added:
"(q) issues general measures in accordance with § 33c, by which the medicinal product for human use shall be labelled as" restricted availability "under § 33b (2) or (3)."
3. in Paragraph 13 (3) (q):
"(q) on the basis of a request from the Ministry of Health, it shall transmit or make available to it the data necessary for the issue of general measures under Articles 77c to 77e and 77g,"
4. In Article 13, at the end of paragraph 3, the dot is replaced by a comma and the following point (t) is added:
"(t) to distributors for each distribution warehouse, manufacturers for each manufacturing site and each warehouse, marketing authorisation holders, transfusion service facilities, providers of medical services providing medical care for each pharmacy, and each separate department for dispensing medicinal products and medical devices, the workplace identification code.";
5. In the first sentence of Article 33 (2), the word "electronic 'shall be inserted after the words" the marketing authorisation holder', the words "including the reasons for such interruption or termination ', the sentence" Part of the notice of interruption or termination of the marketing of a medicinal product for human use in the Czech Republic' shall be inserted after the words "the information on the reason for such interruption or termination ', as well as information on the actual quantity of medicinal product for human use available to the marketing authorisation holder on the date of notification and intended for the marketing of the medicinal product for human use in the Czech Republic', and, in the sentence of the sixth sentence, the words" information on the volume of medicinal product for use for sale of the medicinal product for human use for the marketing in the Czech Republic, where it is suspected of a danger of availability of the medicinal product for sale, ';
6. in Paragraph 33 (3) (g) (4):
"4. publish, through the publicly available technical information service referred to in point 1, a list indicating the distributor or distributors providing the distribution of a medicinal product for human use, marked" limited availability "in accordance with Section 33b on the market in the Czech Republic,"
7. The following Sections 33a to 33c are inserted after Section 33, including the title:
(1) The marketing authorisation holder is required to provide, for the needs of patients in the Czech Republic, a medicinal product for human use which has a fixed remuneration from public health insurance or a maximum price, with the exception of a medicinal product for human use as referred to in paragraph 4, so that, after the notified date of interruption or termination of supplies as referred to in paragraph 2 of Article 33, it provides, without undue delay, to the market in the Czech Republic, such medicinal product for human use or any other medicinal product which has a fixed remuneration from public health insurance or a maximum price and which may replace it, taking into account of the dosage, at least:
(a) twice the average monthly supply of the medicinal product for which interruption or termination of supplies has been notified pursuant to Article 33 (2); or
(b) the average monthly supply of the medicinal product for which the interruption or termination of supplies has been notified pursuant to Article 33 (2), where, in the last 2 years before that notification, the marketing authorisation holder has marketed the medicinal product for human use in the Czech Republic without interruption of supply, or where such interruption of supply has lasted for a maximum of 20 days in its total over the last 2 years.
(2) The average monthly supply of a medicinal product for human use referred to in paragraph 1 shall be one twelfth of the sum of the supply volume data reported in accordance with § 33 (2) fifth sentence of the preceding 12 consecutive calendar months in which the medicinal product has not been labelled as "restricted availability 'under § 33b (2) or (3).
(3) The marketing authorisation holder may not fulfil the obligation under paragraph 1 for a period of 12 months from the date of placing on the market of the medicinal product for human use in the Czech Republic. The marketing authorisation holder may also fulfil the obligation referred to in paragraph 1 by supplying a medicinal product whose labelling and package leaflet are not in the Czech language, provided that the Institute allows such delivery under Paragraph 38 of this Law. Where the Institute rejects an application pursuant to Paragraph 38 to allow the placing on the market of a medicinal product the labelling and package leaflet of which is not in the Czech language, even if the marketing authorisation holder has offered to affix a label to such a medicinal product with the Czech name of the medicinal product and the Czech package leaflet externally attached to the outer packaging of that medicinal product, the marketing authorisation holder may not fulfil the obligation referred to in paragraph 1 in the quantity indicated in the application.
(4) The Ministry shall, on the basis of the data obtained from its official activities, continuously evaluate which medicinal products for human use are not required under paragraph 1. Human medicinal products as referred to in the first sentence shall be provided for in implementing legislation.
Labelling of a medicinal product for human use by the indication "restricted accessibility"
(1) Without undue delay upon receipt of a notice of interruption or termination of the placing on the market of a medicinal product for human use pursuant to Article 33 (2) The Institute shall publish this information on its website, together with the date on which the interruption or termination of the marketing of the medicinal product for human use is reported to occur and whether the medicinal product for human use is substitutable to another medicinal product for human use and for which.
(2) The Institute shall evaluate the information provided by the marketing authorisation holder and other information collected by it on the quantity of the medicinal product for human use, which has a fixed remuneration from public health insurance or the maximum price and for which interruption or termination of marketing has been announced, with the exception of the medicinal product for human use referred to in § 33a (4), on the market in the Czech Republic. If, following the evaluation of the information referred to in the first sentence, the Institute concludes that the actual amount of the medicinal product for human use does not adequately cover the needs of patients in the Czech Republic, and at the same time this need cannot be replaced in an appropriate amount by another medicinal product for human use of the corresponding therapeutic properties, it shall, for the very necessary period, indicate the indication "limited availability '.
(3) The "restricted availability" of the Institute will also indicate for an essential period the medicinal product for human use corresponding to the therapeutic properties, which is replaced by a medicinal product for human use for which an interruption of marketing has been notified in accordance with Article 33 (2).
(4) The marketing authorisation holder of a medicinal product for human use, bearing the indication "restricted availability 'referred to in paragraph 2, shall, within 30 days of the date of the designation, complete the notification of the interruption of the placing on the market of the medicinal product for human use in the Czech Republic pursuant to Article 33 (2) on the information on the action taken to remove the reason for the interruption.
The Institute, for the purposes of the designation of a medicinal product for human use, shall issue a measure of a general nature with the indication "restricted availability 'referred to in Article 33b (2) or (3), without a procedure for its proposal. A measure of a general nature as referred to in the first sentence shall take effect on the date specified therein and be notified in a way that allows remote access. The Institute of General Measures, issued in accordance with the first sentence, shall, without prejudice to the grounds for its issue, abolish by analogy, in accordance with the procedure laid down in the first and second sentences.';
8. In Paragraph 38, the first sentence is added, "including to the extent that a medicinal product is not subject to a prescription or a medicinal product which may be issued without a prescription with a restriction, if the marketing authorisation holder so requests'.
9. In Article 77 (1) (f), the words "in the case of a provider of medical services providing medical care, a distributor and a transfusal service," and the words "also a price indication," shall be inserted after the word "distributed"; the words "the distributor shall provide electronically the quantity of the medicinal product in question, which is indicated as" restricted availability, "as referred to in Article 33b, which was available at the end of the preceding day of the indication by this attribute," shall be inserted after the word "distributed"; in case of suspicion, the distributor shall provide electronically information on the quantity of medicinal product for human use placed on the market in the Czech Republic available to him; ';
10. in Paragraph 77 (1) (h), including footnote 125:
"(h) to ensure the supply of medicinal products for human use to operators authorised to issue medicinal products or to military health service providers (125) for patients who are active in the service, at a quantity and intervals corresponding to the needs of patients in the Czech Republic; when ordering medicinal products for human use, a distributor shall not in any way favour a particular operator authorised to issue medicinal products or a military distributor of medicinal products; In addition, in the case of a medicinal product for human use ordered in accordance with § 82 (3) (h) or (l), it shall be required to ensure that it is delivered within 2 working days of the date of receipt of the request, if available, for the requirements of the military health service provider, this shall apply mutatis mutandis;
125) § 3 of Decree No. 156 / 2015 Coll., on the terms of the provision of health services by military providers, the disciplines of outpatient care for which an occupational soldier may exercise the freedom to choose a health service provider, and the conditions for organising the performance of tasks of military faculty hospitals (on the terms of the provision of health services by military providers). "
11. In Paragraph 77, at the end of paragraph 1, the dot is replaced by a comma and the following point (s) is added:
"(s) in the case of a medicinal product for human use, marked" restricted availability, "which was the marketing authorisation holder for the Czech Republic, do not distribute such medicinal product for human use abroad."
12. The following Sections 77e to 77h, including the title and footnote 126, are inserted after Section 77d:
Reserve system
(1) The Ministry of Health, in order to establish a prediction of the need for medicinal products for human use relevant to the provision of health services in the Czech Republic, evaluates information on the indications and use of medicinal products for human use which may affect their availability to patients in the Czech Republic, information on the volume of medicinal products for human use on the market in the Czech Republic, the planned volume and time intervals of supply of medicinal products for human use in the Czech Republic and the volume of medicinal products for human use prescribed, issued and used in the provision of health services. The first Ministry of Health receives information from the Institute, Marketing Authorisation Holders, Distributors and Health Service Providers. In assessing the information referred to in the first sentence, the Ministry of Health shall take into account the interruption in the supply of the medicinal product for human use in the last 2 years and shall take into account the substitutability of the medicinal product for human use to another medicinal product for human use corresponding to the therapeutic properties.
(2) If, after assessing the information referred to in paragraph 1, the Ministry of Health concludes that the planned volume of supplies of medicinal products for human use on the market in the Czech Republic does not correspond to the predicted need for medicinal products for human use referred to in paragraph 1, it shall include the medicinal product for human use in the reserve supply system by measures of a general nature. A general measure shall be issued by the Ministry of Health for a maximum period of 12 months, but may be extended by a maximum of 12 months after evaluation of the information referred to in the first sentence.
(3) In the case of a medicinal product for human use included in the reserve supply system referred to in paragraph 2, the distributor shall immediately establish and maintain a quantity corresponding to the average monthly volume of that medicinal product distributed by him.
(4) The average monthly volume referred to in paragraph 3 shall mean one twelfth of the sum of the data reported under the legislation on the manufacture and distribution of medication126) of the quantity of medicinal products for human use delivered to operators authorised to supply pursuant to Paragraph 82 (2) and the quantity of medicinal products for human use distributed abroad in the last 12 consecutive calendar months.
When issuing measures of a general nature pursuant to Article 77e (2), the time limit for making comments and objections shall be 5 days from the date of publication of the proposal. The draft measure of a general nature referred to in Article 77e (2) shall be served in a manner which allows remote access. A measure of a general nature pursuant to Article 77e (2) shall take effect on the date stated therein and be notified in a manner which allows remote access.
(1) In cases where the volume of a medicinal product for human use included in the reserve supply system no longer covers the current needs of patients in the Czech Republic, the Ministry of Health may, by measures of a general nature, impose an obligation to release the stocks of that medicinal product under § 77e (3) in order to distribute to operators authorised to supply pursuant to § 82 (2).
(2) During the period of validity of the general measures referred to in paragraph 1, the obligation to create and maintain stocks of the medicinal product for human use referred to in Article 77e (3) shall not apply.
A measure of a general nature pursuant to Paragraph 77g (1) shall be issued by the Ministry of Health without a procedure for proposing a measure of a general nature. A measure of a general nature as referred to in the first sentence shall take effect on the date specified therein and be notified in a way that allows remote access. If the reasons for its issue are omitted, the Ministry of Health shall abolish general measures in accordance with the procedure laid down in the first and second sentences by analogy.
126) Decree No. 229 / 2008 Coll., on the production and distribution of medicines, as amended. '
13. in Article 80 (4), the words "a specific pharmacy provider" are replaced by the words "a specific medical care provider"; and the words "choice of pharmacy provider" are replaced by the words "choice of medical care provider."
14. In Paragraph 80 (7), the words "a healthcare provider 'are replaced by the words" a healthcare provider'.
15. in Paragraph 80, the following paragraphs 9 and 10 are added:
"(9) Where a prescriber prescribes a medicinal product for human use on an electronic prescription, which is indicated by the indication" restricted availability 'in accordance with § 33b, the Institute shall transmit to him, via eRecept, the latest information on the quantity of that medicinal product reported under § 82 (3) (d), including the date and time of the last report made, as well as information on which providers of medical services providing medical care have this medicinal product.
(10) The data referred to in paragraph 9 shall also be made available by the Institute to a patient to whom a medicinal product for human use has been prescribed for an electronic prescription by means of a web or mobile application for patients under Paragraph 81 (1) (f). ';
16. In Paragraph 81, at the end of paragraph 3, the dot is replaced by a comma and the following point (p) is added:
"(p) access for healthcare providers providing medical care to the electronic prescription inspection service according to § 81fc."
17. in Article 81 (4) (b), the words "the provider of medical care" shall be replaced by the words "the provider of medical care services."
18. in Article 81a (1), the sentence "The provider of medical care services approaches the eRecept system when using the service provided by § 81fc is inserted after the second sentence by means of a department certificate."
19. in Article 81d (2), the words "identity card or passport" shall be replaced by the words "patient identification document or his legal representative."
20. in Article 81d (3) (d), the words "the provider of medical care" are replaced by the words "the provider of medical care services."
21. Paragraph 81d (9) reads:
"(9) The eRecept system shall allow for consultation in accordance with paragraphs 6 to 8 by means of a pharmaceutical record on the patient's data referred to in paragraph 3 for a period of 5 years from the creation of such data. ';
22. The following Section 81fc is inserted after Section 81fb, which includes the title:
Electronic recipe view service
(1) In order to inform the patient about the availability of a particular patient of a prescribed medicinal product, a health service provider providing medical care may use an electronic prescription provided by the Institute through the eRecept system.
(2) The electronic recipe consultation service, based on the electronic recipe identifier, makes information about:
(a) the name of the medicinal product for human use prescribed on the electronic recipe;
(b) the number of packages of the medicinal product for human use prescribed on the electronic recipe; and
(c) the period of validity of the electronic recipe. ';
23. In Article 82 (3) (d), the words "and, in the case of a provider of medical services providing medical care and transfusions services, the identification code of the workplace" and the words "public health insurance" shall be inserted after the words "the Institute shall provide electronically the information on the quantity of the medicinal product for human use, marked" limited availability "in accordance with Article 33b, which they had at the end of the day preceding the date of the designation with this flag, and shall also provide electronically the information on the quantity of the medicinal product for human use available to them at regular intervals; in the event of a suspicion by the Institute of a threat to the availability of a medicinal product for human use at the request of the Institute, published in a way that allows remote access on its website, provide it electronically with information on the quantity of medicinal product for human use at their disposal; ';
24. in § 82 (3) (h):
"(h) in the case of a medicinal product which is marked with a" limited availability "in accordance with Paragraph 33b, it shall be ordered so that the quantity of such medicinal product in the pharmacy does not exceed the quantity corresponding to the normal number of packages issued per calendar week in the last 12 calendar months and shall be used solely for dispensing to patients or health service providers; where no packaging of such labelled medicinal product has been supplied by the pharmacy operator in the last 12 calendar months, he may order only the quantity indicated on the applicable prescription submitted in the pharmacy, '.
25. In Paragraph 82, at the end of paragraph 3, the dot is replaced by a comma and the following point (l) is added:
"(l) if a pharmacy operator who issues medicinal products for human use to providers of health services providing bed care (9) is required, in the case of a medicinal product for human use which is marked with a" restricted availability "in accordance with § 33b (2), to order it for the purpose of dispensing to health care providers providing bed care in such a way that the quantity of such medicinal product for human use or replacing a medicinal product for human use referred to in § 33b (3) in a given pharmacy does not exceed the amount corresponding to the sum of the normal number of packages of a medicinal product for human use referred to in the" restricted availability "under § 33b (2) and the replacement medicinal product for human medicinal product referred to health service providers providing bed care for 2 calendar weeks in the last 12 calendar months; where the pharmacy operator has not supplied any packaging of such labelled medicinal product in the last 12 calendar months, the pharmacy operator may order only the amount needed for the treatment of the currently hospitalised patient. ';
26. In Paragraph 82 (4), the words "bed care providers, bed care providers' shall be replaced by the words" health care providers, bed care providers' and the words "pharmacy care 'shall be replaced by" pharmacy care'.
27. In Paragraph 82, the following paragraph 8 is added:
"(8) The Institute shall make available to the provider of medical services providing medical care in a way that allows remote access to the current data on the quantity of the medicinal product for human use, marked" restricted availability "in accordance with § 33b, provided under § 77 (1) (f), including the date and time of the last report made, as well as information on which distributors have the medicinal product for human use. '
28. in Article 83 (2) and (3):
"(2) If the prescribing physician indicates on the prescription that he insists on the issue of the prescribed medicinal product for human use, only the medicinal product may be issued by the operator authorised to issue the medicinal product under Paragraph 82 (2). If a medicinal product is prescribed by an international non-proprietary name of the active substance, the operator shall inform the patient of the appropriate medicinal products with the prescribed route of administration and the pharmaceutical form at his disposal. In other cases, it informs the patient of possible alternatives to the prescribed medicinal product and, with its consent, is entitled to replace the prescribed medicinal product with such a medicinal product which is consistent with its efficacy and safety and contains the active substance with the same international non-proprietary name, the same route of administration and the same pharmaceutical form. The implementing legislation lays down the conditions for the issue and the method of recording the substitution of the medicinal product.
(3) If the medicinal product prescribed by the physician is not available and the immediate release of the medicinal product is necessary, and it cannot be followed in accordance with paragraph 2, it shall issue a replacement medicinal product corresponding to the therapeutic properties at its disposal. The implementing act shall lay down the conditions for the supply of the replacement medicinal product, the extent of the replacement of the prescribed medicinal product and the method of recording the refund. ';
29. in Paragraph 99 (2) (b), "fourth" is replaced by "fifth."
30. in Article 99 (2) (i), the words "including their warehouses," shall be deleted after the words "distributor's identification number," the words "addresses and workplace identification code of each distribution warehouse allocated by the Institute," and at the end of the text the words "and" shall be replaced by a comma. "
31. in Article 99 (2) (j), the words "and separate departments for the supply of medicinal products and medical devices" and the words "operator identification number," shall be inserted after the words "workplace identification code allocated by the Institute,";
32. In Paragraph 99, at the end of paragraph 2, the dot is replaced by "a 'and the following point (k) is added:
"(k) the list of medicinal products for human use, marked" restricted availability, "including the indication of the date of designation in the current version."
33. In Paragraph 99, paragraphs 12 to 14 are added:
"(12) The Institute provides the Ministry of Health and does not provide other persons with data
(a) notified pursuant to Article 33 (2) on the quantity of medicinal product for human use which was the marketing authorisation holder in the Czech Republic and which was available to the marketing authorisation holder at the time of the notification of the interruption or termination of the marketing of the medicinal product for human use in the Czech Republic;
(b) granted at the request of the Institute pursuant to § 33 (2)
1. the planned volume and time intervals of supply of medicinal products for human use on the market in the Czech Republic; or
2. the quantity of medicinal product for human use which is the marketing authorisation holder for the market in the Czech Republic, which is available to him,
(c) provided under Paragraph 77 (1) (f) concerning the quantity of medicinal product for human use
1. marked with the "restricted availability" flag in accordance with § 33b;
2. placed on the market in the Czech Republic, which it has at its disposal, at the request of the Constitution,
(d) provided under Paragraph 82 (3) (d) concerning the quantity of medicinal product for human use
1. marked with the "restricted availability" flag in accordance with § 33b;
2. placed on the market in the Czech Republic, which it has at its disposal, at the request of the Constitution.
The Ministry of Health shall not provide data obtained under points (a) to (d) to other persons.
(13) In the event of a state of threat to the State or to the state of war, the Department of Defence shall, at its request, provide all information concerning the availability of medicinal products for human use at its disposal.
(14) Prohibition of the provision of information under paragraph
(a) 12 (c) shall not apply to the transmission of data pursuant to Paragraph 82 (8);
(b) 12 (d) shall not apply to the transmission of data pursuant to Paragraph 80 (9) and (10). ';
34. in Paragraph 103 (2):
"(2) The legal or commercial natural person referred to in Article 24 (1) shall commit an offence by:
(a) imports, exports or distributes a human transfusion product or raw material for further production without the consent given in accordance with Article 24 (4);
(b) it imports, exports or distributes a human transfusion product or raw material for further production, contrary to the conditions of the consent given pursuant to Article 24 (4);
(c) it shall not inform the third country of imports or of exports to or distribution to another Member State pursuant to Article 24 (8). ";
35. In Paragraph 103, at the end of paragraph 9, the dot is replaced by a comma and the following points (g) to (i) are added:
"(g) in contravention of Article 82 (3) (d), does not provide data on the quantity of a medicinal product for human use, marked" restricted availability "as referred to in Article 33b, which was available at the end of the day preceding the date of the labelling with this flag, or does not provide data on such medicinal product for human use within a specified periodic interval;
(h) in contravention of Paragraph 82 (3) (d), does not provide, at the request of the Institute, information on the quantity of medicinal product for human use available at the time of publication of the call; or
(i) prescribe or issue a medicinal product for human use in contravention of a general measure as referred to in Article 112c (1). ';
36. in Article 103 (10) (e), the words "bed care provider" shall be replaced by the words "bed care provider";
37.In Paragraph 103 (10) (g), "4" is replaced by "5."
38. in Paragraph 103 (10), the word "or" shall be deleted at the end of point (h).
39. In Article 103, at the end of paragraph 10, the dot is replaced by "or 'and the following point (j) is added:
"(j) order a medicinal product for human use marked" restricted availability "in contravention of the quantitative limit laid down in Article 82 (3) (h) or (l)."
40. In Paragraph 105 (2), the word "or 'shall be deleted at the end of point (r).
41. In Paragraph 105, at the end of paragraph 2, the dot is replaced by a comma and the following points (t) to (w) are added:
"(t) in contravention of § 77 (1) (s), distributes a medicinal product for human use, marked" restricted availability "abroad,
(u) in contravention of § 77e (3), does not create or maintain a supply of a medicinal product for human use included in the reserve supply system;
(v) in contravention of a measure of a general nature issued pursuant to Paragraph 77g (1), they shall not release a medicinal product for human use included in the reserve supply system for distribution to operators authorised to supply pursuant to Section 82 (2); or
(w) distributes the medicinal product for human use in contravention of a general measure as referred to in Article 112c (1). "
42. In Article 105 (5) (c), the word "third 'is replaced by the word" fourth' and the words "or, at the end of the text, the notification of the interruption of the placing on the market of a medicinal product for human use in the Czech Republic pursuant to Article 33b (4) 'are added.
43. In Paragraph 105 (5) (d), the words "fourth and fifth" are replaced by the words "fifth and sixth."
44. in Article 105 (5) (j), the words "point 4" are replaced by the words "section 33a (1)."
45. in Article 107 (1) (c), "§ 103 (9) (a), (b), (c) or (e)" shall be replaced by "§ 103 (9) (a), (b), (c), (e), (g), (h) or (i)" and "§ 103 (10) (a), (b), (d), (f), (i) or (j)" shall be replaced by "§ 103 (10) (a), (b), (d), (f), (i) or (j)."
46. in Article 107 (1) (d), "or (p)" shall be replaced by "(p), (u), (v) or (w)";
47. in Article 107 (1) (e), "to (s)" is replaced by "(r), (s) or (t)."
48. in Paragraph 111a (1) (a), the words "war or emergency" are replaced by the words "emergency, state of danger or state of war."
49. After Paragraph 112b, the following Sections 112c and 112d are inserted:
Specific procedures to ensure the availability of a medicinal product for human use relevant to the provision of health services
(1) The Ministry of Health may temporarily adjust the conditions for the distribution, prescription or supply of a medicinal product of general nature when it threatens the availability of a medicinal product of human importance for the provision of health services.
(2) The general measure referred to in paragraph 1 shall be issued by the Ministry of Health. In preparing this measure, the Ministry of Health shall request information from the Institute on the availability of the medicinal product for human use and on the possibilities for adjusting the conditions of distribution, prescription or dispensing of such medicinal product, including the duration of such restriction. The Institute shall provide the information referred to in the first sentence to the Ministry of Health without delay.
(3) A measure of a general nature as referred to in paragraph 1 shall be issued by the Ministry of Health without a procedure for proposing a measure of a general nature and shall take effect on the date stated therein and shall be notified in a manner which allows remote access. If the reasons for its issue are omitted, the Ministry of Health shall abolish general measures in accordance with the procedure laid down in the first and second sentences by analogy.
(1) The Ministry of Health may, in order to ensure the availability of a medicinal product for human use relevant to the provision of health services and on the basis of information on the availability of such a medicinal product on the market in the Czech Republic, issue a decision imposing on the health insurance undertaking the payment of a medicinal product for human use of such medicinal products which is replaced by a medicinal product for human use which has been labelled as "restricted availability" in accordance with § 33b and for which a decision has been given pursuant to § 8 (6) or a consent pursuant to § 49 (3).
(2) The decision referred to in paragraph 1 shall include, in particular:
(a) the name of the medicinal product,
(b) the supplement to the name,
(c) the code of the Institute, if assigned to the medicinal product,
(d) identification details of the marketing authorisation holder or manufacturer,
(e) identification of the distributor of the medicinal product,
(f) the amount of the payment for packing;
(g) the number of packages,
(h) the aliquot of the total amount of remuneration calculated in accordance with points (f) and (g) per health insurance undertaking; the aliquot share is the share of insured persons in the total of all insured persons in the Czech Republic on 1 January of the calendar year in which the decision is given.
(3) Public health insurance undertakings are a party to the proceedings.
(4) No decomposition may be brought against the decision referred to in paragraph 1. ';
50. in Article 114 (1), the text "Article 33a (4)" and the text "Article 53 (8)" shall be inserted after the text "Article 33 (2)";
51. in § 114 (2), the text "§ 53 (8)" is inserted after the text "§ 49b (2)."
Transitional provisions
1. Paragraph 33a (2) of Act No. 378 / 2007 Coll., as effective from the date of entry into force of this Act, from the first day of the sixth calendar month until the end of the 12th calendar month following the date of entry into force of this Act, and the average monthly delivery for that period shall be deemed to be, for the purposes of Article 33a (1) of the Act No. 378 / 2007 Coll., as effective from the date of entry into force of the Act, one-fourteenth of the figures on the volume of supplies reported pursuant to § 33 (2) of the fifth sentence of Act No. 378 / 2007 Coll., as effective from the date of entry into force of the Act.
2. Paragraph 33a (1) shall apply only to the notification of the interruption or termination of the placing on the market of a medicinal product for human use in the Czech Republic, which was made after the entry into force of this Act.
Amendment to the Public Health Insurance Act
Act No. 1 / 2006, Act No. 1 / 2006, Act No. 5 / 2006, Act No. 5 / 2006, Act No. 5 / 2006, Act No. 5 / 2006, Act No. 5 / 2006, Act No. 5 / 2006, Act No. 5 / 2006, Act No. 5 / 2006, Act No. 5 / 2006, Act No. 5 / 2006, Act No. 5 / 2006, Act No. 5 / 2006, Act No. 5 / 2006, Act No. 5 / 2006, Act No. 5 / 2006, Act No. 5 / 2006, Act No. 5 / 2006, Act No. 5 / 2006, Act No. 5 / 2006, Act No. 6 / 2006, Act No. 5 / 2006, Act No. 5 / 2006, Act No. 5 / 2006, Act No. 5 / 2006, Act No. 5 / 2006, Act No. 5 / 2006, Act No. 5, Act No. 5 / 2006, Act No. 5 / 2006, Act No. 5, Act No. 5, Act No. 5, Act No. 2006, Act No 2006, No 2006, No 2006, No 2006, No 2006, No 2006, No 2006, No 2006, No 2006, No 2006, No 2006, No 2006, No 2006, No 2006, No 2006, No 2006, No 2006, No 2006, No Act No. 47 / 2016 Coll., Act No. 66 / 2017 Coll., Act No. 150 / 2017 Coll., Act No. 183 / 2017 Coll., Act No. 200 / 2017 Coll., Act No. 111 / 2019 Coll., Act No. 262 / 2019 Coll., Act No. 314 / 2017 Coll., Act No. 166 / 2018 Coll., Act No. 165 / 2020 Coll., Act No. 205 / 2020 Coll., Act No. 538 / 2020 Coll., Act No. 221 / 2022 Coll., Act No. 322 / 2019 Coll., Act No. 261 / 2021 Coll.
1. In Article 15 (5), the words "or according to Article 32d 'shall be inserted after the words" (§ 39h)'.
2. In Article 17, at the end of paragraph 7, the dot is replaced by a comma and the following point (h) is added:
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Regulation Information
| Citation | Act No. 456 / 2023 Coll., amending Act No. 378 / 2007 Coll., on Medicines and on Amendments to Certain Related Acts (Law on Medicines), as amended, and Act No. 48 / 1997 Coll., on Public Health Insurance and on the Amendment and Addition of Certain Related Acts, as amended |
|---|---|
| Regulation Type | Law |
| Author | - |
| Collection | Code of Laws |
| Date of Promulgation | 29.12.2023 |
|---|---|
| Effective from | 01.01.2024 |
| Effective until | - |
| Status | Valid |
Parliamentary Paper:
Paper No. 476
Public Contracts 3
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